Ibuprofen Details

Side effects of Ibuprofen:

Cardiovascular Risk •
NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk.
MOTRIN tablets are contraindicated for treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery.

Gastrointestinal Risk 

NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events

Renal Effects
Long-term administration of NSAIDs has resulted in renal papillary necrosis and other renal injury. Renal toxicity has also been seen in patients in whom renal prostaglandins have a compensatory role in the maintenance of renal perfusion. In these patients, administration of a NSAID may cause a dosedependent reduction in prostaglandin formation and, secondarily, in renal blood flow, which may precipitate overt renal decompensation. Patients at greatest risk of this reaction are those with impaired renal function, heart failure, liver dysfunction, those taking diuretics and ACE inhibitors, and the elderly. Discontinuation of NSAID therapy is usually followed by recovery to the pretreatment state. Advanced Renal Disease No information is available from controlled clinical studies regarding the use of MOTRIN tablets in patients with advanced renal disease. Therefore, treatment with MOTRIN tablets is not recommended in these patients with advanced renal disease. If MOTRIN tablet therapy must be initiated, close monitoring of the patients renal function is advisable

Hepatic effects
Borderline elevations of one or more liver tests may occur in up to 15% of patients taking NSAIDs, including MOTRIN tablets. These laboratory abnormalities may progress, may remain unchanged, or may be transient with continuing therapy. Notable elevations of ALT or AST (approximately three or more times the upper limit of normal) have been reported in approximately 1% of patients in clinical trials with NSAIDs. In addition, rare cases of severe hepatic reactions, including jaundice, fulminant hepatitis, liver necrosis, and hepatic failure, some of them with fatal outcomes have been reported. A patient with symptoms and/or signs suggesting liver dysfunction, or with abnormal liver test values, should be evaluated for evidence of the development of a more severe hepatic reaction while on therapy with MOTRIN tablets. If clinical signs and symptoms consistent with liver disease develop, or if systemic manifestations occur (e.g., eosinophilia, rash, etc.), MOTRIN tablets should be discontinued.

Dosing/Administration

Adult Dosing

Important Note

• Use the lowest effective dose of ibuprofen for the shortest possible duration to reduce the risk of serious adverse effects. After the initial response to treatment is observed, adjust the ibuprofen dose and frequency to suit the individual patient's needs [2].
• Beers Criteria: Use caution or avoid use as potentially inappropriate in older adults [3].
• Orphan drug designation (IV): Prevention of patent ductus arteriosus

Cystic fibrosis

• Initial, 20 to 30 mg/kg orally twice daily; MAX, 1600 mg/dose; titration, adjust to provide a peak plasma concentration of 50 to 100 mcg/mL [4]

Fever

• (Oral) Nonprescription dosing, 200 to 400 mg orally every 4 to 6 hours as needed; MAX 1200 mg/day; do not take longer than 10 days unless directed by physician.
• (Injection) 400 mg IV every 4 to 6 hours OR alternatively 100 to 200 mg IV every 4 hours as needed, infused over at least 30 minutes, MAX 3200 mg/day (FDA dosage) [5]
• (Injection) 400 mg IV every 4 hours as needed, infused over 5 to 10 minutes when diluted in NS to a concentration less than 4 mg/mL (off-label dosage) [6]

Headache

• 200 to 400 mg ORALLY every 4 to 6 hours as needed; MAX dose, 1200 mg in 24 hours [7]

Migraine

• 400 mg ORALLY once daily up to 10 days [8]

Osteoarthritis

• 1200 to 3200 mg/day ORALLY divided in 3 to 4 doses; for non-prescription dosing, do not take longer than 10 days unless directed by a physician

Pain

• (Oral) Non-prescription dosing, 200 to 400 mg orally every 4 to 6 hours as needed, MAX 1200 mg/day; do not take longer than 10 days unless directed by a physician
• (Injection) 400 to 800 mg IV every 6 hours as needed, infused over at least 30 minutes; MAX 3200 mg/day (FDA dosage) [5]
• (Injection) 800 mg IV every 6 hours as needed, infused over 5 to 10 minutes when diluted in NS to a concentration less than 4 mg/mL (off-label dosage) [6]

Primary dysmenorrhea

• 400 mg ORALLY every 4 hours as needed; for non-prescription dosing, do not take longer than 10 days unless directed by a physician

Rheumatoid arthritis

• 1200 to 3200 mg/day ORALLY divided in 3 to 4 doses; for non-prescription dosing, do not take longer than 10 days unless directed by a physician

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Medication Safety

Adverse Effects

See 'In-Depth Answers' for detailed results.

Common

• Cardiovascular: Hypotension (intravenous, up to 10% )
• Dermatologic: Injection site pain (Pediatric, 2% or greater ), Rash (oral, 3% to 9% )
• Endocrine metabolic: Hypernatremia (intravenous, up to 10% ), Hypoalbuminemia (intravenous, 3% to 10% ), Hypoproteinemia (intravenous, up to 13% ), Serum lactate dehydrogenase level elevated (intravenous, 3% to 10% )
• Gastrointestinal: Flatulence (injection, 7% to 16% ), Heartburn (oral, 3% to 9% ), Nausea (Oral, 3% to 9% ; Intravenous, 53% to 57% (adults) , 2% or greater (pediatrics)), Vomiting (Intravenous, 15% to 22% (adults) , 2% or greater (pediatrics) )
• Hematologic: Thrombocytosis (intravenous, 3% to 10% )
• Immunologic: Bacteremia (injection, 13% )
• Neurologic: Dizziness (oral, 3% to 9%; intravenous 4% to 6% ), Headache (Oral, 1% to 3% (adults) ; intravenous, 9% to 11% (adults) , 2% or greater (pediatrics) )
• Renal: Serum blood urea nitrogen raised (intravenous, up to 10% ), Urinary retention (intravenous, 3% to 5% )
• Respiratory: Bacterial pneumonia (intravenous, 3% to 10% )

Serious

• Cardiovascular: Cardiac arrest, Congestive heart failure (Oral, less than 1% (adults) ), Hypertension (oral, less than 1%; intravenous, up to 10% ), Myocardial infarction, Thrombotic tendency observations
• Dermatologic: Erythema multiforme (oral, less than 1% .), Erythroderma, Stevens-Johnson syndrome (oral, less than 1% ), Toxic epidermal necrolysis
• Endocrine metabolic: Hyperkalemia
• Gastrointestinal: Gastrointestinal hemorrhage (Oral, less than 1% ), Gastrointestinal perforation (Oral, less than 1% ), Gastrointestinal ulcer, Inflammatory disorder of digestive tract, Melena (oral, less than 1% ), Pancreatitis (oral, less than 1% )
• Hematologic: Agranulocytosis (oral, less than 1% ), Anemia (Intravenous, 2% to 36% (adults) , 2% or greater (pediatrics) ), Aplastic anemia (oral, less than 1% ), Hemolytic anemia (oral, less than 1% ), Hemorrhage (intravenous, 4% to 10% ), Neutropenia (intravenous, 7% to 13%; oral, less than 1% ), Thrombocytopenia (less than 1% ), Wound hemorrhage (intravenous, 1% to 3% )
• Hepatic: Fulminant hepatitis (rare ), Hepatic necrosis (rare ), Hepatitis (oral, less than 1% ), Hepatotoxicity (rare ), Jaundice (oral, less than 1% ), Liver failure (rare ), Vanishing bile duct syndrome
• Immunologic: Anaphylactoid reaction (oral, less than 1% ), Hypersensitivity reaction (oral, less than 1% )
• Neurologic: Aseptic meningitis (oral, less than 1% ), Cerebrovascular accident
• Ophthalmic: Amblyopia (oral, less than 1% )
• Otic: Hearing loss (oral, less than 1% )
• Psychiatric: Depression (oral, less than 1% )
• Renal: Acute renal failure (Oral, less than 1% ), Azotemia (oral, less than 1% ), Hematuria (oral, less than 1% ), Injury of kidney, Papillary necrosis (Oral, less than 1% )
• Other: Reye's syndrome

Medication Safety

Precautions

See 'In-Depth Answers' for detailed results.

Beers Criteria: Avoid chronic use in older adults unless other alternatives are not effective and patient can take gastroprotective agent (ie, proton pump inhibitor or misoprostol) due to increased risk of gastrointestinal bleeding and peptic ulcer disease, especially in high-risk groups (eg, patients with a history of gastric or duodenal ulcers, patients older than 75 years old, with concomitant use of oral or parenteral corticosteroids, anticoagulants, or antiplatelet agents). Avoid use in older adults with heart failure as fluid retention and heart failure exacerbation may occur. Avoid use in older adults with stage 4 or 5 chronic kidney disease stage as use may increase risk of kidney injury [3].

Cardiovascular: Increased risk for reinfarction and death (as early as the first week of treatment) has been reported in patients treated with NSAIDs after a myocardial infarction. Avoid use in patients with a recent myocardial infarction unless the benefits outweigh the risks. Monitoring recommended [5].

Cardiovascular: Fluid retention and edema have been reported with NSAID use [5].

Cardiovascular: Use caution in patients with hypertension, fluid retention, or heart failure. New or worsening symptoms, including peripheral edema and fluid retention, may occur along with increased risk of cardiovascular events [15].

Cardiovascular: Increased hospitalizations for heart failure have been reported with NSAID use. Avoid use in patients with severe heart failure unless the benefits outweigh the risks. Monitoring recommended [5].

Chronic use: Chronic use increases risk of serious and potentially fatal adverse effects, including anemia and gastrointestinal or renal injury [15][16]

Concomitant use: ACE inhibitors, thiazides, or loop diuretics increases risk of renal toxicity and injury [15][16]

Concomitant use: Increased risk of serious gastrointestinal events with oral corticosteroids [15][16]

Concomitant use: Smoking or alcohol use increases risk of potentially fatal gastrointestinal bleeding, ulceration, or perforation that may occur without warning [15][16]

Dermatologic: Potentially fatal skin reactions, including exfoliative dermatitis, Stevens Johnson syndrome, and toxic epidermal necrolysis, may occur [15][16]

Gastrointestinal: Serious adverse gastrointestinal events including bleeding, ulceration, and perforation have been reported and may be fatal. Events may occur without warning, patient may not be symptomatic. Risk increased with duration of therapy, concomitant oral corticosteroids, aspirin, anticoagulants, SSRIs, smoking, or alcohol use, and in the elderly or patients with poor general health, coagulopathies, or advanced liver disease. Use lowest effective dose for shortest duration, do not administer more than one NSAID at a time, and avoid use in high-risk patients if possible. Monitoring recommended [16].

General health: Patients with poor general health are at greater risk for gastrointestinal injury [15][16]

Hematologic: Bleeding may occur as ibuprofen inhibits platelet aggregation [15][16]

Hepatic: Liver dysfunction increases risk of renal toxicity and injury and severe and possibly fatal hepatic reactions [15][16]

Hepatic: Jaundice, fatal fulminant hepatitis, liver necrosis, and hepatic failure have been reported [15]. Elevated liver enzymes may occur. Discontinue use if symptoms consistent with liver disease, or systemic manifestations (such as rash, eosinophilia), occur [16]

Immunologic: Anaphylactic reactions may occur, with or without known hypersensitivity to ibuprofen and in patients with aspirin-sensitive asthma [16]

Immunologic: Use caution in patients with aspirin triad, manifested as bronchospasm in asthmatic patients with rhinitis with or without nasal polyps following aspirin or NSAID administration, due to risk of severe and potentially fatal bronchospasm [15][16]

Immunologic: Use caution in patients with lupus erythematosus or related connective tissue diseases as aseptic meningitis with fever and coma has been reported [15][16]

Ophthalmic: Blurred or diminished vision, scotomata, and changes in color vision have been reported [15]

Renal: Renal papillary necrosis, renal toxicity, and other renal injury has been reported. Correct volume status prior to initiation in dehydrated or hypovolemic patients. Monitoring recommended in patients with dehydration, heart failure, hepatic impairment, hypovolemia, or renal impairment [5].

Renal: Hyperkalemia and increased serum potassium has been reported, even in patients without renal impairment [5].

Renal: Avoid use in patients with advanced renal disease unless the benefits outweigh the risks; monitoring recommended [5]

Reproductive: Avoid use in pregnant patients during third trimester due to risk of premature closure of ductus arteriosus [15][16]

Respiratory: Patients with preexisting asthma are at risk of severe and potentially fatal bronchospasm [15][16]

Drugs:	Severity:	Documentation:	Summary:
KETOROLAC -- NSAIDS	Contraindicated	Fair	Concurrent use of KETOROLAC and NSAIDS may result in enhanced gastrointestinal adverse effects (peptic ulcers, gastrointestinal bleeding and/or perforation).
NSAID -- TRICYCLIC ANTIDEPRESSANTS Ibuprofen interact(s) with:Interacting substances	Major	Excellent	Concurrent use of NSAID and TRICYCLIC ANTIDEPRESSANTS may result in an increased risk of bleeding.
NSAID -- SEROTONIN NOREPINEPHRINE REUPTAKE INHIBITORS Ibuprofen interact(s) with:Interacting substances	Major	Excellent	Concurrent use of NSAID and SEROTONIN NOREPINEPHRINE REUPTAKE INHIBITORS may result in an increased risk of bleeding.
CYCLOSPORINE -- NONSTEROIDAL ANTIINFLAMMATORY AGENTS	Major	Excellent	Concurrent use of CYCLOSPORINE and NONSTEROIDAL ANTIINFLAMMATORY AGENTS may result in an increased risk of cycloSPORINE nephrotoxicity.
NSAID -- SSRI Ibuprofen interact(s) with:Interacting substances	Major	Excellent	Concurrent use of NSAID and SSRI may result in an increased risk of bleeding.
NSAIDS -- POTASSIUM-SPARING DIURETICS Ibuprofen interact(s) with:Interacting substances	Major	Good	Concurrent use of NSAIDS and POTASSIUM-SPARING DIURETICS may result in reduced diuretic effectiveness, hyperkalemia, or possible nephrotoxicity.
GINKGO -- NONSTEROIDAL ANTIINFLAMMATORY AGENTS	Major	Good	Concurrent use of GINKGO and NONSTEROIDAL ANTIINFLAMMATORY AGENTS may result in an increased risk of bleeding.
LOW-MOLECULAR-WEIGHT HEPARINS -- NSAIDS Ibuprofen interact(s) with:Interacting substances	Major	Good	Concurrent use of LOW-MOLECULAR-WEIGHT HEPARINS and NSAIDS may result in an increased risk of bleeding.
NSAIDS -- THIAZIDE DIURETICS Ibuprofen interact(s) with:Interacting substances	Major	Good	Concurrent use of NSAIDS and THIAZIDE DIURETICS may result in reduced diuretic effectiveness and possible nephrotoxicity.
ASPIRIN [Systemic] -- IBUPROFEN [Systemic]	Major	Good	Concurrent use of ASPIRIN and IBUPROFEN may result in decreased antiplatelet effect of aspirin and additive risk of bleeding.
TACROLIMUS -- NONSTEROIDAL ANTIINFLAMMATORY AGENTS	Major	Good	Concurrent use of TACROLIMUS and NONSTEROIDAL ANTIINFLAMMATORY AGENTS may result in acute renal failure.
LOOP DIURETICS -- NSAIDS Ibuprofen interact(s) with:Interacting substances	Major	Good	Concurrent use of LOOP DIURETICS and NSAIDS may result in reduced diuretic effectiveness and possible nephrotoxicity.
IBUPROFEN [Systemic] -- METHOTREXATE [Systemic]	Major	Good	Concurrent use of METHOTREXATE and IBUPROFEN may result in an increased risk of methotrexate toxicity (leukopenia, thrombocytopenia, anemia, nephrotoxicity, mucosal ulcerations).
PEMETREXED -- NSAIDS	Major	Fair	Concurrent use of PEMETREXED and NSAIDS may result in pemetrexed toxicity (myelosuppression, renal toxicity, and gastrointestinal toxicity).
ANTIPLATELET AGENTS -- NSAIDS Ibuprofen interact(s) with:Interacting substances	Major	Fair	Concurrent use of ANTIPLATELET AGENTS and NSAIDS may result in increased risk of bleeding.
DICLOFENAC -- NSAIDS AND SALICYLATES	Major	Fair	Concurrent use of DICLOFENAC and NSAIDS AND SALICYLATES may result in increased risk of bleeding.
INDOMETHACIN -- NSAIDS AND SALICYLATES	Major	Fair	Concurrent use of INDOMETHACIN and NSAIDS AND SALICYLATES may result in increased risk of bleeding.
PENTOSAN POLYSULFATE SODIUM -- NONSTEROIDAL ANTIINFLAMMATORY AGENTS	Major	Fair	Concurrent use of PENTOSAN POLYSULFATE SODIUM and NONSTEROIDAL ANTIINFLAMMATORY AGENTS may result in an increased risk of bleeding.
PENTOXIFYLLINE -- NONSTEROIDAL ANTIINFLAMMATORY AGENTS	Major	Fair	Concurrent use of PENTOXIFYLLINE and NONSTEROIDAL ANTIINFLAMMATORY AGENTS may result in an increased risk of bleeding.
PRALATREXATE -- NONSTEROIDAL ANTIINFLAMMATORY AGENTS	Major	Fair	Concurrent use of PRALATREXATE and NONSTEROIDAL ANTIINFLAMMATORY AGENTS may result in increased pralatrexate exposure.
FEVERFEW -- NONSTEROIDAL ANTIINFLAMMATORY AGENTS	Major	Fair	Concurrent use of FEVERFEW and NONSTEROIDAL ANTIINFLAMMATORY AGENTS may result in increased risk of adverse effects from the nonsteroidal antiinflammatory agent (ie, gastrointestinal, renal effects).
GOSSYPOL -- NONSTEROIDAL ANTIINFLAMMATORY DRUGS	Major	Fair	Concurrent use of GOSSYPOL and NONSTEROIDAL ANTIINFLAMMATORY DRUGS may result in increased risk of adverse gastrointestinal effects.
LITHIUM -- NSAIDS	Major	Fair	Concurrent use of LITHIUM and NSAIDS may result in lithium toxicity.
ANTICOAGULANTS -- NSAIDS Ibuprofen interact(s) with:Interacting substances	Major	Fair	Concurrent use of ANTICOAGULANTS and NSAIDS may result in increased risk of bleeding.
BETRIXABAN -- NSAID	Major	Fair	Concurrent use of BETRIXABAN and NSAID may result in increased risk of bleeding.
MEADOWSWEET -- NONSTEROIDAL ANTIINFLAMMATORY AGENTS	Major	Fair	Concurrent use of MEADOWSWEET and NONSTEROIDAL ANTIINFLAMMATORY AGENTS may result in increased risk of bleeding.
NSAIDS -- NSAIDS AND SALICYLATES Ibuprofen interact(s) with:Interacting substances	Major	Fair	Concurrent use of NSAIDS and NSAIDS AND SALICYLATES may result in increased risk of bleeding.
DESMOPRESSIN -- NSAIDS	Major	Fair	Concurrent use of DESMOPRESSIN and NSAIDS may result in increased risk of hyponatremia.
DIGOXIN -- NSAIDS	Major	Fair	Concurrent use of DIGOXIN and NSAIDS may result in increased serum concentration of digoxin; prolonged half-life of digoxin.
CORTICOSTEROIDS -- NSAIDS Ibuprofen interact(s) with:Interacting substances	Major	Fair	Concurrent use of CORTICOSTEROIDS and NSAIDS may result in increased risk of gastrointestinal ulcer or bleeding.
ACE INHIBITORS AND ANGIOTENSIN RECEPTOR BLOCKERS -- NSAIDS Ibuprofen interact(s) with:Interacting substances	Moderate	Excellent	Concurrent use of ACE INHIBITORS AND ANGIOTENSIN RECEPTOR BLOCKERS and NSAIDS may result in renal dysfunction and/or increased blood pressure.
BETA-ADRENERGIC BLOCKERS -- NSAIDS Ibuprofen interact(s) with:Interacting substances	Moderate	Good	Concurrent use of BETA-ADRENERGIC BLOCKERS and NSAIDS may result in increased blood pressure.
AMIKACIN [Systemic] -- IBUPROFEN [Systemic]	Moderate	Good	Concurrent use of AMIKACIN and IBUPROFEN may result in increase amikacin exposure.
L-METHYLFOLATE -- NONSTEROIDAL ANTIINFLAMMATORY AGENTS	Moderate	Fair	Concurrent use of L-METHYLFOLATE and NONSTEROIDAL ANTIINFLAMMATORY AGENTS may result in decreased l-methylfolate efficacy.
IBUPROFEN [Systemic] -- ANISINDIONE [Systemic]	Moderate	Fair	Concurrent use of ANISINDIONE and IBUPROFEN may result in an increased risk of bleeding.
LEVOFLOXACIN -- NONSTEROIDAL ANTIINFLAMMATORY AGENTS	Moderate	Fair	Concurrent use of LEVOFLOXACIN and NONSTEROIDAL ANTIINFLAMMATORY AGENTS may result in an increased risk of seizures.
MIFEPRISTONE -- SELECTED NONSTEROIDAL ANTIINFLAMMATORY AGENTS	Moderate	Fair	Concurrent use of MIFEPRISTONE and SELECTED NONSTEROIDAL ANTIINFLAMMATORY AGENTS may result in increased exposure to the NSAID.
IBUPROFEN [Systemic] -- DICUMAROL [Systemic]	Moderate	Fair	Concurrent use of DICUMAROL and IBUPROFEN may result in an increased risk of bleeding.

Precautions