No black box warning on record for Ibuprofen

As of the latest FDA labeling reviewed, Ibuprofen (ibuprofen) does not carry a black box warning. Standard warnings and precautions still apply — see the full Ibuprofen medicine page for the complete safety profile.

Other warnings & precautions

Cardiovascular Risk (Boxed Warning): NSAIDs increase the risk of serious cardiovascular thrombotic events (myocardial infarction, stroke) which can be fatal. Risk increases with duration of use and may be higher in patients with cardiovascular disease. Ibuprofen is CONTRAINDICATED for perioperative pain in the setting of coronary artery bypass graft (CABG) surgery.
GI Risk (Boxed Warning): NSAIDs increase the risk of serious GI adverse events including bleeding, ulceration, and perforation of the stomach or intestine, which can be fatal. These events can occur at any time without warning. Elderly patients are at greater risk.
Renal Effects: Long-term NSAID use can cause renal papillary necrosis and other renal injury. NSAIDs can precipitate acute renal failure in patients with pre-existing renal disease, heart failure, liver cirrhosis, or volume depletion (third trimester of pregnancy, concurrent diuretic use).
Third Trimester Pregnancy: Ibuprofen is CONTRAINDICATED in the third trimester of pregnancy. NSAIDs can cause premature closure of the ductus arteriosus and fetal renal dysfunction. Use at ≥30 weeks gestation only if clearly needed and close fetal monitoring.
Aspirin-Exacerbated Respiratory Disease (AERD): NSAIDs can trigger severe bronchospasm in patients with AERD (aspirin-sensitive asthma, nasal polyps). Contraindicated in this population.

Other warnings & precautions

Cardiovascular Risk (Boxed Warning): NSAIDs increase the risk of serious cardiovascular thrombotic events (myocardial infarction, stroke) which can be fatal. Risk increases with duration of use and may be higher in patients with cardiovascular disease. Ibuprofen is CONTRAINDICATED for perioperative pain in the setting of coronary artery bypass graft (CABG) surgery.

GI Risk (Boxed Warning): NSAIDs increase the risk of serious GI adverse events including bleeding, ulceration, and perforation of the stomach or intestine, which can be fatal. These events can occur at any time without warning. Elderly patients are at greater risk.

Renal Effects: Long-term NSAID use can cause renal papillary necrosis and other renal injury. NSAIDs can precipitate acute renal failure in patients with pre-existing renal disease, heart failure, liver cirrhosis, or volume depletion (third trimester of pregnancy, concurrent diuretic use).

Third Trimester Pregnancy: Ibuprofen is CONTRAINDICATED in the third trimester of pregnancy. NSAIDs can cause premature closure of the ductus arteriosus and fetal renal dysfunction. Use at ≥30 weeks gestation only if clearly needed and close fetal monitoring.

Aspirin-Exacerbated Respiratory Disease (AERD): NSAIDs can trigger severe bronchospasm in patients with AERD (aspirin-sensitive asthma, nasal polyps). Contraindicated in this population.

Ibuprofen Black Box Warning

No black box warning on record for Ibuprofen

Other warnings & precautions

Ibuprofen Black Box Warning

No black box warning on record for Ibuprofen

Other warnings & precautions