{"id":"naproxen-sodium-er-bayh6689","safety":{"commonSideEffects":[{"rate":"10-20","effect":"Gastrointestinal upset / dyspepsia"},{"rate":"5-10","effect":"Nausea"},{"rate":"5-10","effect":"Headache"},{"rate":"3-5","effect":"Dizziness"},{"rate":null,"effect":"Cardiovascular events (with chronic use)"},{"rate":null,"effect":"Renal impairment (with chronic use)"}]},"_chembl":{"chemblId":"CHEMBL1200806","moleculeType":"Small molecule","molecularWeight":"252.25"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Naproxen blocks both COX-1 and COX-2 enzymes, which are responsible for producing prostaglandins that mediate inflammation, pain, and fever. The extended-release formulation provides sustained drug delivery over time, allowing for less frequent dosing while maintaining therapeutic levels. This mechanism makes it effective for chronic pain and inflammatory conditions.","oneSentence":"Naproxen sodium ER is a nonsteroidal anti-inflammatory drug (NSAID) that inhibits cyclooxygenase (COX) enzymes to reduce prostaglandin synthesis, thereby decreasing inflammation and pain.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:50:17.480Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Chronic pain management"},{"name":"Osteoarthritis"},{"name":"Rheumatoid arthritis"}]},"trialDetails":[{"nctId":"NCT01427803","phase":"PHASE3","title":"Actual Use Trial of Naproxen Sodium","status":"COMPLETED","sponsor":"Bayer","startDate":"2011-09","conditions":"Pain","enrollment":778},{"nctId":"NCT01383486","phase":"PHASE3","title":"Self Selection Trial of Naproxen Sodium","status":"COMPLETED","sponsor":"Bayer","startDate":"2011-07","conditions":"Pain","enrollment":253},{"nctId":"NCT00720057","phase":"PHASE3","title":"Assessing the Analgesic Efficacy of Naproxen Sodium in Postsurgical Dental Pain.","status":"COMPLETED","sponsor":"Bayer","startDate":"2008-06","conditions":"Toothache","enrollment":312},{"nctId":"NCT00751400","phase":"PHASE3","title":"Naproxen Sodium Extended-Release Actual Use Study","status":"COMPLETED","sponsor":"Bayer","startDate":"2008-07","conditions":"Pain","enrollment":497},{"nctId":"NCT01389284","phase":"PHASE3","title":"Evaluate Efficacy and Safety of Extended Release (ER) Naproxen Sodium","status":"COMPLETED","sponsor":"Bayer","startDate":"2011-06","conditions":"Pain, Postoperative","enrollment":300},{"nctId":"NCT00818415","phase":"PHASE1","title":"Naproxen Sodium ER Pharmacokinetic Study","status":"COMPLETED","sponsor":"Bayer","startDate":"2008-11","conditions":"Pain","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":[],"phase":"phase_3","status":"active","brandName":"Naproxen sodium ER (BAYH6689)","genericName":"Naproxen sodium ER (BAYH6689)","companyName":"Bayer","companyId":"bayer","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Naproxen sodium ER is a nonsteroidal anti-inflammatory drug (NSAID) that inhibits cyclooxygenase (COX) enzymes to reduce prostaglandin synthesis, thereby decreasing inflammation and pain. Used for Chronic pain management, Osteoarthritis, Rheumatoid arthritis.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}