{"id":"tramadol-hcl-acetaminophen-ir","safety":{"commonSideEffects":[{"rate":"10-20%","effect":"Nausea"},{"rate":"10-20%","effect":"Dizziness"},{"rate":"10-20%","effect":"Headache"},{"rate":"5-10%","effect":"Vomiting"},{"rate":"5-10%","effect":"Constipation"},{"rate":"5-10%","effect":"Diarrhea"},{"rate":"5-10%","effect":"Fatigue"},{"rate":"5-10%","effect":"Sleep disorder"},{"rate":"5-10%","effect":"Sweating"},{"rate":"5-10%","effect":"Yawning"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"groq-llama-8b","explanation":"Tramadol HCl, an opioid agonist, binds to mu-opioid receptors in the brain, while acetaminophen, a non-opioid analgesic, works by inhibiting the production of prostaglandins, which are chemicals that cause pain and inflammation.","oneSentence":"Tramadol HCl/Acetaminophen IR is a combination of a centrally acting opioid analgesic and a non-opioid analgesic that works by affecting the central nervous system to relieve pain.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:39:43.248Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Moderate to moderately severe pain"},{"name":"Severe pain"}]},"trialDetails":[{"nctId":"NCT01814878","phase":"PHASE3","title":"A Study Comparing the Effectiveness and Safety of Extended Release (ER) Tramadol Hydrochloride (HCl)/Acetaminophen With Immediate Release (IR) Tramadol HCl/Acetaminophen in Participants With Moderate to Severe Postoperative Pain","status":"COMPLETED","sponsor":"Janssen Korea, Ltd., Korea","startDate":"2009-11","conditions":"Pain, Postoperative","enrollment":320}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":20,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Ultracet"],"phase":"phase_3","status":"active","brandName":"Tramadol HCl/Acetaminophen IR","genericName":"Tramadol HCl/Acetaminophen IR","companyName":"Janssen Korea, Ltd., Korea","companyId":"janssen-korea-ltd-korea","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Tramadol HCl/Acetaminophen IR is a combination of a centrally acting opioid analgesic and a non-opioid analgesic that works by affecting the central nervous system to relieve pain. Used for Moderate to moderately severe pain, Severe pain.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}