Black Box Warning

BOXED WARNING — Cardiovascular Risk: NSAIDs may cause serious cardiovascular thrombotic events (MI, stroke). Risk increases with dose and duration. Naproxen has a potentially lower cardiovascular risk than other NSAIDs based on some meta-analyses, but risk is not zero. Contraindicated after CABG surgery.

What this means:A black box warning is the FDA's strongest required safety notice. It signals a serious or life-threatening risk. Patients should review this with their prescriber before starting, continuing, or switching Naproxen.

Other warnings & precautions

BOXED WARNING — Gastrointestinal Risk: NSAIDs cause serious GI events including bleeding, ulceration, and perforation — which can occur at any time without warning. Higher risk in elderly patients (≥65 years), those with prior GI ulcers, smoking, alcohol use, and concurrent anticoagulants.
Renal Risk: May cause fluid retention, edema, and acute kidney injury. NSAIDs reduce renal prostaglandins critical for maintaining renal blood flow in volume-depleted states.
Third trimester of pregnancy: NSAIDs can cause premature closure of the ductus arteriosus. Avoid at ≥30 weeks gestation. From 20–29 weeks, limit use to <48 hours.
OTC labeling: Do not use for more than 10 days for pain or 3 days for fever without consulting a physician.

Black Box Warning

Other warnings & precautions

BOXED WARNING — Gastrointestinal Risk: NSAIDs cause serious GI events including bleeding, ulceration, and perforation — which can occur at any time without warning. Higher risk in elderly patients (≥65 years), those with prior GI ulcers, smoking, alcohol use, and concurrent anticoagulants.
Renal Risk: May cause fluid retention, edema, and acute kidney injury. NSAIDs reduce renal prostaglandins critical for maintaining renal blood flow in volume-depleted states.
Third trimester of pregnancy: NSAIDs can cause premature closure of the ductus arteriosus. Avoid at ≥30 weeks gestation. From 20–29 weeks, limit use to <48 hours.
OTC labeling: Do not use for more than 10 days for pain or 3 days for fever without consulting a physician.

Naproxen Black Box Warning

Black Box Warning

Other warnings & precautions

Naproxen Black Box Warning

Black Box Warning

Other warnings & precautions