{"id":"commercial-naproxen-sodium-tablet","safety":{"commonSideEffects":[{"rate":"10-20","effect":"Gastrointestinal upset (nausea, dyspepsia, abdominal pain)"},{"rate":"5-15","effect":"Heartburn"},{"rate":"3-9","effect":"Dizziness"},{"rate":"2-5","effect":"Headache"},{"rate":"1-3","effect":"Rash"},{"rate":"<1","effect":"Gastrointestinal bleeding (serious, rare)"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Naproxen is a nonsteroidal anti-inflammatory drug (NSAID) that non-selectively blocks COX-1 and COX-2 enzymes. By inhibiting prostaglandin production, it reduces inflammatory mediators and pain signals. The sodium salt formulation allows faster absorption and onset of action compared to base naproxen.","oneSentence":"Naproxen sodium inhibits cyclooxygenase (COX) enzymes to reduce prostaglandin synthesis, thereby decreasing inflammation, pain, and fever.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:06:51.109Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Mild to moderate pain"},{"name":"Fever"},{"name":"Inflammation associated with conditions such as headache, muscular aches, backache, minor arthritis pain, menstrual cramps, and the common cold"}]},"trialDetails":[{"nctId":"NCT03879408","phase":"PHASE2","title":"Naproxen Sodium/Acetaminophen Proof of Concept Dosing Study","status":"COMPLETED","sponsor":"Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division","startDate":"2019-05-28","conditions":"Pain","enrollment":290},{"nctId":"NCT03566979","phase":"PHASE3","title":"Efficacy and Safety Study of a Test Naproxen Sodium 220mg Tablet in Postoperative Dental Pain","status":"COMPLETED","sponsor":"Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division","startDate":"2018-08-13","conditions":"Post-operative Dental Pain","enrollment":501},{"nctId":"NCT02549469","phase":"PHASE1","title":"Bioequivalence of Single Dose Extended Release Naproxen Sodium (660 mg) Tablet Versus Naproxen Sodium (220 mg) Tablet Three Times Daily","status":"COMPLETED","sponsor":"Bayer","startDate":"2007-03","conditions":"Pain","enrollment":32},{"nctId":"NCT00818415","phase":"PHASE1","title":"Naproxen Sodium ER Pharmacokinetic Study","status":"COMPLETED","sponsor":"Bayer","startDate":"2008-11","conditions":"Pain","enrollment":32},{"nctId":"NCT00751556","phase":"PHASE1","title":"Single/Multiple Dose Bioavailability Trial","status":"COMPLETED","sponsor":"Bayer","startDate":"2008-02","conditions":"Healthy","enrollment":32}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Commercial NPX tablet"],"phase":"phase_3","status":"active","brandName":"Commercial naproxen sodium tablet","genericName":"Commercial naproxen sodium tablet","companyName":"Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division","companyId":"johnson-johnson-consumer-inc-mcneil-consumer-healthcare-division","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Naproxen sodium inhibits cyclooxygenase (COX) enzymes to reduce prostaglandin synthesis, thereby decreasing inflammation, pain, and fever. Used for Mild to moderate pain, Fever, Inflammation associated with conditions such as headache, muscular aches, backache, minor arthritis pain, menstrual cramps, and the common cold.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}