Ibuprofen (Lexi-Drugs)

ALERT: US Boxed Warning
  Serious cardiovascular thrombotic events (excluding NeoProfen):
  Serious gastrointestinal bleeding, ulcerations, and perforation (excluding NeoProfen):
Pronunciation

(eye byoo PROE fen)

Brand Names: US

Addaprin [OTC]; Advil Junior Strength [OTC]; Advil Migraine [OTC]; Advil [OTC]; Caldolor; Childrens Advil [OTC]; Childrens Motrin [OTC]; Dyspel [OTC]; Genpril [OTC]; GoodSense Ibuprofen Childrens [OTC]; GoodSense Ibuprofen [OTC]; I-Prin [OTC] [DSC]; IBU; IBU-200 [OTC]; Ibuprofen Childrens [OTC]; Ibuprofen Comfort Pac [DSC]; Infants Advil [OTC]; KS Ibuprofen [OTC]; Motrin IB [OTC]; Motrin Infants Drops [OTC]; NeoProfen; Provil [OTC]

Brand Names: Canada

APO-Ibuprofen FC; Caldolor; PMS-Ibuprofen; TEVA-Profen

Dosing: Adult

Analgesia (mild to moderate pain):

Oral:

200 to 800 mg 3 to 4 times daily; usual dose: 400 mg; usual daily dose: 1,200 to 2,400 mg/day (Becker 2010; Blondell 2013; Derry 2009; Roelofs 2008); maximum: 3,200 mg/day (Blondell 2013; Derry 2009)

American Pain Society: 200 to 400 mg every 4 to 6 hours; maximum: 3,200 mg/day (APS 2016)

Manufacturer’s labeling: Dosing in the prescribing information may not reflect current clinical practice. 400 mg every 4 to 6 hours as needed; maximum: 3,200 mg/day

IV (Caldolor): 400 to 800 mg every 6 hours as needed (maximum: 3,200 mg/day). Note: Patients should be well hydrated prior to administration.

Antipyretic: IV (Caldolor): Note: Patients should be well hydrated prior to administration. Initial: 400 mg, then every 4 to 6 hours or 100 to 200 mg every 4 hours as needed (maximum: 3,200 mg/day)

Dysmenorrhea: Oral:

200 to 800 mg three to four times daily; usual daily dose: 1,200 to 2,400 mg/day; most sources did not exceed a daily dose of 2,400 mg/day and a maximum duration of 3 to 5 days (Majoribanks 2010).

Manufacturer’s labeling: Dosing in the prescribing information may not reflect current clinical practice. 400 mg every 4 hours as needed; maximum: 3,200 mg/day

Gout, acute flares (alternative agent) (off-label use): Oral: 800 mg three times daily; initiate within 24 to 48 hours of flare onset preferably; discontinue 2 to 3 days after resolution of clinical signs; usual duration: 5 to 7 days (ACR [Khanna 2012]; Becker 2018)

Osteoarthritis: Oral: 400 to 800 mg 3 to 4 times daily (maximum: 3,200 mg/day)

Rheumatoid arthritis: Oral: 400 to 800 mg 3 to 4 times daily (maximum: 3,200 mg/day)

OTC labeling:

Analgesic, antipyretic: Oral: 200 mg every 4 to 6 hours as needed; if no relief may increase to 400 mg every 4 to 6 hours as needed (maximum: 1,200 mg/day); Duration: treatment for >10 days as an analgesic or >3 days as an antipyretic is not recommended unless directed by health care provider.

Migraine: Oral: 400 mg at onset of symptoms (maximum: 400 mg/24 hours unless directed by health care provider)

Pericarditis (off-label use): Oral: Note: Administer in combination with colchicine therapy. Concurrent gastroduodenal prophylaxis with a proton pump inhibitor has been used and is recommended (ESC [Adler 2015]; Imazio 2013; Imazio 2005). With pericarditis postmyocardial infarction, the ACCF/AHA prefers the use of aspirin (ACCF/AHA [O’Gara 2013]).

Acute pericarditis: 600 mg every 8 hours for 7 to 14 days followed by a gradual tapering of the dose by 200 to 400 mg every 1 to 2 weeks (ESC [Adler 2015])

Recurrent pericarditis: 600 mg every 8 hours (range: 1,200 to 2,400 mg) for weeks to months until complete symptom resolution followed by a gradual tapering of the dose by 200 to 400 mg every 1 to 2 weeks (ESC [Adler 2015])

Dosing: Geriatric

Refer to adult dosing. Use with caution; consider reduced initial dosage.

Dosing: Renal Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling; use with caution; avoid use in advanced renal disease.

KDIGO 2012 guidelines provide the following recommendations for NSAIDs:

eGFR 30 to <60 mL/minute/1.73 m2: Avoid use in patients with intercurrent disease that increases risk of acute kidney injury.

eGFR <30 mL/minute/1.73 m2: Avoid use.

Hemodialysis: Not dialyzable (NCS/SCCM [Frontera 2016])

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling; use caution and discontinue if hepatic function worsens.

Dosing: Pediatric

Note: To reduce the risk of adverse cardiovascular and GI effects, use the lowest effective dose for the shortest period of time to achieve treatment goals. Oral liquid products are available in two concentrations (ie, concentrated infant drops: 50 mg/1.25 mL and suspension: 100 mg/5 mL); precautions should be taken to verify and avoid confusion between the different concentrations; dose should be clearly presented as “mg”.

Analgesic:

IV: Ibuprofen injection (Caldolor): Note: Patients should be well hydrated prior to administration.

Infants 6 months to Children <12 years: 10 mg/kg/dose (maximum dose: 400 mg/dose) every 4 to 6 hours as needed; maximum daily dose: 40 mg/kg/day or 2,400 mg/day, whichever is less

Children and Adolescents 12 to 17 years: 400 mg every 4 to 6 hours as needed; maximum daily dose: 2,400 mg/day

Oral:

Weight-directed dosing: Infants and Children <50 kg: Limited data available in infants <6 months: 4 to 10 mg/kg/dose every 6 to 8 hours; maximum single dose: 400 mg; maximum daily dose: 40 mg/kg/day (APS 2008; Berde 1990; Berde 2002; Kliegman 2011)

Fixed dosing:

Infants and Children 6 months to 11 years: See table based upon manufacturer’s labeling; use of weight to select dose is preferred; if weight is not available, then use age; doses may be repeated every 6 to 8 hours; maximum: 4 doses/day; treatment of sore throat for >2 days or use in infants and children <3 years of age with sore throat is not recommended, unless directed by health care provider.

Ibuprofen Dosing
Weight (preferred)A Age Dosage

(mg)

kg lbs
5.4 to 8.1 12 to 17 6 to 11 months 50
8.2 to 10.8 18 to 23 12 to 23 months 75
10.9 to 16.3 24 to 35 2 to 3 years 100
16.4 to 21.7 36 to 47 4 to 5 years 150
21.8 to 27.2 48 to 59 6 to 8 years 200
27.3 to 32.6 60 to 71 9 to 10 years 250
32.7 to 43.2 72 to 95 11 years 300
AManufacturer’s recommendations are based on weight in pounds (OTC labeling); weight in kg listed here is derived from pounds and rounded; kg weight listed also is adjusted to allow for continuous weight ranges in kg.

Children ≥12 years and Adolescents: Oral: 200 mg every 4 to 6 hours as needed; if pain does not respond may increase to 400 mg; maximum daily dose: 1,200 mg/day; treatment of pain for >10 days is not recommended, unless directed by health care provider

Antipyretic:

IV: Ibuprofen injection (Caldolor): Note: Patients should be well hydrated prior to administration.

Infants 6 months to Children <12 years: 10 mg/kg/dose (maximum dose: 400 mg/dose) every 4 to 6 hours as needed; maximum daily dose: 40 mg/kg/day or 2,400 mg/day, whichever is less

Children and Adolescents 12 to 17 years: 400 mg every 4 to 6 hours as needed; maximum daily dose: 2,400 mg/day

Oral:

Weight-directed dosing: Infants ≥6 months, Children, and Adolescents: 5 to 10 mg/kg/dose every 6 to 8 hours; maximum single dose: 400 mg; maximum daily dose: 40 mg/kg/day up to 1,200 mg, unless directed by physician; under physician supervision daily doses ≤2,400 mg may be used (Kliegman 2011; Litalien 2001; Sullivan 2011)

Fixed dosing:

Infants and Children 6 months to 11 years: Oral: See table based upon manufacturer’s labeling; use of weight to select dose is preferred; if weight is not available, then use age; doses may be repeated every 6 to 8 hours; maximum: 4 doses/day; treatment for >3 days is not recommended unless directed by health care provider

Weight (preferred)A Age Dosage

(mg)

kg lbs
5.4 to 8.1 12 to 17 6 to 11 months 50
8.2 to 10.8 18 to 23 12 to 23 months 75
10.9 to 16.3 24 to 35 2 to 3 years 100
16.4 to 21.7 36 to 47 4 to 5 years 150
21.8 to 27.2 48 to 59 6 to 8 years 200
27.3 to 32.6 60 to 71 9 to 10 years 250
32.7 to 43.2 72 to 95 11 years 300
AManufacturer’s recommendations are based on weight in pounds (OTC labeling); weight in kg listed here is derived from pounds and rounded; kg weight listed also is adjusted to allow for continuous weight ranges in kg.

Children ≥12 years and Adolescents: Oral: 200 mg every 4 to 6 hours as needed; if fever does not respond may increase to 400 mg; maximum daily dose: 1,200 mg/day; treatment of fever >3 days is not recommended, unless directed by health care provider

Cystic fibrosis, mild disease (to slow lung disease progression): Limited data available: Children and Adolescents 6 to 17 years with FEV1 >60% predicted (Mogayzel 2013): Oral: Initial: 20 to 30 mg/kg/dose twice daily; titrate to achieve peak plasma concentrations of 50 to 100 mcg/mL; should not eat or take pancreatic enzymes for 2 hours after the ibuprofen dose. Dosing based on a study of 41 patients (ages: 5 to 39 years); mean required dose: ~25 mg/kg/dose twice daily, reported range: 16.2 to 31.6 mg/kg/dose every 12 hours required to achieve target concentration; results showed that chronic ibuprofen use (over 4 years) slowed the rate of decline in FEV1; patients 5 to 13 years old with mild lung disease were observed to have greatest benefit; (Konstan 1995). A follow up observational study (n=1,365; ages: 6 to 17 years) under noncontrolled conditions (real world) showed significant improvement in the rate of decline of lung disease progression with chronic ibuprofen therapy (Konstan 2007). Note: Timing of blood sampling postdose is based on dosage form: Oral suspension: Obtain blood samples at 30, 45, and 60 minutes postdose; tablets: Obtain blood samples at 1, 2, and 3 hours postdose (Litalien 2001; Scott 1999).

Juvenile idiopathic arthritis (JIA): Children and Adolescents: Usual range: 30 to 40 mg/kg/day in 3 to 4 divided doses; start at lower end of dosing range and titrate; patients with milder disease may be treated with 20 mg/kg/day; patients with more severe disease may require up to 50 mg/kg/day; maximum single dose: 800 mg; maximum daily dose: 2,400 mg/day (Giannini 1990; Kliegman 2011; Litalien 2001)

Dosing: Renal Impairment: Pediatric

Infants, Children, and Adolescents: Oral, IV (Caldolor): There are no dosage adjustments provided in the manufacturer’s labeling; avoid use in advanced disease.

KDIGO 2012 guidelines provide the following recommendations for NSAIDs (KDIGO 2013):

eGFR 30 to <60 mL/minute/1.73 m2: Avoid use in patients with intercurrent disease that increases risk of acute kidney injury

eGFR <30 mL/minute/1.73 m2: Avoid use

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer’s labeling; use caution and discontinue if hepatic function worsens.

Use: Labeled Indications

Oral: Inflammatory diseases and rheumatoid disorders, mild to moderate pain, fever, dysmenorrhea, osteoarthritis

Ibuprofen injection (Caldolor): Management of mild to moderate pain and management of moderate to severe pain as an adjunct to opioid analgesics in adults and children 6 months and older; reduction of fever in adults and children 6 months and older.

Ibuprofen lysine injection (NeoProfen): Patent ductus arteriosus (PDA): To close a clinically significant PDA in premature infants weighing between 500-1500 g who are no more than 32 weeks of gestational age when usual medical management (eg, diuretics, fluid restriction, respiratory support) is ineffective.

OTC labeling: Reduction of fever; management of pain due to headache, migraine, sore throat, arthritis, physical or athletic overexertion (eg, sprains/strains), menstrual pain, dental pain, minor muscle/bone/joint pain, backache, pain due to the common cold and flu

Use: Off-Label: Adult

  Gout, acute flaresLevel of Evidence [C, G]

Clinical experience suggests the utility of ibuprofen as an alternative option for acute gout flares Ref.

Based on the 2012 American College of Rheumatology guidelines for management of gout, NSAIDs are effective and recommended agents in the treatment of acute gout flares.

  PericarditisLevel of Evidence [B, G]

Data from double-blind, placebo-controlled, multicenter trials indicate that colchicine in combination with aspirin or ibuprofen significantly reduces the incidence of symptoms at 72 hours and the risk of recurrence in acute and recurrent pericarditis. Based on Brazilian Society of Cardiology guidelines for the management of myocarditis and pericarditis and European Society of Cardiology (ESC) guidelines for the management of pericardial diseases, nonsteroidal anti-inflammatory drugs (NSAIDs) (typically, aspirin or ibuprofen) in combination with colchicine are recommended as first-line treatment to manage pain and resolve inflammation in idiopathic and viral acute and recurrent pericarditis. Access Full Off-Label Monograph

Level of Evidence Definitions
  Level of Evidence Scale
Clinical Practice Guidelines

Ankylosing Spondylitis:

ACR/SAA/SPARTAN, “Recommendations for the Treatment of Ankylosing Spondylitis and Nonradiographic Axial Spondyloarthritis,” 2016

Critical Care:

“Clinical Practice Guidelines for the Management of Pain, Agitation, and Delirium in Adult Patients in the Intensive Care Unit,” January 2013

Drug-Induced Liver Injury:

American College of Gastroenterology (ACG), “2014 ACG Guideline for Idiosyncratic Drug-induced Liver Injury,” July 2014

Gout:

BSR/BHPR, Guideline for the Management of Gout, 2007

Juvenile Idiopathic Arthritis:

American College of Rheumatology, “2013 Update of the 2011 American College of Rheumatology Recommendations for the Treatment of Juvenile Idiopathic Arthritis,” 2013

Osteoarthritis:

American College of Rheumatology, “Recommendations for the Use of Nonpharmacologic and Pharmacologic Therapies in Osteoarthritis of the Hand, Hip, and Knee,” 2012

Pericarditis:

European Society of Cardiology, “Guidelines on the Diagnosis and Management of Pericardial Diseases,” April 2004

Surgery:

STS, “2012 Update to the Society of Thoracic Surgeons Guideline on Use of Antiplatelet Drugs in Patients Having Cardiac and Noncardiac Operations,” November 2012

Other:

Canadian Cardiovascular Society, “The Use of Antiplatelet Therapy in the Outpatient Setting: Canadian Cardiovascular Society Guidelines,” May 2011

Administration: IV

Caldolor: For IV administration only; infuse over at least 30 minutes (adults).

Administration: Injectable Detail

Caldolor: pH: ~7.4

Administration: Oral

Administer with food or milk.

Administration: Pediatric

Oral: Administer with food or milk to decrease GI upset; shake suspension well before use

IV:

Ibuprofen injection (Caldolor): For IV administration only; in pediatric patients, doses are infused over at least 10 minutes; in adults, doses are infused over at least 30 minutes

Ibuprofen lysine injection (NeoProfen): For IV administration only; administration via umbilical arterial line has not been evaluated. Infuse over 15 minutes through IV port closest to insertion site. Avoid extravasation. Do not administer simultaneously via same line with TPN. If needed, interrupt TPN for 15 minutes prior to and after ibuprofen administration, keeping line open with dextrose or saline.

Dietary Considerations

Some products may contain phenylalanine and/or potassium.

Storage/Stability

Ibuprofen injection (Caldolor): Store intact vials at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Must be diluted prior to use. Diluted solutions are stable in D5W, LR, or NS for 24 hours at 20°C to 25°C (68°F to 77°F).

Ibuprofen lysine injection (NeoProfen): Store at 20°C to 25°C (68°F to 77°F); excursions are permitted between 15°C and 30°C (59°F and 86°F). Protect from light. Store vials in carton until use. After first withdrawal from vial, discard remaining solution (preservative free). Following dilution in D5W or NS, use within 30 minutes.

Suspension: Store at 15°C to 30°C (59°F to 86°F).

Tablet: Store at 20°C to 25°C (68°F to 77°F).

Preparation for Administration: Adult

Ibuprofen injection (Caldolor): Must be diluted prior to use. Dilute with D5W, NS or LR to a final concentration ≤4 mg/mL.

Preparation for Administration: Pediatric

IV:

Ibuprofen injection (Caldolor): Must be diluted prior to use. Dilute with D5W, NS or LR to a final concentration ≤4 mg/mL.

Ibuprofen lysine injection (NeoProfen): Dilute with dextrose or saline to an appropriate volume.

Compatibility

See Trissel’s IV Compatibility Database

Medication Patient Education with HCAHPS Considerations

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience heartburn, diarrhea, constipation, or flatulence. Have patient report immediately to prescriber signs of aseptic meningitis (headache, fever, chills, severe nausea or vomiting, stiff neck, rash, sensitivity to bright lights, fatigue, or confusion), signs of abdominal ulcers (severe abdominal or back pain; black, tarry, or bloody stools; vomiting blood or vomit that looks like coffee grounds; or weight gain or abnormal swelling), signs of bleeding (vomiting blood or vomit that looks like coffee grounds; coughing up blood; hematuria; black, red, or tarry stools; bleeding from the gums; abnormal vaginal bleeding; bruises without a reason or that get bigger; or any severe or persistent bleeding), signs of kidney problems (urinary retention, hematuria, change in amount of urine passed, or weight gain), signs of high potassium (abnormal heartbeat, confusion, dizziness, passing out, weakness, shortness of breath, numbness or tingling feeling), signs of liver problems (dark urine, fatigue, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or jaundice), signs of severe cerebrovascular disease (change in strength on one side is greater than the other, difficulty speaking or thinking, change in balance, or vision changes), shortness of breath, excessive weight gain, swelling of arms or legs, angina, tachycardia, severe headache, severe dizziness, passing out, severe loss of strength and energy, tinnitus, severe nausea, vomiting, severe abdominal pain, severe back pain, vision changes, or signs of Stevens-Johnson syndrome/toxic epidermal necrolysis (red, swollen, blistered, or peeling skin [with or without fever]; red or irritated eyes; or sores in mouth, throat, nose, or eyes) (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating, and advising patients.

Medication Safety Issues
  Sound-alike/look-alike issues:
  Geriatric Patients: High-Risk Medication:
  Administration issues:
Medication Guide and/or Vaccine Information Statement (VIS)

An FDA-approved patient medication guide, which is available with the product information and at http://www.fda.gov/downloads/Drugs/DrugSafety/UCM387559.pdf, must be dispensed with this medication.

Contraindications

Hypersensitivity to ibuprofen (eg, anaphylactic reactions, serious skin reactions) or any component of the formulation; history of asthma, urticaria, or allergic-type reaction to aspirin or other NSAIDs; aspirin triad (eg, bronchial asthma, aspirin intolerance, rhinitis); use in the setting of coronary artery bypass graft (CABG) surgery

Ibuprofen lysine (NeoProfen): Preterm neonates: With proven or suspected infection that is untreated; congenital heart disease in whom patency of the PDA is necessary for satisfactory pulmonary or systemic blood flow (eg, pulmonary atresia, severe coarctation of the aorta, severe tetralogy of Fallot); bleeding (especially those with active intracranial hemorrhage or GI bleeding); thrombocytopenia; coagulation defects; proven or suspected necrotizing enterocolitis; or significant renal function impairment.

Canadian labeling: Additional contraindications (not in US labeling): Cerebrovascular bleeding or other bleeding disorders; active gastric/duodenal/peptic ulcer, active GI bleeding; inflammatory bowel disease; uncontrolled heart failure; moderate [IV formulation only] to severe renal impairment (creatinine clearance [CrCl] <30 mL/minute); deteriorating renal disease; moderate [IV formulation only] to severe hepatic impairment; active hepatic disease; hyperkalemia; third trimester of pregnancy; breast-feeding; patients <18 years of age [IV formulation only]; patients <12 years of age [oral formulation only]; systemic lupus erythematosus [oral formulation only]; children suffering from dehydration as a result of acute diarrhea, vomiting, or lack of fluid intake

OTC labeling: When used for self-medication, do not use if previous allergic reaction to any other pain reliever/fever reducer; prior to or following cardiac surgery.

Warnings/Precautions

Concerns related to adverse effects:

• Anaphylactoid reactions: Even in patients without prior exposure anaphylactoid reactions may occur; patients with “aspirin triad” (bronchial asthma, aspirin intolerance, rhinitis) may be at increased risk. Contraindicated in patients who experience bronchospasm, asthma, rhinitis, or urticaria with NSAID or aspirin therapy.

• Cardiovascular events: [US Boxed Warning]: NSAIDs cause an increased risk of serious (and potentially fatal) adverse cardiovascular thrombotic events, including fatal MI and stroke. Risk may occur early during treatment and may increase with duration of use. Relative risk appears to be similar in those with and without known cardiovascular disease or risk factors for cardiovascular disease; however, absolute incidence of cardiovascular events (which may occur early during treatment) was higher in patients with known cardiovascular disease or risk factors. New-onset hypertension or exacerbation of hypertension may occur (NSAIDS may also impair response to ACE inhibitors, thiazide diuretics, or loop diuretics); may contribute to cardiovascular events; monitor blood pressure; use with caution in patients with hypertension. May cause sodium and fluid retention; use with caution in patients with edema. Avoid use in heart failure (ACCF/AHA [Yancy 2013]). Avoid use in patients with a recent MI unless benefits outweigh risk of cardiovascular thrombotic events. Use the lowest effective dose for the shortest duration of time, consistent with individual patient goals, to reduce risk of cardiovascular events; alternate therapies should be considered for patients at high risk.

• CNS effects: May cause drowsiness, dizziness, blurred vision, and other neurologic effects which may impair physical or mental abilities; patients must be cautioned about performing tasks which require mental alertness (eg, operating machinery or driving).

• Gastrointestinal events: [US Boxed Warning]: NSAIDs cause an increased risk of serious gastrointestinal inflammation, ulceration, bleeding, and perforation (may be fatal); elderly patients and patients with history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events. These events may occur at any time during therapy and without warning. Avoid use in patients with active GI bleeding. In patients with a history of acute lower GI bleeding, avoid use of non-aspirin NSAIDs, especially if due to angioectasia or diverticulosis (Strate 2016). Use caution with a history of GI ulcers, concurrent therapy known to increase the risk of GI bleeding (eg, aspirin, anticoagulants and/or corticosteroids, selective serotonin reuptake inhibitors), advanced hepatic disease, coagulopathy, smoking, use of alcohol, or in elderly or debilitated patients. Use the lowest effective dose for the shortest duration of time, consistent with individual patient goals, to reduce risk of GI adverse events; alternate therapies should be considered for patients at high risk. When used concomitantly with aspirin, a substantial increase in the risk of gastrointestinal complications (eg, ulcer) occurs; concomitant gastroprotective therapy (eg, proton pump inhibitors) is recommended (Bhatt 2008).

• Hematologic effects: Platelet adhesion and aggregation may be decreased; may prolong bleeding time; patients with coagulation disorders or who are receiving anticoagulants should be monitored closely. Anemia may occur; patients on long-term NSAID therapy should be monitored for anemia. Rarely, NSAID use has been associated with potentially severe blood dyscrasias (eg, agranulocytosis, thrombocytopenia, aplastic anemia).

• Hepatic effects: Transaminase elevations have been reported with use; closely monitor patients with any abnormal LFT. Rare (sometimes fatal) severe hepatic reactions (eg, fulminant hepatitis, liver necrosis, hepatic failure) have occurred with NSAID use; discontinue immediately if signs or symptoms of hepatic disease develop or if systemic manifestations occur.

• Hyperkalemia: NSAID use may increase the risk of hyperkalemia, particularly in the elderly, diabetics, renal disease, and with concomitant use of other agents capable of inducing hyperkalemia (eg, ACE-inhibitors). Monitor potassium closely.

• Ophthalmic events: Blurred/diminished vision, scotomata, and changes in color vision have been reported. Discontinue therapy and refer for ophthalmologic evaluation if symptoms occur. Periodically evaluate vision in all patients receiving long-term therapy.

• Renal effects: NSAID use may compromise existing renal function; dose-dependent decreases in prostaglandin synthesis may result from NSAID use, reducing renal blood flow which may cause renal decompensation (usually reversible). Patients with impaired renal function, dehydration, hypovolemia, heart failure, hepatic impairment, those taking diuretics and ACE inhibitors, and the elderly are at greater risk of renal toxicity. Rehydrate patient before starting therapy; monitor renal function closely. Long-term NSAID use may result in renal papillary necrosis and other renal injury.

• Skin reactions: NSAIDs may cause potentially fatal serious skin adverse events including exfoliative dermatitis, Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN); may occur without warning; discontinue use at first sign of skin rash (or any other hypersensitivity).

Disease-related concerns:

• Aseptic meningitis: May increase the risk of aseptic meningitis, especially in patients with systemic lupus erythematosus (SLE) and mixed connective tissue disorders.

• Asthma: Contraindicated in patients with aspirin-sensitive asthma; severe and potentially fatal bronchospasm may occur. Use caution in patients with other forms of asthma.

• Coronary artery bypass graft surgery: [US Boxed Warning]: Use is contraindicated in the setting of coronary artery bypass graft (CABG) surgery. Risk of MI and stroke may be increased with use following CABG surgery.

• Hepatic impairment: Use with caution in patients with hepatic impairment; patients with advanced hepatic disease are at an increased risk of GI bleeding with NSAIDs.

• Renal impairment: Avoid use in patients with advanced renal disease; discontinue use with persistent or worsening abnormal renal function tests. Use of ibuprofen lysine (NeoProfen) is contraindicated in preterm infants with significant renal impairment.

Special populations:

• Elderly: Elderly patients are at greater risk for serious GI events; use with caution.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Dosage form specific issues:

• Benzyl alcohol and derivatives: Some dosage forms may contain sodium benzoate/benzoic acid; benzoic acid (benzoate) is a metabolite of benzyl alcohol; large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity (“gasping syndrome”) in neonates; the “gasping syndrome” consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension, and cardiovascular collapse (AAP [“Inactive” 1997]; CDC 1982); some data suggests that benzoate displaces bilirubin from protein binding sites (Ahlfors 2001); avoid or use dosage forms containing benzyl alcohol derivative with caution in neonates. See manufacturer’s labeling.

• Ibuprofen injection (Caldolor): Must be diluted prior to administration; hemolysis can occur if not diluted.

• Ibuprofen lysine injection (NeoProfen): Hold second or third doses if urinary output is <0.6 mL/kg/hour. May alter signs of infection. May inhibit platelet aggregation; monitor for signs of bleeding. May displace bilirubin; use caution when total bilirubin is elevated. Long-term evaluations of neurodevelopment, growth, or diseases associated with prematurity following treatment have not been conducted. A second course of treatment, alternative pharmacologic therapy or surgery may be needed if the ductus arteriosus fails to close or reopens following the initial course of therapy. Avoid extravasation.

• Phenylalanine: Some products may contain phenylalanine.

• Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Isaksson 2002; Lucente 2000; Shelley 1995). Thrombocytopenia, ascites, pulmonary deterioration, and renal and hepatic failure have been reported in premature neonates after receiving parenteral products containing polysorbate 80 (Alade 1986; CDC 1984). See manufacturer’s labeling.

• Propylene glycol: Some dosage forms may contain propylene glycol; large amounts are potentially toxic and have been associated hyperosmolality, lactic acidosis, seizures and respiratory depression; use caution (AAP [“Inactive” 1997]; Zar 2007).

Other warnings/precautions:

• Self-medication (OTC use): Prior to self-medication, patients should contact health care provider if they have had recurring stomach pain or upset, ulcers, bleeding problems, high blood pressure, heart or kidney disease, other serious medical problems, are currently taking a diuretic, aspirin, anticoagulant, or are ≥60 years of age. If patients are using for migraines, they should also contact health care provider if they have not had a migraine diagnosis by health care provider, a headache that is different from usual migraine, worst headache of life, fever and neck stiffness, headache from head injury or coughing, first headache at ≥50 years of age, daily headache, or migraine requiring bed rest. Recommended dosages should not be exceeded, due to an increased risk of GI bleeding. Stop use and consult a health care provider if symptoms do not improve within first 24 hours of use (children) get worse, or newly appear, fever lasts for >3 days or pain lasts >3 days (children) and >10 days (adults). Do not give for >10 days unless instructed by healthcare provider. Consuming ≥3 alcoholic beverages/day or taking longer than recommended may increase the risk of GI bleeding.

• Surgical/dental procedures: Withhold for at least 4 to 6 half-lives prior to surgical or dental procedures.

Geriatric Considerations

Elderly patients are at high risk for adverse effects from NSAIDs. Up to 60% of elderly patients can develop an asymptomatic peptic ulcer and/or hemorrhage. Using the lowest effective dose for shortest period possible is recommended. Use of NSAIDs can compromise existing renal function, especially when CrCl is <30 mL/minute. CNS adverse effects such as confusion, agitation, and hallucination may occur even with lower doses in elderly patients.

Warnings: Additional Pediatric Considerations

Oral liquid products are available in two concentrations (ie, concentrated infant drops: 50 mg/1.25 mL and suspension: 100 mg/5 mL); precautions should be taken to verify and avoid confusion between the different concentrations; dose should be clearly presented as “mg”.

A single-center, 10-year, retrospective review of pediatric patients diagnosed with acute kidney injury (AKI) (n=1,015; ages: ≤18 years) reported NSAIDS as a potential cause of AKI in 2.7% of patients (n=27); a higher incidence (6.6%) was reported when additional exclusion factors were included in the data analysis. Dosing information was available for 74% of the NSAID-associated AKI cases (n=20); dosing was within the recommended range in 75% (n=15) of these cases. The median age of children with NSAID-associated AKI was 14.7 years (range: 0.5 to 17.7 years) and 15% of patients were <5 years and more likely to require dialysis than the older patients. Some experts suggest the incidence of NSAID-associated AKI found in this study is conservative due to aggressive exclusion criteria (eg, concurrent aminoglycoside or other nephrotoxic therapy) and the actual incidence may be higher (Brophy 2013; Misurac 2013). IV ibuprofen is as effective as IV indomethacin for the treatment of PDA in preterm neonates, but is less likely to cause adverse effects on renal function (eg, oliguria, increased serum creatinine) (Aranda 2006; Lago 2002; Ohlsson 2013; Van Overmeire 2000). Ibuprofen (compared to indomethacin) also has been shown to decrease the risk of developing NEC (Ohlsson 2013).

In neonates, pulmonary hypertension has occurred following use for treatment of PDA; ten cases have been reported; three following early (prophylactic) administration of tromethamine ibuprofen (not available in US) and seven cases following L-lysine ibuprofen therapy (Bellini 2006; Gournay 2002; Ohlsson 2013). Avoid extravasation of ibuprofen lysine injection (NeoProfen); IV solution may be irritating to tissues. Use with caution in neonates with controlled infection or those at risk for infection; ibuprofen may alter the usual signs of infection. Use with caution in neonates when total bilirubin is elevated; ibuprofen may displace bilirubin from albumin-binding sites. Intraventricular hemorrhage has been reported; overall incidence: 29%; grade 3/4: 15%. Long-term evaluations of neurodevelopmental outcome, growth, or diseases associated with prematurity (eg, chronic lung disease, retinopathy of prematurity) following treatment have not been conducted.

Some dosage forms may contain propylene glycol; in neonates large amounts of propylene glycol delivered orally, intravenously (eg, >3,000 mg/day), or topically have been associated with potentially fatal toxicities which can include metabolic acidosis, seizures, renal failure, and CNS depression; toxicities have also been reported in children and adults including hyperosmolality, lactic acidosis, seizures and respiratory depression; use caution (AAP 1997; Shehab 2009).

Pregnancy Considerations

Birth defects have been observed following in utero NSAID exposure in some studies; however, data is conflicting (Bloor 2013). Nonteratogenic effects, including prenatal constriction of the ductus arteriosus, persistent pulmonary hypertension of the newborn, oligohydramnios, necrotizing enterocolitis, renal dysfunction or failure, and intracranial hemorrhage have been observed in the fetus/neonate following in utero NSAID exposure. In addition, nonclosure of the ductus arteriosus postnatally may occur and be resistant to medical management (Bermas 2014; Bloor 2013). Because NSAIDs cause premature closure of the ductus arteriosus, prescribing information for ibuprofen specifically states use should be avoided starting at 30-weeks gestation.

Use of NSAIDs can be considered for the treatment of mild rheumatoid arthritis flares in pregnant women; however, use should be minimized or avoided early and late in pregnancy (Bermas 2014; Saavedra Salinas 2015). If treatment of migraine is needed in pregnant women, ibuprofen is preferred when an NSAID is required; however, other agents are recommended as initial therapy (Amundsen 2015).

The chronic use of NSAIDs in women of reproductive age may be associated with infertility that is reversible upon discontinuation of the medication. Consider discontinuing use in women having difficulty conceiving or those undergoing investigation of fertility. The use of NSAIDs close to conception may be associated with an increased risk of miscarriage (Bloor 2013; Bermas 2014).

Breast-Feeding Considerations

Ibuprofen is present in breast milk.

The relative infant dose (RID) of ibuprofen is 0.6% to 0.9% when calculated using the highest breast milk concentration located and compared to an infant therapeutic dose of 10 to 15 mg/kg/day. In general, breastfeeding is considered acceptable when the RID is <10%; when an RID is >25%, breastfeeding should generally be avoided (Anderson 2016; Ito 2000). Using the highest milk concentration (0.59 mcg/mL), the estimated daily infant dose via breast milk is 0.089 mg/kg/day. This milk concentration was obtained following maternal administration of oral ibuprofen ≥600 mg/day (Rigourd 2014).

Based on the available data, adverse events have not been reported in breastfeeding infants and milk production is not affected.

In general, NSAIDs may be used in postpartum women who wish to breastfeed and if needed for postpartum pain, ibuprofen is the preferred agent (Montgomery 2012). Ibuprofen is considered compatible with breastfeeding when used in usual recommended doses (WHO 2002). Use should be avoided in women breastfeeding infants with platelet dysfunction or thrombocytopenia (Bloor 2013; Sammaritano 2014). The manufacturer recommends that the decision to breastfeed during therapy consider the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother.

Lexicomp Pregnancy & Lactation, In-Depth
Briggs’ Drugs in Pregnancy & Lactation
Adverse Reactions

Oral:

>10%:

Hematologic & oncologic: Decreased hemoglobin (7% to 23%)

Hepatic: Increased serum alanine aminotransferase (≤15%), increased serum aspartate aminotransferase (≤15%)

1% to 10%:

Cardiovascular: Edema

Central nervous system: Dizziness (3% to 9%), headache, nervousness

Dermatologic: Skin rash (3% to 9%), maculopapular rash, pruritus

Endocrine & metabolic: Fluid retention

Gastrointestinal: Epigastric pain (3% to 9%), heartburn (3% to 9%), nausea (3% to 9%), abdominal cramps, abdominal distress, abdominal pain, bloating, constipation, decreased appetite, diarrhea, dyspepsia, flatulence, nausea and vomiting, vomiting

Hematologic & oncologic: Anemia, prolonged bleeding time

Hepatic: Increased liver enzymes

Otic: Tinnitus (<3%)

Renal: Renal function abnormality

Frequency not defined:

Cardiovascular: Hypertension, syncope, tachycardia

Central nervous system: Anxiety, malaise, vertigo

Dermatologic: Diaphoresis, ecchymoses

Endocrine & metabolic: Weight changes

Gastrointestinal: Duodenitis, esophagitis, glossitis, hematemesis, rectal hemorrhage, stomatitis

Genitourinary: Dysuria, oliguria, proteinuria

Hematologic & oncologic: Leukopenia

Infection: Infection, sepsis

Neuromuscular & skeletal: Asthenia, tremor

Renal: Interstitial nephritis

Respiratory: Asthma, dyspnea

<1%, postmarketing, and/or case reports: Abnormal dreams, abnormal hepatic function tests, acidosis, acute renal failure, agranulocytosis, alopecia, amblyopia, anaphylactoid shock, anaphylaxis, anemia, angioedema, aplastic anemia, apnea, aseptic meningitis, auditory impairment, azotemia, blurred vision, bronchospasm, cardiac arrhythmia, cardiac failure, cataract, cerebrovascular accident, change in appetite, chills, coma, confusion, conjunctivitis, cystitis, decreased creatinine clearance, decreased hematocrit, depression, diplopia, DRESS syndrome (Koca 2016; Roales-Gómez 2014), drowsiness, duodenal ulcer, emotional lability, eosinophilia, epistaxis, eructation, erythema multiforme, exfoliative dermatitis, fever, gastric ulcer, gastritis, gastrointestinal hemorrhage, gastrointestinal perforation, gastrointestinal ulcer, gingival ulceration, glomerulonephritis, gynecomastia, hallucination, hearing loss, heavy menstrual bleeding, hematuria, hemolytic anemia, hemorrhage, Henoch-Schonlein purpura, hepatic failure, hepatic necrosis, hepatitis, hepatorenal syndrome, hepatotoxicity (idiosyncratic) (Chalasani 2014), hyperglycemia, hypoglycemia, hypotension, increased serum creatinine, insomnia, jaundice, lymphadenopathy, melena, myocardial infarction, neutropenia, nonthrombocytopenic purpura, occult blood in stools, optic neuritis, palpitations, pancreatitis, pancytopenia, paresthesia, pneumonia, polyuria, pseudotumor cerebri, renal papillary necrosis, renal tubular necrosis, respiratory depression, rhinitis, scotoma, seizure, serum sickness, sinus bradycardia, sinus tachycardia, skin photosensitivity, Stevens-Johnson syndrome, systemic lupus erythematosus, thrombocytopenia, thrombosis, toxic epidermal necrolysis, urticaria, vasculitis, vesiculobullous dermatitis, vision color changes, vision loss, xerophthalmia, xerostomia

Injection: Ibuprofen (Caldolor):

>10%:

Central nervous system: Headache (12%; children: ≥2%)

Endocrine & metabolic: Hypokalemia (4% to 19%)

Gastrointestinal: Vomiting (22%; children: ≥2%), flatulence (16%)

Hematologic & oncologic: Anemia (4% to 36%; children: ≥2%), eosinophilia (26%), neutropenia (13%), hypoproteinemia (10% to 13%)

Hepatic: Increased serum alanine aminotransferase (≤15%), increased serum aspartate aminotransferase (≤15%)

Infection: Bacteremia (13%)

1% to 10%:

Cardiovascular: Hypertension (10%), hypotension (7% to 10%), peripheral edema (3%)

Central nervous system: Dizziness (4% to 6%), infusion-site pain (children: ≥2%)

Endocrine & metabolic: Hypoalbuminemia (10%), hypernatremia (7% to 10%), increased lactate dehydrogenase (7% to 10%)

Gastrointestinal: Diarrhea (10%), dyspepsia (1% to 4%), abdominal distress (≤3%), nausea (children: ≥2%)

Genitourinary: Urinary retention (5%)

Hematologic & oncologic: Hemorrhage (10%), thrombocythemia (3% to 10%), wound hemorrhage (3%), decreased hemoglobin (2% to 3%)

Renal: Increased blood urea nitrogen (10%)

Respiratory: Bacterial pneumonia (3% to 10%), cough (3%)

Frequency not defined:

Dermatologic: Exfoliative dermatitis, skin rash, Stevens-Johnson syndrome, toxic epidermal necrolysis

Hypersensitivity: Hypersensitivity reaction

<1%, postmarketing, and/or case reports: Abdominal pain, anaphylaxis, cerebrovascular accident, esophageal perforation, gastrointestinal hemorrhage, gastrointestinal inflammation, gastrointestinal tract perforation, gastrointestinal ulcer, hepatotoxicity (idiosyncratic) (Chalasani 2014), myocardial infarction, nasal congestion, thrombosis

Injection: Ibuprofen lysine (NeoProfen):

>10%:

Central nervous system: Intraventricular hemorrhage (29%)

Dermatologic: Skin irritation (≤16%), skin lesion (≤16%)

Endocrine & metabolic: Hypocalcemia (12%), hypoglycemia (12%)

Gastrointestinal: Enterocolitis (22%)

Hematologic & oncologic: Anemia (32%)

Infection: Sepsis (43%)

Respiratory: Apnea (28%), respiratory tract infection (19%)

1% to 10%:

Cardiovascular: Edema (4%)

Endocrine & metabolic: Adrenocortical insufficiency (7%), hypernatremia (7%)

Genitourinary: Urinary tract infection (9%), decreased urine output (3%)

Renal: Increased blood urea nitrogen (7%), renal insufficiency (6%), increased serum creatinine (3%)

Respiratory: Respiratory failure (10%), atelectasis (4%)

Frequency not defined:

Cardiovascular: Cardiac failure, hypotension, tachycardia

Central nervous system: Seizure

Endocrine & metabolic: Hyperglycemia

Gastrointestinal: Abdominal distention, cholestasis, gastritis, gastroesophageal reflux disease, inguinal hernia, intestinal obstruction

Genitourinary: Oliguria

Hematologic & oncologic: Neutropenia, prolonged bleeding time, thrombocytopenia

Hepatic: Jaundice

Infection: Infection

Local: Injection site reaction

Renal: Renal failure syndrome

Miscellaneous: Reduced intake of food/fluids

<1%, postmarketing, and/or case reports: Gastrointestinal perforation, hepatotoxicity (idiosyncratic) (Chalasani 2014), necrotizing enterocolitis, pulmonary hypertension

Allergy and Idiosyncratic Reactions
Metabolism/Transport Effects

Substrate of CYP2C19 (minor), CYP2C9 (minor); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential

Drug Interactions 

5-Aminosalicylic Acid Derivatives: Nonsteroidal Anti-Inflammatory Agents may enhance the nephrotoxic effect of 5-Aminosalicylic Acid Derivatives. Risk C: Monitor therapy

Acemetacin: May enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents. Risk X: Avoid combination

Agents with Antiplatelet Properties (e.g., P2Y12 inhibitors, NSAIDs, SSRIs, etc.): May enhance the antiplatelet effect of other Agents with Antiplatelet Properties. Risk C: Monitor therapy

Alcohol (Ethyl): May enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents. Specifically, the risk of GI bleeding may be increased with this combination. Risk C: Monitor therapy

Aliskiren: Nonsteroidal Anti-Inflammatory Agents may diminish the antihypertensive effect of Aliskiren. Nonsteroidal Anti-Inflammatory Agents may enhance the nephrotoxic effect of Aliskiren. Management: Monitor renal function periodically in patients receiving aliskiren and any nonsteroidal anti-inflammatory agent. Patients at elevated risk of renal dysfunction include those who are elderly, are volume depleted, or have pre-existing renal dysfunction. Risk C: Monitor therapy

Aminoglycosides: Nonsteroidal Anti-Inflammatory Agents may decrease the excretion of Aminoglycosides. Data only in premature infants. Risk C: Monitor therapy

Aminolevulinic Acid (Systemic): Photosensitizing Agents may enhance the photosensitizing effect of Aminolevulinic Acid (Systemic). Risk X: Avoid combination

Aminolevulinic Acid (Topical): Photosensitizing Agents may enhance the photosensitizing effect of Aminolevulinic Acid (Topical). Risk C: Monitor therapy

Angiotensin II Receptor Blockers: May enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents. Specifically, the combination may result in a significant decrease in renal function. Nonsteroidal Anti-Inflammatory Agents may diminish the therapeutic effect of Angiotensin II Receptor Blockers. The combination of these two agents may also significantly decrease glomerular filtration and renal function. Risk C: Monitor therapy

Angiotensin-Converting Enzyme Inhibitors: May enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents. Specifically, the combination may result in a significant decrease in renal function. Nonsteroidal Anti-Inflammatory Agents may diminish the antihypertensive effect of Angiotensin-Converting Enzyme Inhibitors. Risk C: Monitor therapy

Anticoagulants: Agents with Antiplatelet Properties may enhance the anticoagulant effect of Anticoagulants. Risk C: Monitor therapy

Anticoagulants: Nonsteroidal Anti-Inflammatory Agents may enhance the anticoagulant effect of Anticoagulants. Risk C: Monitor therapy

Apixaban: Nonsteroidal Anti-Inflammatory Agents (Nonselective) may enhance the adverse/toxic effect of Apixaban. Specifically, the risk of bleeding may be increased. Management: A comprehensive risk to benefit assessment should be done for all patients before any concurrent use of apixaban and nonsteroidal anti-inflammatory drugs (NSAIDs). If combined, monitor patients extra closely for signs and symptoms of bleeding. Risk D: Consider therapy modification

Beta-Blockers: Nonsteroidal Anti-Inflammatory Agents may diminish the antihypertensive effect of Beta-Blockers. Exceptions: Levobunolol; Metipranolol. Risk C: Monitor therapy

Bile Acid Sequestrants: May decrease the absorption of Nonsteroidal Anti-Inflammatory Agents. Risk D: Consider therapy modification

Bisphosphonate Derivatives: Nonsteroidal Anti-Inflammatory Agents may enhance the adverse/toxic effect of Bisphosphonate Derivatives. Both an increased risk of gastrointestinal ulceration and an increased risk of nephrotoxicity are of concern. Risk C: Monitor therapy

Cephalothin: Agents with Antiplatelet Properties may enhance the adverse/toxic effect of Cephalothin. Specifically, the risk for bleeding may be increased. Risk C: Monitor therapy

Collagenase (Systemic): Agents with Antiplatelet Properties may enhance the adverse/toxic effect of Collagenase (Systemic). Specifically, the risk of injection site bruising and/or bleeding may be increased. Risk C: Monitor therapy

Corticosteroids (Systemic): May enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents (Nonselective). Risk C: Monitor therapy

CycloSPORINE (Systemic): Nonsteroidal Anti-Inflammatory Agents may enhance the nephrotoxic effect of CycloSPORINE (Systemic). CycloSPORINE (Systemic) may increase the serum concentration of Nonsteroidal Anti-Inflammatory Agents. Nonsteroidal Anti-Inflammatory Agents may increase the serum concentration of CycloSPORINE (Systemic). Management: Consider alternatives to nonsteroidal anti-inflammatory agents (NSAIDs). Monitor for evidence of nephrotoxicity, as well as increased serum cyclosporine concentrations and systemic effects (eg, hypertension) during concomitant therapy with NSAIDs. Risk D: Consider therapy modification

Dabigatran Etexilate: Nonsteroidal Anti-Inflammatory Agents (Nonselective) may enhance the adverse/toxic effect of Dabigatran Etexilate. Specifically, the risk of bleeding may be increased. Management: A comprehensive risk to benefit assessment should be done for all patients before any concurrent use of dabigatran and nonsteroidal anti-inflammatory drugs (NSAIDs). If combined, monitor patients extra closely for signs and symptoms of bleeding. Risk D: Consider therapy modification

Dasatinib: May enhance the anticoagulant effect of Agents with Antiplatelet Properties. Management: Drugs listed as exceptions to this monograph are discussed in further detail in separate drug interaction monographs. Risk C: Monitor therapy

Deferasirox: Nonsteroidal Anti-Inflammatory Agents may enhance the adverse/toxic effect of Deferasirox. Specifically, the risk for GI ulceration/irritation or GI bleeding may be increased. Risk C: Monitor therapy

Deoxycholic Acid: Agents with Antiplatelet Properties may enhance the adverse/toxic effect of Deoxycholic Acid. Specifically, the risk for bleeding or bruising in the treatment area may be increased. Risk C: Monitor therapy

Desmopressin: Nonsteroidal Anti-Inflammatory Agents may enhance the adverse/toxic effect of Desmopressin. Risk C: Monitor therapy

Dexibuprofen: Nonsteroidal Anti-Inflammatory Agents may enhance the adverse/toxic effect of Dexibuprofen. Risk X: Avoid combination

Dexketoprofen: May enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents. Risk X: Avoid combination

Diclofenac (Systemic): May enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents. Management: Seek alternatives to the combined use of diclofenac with other nonsteroidal anti-inflammatory agents (NSAIDs). Avoid the use of diclofenac/misoprostol with other NSAIDs. Risk D: Consider therapy modification

Digoxin: Nonsteroidal Anti-Inflammatory Agents may increase the serum concentration of Digoxin. Risk C: Monitor therapy

Drospirenone: Nonsteroidal Anti-Inflammatory Agents may enhance the hyperkalemic effect of Drospirenone. Risk C: Monitor therapy

Edoxaban: Nonsteroidal Anti-Inflammatory Agents (Nonselective) may enhance the adverse/toxic effect of Edoxaban. Specifically, the risk of bleeding may be increased. Management: A comprehensive risk to benefit assessment should be done for all patients before any concurrent use of edoxaban and nonsteroidal anti-inflammatory drugs (NSAIDs). If combined, monitor patients extra closely for signs and symptoms of bleeding. Risk D: Consider therapy modification

Eplerenone: Nonsteroidal Anti-Inflammatory Agents may diminish the antihypertensive effect of Eplerenone. Nonsteroidal Anti-Inflammatory Agents may enhance the hyperkalemic effect of Eplerenone. Risk C: Monitor therapy

Fat Emulsion (Fish Oil Based): May enhance the adverse/toxic effect of Agents with Antiplatelet Properties. Risk C: Monitor therapy

Felbinac: May enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents. Risk C: Monitor therapy

Floctafenine: May enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents. Risk X: Avoid combination

Glucosamine: May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Risk C: Monitor therapy

Haloperidol: Nonsteroidal Anti-Inflammatory Agents may enhance the adverse/toxic effect of Haloperidol. Specifically including drowsiness and confusion. Risk C: Monitor therapy

Herbs (Anticoagulant/Antiplatelet Properties) (eg, Alfalfa, Anise, Bilberry): May enhance the adverse/toxic effect of Agents with Antiplatelet Properties. Bleeding may occur. Risk D: Consider therapy modification

Herbs (Anticoagulant/Antiplatelet Properties) (eg, Alfalfa, Anise, Bilberry): May enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents. Bleeding may occur. Management: Concomitant treatment with these agents should generally be avoided. If used concomitantly, increased diligence in monitoring for adverse effects (eg, bleeding, bruising, altered mental status due to CNS bleeds) must be employed. Risk D: Consider therapy modification

HydrALAZINE: Nonsteroidal Anti-Inflammatory Agents may diminish the antihypertensive effect of HydrALAZINE. Risk C: Monitor therapy

Ibritumomab Tiuxetan: Agents with Antiplatelet Properties may enhance the adverse/toxic effect of Ibritumomab Tiuxetan. Both agents may contribute to impaired platelet function and an increased risk of bleeding. Risk C: Monitor therapy

Ibrutinib: May enhance the adverse/toxic effect of Agents with Antiplatelet Properties. Risk C: Monitor therapy

Imatinib: Ibuprofen may decrease the serum concentration of Imatinib. Specifically, ibuprofen may decrease intracellular concentrations of imatinib, leading to decreased clinical response. Management: Consider using an alternative to ibuprofen in patients who are being treated with imatinib. Available evidence suggests other NSAIDs do not interact in a similar manner. Risk D: Consider therapy modification

Inotersen: May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Risk C: Monitor therapy

Ketorolac (Nasal): May enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents. Risk X: Avoid combination

Ketorolac (Systemic): May enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents. Risk X: Avoid combination

Limaprost: May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Risk C: Monitor therapy

Lithium: Nonsteroidal Anti-Inflammatory Agents may increase the serum concentration of Lithium. Risk D: Consider therapy modification

Loop Diuretics: Nonsteroidal Anti-Inflammatory Agents may diminish the diuretic effect of Loop Diuretics. Loop Diuretics may enhance the nephrotoxic effect of Nonsteroidal Anti-Inflammatory Agents. Management: Monitor for evidence of kidney injury or decreased therapeutic effects of loop diuretics with concurrent use of an NSAID. Consider avoiding concurrent use in CHF or cirrhosis. Concomitant use of bumetanide with indomethacin is not recommended. Risk D: Consider therapy modification

Lumacaftor: May decrease the serum concentration of Ibuprofen. Risk C: Monitor therapy

Macimorelin: Nonsteroidal Anti-Inflammatory Agents may diminish the diagnostic effect of Macimorelin. Risk X: Avoid combination

Methotrexate: Nonsteroidal Anti-Inflammatory Agents may increase the serum concentration of Methotrexate. Management: Alternative anti-inflammatory therapy should be considered whenever possible, especially if the patient is receiving higher, antineoplastic doses of methotrexate. Risk D: Consider therapy modification

Mifamurtide: Nonsteroidal Anti-Inflammatory Agents may diminish the therapeutic effect of Mifamurtide. Risk X: Avoid combination

Morniflumate: May enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents. Risk X: Avoid combination

Multivitamins/Fluoride (with ADE): May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Risk C: Monitor therapy

Multivitamins/Minerals (with ADEK, Folate, Iron): May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Risk C: Monitor therapy

Multivitamins/Minerals (with AE, No Iron): May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Risk C: Monitor therapy

Naftazone: May enhance the antiplatelet effect of Nonsteroidal Anti-Inflammatory Agents. Risk C: Monitor therapy

Nonsteroidal Anti-Inflammatory Agents (COX-2 Selective): Nonsteroidal Anti-Inflammatory Agents may enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents (COX-2 Selective). Risk X: Avoid combination

Obinutuzumab: Agents with Antiplatelet Properties may enhance the adverse/toxic effect of Obinutuzumab. Specifically, the risk of serious bleeding-related events may be increased.Risk C: Monitor therapy

Omacetaxine: Nonsteroidal Anti-Inflammatory Agents may enhance the adverse/toxic effect of Omacetaxine. Specifically, the risk for bleeding-related events may be increased. Management: Avoid concurrent use of nonsteroidal antiinflammatory drugs (NSAIDs) with omacetaxine in patients with a platelet count of less than 50,000/uL. Risk X: Avoid combination

Omega-3 Fatty Acids: May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Risk C: Monitor therapy

Pelubiprofen: May enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents. Risk X: Avoid combination

PEMEtrexed: Ibuprofen may increase the serum concentration of PEMEtrexed. Management: In patients with an estimated creatinine clearance of 45 to 79 mL/min, avoid ibuprofen for 2 days before, the day of, and 2 days following the administration of pemetrexed. Monitor for increased pemetrexed toxicities if combined. Risk D: Consider therapy modification

Pentosan Polysulfate Sodium: May enhance the adverse/toxic effect of Agents with Antiplatelet Properties. Specifically, the risk of bleeding may be increased by concurrent use of these agents. Risk C: Monitor therapy

Pentoxifylline: May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Risk C: Monitor therapy

Phenylbutazone: May enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents. Risk X: Avoid combination

Porfimer: Photosensitizing Agents may enhance the photosensitizing effect of Porfimer. Risk C: Monitor therapy

Potassium-Sparing Diuretics: Nonsteroidal Anti-Inflammatory Agents may diminish the antihypertensive effect of Potassium-Sparing Diuretics. Nonsteroidal Anti-Inflammatory Agents may enhance the hyperkalemic effect of Potassium-Sparing Diuretics. Risk C: Monitor therapy

PRALAtrexate: Nonsteroidal Anti-Inflammatory Agents may increase the serum concentration of PRALAtrexate. More specifically, NSAIDS may decrease the renal excretion of pralatrexate. Management: Closely monitor for increased pralatrexate serum levels and/or toxicity if used concomitantly with an NSAID. Monitor for decreased pralatrexate serum levels with NSAID discontinuation. Risk C: Monitor therapy

Probenecid: May increase the serum concentration of Nonsteroidal Anti-Inflammatory Agents. Risk C: Monitor therapy

Prostacyclin Analogues: May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Risk C: Monitor therapy

Prostaglandins (Ophthalmic): Nonsteroidal Anti-Inflammatory Agents may diminish the therapeutic effect of Prostaglandins (Ophthalmic). Nonsteroidal Anti-Inflammatory Agents may also enhance the therapeutic effects of Prostaglandins (Ophthalmic). Risk C: Monitor therapy

Quinolones: Nonsteroidal Anti-Inflammatory Agents may enhance the neuroexcitatory and/or seizure-potentiating effect of Quinolones. Nonsteroidal Anti-Inflammatory Agents may increase the serum concentration of Quinolones. Risk C: Monitor therapy

Rivaroxaban: Nonsteroidal Anti-Inflammatory Agents (Nonselective) may enhance the adverse/toxic effect of Rivaroxaban. Specifically, the risk of bleeding may be increased. Management: A comprehensive risk to benefit assessment should be done for all patients before any concurrent use of rivaroxaban and nonsteroidal anti-inflammatory drugs (NSAIDs). If combined, monitor patients extra closely for signs and symptoms of bleeding. Risk D: Consider therapy modification

Salicylates: Nonsteroidal Anti-Inflammatory Agents (Nonselective) may enhance the adverse/toxic effect of Salicylates. An increased risk of bleeding may be associated with use of this combination. Nonsteroidal Anti-Inflammatory Agents (Nonselective) may diminish the cardioprotective effect of Salicylates. Salicylates may decrease the serum concentration of Nonsteroidal Anti-Inflammatory Agents (Nonselective). Exceptions: Choline Magnesium Trisalicylate. Risk D: Consider therapy modification

Salicylates: Agents with Antiplatelet Properties may enhance the adverse/toxic effect of Salicylates. Increased risk of bleeding may result. Risk C: Monitor therapy

Selective Serotonin Reuptake Inhibitors: May enhance the antiplatelet effect of Nonsteroidal Anti-Inflammatory Agents (Nonselective). Nonsteroidal Anti-Inflammatory Agents (Nonselective) may diminish the therapeutic effect of Selective Serotonin Reuptake Inhibitors. Management: Consider using alternative analgesics, when appropriate, and/or addition of a gastroprotective agent. Monitor patients closely for signs/symptoms of bleeding, and for evidence of diminished SSRI effectiveness with concurrent use. Risk D: Consider therapy modification

Serotonin/Norepinephrine Reuptake Inhibitors: May enhance the antiplatelet effect of Nonsteroidal Anti-Inflammatory Agents (Nonselective). Risk C: Monitor therapy

Sodium Phosphates: May enhance the nephrotoxic effect of Nonsteroidal Anti-Inflammatory Agents. Specifically, the risk of acute phosphate nephropathy may be enhanced. Management: Consider avoiding this combination by temporarily suspending treatment with NSAIDs, or seeking alternatives to oral sodium phosphate bowel preparation. If the combination cannot be avoided, maintain adequate hydration and monitor renal function closely. Risk D: Consider therapy modification

Tacrolimus (Systemic): Nonsteroidal Anti-Inflammatory Agents may enhance the nephrotoxic effect of Tacrolimus (Systemic). Risk C: Monitor therapy

Talniflumate: May enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents. Risk X: Avoid combination

Tenofovir Products: Nonsteroidal Anti-Inflammatory Agents may enhance the nephrotoxic effect of Tenofovir Products. Management: Seek alternatives to these combinations whenever possible. Avoid use of tenofovir with multiple NSAIDs or any NSAID given at a high dose. Risk D: Consider therapy modification

Tenoxicam: May enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents. Risk X: Avoid combination

Thiazide and Thiazide-Like Diuretics: May enhance the nephrotoxic effect of Nonsteroidal Anti-Inflammatory Agents. Nonsteroidal Anti-Inflammatory Agents may diminish the therapeutic effect of Thiazide and Thiazide-Like Diuretics. Risk C: Monitor therapy

Thrombolytic Agents: Agents with Antiplatelet Properties may enhance the anticoagulant effect of Thrombolytic Agents. Risk C: Monitor therapy

Tipranavir: May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Risk C: Monitor therapy

Tolperisone: Nonsteroidal Anti-Inflammatory Agents may enhance the adverse/toxic effect of Tolperisone. Specifically, the risk of hypersensitivity reactions may be increased. Tolperisone may enhance the therapeutic effect of Nonsteroidal Anti-Inflammatory Agents. Risk C: Monitor therapy

Tricyclic Antidepressants (Tertiary Amine): May enhance the antiplatelet effect of Nonsteroidal Anti-Inflammatory Agents (Nonselective). Risk C: Monitor therapy

Urokinase: Agents with Antiplatelet Properties may enhance the anticoagulant effect of Urokinase. Risk X: Avoid combination

Vancomycin: Nonsteroidal Anti-Inflammatory Agents may increase the serum concentration of Vancomycin. Risk C: Monitor therapy

Verteporfin: Photosensitizing Agents may enhance the photosensitizing effect of Verteporfin. Risk C: Monitor therapy

Vitamin E (Systemic): May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Risk C: Monitor therapy

Vitamin K Antagonists (eg, warfarin): Nonsteroidal Anti-Inflammatory Agents (Nonselective) may enhance the anticoagulant effect of Vitamin K Antagonists. Risk D: Consider therapy modification

Voriconazole: May increase the serum concentration of Ibuprofen. Specifically, concentrations of the S-(+)-ibuprofen enantiomer may be increased. Risk C: Monitor therapy

Zaltoprofen: May enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents. Risk X: Avoid combination

Food Interactions

Ibuprofen peak serum levels may be decreased if taken with food. Management: Administer with food.

Test Interactions

May interfere with urine detection of phencyclidine (false-positives) (Marchei 2007). May lead to false-positive aldosterone/renin ratio (ARR) (Funder 2016).

Genes of Interest
Monitoring Parameters

CBC, chemistry profile, occult blood loss and periodic liver function tests; monitor response (pain, range of motion, grip strength, mobility, ADL function), inflammation; observe for weight gain, edema; monitor renal function (urine output, serum BUN and creatinine); observe for bleeding, bruising; evaluate gastrointestinal effects (abdominal pain, bleeding, dyspepsia); mental confusion, disorientation; blood pressure; periodic ophthalmic exams with long-term therapy; signs of infection (ibuprofen lysine)

Reference Range

Plasma concentrations >200 mcg/mL may be associated with severe toxicity

Advanced Practitioners Physical Assessment/Monitoring

Evaluate cardiac risk and potential for GI bleeding prior to prescribing this medication. Assess patient for allergic reaction to salicylates or other NSAIDs. Monitor blood pressure prior to treatment and periodically throughout. Periodic ophthalmic exams are recommended for long-term therapy.

Nursing Physical Assessment/Monitoring

Assess patient for allergic reaction to salicylates or other NSAIDs. Monitor blood pressure prior to treatment and periodically throughout. Monitor for adverse gastrointestinal response prior to treatment and periodically throughout.

Dosage Forms Considerations

EnovaRX-Ibuprofen cream is compounded from a kit. Refer to manufacturer’s labeling for compounding instructions.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Capsule, Oral:

Advil: 200 mg

Advil Migraine: 200 mg

GoodSense Ibuprofen: 200 mg [gluten free; contains brilliant blue fcf (fd&c blue #1)]

KS Ibuprofen: 200 mg [contains fd&c blue #2 (indigotine)]

Generic: 200 mg

Kit, Combination:

Ibuprofen Comfort Pac: 800 mg [DSC] [contains methylparaben, trolamine (triethanolamine)]

Solution, Intravenous:

Caldolor: 800 mg/8 mL (8 mL)

Solution, Intravenous, as lysine [preservative free]:

NeoProfen: 10 mg/mL (2 mL)

Generic: 10 mg/mL (2 mL)

Suspension, Oral:

Childrens Advil: 100 mg/5 mL (120 mL) [fruit flavor]

Childrens Advil: 100 mg/5 mL (120 mL) [contains edetate disodium, fd&c red #40, polysorbate 80, propylene glycol, sodium benzoate]

Childrens Advil: 100 mg/5 mL (120 mL) [alcohol free; grape flavor]

Childrens Advil: 100 mg/5 mL (120 mL) [alcohol free; contains brilliant blue fcf (fd&c blue #1), edetate disodium, fd&c red #40, polysorbate 80, propylene glycol, sodium benzoate; grape flavor]

Childrens Advil: 100 mg/5 mL (120 mL) [alcohol free; contains brilliant blue fcf (fd&c blue #1), propylene glycol, sodium benzoate; blue raspberry flavor]

Childrens Advil: 100 mg/5 mL (30 mL, 120 mL) [alcohol free, dye free; contains edetate disodium, polysorbate 80, propylene glycol, sodium benzoate; white grape flavor]

Childrens Advil: 100 mg/5 mL (120 mL) [alcohol free, dye free, sugar free; contains edetate disodium, polysorbate 80, propylene glycol, sodium benzoate; berry flavor]

Childrens Motrin: 100 mg/5 mL (120 mL) [alcohol free; contains fd&c blue #1 aluminum lake, fd&c red #40, polysorbate 80, sodium benzoate]

Childrens Motrin: 100 mg/5 mL (30 mL, 120 mL) [alcohol free; contains fd&c red #40, fd&c yellow #10 (quinoline yellow), polysorbate 80, sodium benzoate; berry flavor]

Childrens Motrin: 100 mg/5 mL (120 mL) [alcohol free; contains fd&c red #40, fd&c yellow #10 (quinoline yellow), sodium benzoate; berry flavor]

Childrens Motrin: 100 mg/5 mL (120 mL) [alcohol free; contains fd&c red #40, polysorbate 80, sodium benzoate]

Childrens Motrin: 100 mg/5 mL (120 mL) [alcohol free, dye free; contains polysorbate 80, sodium benzoate; berry flavor]

Childrens Motrin: 100 mg/5 mL (120 mL [DSC]) [alcohol free, dye free; contains sodium benzoate]

GoodSense Ibuprofen Childrens: 100 mg/5 mL (120 mL) [alcohol free, dye free, gluten free; contains polysorbate 80, sodium benzoate, sorbitol; berry flavor]

Ibuprofen Childrens: 100 mg/5 mL (118 mL) [contains fd&c red #40, fd&c yellow #10 (quinoline yellow), polysorbate 80, propylene glycol, sodium benzoate; berry flavor]

Ibuprofen Childrens: 100 mg/5 mL (118 mL) [alcohol free; contains corn starch, fd&c red #40, fd&c yellow #10 (quinoline yellow), polysorbate 80, sodium benzoate; berry flavor]

Ibuprofen Childrens: 100 mg/5 mL (118 mL) [alcohol free; contains corn starch, fd&c red #40, polysorbate 80, sodium benzoate; bubble-gum flavor]

Ibuprofen Childrens: 100 mg/5 mL (120 mL, 240 mL) [alcohol free; contains fd&c red #40, fd&c yellow #10 (quinoline yellow), polysorbate 80, sodium benzoate]

Ibuprofen Childrens: 100 mg/5 mL (118 mL) [alcohol free, dye free; contains corn starch, polysorbate 80, sodium benzoate; berry flavor]

Infants Advil: 50 mg/1.25 mL (30 mL) [alcohol free, dye free; contains edetate disodium, polysorbate 80, propylene glycol, sodium benzoate]

Infants Advil: 50 mg/1.25 mL (15 mL) [alcohol free, dye free; contains edetate disodium, polysorbate 80, propylene glycol, sodium benzoate; white grape flavor]

Motrin Infants Drops: 50 mg/1.25 mL (15 mL) [contains fd&c red #40, polysorbate 80, sodium benzoate; berry flavor]

Motrin Infants Drops: 50 mg/1.25 mL (15 mL) [alcohol free; contains fd&c red #40, polysorbate 80, sodium benzoate, sorbitol]

Motrin Infants Drops: 50 mg/1.25 mL (15 mL) [alcohol free; contains fd&c red #40, polysorbate 80, sodium benzoate, sorbitol; berry flavor]

Motrin Infants Drops: 50 mg/1.25 mL (30 mL) [alcohol free, dye free; contains polysorbate 80, sodium benzoate, sorbitol]

Generic: 100 mg/5 mL (5 mL, 118 mL, 120 mL, 473 mL)

Tablet, Oral:

Addaprin: 200 mg

Advil: 200 mg

Advil: 200 mg [contains methylparaben, propylparaben, sodium benzoate]

Advil Junior Strength: 100 mg

Dyspel: 200 mg

Genpril: 200 mg

GoodSense Ibuprofen: 200 mg [gluten free; contains corn starch, fd&c red #40 aluminum lake, fd&c yellow #6 aluminum lake]

I-Prin: 200 mg [DSC]

IBU: 400 mg, 600 mg, 800 mg

IBU-200: 200 mg [dye free; contains corn starch]

Motrin IB: 200 mg

Motrin IB: 200 mg [contains corn starch, fd&c red #40 aluminum lake, fd&c yellow #6 aluminum lake]

Motrin IB: 200 mg [contains fd&c yellow #6 (sunset yellow)]

Provil: 200 mg

Generic: 200 mg, 400 mg, 600 mg, 800 mg

Tablet Chewable, Oral:

Advil Junior Strength: 100 mg [scored; contains aspartame, fd&c blue #2 aluminum lake; grape flavor]

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Intravenous:

Caldolor: 100 mg/mL (4ml, 8ml)

Tablet, Oral:

Generic: 600 mg

Anatomic Therapeutic Chemical (ATC) Classification
  • C01EB16
  • M01AE01
  • M02AA13
Generic Available (US)

May be product dependent

Pricing: US

Capsules (Advil Migraine Oral)

200 mg (per each): $0.17

Capsules (Advil Oral)

200 mg (per each): $0.13

Capsules (Ibuprofen Oral)

200 mg (per each): $0.07 – $0.10

Chewable (Advil Junior Strength Oral)

100 mg (per each): $0.18

Solution (Caldolor Intravenous)

800 mg/8 mL (per mL): $2.51

Solution (Ibuprofen Lysine Intravenous)

10 mg/mL (per mL): $243.60 – $273.74

Solution (NeoProfen Intravenous)

10 mg/mL (per mL): $403.08

Suspension (Childrens Advil Oral)

100 mg/5 mL (per mL): $0.04

Suspension (Childrens Motrin Oral)

100 mg/5 mL (per mL): $0.05

Suspension (Ibuprofen Oral)

100 mg/5 mL (per mL): $0.16 – $0.38

Suspension (Infants Advil Oral)

50 mg/1.25 mL (per mL): $0.27

Suspension (Motrin Infants Drops Oral)

50 mg/1.25 mL (per mL): $0.36

Tablets (Advil Junior Strength Oral)

100 mg (per each): $0.18

Tablets (Advil Oral)

200 mg (per each): $0.08

Tablets (IBU Oral)

400 mg (per each): $0.21

600 mg (per each): $0.29

800 mg (per each): $0.38

Tablets (Ibuprofen Oral)

200 mg (per each): $0.03 – $0.08

400 mg (per each): $0.07 – $0.40

600 mg (per each): $0.12 – $4.13

800 mg (per each): $0.12 – $4.38

Tablets (Motrin IB Oral)

200 mg (per each): $0.12

Tablets (Provil Oral)

200 mg (per each): $0.07

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer’s AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Mechanism of Action

Reversibly inhibits cyclooxygenase-1 and 2 (COX-1 and 2) enzymes, which results in decreased formation of prostaglandin precursors; has antipyretic, analgesic, and anti-inflammatory properties

Other proposed mechanisms not fully elucidated (and possibly contributing to the anti-inflammatory effect to varying degrees), include inhibiting chemotaxis, altering lymphocyte activity, inhibiting neutrophil aggregation/activation, and decreasing proinflammatory cytokine levels.

Pharmacodynamics/Kinetics

Onset of action: Oral: Analgesic: Within 30 to 60 minutes (Davies 1998; Mehlisch 2013); Antipyretic: Single oral dose 8 mg/kg (Kauffman 1992): Infants ≤1 year: 69 ± 22 minutes; Children ≥6 years: Single oral dose 8 mg/kg (Kauffman 1992): 109 ± 64 minutes; Adults: <1 hour (Sullivan 2011)

Maximum effect: Antipyretic: 2 to 4 hours

Duration: Oral: Antipyretic: 6 to 8 hours (Sullivan 2011)

Absorption: Oral: Rapid (85%)

Distribution: Vd:

Oral: Febrile children <11 years: 0.2 L/kg; Adults: 0.12 L/kg

IV: Ibuprofen (Caldolor):

Pediatric patients 6 months to <2 years: 0.31 L/kg

Pediatric patients 2 to 16 years: 0.23 L/kg

IV: Ibuprofen lysine: Premature neonates, GA <32 weeks: Variable results observed: 0.32 L/kg, others have reported: a central compartment Vd that decreases with increasing PNA and ductal closure (Van Overmeire, 2001) and a Vd, apparent: 0.062 L/kg in 21 premature neonates (GA <32 weeks, PNA: <1 day) (Aranda 1997); a 2-compartment open model was observed

Protein binding: >99%; Premature infants: ~95% (Aranda 1997)

Bioavailability: 80%

Metabolism: Hepatic via oxidation; Note: Ibuprofen is a racemic mixture of R and S isomers; the R isomer (thought to be inactive) is slowly and incompletely (~60%) converted to the S isomer (active) in adults; the amount of conversion in children is not known, but it is thought to be similar to adults; a study in preterm neonates estimated the conversion to be 61% after prophylactic ibuprofen use and 86% after curative treatment (Gregoire 2004).

Half-life elimination: IV:

Ibuprofen (Caldor):

Pediatric patients: 6 months to <2 years: 1.8 hours; 2 to 16 years: ~1.5 hours

Adults: 2.22 to 2.44 hours

Ibuprofen lysine (Neoprofen):

Premature neonates, GA <32 weeks: Reported data highly variable

R-enantiomer: 10 hours; S-enantiomer: 25.5 hours (Gregoire 2004)

Age-based observations:

PNA <1 day: 30.5 ± 4.2 hours (Aranda 1997)

PNA 3 days: 43.1 ± 26.1 hours (Van Overmeire 2001)

PNA 5 days: 26.8 ± 23.6 hours (Van Overmeire 2001)

Half-life elimination: Oral:

Children 3 months to 10 years: Oral suspension: 1.6 ± 0.7 hours (Kauffman 1992)

Adults: ~2 hours; End-stage renal disease: Unchanged (Aronoff 2007)

Time to peak: Tablets: 1 to 2 hours; Suspension: 1 hour

Children with cystic fibrosis (Scott 1999):

Suspension (n=22): 0.74 ± 0.43 hours (median: 30 minutes)

Chewable tablet (n=4): 1.5 ± 0.58 hours (median: 1.5 hours)

Tablet (n=12): 1.33 ± 0.95 hours (median: 1 hour)

Excretion: Urine (primarily as metabolites (45% to 80%); ~1% as unchanged drug and 14% as conjugated); some feces

Dental Use

Management of pain and swelling

Local Anesthetic/Vasoconstrictor Precautions

No information available to require special precautions

Dental Health Professional Considerations

Preoperative use of ibuprofen at a dose of 400-600 mg every 6 hours 24 hours before the appointment decreases postoperative edema and hastens healing time.

New information from the FDA states that ibuprofen can interfere with the antiplatelet effect of low-dose aspirin (81 mg/day), potentially rendering aspirin less effective when used for cardioprotection and stroke protection. In situations where these drugs could be used concomitantly, the FDA has provided the following information.

Patients who use immediate release aspirin (not enteric-coated aspirin) and take a single dose or chronic doses of ibuprofen 400 mg, should dose the ibuprofen at least 30 minutes or longer after aspirin ingestion or more than 8 hours before aspirin ingestion to avoid attenuation of aspirin’s effect.

At this time, recommendations about the timing of ibuprofen 400 mg in patients taking enteric-coated low-dose aspirin cannot be made based on available data. One study however, showed that the antiplatelet effect of enteric-coated low-dose aspirin was attenuated when ibuprofen 400 mg was dosed 2, 7, and 12 hours after aspirin (Catella-Lawson 2001).

With occasional use of ibuprofen, there is likely to be minimal risk from any attenuation of the antiplatelet effect of low-dose aspirin, because of a long-lasting effect of aspirin on platelets.

Other over-the-counter (OTC) NSAIDs (ie, naproxen sodium and ketoprofen) should be viewed as having the potential to interfere with the antiplatelet effect of low-dose aspirin until proven otherwise. However, the FDA is unaware of any studies that have looked at the same type of interference by ketoprofen with low-dose aspirin. One study of naproxen and low-dose aspirin has suggested that naproxen may interfere with aspirin’s antiplatelet activity when they are coadministered (Steinhubl 2005). However, naproxen 500 mg administered 2 hours before or after aspirin 100 mg, did not interfere with aspirin’s antiplatelet effect. The FDA stated that there is no data looking at doses of naproxen <500 mg. Naproxen OTC strength is 220 mg tablets.

Ibuprofen, prescription dose of 800 mg 3 times daily, significantly diminishes the antiplatelet effects of low-dose aspirin (baby) in healthy volunteers. Diclofenac (Systemic), 50 mg 3 times daily, did not interfere with the antiplatelet effects of low-dose aspirin (baby) in healthy volunteers. Ibuprofen, and possibly other nonselective NSAIDs, may reduce the cardioprotective effects of aspirin. It seems prudent to avoid regular, frequent use of ibuprofen in patients receiving aspirin for its cardioprotective effects. Alternative analgesics (eg, acetaminophen) or prescription diclofenac in place of prescription ibuprofen may be a safer choice.

Effects on Dental Treatment

The FDA notified consumers and healthcare professionals that the administration of ibuprofen for pain relief to patients taking aspirin for cardioprotection may interfere with aspirin’s cardiovascular benefits. The FDA states that ibuprofen can interfere with the antiplatelet effect of low-dose aspirin (81 mg/day). This could result in diminished effectiveness of aspirin as used for cardioprotection and stroke prevention. The FDA adds that although ibuprofen and aspirin can be taken together, it is recommended that consumers talk with their healthcare providers for additional information. For more information, including how to advise aspirin patients requiring ibuprofen for pain relief, see Effects on Bleeding and Dental Health Professional Considerations. (http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm110510.htm)

Effects on Bleeding

Nonselective NSAIDs such as ibuprofen inhibit platelet aggregation and prolong bleeding time in some patients. Unlike aspirin, the NSAID effect on platelet function is quantitatively less, of shorter duration, and reversible.

Dental Usual Dosing

Analgesic/pain/fever/dysmenorrhea: Oral:

Children: 4-10 mg/kg/dose every 6-8 hours

Adults: 200-400 mg/dose every 4-6 hours (maximum daily dose: 1.2 g, unless directed by physician; under physician supervision daily doses ≤3.2 g may be used)

OTC labeling (analgesic, antipyretic): Note: Treatment for >10 days is not recommended unless directed by healthcare provider. Oral:

Children 6 months to 11 years: See table; use of weight to select dose is preferred; doses may be repeated every 6-8 hours (maximum: 4 doses/day)

Children ≥12 years and Adults: 200 mg every 4-6 hours as needed (maximum: 1200 mg/24 hours)

Ibuprofen Dosing (Infants and Children 6 months to 11 years)
Weight (Preferred)a Age Dosage

(mg)

kg lb
aManufacturer’s recommendations are based on weight in pounds (OTC labeling); weight in kg listed here is derived from pounds and rounded; kg weight listed also is adjusted to allow for continuous weight ranges in kg.
5.4 to 8.1 12 to 17 6 to 11 mo 50
8.2 to 10.8 18 to 23 12 to 23 mo 75
10.9 to 16.3 24 to 35 2 to 3 y 100
16.4 to 21.7 36 to 47 4 to 5 y 150
21.8 to 27.2 48 to 59 6 to 8 y 200
27.3 to 32.6 60 to 71 9 to 10 y 250
32.7 to 43.2 72 to 95 11 y 300
Index Terms

p-Isobutylhydratropic Acid; Ibuprofen Lysine

FDA Approval Date
September 19, 1974
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Imazio M, Bobbio M, Cecchi E, et al. Colchicine in addition to conventional therapy for acute pericarditis: results of the COlchicine for acute PEricarditis (COPE) trial. Circulation. 2005;112(13):2012-2016.[PubMed 16186437]

Imazio M, Brucato A, Cemin R, et al; ICAP Investigators. A randomized trial of colchicine for acute pericarditis. N Engl J Med. 2013;369(16):1522-1528.[PubMed 23992557]

Imazio M, Brucato A, Trinchero R, et al, “Individualized Therapy for Pericarditis,” Expert Rev Cardiovasc Ther, 2009, 7(8):965-975.[PubMed 19673674]

“Inactive” ingredients in pharmaceutical products: update (subject review). American Academy of Pediatrics (AAP) Committee on Drugs. Pediatrics. 1997;99(2):268-278.[PubMed 9024461]

Isaksson M, Jansson L. Contact allergy to Tween 80 in an inhalation suspension. Contact Dermatitis. 2002;47(5):312-313.[PubMed 12534540]

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Kauffman RE and Nelson MV, “Effect of Age on Ibuprofen Pharmacokinetics and Antipyretic Response,” J Pediatr, 1992, 121(6):969-73.[PubMed 1447669]

Khanna D, Khanna PP, Fitzgerald JD, et al; American College of Rheumatology. 2012 American College of Rheumatology guidelines for management of gout. Part 2: therapy and antiinflammatory prophylaxis of acute gouty arthritis. Arthritis Care Res (Hoboken). 2012;64(10):1447-1461. doi: 10.1002/acr.21773.[PubMed 23024029]

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Kliegman RM, Stanton BF, St. Gemell JW, et al, eds. Nelson Textbook of Pediatrics. 19th ed. Philadelphia, PA: Saunders Elsevier; 2011.

Koca T, Akcam M. Ibuprofen induced DRESS syndrome in a child. Indian Pediatr. 2016;53(8):745.[PubMed 27567654]

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Litalien C, Jacqz-Aigrain E. Risks and benefits of nonsteroidal anti-inflammatory drugs in children: a comparison with paracetamol. Paediatr Drugs. 2001;3(11):817-858.[PubMed 11735667]

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Marchei E, Pellegrini M, Pichini S, et al, “Are False-Positive Phencyclidine Immunoassay Instant-View Multi-Test Results Caused by Overdose Concentrations of Ibuprofen, Metamizol, and Dextromethorphan?” Ther Drug Monit, 2007, 29(5):671-3.[PubMed 17898664]

Marjoribanks J, Proctor M, Farquhar C, Derks RS. Nonsteroidalanti-inflammatory drugs for dysmenorrhoea. Cochrane Database Syst Rev. 2010;(1):CD001751.[PubMed 20091521]10.1002/14651858.CD001751.pub2

Mehlisch DR, Sykes J. Ibuprofen blood plasma levels and onset of analgesia. Int J Clin Pract Suppl. 2013;(178):3-8. doi: 10.1111/ijcp.12053.[PubMed 23163542]

Midol liquid gels (ibuprofen) [prescribing information]. Morristown, NJ: Bayer HealthCare LLC; received May 2017.[PubMed 23163542]

Montgomery A, Hale TW, Academy Of Breastfeeding Medicine. ABM clinical protocol #15: analgesia and anesthesia for the breastfeeding mother, revised 2012. Breastfeed Med. 2012;7(6):547-553.[PubMed 23215911]

Motrin (ibuprofen) [prescribing information]. Fort Washington, PA: Johnson & Johnson Consumer Inc.; August 2016.

Motrin IB (ibuprofen) [prescribing information]. Fort Washington, PA: Johnson & Johnson Consumer Inc.; received March 2017.

Neoprofen (ibuprofen) [prescribing information]. Lebanon, NJ: Recordati Rare Diseases; December 2018.

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Brand Names: International

Actiprofen (IE); Actron (CR, DO, GT, HN, NI, PA, PY, SV, UY); Adagin (RO); Adex 200 (IL); Adex Liqui-Gels (IL); Advel (BD); Advil (AU, BR, CO, EE, FR, HK, HU, IE, IL, LB, MX, PH, PL, QA, RO, SA, VE, VN, ZA); Afebril (EC, PY); Aktren (AT); Algofen (IT); Am-Fam 400 (IN); Anafen (ID); Anco (DE); Antarene (FR); Arfen (ID); Argifen (ES); Asfen-400 (ET); Balkaprofen (BF, BJ, CI, ET, GH, GM, GN, KE, LR, MA, ML, MR, MU, MW, NE, NG, SC, SD, SL, SN, TN, TZ, UG, ZM, ZW); Bebyzal (KR); Bestafen (MX); Bifen (HK, SG); Bofen (UA); Brufen (AE, AT, AU, BD, BE, BH, CH, CY, CZ, DE, DK, EE, EG, ES, FI, FR, GB, GR, HK, HR, HU, ID, IE, IQ, IR, IT, JO, JP, KR, KW, LB, LK, LT, LU, LV, LY, MT, NL, NO, NZ, OM, PH, PK, PT, QA, RO, RU, SA, SE, SG, SI, SK, SY, TR, TW, VN, YE, ZA, ZW); Brufen 400 (IL); Brufen Forte (ID); Brufen Retard (SG); Brufen Syrup for Children (KR); Brufort (IT); Brupro (IE); Bufect (ID, LK); Bufect Forte (ID); Buplex (IE); Buprex (EC); Buprophar (BE); Burana (FI); Butafen (ET); Carol (KR); Cefen (TH); Cuprofen (TH); Dafen-Q (KR); Dalsy (ES); Degiton (TW); Diffutab SR 600 (KR); Dolafen (PH); Dolan FP (PH); Dolex (ZW); Dolgit (AE, CY, DE, EG, IQ, IR, JO, KW, LB, LY, OM, QA, SA, SY, YE); Dolocyl (CH); Dolomax (PE); Doloral (PE); Dolormin (DE); Dolprin (CR, DO, GT, HN, NI, PA, SV); Drin (GR); Druisel (AR); Easofen (MT); Evofen (MY); Expanfen (FR); Extrapan Gel (HK); Farsifen Forte (ID); Febratic (MX); Febryn (HK); Fenatic (ID); Fenbid (AE, BF, BJ, CI, CN, CY, EG, ET, GB, GH, GM, GN, IQ, IR, JO, KE, KW, LB, LR, LY, MA, ML, MR, MU, MW, NE, NG, OM, QA, SA, SC, SD, SL, SN, SY, TN, TZ, UG, YE, ZM, ZW); Fenpaed (NZ); Fever-Free (PH); Flamex (BD); Focus (IT); Genofen (ET); Gofen (LK, PH, TZ); Gyno-neuralgin (DE); Hagifen (VN); Ibufac (MY); Ibufen (IL, KR); Ibuflam (MX); Ibufug (DE); Ibugesic (IN, LB, LK); Ibugic (BE); Ibulgan (AE, BB, BF, BH, BJ, BM, BS, BZ, CI, CY, EG, ET, GH, GM, GN, GY, IL, IQ, IR, JM, JO, KE, KW, LB, LR, LY, MA, ML, MR, MU, MW, NE, NG, OM, QA, SA, SC, SD, SL, SN, SR, SY, TN, TT, TZ, UG, YE, ZM, ZW); Ibumetin (AT, DK, FI, NL, NO, SE); Ibunorm (UA); Ibupirac (AR, CL); Ibuprofen (HK); Ibusal (FI); Ibuspan (ZW); Ibutop (BH); Imet (UA); Infacalm (HK); Inufen (ET); Ipren (DK, RU, SE); Iprox (ID); Ipufen (TW); Irfen (AE, CH, CY, EG, IQ, IR, JO, KW, LB, LY, OM, QA, SA, SY, YE); Junifen (ES); Liptan (AE, CY, IL, IQ, IR, JO, JP, KW, LB, LY, OM, QA, SA, SY, YE); Medicol (PH); Medicol Advance (PH); Mensoton (DE); Mepabrufen (EG); Mofen (ID); Moris (ID); Moris Forte (ID); Motrin (AE, CO, CR, CY, DO, EG, GT, HN, IQ, IR, JO, KW, LB, LY, MX, NI, OM, PA, PE, QA, SA, SV, SY, YE); Mutrim (PH); Neoprofen (BM); Neutropain (HK); Nobafon (TW); Noritis (BF, BJ, CI, ET, GH, GM, GN, KE, LR, MA, ML, MR, MU, MW, NE, NG, SC, SD, SL, SN, TN, TZ, UG, ZM, ZW); Novogent (DE); Nureflex (AT); Nurofen (AT, AU, BE, BF, BG, BJ, CI, CY, CZ, DK, ES, ET, FR, GB, GH, GM, GN, HR, HU, IE, IS, KE, LR, LT, LU, LV, MA, ML, MR, MU, MW, MY, NE, NG, NL, NZ, SC, SD, SE, SG, SI, SK, SL, SN, TN, TR, TZ, UA, UG, VN, ZM, ZW); Nurofen for Children (SG, TH); Nurofen Gel (IL, NZ); Nurofen Pro san sucre (FR); Nuroffen (MT); Optifen (CH); Opturem (DE); Ostarin (ID); P-Fen (TH); Panafen (NZ); Pedea (AT, BE, BG, CH, CZ, DE, DK, EE, ES, FI, FR, GB, GR, IE, IT, KR, NL, NO, PL, PT, RU, SE, SK, TR); Peflam (BD); Perfen (TW); Perofen (BB, BM, BS, BZ, GY, HK, JM, SG, SR, TT); Profen (BD, HK); Profinal (AE, BH, EG, KW, LB, QA, SA); Proris (ID); Prosinal (ID); Provon (PE); Quadrax (MX); Rafen (AU); Ranofen (ZA); RatioDolor (AT); Remofen (AE, BH, JO, QA); Rhelafen (ID); Rhelafen Forte (ID); Rheumanox (TH); Rupan (AE, CY, EG, IQ, IR, JO, KW, LB, LY, OM, QA, SA, SY, YE); Ruprofen (TH); Sapofen (AE, BH, JO, KW, QA, SA); Spedifen (CN, FR, MY); Speedifen (TH); Spifen (FR); Syntofene (FR); Tabalon (CR, DO, GT, HN, NI, PA, SV); Tabalon 400 (MX); Tarein (TW); Taskine (AE, CY, EG, IQ, IR, JO, KW, LB, LY, OM, QA, SA, SY, YE); Tefin (IE); Tenvalin (EC); Thomaprodol (AT); Ufen (LK); Upfen (FR); Uprofen (TW); Urem (DE); Vantril (PY); Xfen Flashtab (PH); Zofen (MY); Zorafen (MY)

Last Updated 4/2/19
Ibuprofen (Patient Education – Adult Medication)
You must carefully read the “Consumer Information Use and Disclaimer” below in order to understand and correctly use this information
Pronunciation

(eye byoo PROE fen)

Brand Names: US

Addaprin [OTC]; Advil Junior Strength [OTC]; Advil Migraine [OTC]; Advil [OTC]; Caldolor; Childrens Advil [OTC]; Childrens Motrin [OTC]; Dyspel [OTC]; Genpril [OTC]; GoodSense Ibuprofen Childrens [OTC]; GoodSense Ibuprofen [OTC]; I-Prin [OTC] [DSC]; IBU; IBU-200 [OTC]; Ibuprofen Childrens [OTC]; Ibuprofen Comfort Pac [DSC]; Infants Advil [OTC]; KS Ibuprofen [OTC]; Motrin IB [OTC]; Motrin Infants Drops [OTC]; NeoProfen; Provil [OTC]

Brand Names: Canada

Advil; Advil Pediatric Drops; Caldolor; Children’s Advil; Children’s Europrofen; Ibuprofen Muscle and Joint; Motrin; Motrin (Children’s); Motrin IB; Pamprin Ibuprofen Formula; Super Strength Motrin IB Liquid Gel Capsules

Warning
  • This drug may raise the chance of heart and blood vessel side effects like heart attack and stroke. If these happen, they can be deadly. The risk of these side effects may be greater if you have heart disease or risks for heart disease. However, the risk may also be raised in people who do not have heart disease or risks for heart disease. The risk of these health problems can happen as soon as the first weeks of using this drug and may be greater with higher doses or with long-term use. Do not use this drug right before or after bypass heart surgery.
  • This drug may raise the chance of very bad and sometimes deadly stomach or bowel side effects like ulcers or bleeding. The risk is greater in older people. The risk is also greater in people who have had stomach or bowel ulcers or bleeding before. These problems may occur without warning signs. Talk with the doctor.
What is this drug used for?
  • It is used to ease pain, swelling, and fever.
  • It is used to ease painful period (menstrual) cycles.
  • It is used to treat arthritis.
  • It may be given to you for other reasons. Talk with the doctor.
What do I need to tell my doctor BEFORE I take this drug?
  • If you have an allergy to ibuprofen, aspirin, NSAIDS, or any other part of this drug.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you have any of these health problems: GI (gastrointestinal) bleeding or kidney problems.
  • If you are having trouble getting pregnant or you are having your fertility checked.
  • If you are pregnant or may be pregnant. Do not take this drug if you are in the third trimester of pregnancy. You may also need to avoid this drug at other times during pregnancy. Talk with your doctor to see when you need to avoid taking this drug during pregnancy.
  • If you are taking any other NSAID.
  • If you are taking a salicylate drug like aspirin.
  • If you are taking pemetrexed.
  • This is not a list of all drugs or health problems that interact with this drug.
  • Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this drug with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
What are some things I need to know or do while I take this drug?
  • All products:
  • Tell all of your health care providers that you take this drug. This includes your doctors, nurses, pharmacists, and dentists.
  • Have your blood work checked if you are on this drug for a long time. Talk with your doctor.
  • High blood pressure has happened with drugs like this one. Have your blood pressure checked as you have been told by your doctor.
  • Talk with your doctor before you drink alcohol.
  • If you smoke, talk with your doctor.
  • If you have asthma, talk with your doctor. You may be more sensitive to this drug.
  • You may bleed more easily. Be careful and avoid injury. Use a soft toothbrush and an electric razor.
  • The chance of heart failure is raised with the use of drugs like this one. In people who already have heart failure, the chance of heart attack, having to go to the hospital for heart failure, and death is raised. Talk with the doctor.
  • The chance of heart attack and heart-related death is raised in people taking drugs like this one after a recent heart attack. People taking drugs like this one after a first heart attack were also more likely to die in the year after the heart attack compared with people not taking drugs like this one. Talk with the doctor.
  • If you are taking aspirin to help prevent a heart attack, talk with your doctor.
  • This drug may affect how much of some other drugs are in your body. If you are taking other drugs, talk with your doctor. You may need to have your blood work checked more closely while taking this drug with your other drugs.
  • This drug may raise the chance of a very bad brain problem called aseptic meningitis. Call your doctor right away if you have a headache, fever, chills, very upset stomach or throwing up, stiff neck, rash, bright lights bother your eyes, feeling sleepy, or feeling confused.
  • Liver problems have happened with drugs like this one. Sometimes, this has been deadly. Call your doctor right away if you have signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
  • If you are 60 or older, use this drug with care. You could have more side effects.
  • NSAIDs like this drug may affect egg release (ovulation) in women. This may cause you to not be able to get pregnant. This goes back to normal when this drug is stopped. Talk with your doctor.
  • This drug may cause harm to the unborn baby if you take it while you are pregnant. If you are pregnant or you get pregnant while taking this drug, call your doctor right away.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.
  • Chewable tablet:
  • If you have phenylketonuria (PKU), talk with your doctor. Some products have phenylalanine.
What are some side effects that I need to call my doctor about right away?
  • WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of bleeding like throwing up blood or throw up that looks like coffee grounds; coughing up blood; blood in the urine; black, red, or tarry stools; bleeding from the gums; vaginal bleeding that is not normal; bruises without a reason or that get bigger; or any bleeding that is very bad or that you cannot stop.
  • Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
  • Signs of high potassium levels like a heartbeat that does not feel normal; feeling confused; feeling weak, lightheaded, or dizzy; feeling like passing out; numbness or tingling; or shortness of breath.
  • Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
  • Shortness of breath, a big weight gain, or swelling in the arms or legs.
  • Chest pain or pressure or a fast heartbeat.
  • Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
  • Feeling very tired or weak.
  • Ringing in ears.
  • Very upset stomach or throwing up.
  • Very bad belly pain.
  • Very bad back pain.
  • Change in eyesight.
  • A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.
What are some other side effects of this drug?
  • All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
  • Belly pain or heartburn.
  • Upset stomach or throwing up.
  • Constipation.
  • Diarrhea.
  • Gas.
  • Dizziness.
  • These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
  • You may report side effects to your national health agency.
How is this drug best taken?
  • Use this drug as ordered by your doctor. Read all information given to you. Follow all instructions closely.
  • All oral products:
  • Take with or without food. Take with food if it causes an upset stomach.
  • Take with a full glass of water.
  • Capsule:
  • Swallow whole. Do not chew, break, or crush.
  • Chewable tablet:
  • Chew well before swallowing.
  • All liquid products:
  • Shake well before use.
  • Liquid (suspension):
  • Measure liquid doses carefully. Use the measuring device that comes with this drug. If there is none, ask the pharmacist for a device to measure this drug.
  • Liquid (drops):
  • Measure liquid doses carefully. Use the measuring device that comes with this drug.
  • Injection:
  • It is given as an infusion into a vein over a period of time.
  • All products:
  • Drink lots of noncaffeine liquids unless told to drink less liquid by your doctor.
  • Do not take more than what your doctor told you to take. Taking more than you are told may raise your chance of very bad side effects.
  • Do not take this drug for longer than you were told by your doctor.
What do I do if I miss a dose?
  • All oral products:
  • If you take this drug on a regular basis, take a missed dose as soon as you think about it.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.
  • Many times this drug is taken on an as needed basis. Do not take more often than told by the doctor.
  • Injection:
  • Call your doctor to find out what to do.
How do I store and/or throw out this drug?
  • All oral products:
  • Store at room temperature.
  • Protect from light.
  • Store in a dry place. Do not store in a bathroom.
  • Injection:
  • If you need to store this drug at home, talk with your doctor, nurse, or pharmacist about how to store it.
  • All products:
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
General drug facts
  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else’s drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
Ibuprofen (Patient Education – Pediatric Medication)
You must carefully read the “Consumer Information Use and Disclaimer” below in order to understand and correctly use this information
Pronunciation

(eye byoo PROE fen)

Brand Names: US

Addaprin [OTC]; Advil Junior Strength [OTC]; Advil Migraine [OTC]; Advil [OTC]; Caldolor; Childrens Advil [OTC]; Childrens Motrin [OTC]; Dyspel [OTC]; Genpril [OTC]; GoodSense Ibuprofen Childrens [OTC]; GoodSense Ibuprofen [OTC]; I-Prin [OTC] [DSC]; IBU; IBU-200 [OTC]; Ibuprofen Childrens [OTC]; Ibuprofen Comfort Pac [DSC]; Infants Advil [OTC]; KS Ibuprofen [OTC]; Motrin IB [OTC]; Motrin Infants Drops [OTC]; NeoProfen; Provil [OTC]

Brand Names: Canada

Advil; Advil Pediatric Drops; Caldolor; Children’s Advil; Children’s Europrofen; Ibuprofen Muscle and Joint; Motrin; Motrin (Children’s); Motrin IB; Pamprin Ibuprofen Formula; Super Strength Motrin IB Liquid Gel Capsules

Warning
  • All products other than injection for patent ductus arteriosus (PDA):
  • This drug may raise the chance of heart and blood vessel side effects like heart attack and stroke. If these happen, they can be deadly. The risk of these side effects may be greater if your child has heart disease or risks for heart disease. However, the risk may also be raised in people who do not have heart disease or risks for heart disease. The risk of these health problems can happen as soon as the first weeks of using this drug and may be greater with higher doses or with long-term use. Do not give this drug to your child right before or after bypass heart surgery.
  • This drug may raise the chance of very bad and sometimes deadly stomach or bowel side effects like ulcers or bleeding. The risk is greater in older people. The risk is also greater in people who have had stomach or bowel ulcers or bleeding before. These problems may occur without warning signs. Talk with the doctor.
What is this drug used for?
  • It is used to ease pain, swelling, and fever.
  • It is used to treat arthritis.
  • It is used to treat patent ductus arteriosus (PDA).
  • It may be given to your child for other reasons. Talk with the doctor.
What do I need to tell the doctor BEFORE my child takes this drug?
  • All products:
  • If your child has an allergy to this drug or any part of this drug.
  • If your child has an allergy to aspirin or NSAIDs.
  • If your child is allergic to any drugs like this one or any other drugs, foods, or other substances. Tell the doctor about the allergy and what signs your child had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • Injection for patent ductus arteriosus (PDA):
  • If your child has any health problems that this drug must not be taken with like an untreated infection, certain bleeding problems, and certain types of heart or kidney disease. There are many health problems that your child must not take this drug with.
  • If your child has low platelet levels.
  • If your child has active bleeding.
  • If your child has bowel problems.
  • All products other than injection for patent ductus arteriosus (PDA):
  • If your child has kidney disease.
  • If your child has GI (gastrointestinal) bleeding.
  • If your child is having her fertility checked.
  • If your child is taking any other NSAID.
  • If your child is taking a salicylate drug like aspirin.
  • If your child is taking pemetrexed.
  • If your child is pregnant:
  • Do not give this drug to your child if she is in the third trimester of pregnancy. You may also need to avoid giving this drug to your child at other times during pregnancy. Talk with your child’s doctor to see when you need to avoid giving this drug to your child during pregnancy.
  • This is not a list of all drugs or health problems that interact with this drug.
  • Tell the doctor and pharmacist about all of your child’s drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for your child to take this drug with all of his/her drugs and health problems. Do not start, stop, or change the dose of any drug your child takes without checking with the doctor.
What are some things I need to know or do while my child takes this drug?
  • All products:
  • Tell all of your child’s health care providers that your child is taking this drug. This includes your child’s doctors, nurses, pharmacists, and dentists.
  • Injection for patent ductus arteriosus (PDA):
  • To gain the most benefit, do not miss giving your child doses.
  • Your child may bleed more easily. Talk with the doctor.
  • All products other than injection for patent ductus arteriosus (PDA):
  • Have your child’s blood work checked if he/she is on this drug for a long time. Talk with your child’s doctor.
  • High blood pressure has happened with drugs like this one. Have your child’s blood pressure checked as you have been told by the doctor.
  • Alcohol may interact with this drug. Be sure your child does not drink alcohol.
  • If your child smokes, talk with the doctor.
  • Do not give your child more of this drug than what the doctor told you to give. Giving more of this drug than you are told may raise the chance of very bad side effects.
  • Do not have your child use longer than you have been told by your child’s doctor.
  • If your child has asthma, talk with the doctor. He/she may be more sensitive to this drug.
  • Your child may bleed more easily. Make sure your child is careful and avoids injury. Be sure your child has a soft toothbrush.
  • The chance of heart failure is raised with the use of drugs like this one. In people who already have heart failure, the chance of heart attack, having to go to the hospital for heart failure, and death is raised. Talk with the doctor.
  • The chance of heart attack and heart-related death is raised in people taking drugs like this one after a recent heart attack. People taking drugs like this one after a first heart attack were also more likely to die in the year after the heart attack compared with people not taking drugs like this one. Talk with the doctor.
  • If your child is taking aspirin to help prevent a heart attack, talk with the doctor.
  • This drug may affect how much of some other drugs are in the body. If your child is taking other drugs, talk with the doctor. Your child may need to have blood work checked more closely while taking this drug with other drugs.
  • If your child is or may be sexually active:
  • NSAIDs like this drug may affect egg release (ovulation) in females. This may affect being able to get pregnant. This goes back to normal when this drug is stopped. Talk with the doctor.
  • If your child is pregnant or breast-feeding a baby:
  • This drug may cause harm to the unborn baby if your child takes it during pregnancy. If your child is pregnant or gets pregnant while taking this drug, call the doctor right away.
  • Tell the doctor if your child is breast-feeding a baby. You will need to talk about any risks to the baby.
  • Chewable tablet:
  • If your child has phenylketonuria (PKU), talk with your child’s doctor. Some products have phenylalanine.
What are some side effects that I need to call my child’s doctor about right away?
  • WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your child’s doctor or get medical help right away if your child has any of the following signs or symptoms that may be related to a very bad side effect:
  • All products:
  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of bleeding like throwing up blood or throw up that looks like coffee grounds; coughing up blood; blood in the urine; black, red, or tarry stools; bleeding from the gums; vaginal bleeding that is not normal; bruises without a reason or that get bigger; or any bleeding that is very bad or that you cannot stop.
  • Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
  • Feeling very tired or weak.
  • Injection for patent ductus arteriosus (PDA):
  • Signs of bowel problems like black, tarry, or bloody stools; fever; mucus in the stools; throwing up blood or throw up that looks like coffee grounds; or very bad stomach pain, constipation, or diarrhea.
  • Signs of low blood sugar like dizziness, headache, feeling sleepy, feeling weak, shaking, a fast heartbeat, confusion, hunger, or sweating.
  • Signs of electrolyte problems like mood changes, confusion, muscle pain or weakness, a heartbeat that does not feel normal, seizures, not hungry, or very bad upset stomach or throwing up.
  • Signs of a urinary tract infection (UTI) like blood in the urine, burning or pain when passing urine, feeling the need to pass urine often or right away, fever, lower stomach pain, or pelvic pain.
  • Signs of a weak adrenal gland like a very bad upset stomach or throwing up, very bad dizziness or passing out, muscle weakness, feeling very tired, mood changes, not hungry, or weight loss.
  • Shortness of breath.
  • Long stops between breaths.
  • Fever or chills.
  • This drug may irritate the vein. If the drug leaks from the vein, it may also cause irritation around that area. Tell your child’s nurse if your child has any redness, burning, pain, swelling, or leaking of fluid where the drug is going into your child’s body.
  • All products other than injection for patent ductus arteriosus (PDA):
  • Signs of high potassium levels like a heartbeat that does not feel normal; feeling confused; feeling weak, lightheaded, or dizzy; feeling like passing out; numbness or tingling; or shortness of breath.
  • Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
  • Shortness of breath, a big weight gain, or swelling in the arms or legs.
  • Chest pain or pressure or a fast heartbeat.
  • Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
  • Ringing in ears.
  • Very upset stomach or throwing up.
  • Very bad belly pain.
  • Very bad back pain.
  • Change in eyesight.
  • Liver problems have happened with drugs like this one. Sometimes, this has been deadly. Call the doctor right away if your child has signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
  • A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if your child has signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in the mouth, throat, nose, or eyes.
  • This drug may raise the chance of a very bad brain problem called aseptic meningitis. Call the doctor right away if your child has a headache, fever, chills, very upset stomach or throwing up, stiff neck, rash, bright lights bother the eyes, feeling sleepy, or feeling confused.
What are some other side effects of this drug?
  • All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your child’s doctor or get medical help if any of these side effects or any other side effects bother your child or do not go away:
  • Injection for patent ductus arteriosus (PDA):
  • Irritation where the shot is given.
  • All products other than injection for patent ductus arteriosus (PDA):
  • Belly pain or heartburn.
  • Upset stomach or throwing up.
  • Diarrhea.
  • Constipation.
  • Gas.
  • Dizziness.
  • These are not all of the side effects that may occur. If you have questions about side effects, call your child’s doctor. Call your child’s doctor for medical advice about side effects.
  • You may report side effects to your national health agency.
How is this drug best given?
  • Give this drug as ordered by your child’s doctor. Read all information given to you. Follow all instructions closely.
  • All oral products:
  • Give this drug with or without food. Give with food if it causes an upset stomach.
  • Give this drug with a full glass of water.
  • Capsule:
  • Have your child swallow whole. Do not let your child chew, break, or crush.
  • Chewable tablet:
  • Have your child chew well before swallowing.
  • All liquid products:
  • Shake well before use.
  • Liquid (suspension):
  • Measure liquid doses carefully. Use the measuring device that comes with this drug. If there is none, ask the pharmacist for a device to measure this drug.
  • Liquid (drops):
  • Measure liquid doses carefully. Use the measuring device that comes with this drug.
  • All injection products:
  • It is given as an infusion into a vein over a period of time.
  • All products other than injection for patent ductus arteriosus (PDA):
  • Have your child drink lots of noncaffeine liquids unless told to drink less liquid by your child’s doctor.
What do I do if my child misses a dose?
  • All oral products:
  • If your child takes this drug on a regular basis, give a missed dose as soon as you think about it.
  • If it is close to the time for your child’s next dose, skip the missed dose and go back to your child’s normal time.
  • Do not give 2 doses at the same time or extra doses.
  • Many times this drug is given on an as needed basis. Do not give to your child more often than told by the doctor.
  • All injection products:
  • Call your child’s doctor to find out what to do.
How do I store and/or throw out this drug?
  • All oral products:
  • Store at room temperature.
  • Protect from light.
  • Store in a dry place. Do not store in a bathroom.
  • All injection products:
  • If you need to store this drug at home, talk with your child’s doctor, nurse, or pharmacist about how to store it.
  • All products:
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
General drug facts
  • If your child’s symptoms or health problems do not get better or if they become worse, call your child’s doctor.
  • Do not share your child’s drug with others and do not give anyone else’s drug to your child.
  • Keep a list of all your child’s drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your child’s doctor.
  • Talk with your child’s doctor before giving your child any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your child’s doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.