No black box warning on record for Aspirin

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

Other warnings & precautions

Reye's Syndrome: Aspirin is CONTRAINDICATED in children and adolescents (<18 years) with fever associated with viral illness (influenza, chickenpox). The combination can cause Reye's syndrome — a rare but potentially fatal liver and brain disease. Use acetaminophen or ibuprofen instead for fever in children.
Bleeding Risk: Aspirin irreversibly inhibits platelet COX-1 for the platelet's lifetime (~7–10 days). This antiplatelet effect increases bleeding risk for all surgical procedures and with concurrent anticoagulants. The decision to continue or stop aspirin peri-operatively should be made with the surgical team.
GI Protection: Even low-dose (81mg) aspirin increases GI bleeding risk 2–4 fold. Patients at high GI risk (>60 years, prior ulcer, concurrent NSAID/anticoagulant/corticosteroid use, H. pylori infection) should be prescribed a proton pump inhibitor concurrently.
Primary Prevention Controversy: As of 2022, routine aspirin for primary cardiovascular prevention (no prior MI/stroke) is no longer recommended by major guidelines for most adults due to GI and bleeding risks offsetting benefit, unless patient-specific risk assessment supports it. Discuss with your physician.
Pregnancy Category D: Aspirin use in the third trimester of pregnancy can cause premature closure of the ductus arteriosus, fetal renal dysfunction, and increase peripartum bleeding. Use only if clearly indicated (e.g., pre-eclampsia prevention at 81mg/day with provider guidance in second trimester).

Other warnings & precautions

Reye's Syndrome: Aspirin is CONTRAINDICATED in children and adolescents (<18 years) with fever associated with viral illness (influenza, chickenpox). The combination can cause Reye's syndrome — a rare but potentially fatal liver and brain disease. Use acetaminophen or ibuprofen instead for fever in children.

Bleeding Risk: Aspirin irreversibly inhibits platelet COX-1 for the platelet's lifetime (~7–10 days). This antiplatelet effect increases bleeding risk for all surgical procedures and with concurrent anticoagulants. The decision to continue or stop aspirin peri-operatively should be made with the surgical team.

GI Protection: Even low-dose (81mg) aspirin increases GI bleeding risk 2–4 fold. Patients at high GI risk (>60 years, prior ulcer, concurrent NSAID/anticoagulant/corticosteroid use, H. pylori infection) should be prescribed a proton pump inhibitor concurrently.

Primary Prevention Controversy: As of 2022, routine aspirin for primary cardiovascular prevention (no prior MI/stroke) is no longer recommended by major guidelines for most adults due to GI and bleeding risks offsetting benefit, unless patient-specific risk assessment supports it. Discuss with your physician.

Pregnancy Category D: Aspirin use in the third trimester of pregnancy can cause premature closure of the ductus arteriosus, fetal renal dysfunction, and increase peripartum bleeding. Use only if clearly indicated (e.g., pre-eclampsia prevention at 81mg/day with provider guidance in second trimester).

Aspirin Black Box Warning

No black box warning on record for Aspirin

Other warnings & precautions

Aspirin Black Box Warning

No black box warning on record for Aspirin

Other warnings & precautions