{"id":"cg-5503-tapentadol","safety":{"commonSideEffects":[{"rate":"20-30","effect":"Nausea"},{"rate":"15-25","effect":"Dizziness"},{"rate":"10-20","effect":"Somnolence"},{"rate":"10-15","effect":"Vomiting"},{"rate":"10-15","effect":"Constipation"},{"rate":"5-10","effect":"Headache"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Tapentadol binds to mu-opioid receptors in the central nervous system to produce opioid-mediated pain relief, while simultaneously inhibiting the reuptake of norepinephrine, which enhances descending pain inhibitory pathways. This dual mechanism allows for effective analgesia at lower doses compared to pure opioid agonists, potentially reducing opioid-related side effects.","oneSentence":"Tapentadol is a mu-opioid receptor agonist and norepinephrine reuptake inhibitor that provides analgesia through dual mechanisms.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:05:26.065Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Moderate to severe acute pain"},{"name":"Moderate to severe chronic pain"}]},"trialDetails":[{"nctId":"NCT00364546","phase":"PHASE3","title":"A Study to Evaluate 90-Day Safety of Tapentadol(CG5503) Immediate Release (IR) or Oxycodone Immediate Release in Patients With Chronic Pain","status":"COMPLETED","sponsor":"Johnson & Johnson Pharmaceutical Research & Development, L.L.C.","startDate":"2006-07","conditions":"Osteoarthritis, Pain Intensity Assessment, Arthralgia","enrollment":877}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":1,"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":"CG 5503;tapentadol","genericName":"CG 5503;tapentadol","companyName":"Johnson & Johnson Pharmaceutical Research & Development, L.L.C.","companyId":"johnson-johnson-pharmaceutical-research-development-l-l-c","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Tapentadol is a mu-opioid receptor agonist and norepinephrine reuptake inhibitor that provides analgesia through dual mechanisms. Used for Moderate to severe acute pain, Moderate to severe chronic pain.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}