Naproxen - Warnings and Precautions
The following warnings and precautions are taken directly from the US FDA-approved drug label for Naproxen. This is the same information dispensing pharmacists read.
\u26a0\ufe0f Boxed Warning (Highest FDA Alert)
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS Cardiovascular Thrombotic Events Non-Steroidal Anti-inflammatory Drugs (NSAIDs), a component of naproxen and esomeprazole magnesium delayed-release tablets, cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use [see Warnings and Precautions ]. Naproxen and esomeprazole magnesium delayed-release tablets are contraindicated in the setting of coronary artery bypass graft (CABG) surgery [see Contraindications , and Warnings and Precautions ]. Gastrointestinal Bleeding, Ulceration, and Perforation NSAIDs, a component of naproxen and esomeprazole magnesium delayed-release tablets cause an increased risk of serious gastrointestinal (GI) 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 and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events [see Warnings and Precautions ]. WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS See full prescribing information for complete boxed warning. Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and
5 WARNINGS AND PRECAUTIONS Hepatotoxicity: Inform patients of warning signs and symptoms of hepatotoxicity.
Discontinue if abnormal liver tests persist or worsen or if clinical signs and symptoms of liver disease develop.
Hypertension: Patients taking some antihypertensive medications may have impaired response to these therapies when taking NSAIDs.
Monitor blood pressure. ( 5.4 , 7 ) Heart Failure and Edema: Avoid use of naproxen and esomeprazole magnesium delayed-release tablets in patients with severe heart failure unless benefits are expected to outweigh risk of worsening heart failure.
Renal Toxicity: Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia.
Avoid use of naproxen and esomeprazole magnesium delayed-release tablets in patients with advanced renal disease unless benefits are expected to outweigh risk of worsening renal function.
Anaphylactic Reactions: Seek emergency help if an anaphylactic reaction occurs.
Exacerbation of Asthma Related to Aspirin Sensitivity: Naproxen and esomeprazole magnesium delayed-release tablets are contraindicated in patients with aspirin-sensitive asthma.
Monitor patients with preexisting asthma (without aspirin sensitivity).
Serious Skin Reactions: Discontinue naproxen and esomeprazole magnesium delayed-release tablets at first appearance of skin rash or other signs of hypersensitivity.
Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) : Discontinue and evaluate clinically Fetal Toxicity : Limit use of NSAIDs, including naproxen and esomeprazole magnesium delayed-release tablets, between about 20 weeks to 30 weeks in pregnancy due to the risk of oligohydramnios/fetal renal dysfunction.
Avoid use of NSAIDs in women at about 30 weeks gestation and later in pregnancy due to the risks of oligohydramnios/fetal renal dysfunction and premature closure of the fetal ductus arteriosus ( 5.11 , 8.1 ) Hematologic Toxicity: Monitor hemoglobin or hematocrit in patients with any signs of symptoms of anemia. ( 5.12 , 7 ) Masking of Inflammation and Fever: Potential for diminished utility of diagnostic signs in detecting infections.
Laboratory Monitoring: Obtain CBC and chemistry profile periodically during treatment.
Monitor hemoglobin periodically in patients on long-term treatment who have an initial value of 10 g or less.
Active Bleeding: Withdraw treatment in patients who experience active and clinically significant bleeding.
Concomitant NSAID Use: Do not use naproxen and esomeprazole magnesium delayed-release tablets with other naproxen-containing products or other non-aspirin NSAIDs.
Gastric Malignancy: In adults, symptomatic response to esomeprazole does not preclude the presence of gastric malignancy.
Consider additional follow-up and diagnostic testing.
Acute Tubulointerstitial Nephritis : Discontinue treatment and evaluate patients.
Clostridium difficile -Associated Diarrhea: PPI therapy may be associated with increased risk of Clostridium difficile associated diarrhea.
Bone Fracture: Long-term and multiple daily dose PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist or spine.
Cutaneous and Systemic Lupus Erythematosus: Mostly cutaneous, new onset or exacerbation of existing disease; discontinue naproxen and esomeprazole magnesium delayed-release tablets and refer to specialist for evaluation.
Interaction with Clopidogrel: Avoid concomitant use. ( 5.22 , 7 ) Cyanocobalamin (Vitamin B-12) Deficiency: Daily long-term use (e.g., longer than 3 years) may lead to malabsorption or a deficiency of cyanocobalamin.
Hypomagnesemia and Mineral Metabolism: Reported rarely with prolonged treatment with PPIs.
John’s Wort or Rifampin: Avoid concomitant use. ( 5.25 , 7 ) Interactions with Diagnostic Investigations for Neuroendocrine Tumors: Increases in intragastric pH may result in hypergastrinemia, enterochromaffin-like cell hyperplasia, and increased Chromogranin A levels which may interfere with diagnostic investigations for neuroendocrine tumors.
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