Ibuprofen

ATC code

M01AE01

Therapeutic class

Nonsteroidal Anti-Inflammatory Drug (NSAID) · Propionic acid derivative

Forms

oral tablet, oral capsule, oral suspension, granules for oral solution

Brand names

Difenadol Rapid (ES) · Advil (US) · Motrin (US) · Nurofen (GB) · Brufen (EU)

Overall confidence

medium

Regulatory sources consulted

AEMPS CIMA Ficha Técnica 74559
FDA prescribing information (general class warnings)
CredibleMeds.org
Flockhart Table (Indiana University)
General Clinical Pharmacology Knowledge
AEMPS CIMA · nº registro 74559 ↗
RxNorm rxcui 5640 ↗

Approved indications

Symptomatic treatment of mild to moderate pain and fever.
Relief of symptoms of rheumatoid arthritis and osteoarthritis.

Contraindications

Absolute

Hypersensitivity to ibuprofen, aspirin, or other NSAIDs.
Third trimester of pregnancy.
Severe heart failure (NYHA Class IV).
Severe renal or hepatic failure.
History of gastrointestinal bleeding or perforation related to NSAID therapy.

Clinical warnings

Boxed warning · 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. — FDA
Boxed warning · 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. — FDA

Drug interactions

HighMethotrexateL01BA01
Mechanism: NSAIDs decrease renal clearance of methotrexate by inhibiting tubular secretion, leading to increased plasma concentration and its hematologic and gastrointestinal toxicity.
Recommendation: Avoid concomitant use, especially with high-dose methotrexate (>15 mg/week). If necessary, monitor renal function and signs of methotrexate toxicity closely.
AEMPS CIMAClinical Pharmacology
HighWarfarinB01AA03
Mechanism: Additive pharmacodynamic effect: increased risk of bleeding due to platelet inhibition by ibuprofen and anticoagulation by warfarin. Ibuprofen may also displace warfarin from protein binding sites.
Recommendation: Avoid concomitant use. If unavoidable, monitor INR closely and educate the patient on signs of bleeding.
AEMPS CIMA

Adverse events

Common (≥1%)

dyspepsia · nausea · vomiting · abdominal pain · diarrhea · flatulence · headache

Rare but serious

gastrointestinal bleeding · gastrointestinal perforation · myocardial infarction · stroke · nephropathy · anaphylactic reactions · Stevens-Johnson syndrome

Pregnancy and lactation

FDA category: C/D (3er trimestre)

Contraindicated in the third trimester of pregnancy due to risk of premature closure of the ductus arteriosus. Avoid during the first and second trimesters. Excreted in breast milk in very small amounts; generally considered compatible with breastfeeding.