{"id":"ibuprofen-pseudoephedrine-hydrochloride","safety":{"commonSideEffects":[{"rate":"5-15","effect":"Gastrointestinal upset (nausea, dyspepsia)"},{"rate":"2-5","effect":"Headache"},{"rate":"2-5","effect":"Dizziness"},{"rate":"1-3","effect":"Nervousness or insomnia"},{"rate":"1-2","effect":"Tachycardia"}]},"_chembl":{"chemblId":"CHEMBL1200724","moleculeType":"Small molecule","molecularWeight":"201.70"},"_dailymed":{"setId":"f6894629-6c85-41b2-ae8f-a3a89a7401fd","title":"ADVIL COLD AND SINUS (IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, COATED [HALEON US HOLDINGS LLC]"},"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) that blocks COX-1 and COX-2 enzymes, thereby reducing prostaglandin synthesis and decreasing inflammation, pain, and fever. Pseudoephedrine is a sympathomimetic amine that acts as an alpha-adrenergic agonist, causing vasoconstriction in nasal blood vessels to reduce swelling and nasal congestion. This combination provides dual symptomatic relief for cold and flu symptoms.","oneSentence":"Ibuprofen reduces inflammation and pain by inhibiting cyclooxygenase enzymes, while pseudoephedrine constricts blood vessels in the nasal passages to relieve congestion.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T05:05:32.607Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Relief of pain, fever, and nasal congestion associated with common cold and flu"}]},"trialDetails":[{"nctId":"NCT02963701","phase":"PHASE1","title":"Bioequivalence of a Fixed Dose Combination Tablet Containing 400 mg Ibuprofen and 60 mg Pseudoephedrine-HCl Compared to Two Film Coated Fixed Dose Combination Tablets RhinAdvil(R)(200 mg Ibuprofen and 30 mg Pseudoephedrine-HCl) Administered in Healthy Subjects","status":"COMPLETED","sponsor":"Boehringer Ingelheim","startDate":"2016-12-20","conditions":"Healthy Volunteers","enrollment":56},{"nctId":"NCT01170637","phase":"PHASE1","title":"Bioequivalence of a Fixed Dose Combination Tablet Containing 200 mg Ibuprofen and 30 mg Pseudoephedrine-HCl Compared to RhinAdvil(R)(200 mg Ibuprofen and 30 mg Pseudoephedrine-HCl) as a Fixed Dose Combination Tablet Administered in Healthy Volunteers.","status":"COMPLETED","sponsor":"Boehringer Ingelheim","startDate":"2010-07","conditions":"Healthy","enrollment":47},{"nctId":"NCT03429738","phase":"PHASE1","title":"Single-Dose Bioavailability Study of Two Formulations of Ibuprofen and Pseudoephedrine Hydrochloride Tablets","status":"COMPLETED","sponsor":"Institut für Pharmakologie und Präventive Medizin","startDate":"2014-04-27","conditions":"Pain, Head, Pain, Acute, Pain, Back","enrollment":66},{"nctId":"NCT00223691","phase":"PHASE1","title":"Treatment of Orthostatic Hypotension in Autonomic Failure","status":"COMPLETED","sponsor":"Vanderbilt University","startDate":"2002-03","conditions":"Autonomic Failure, Orthostatic Hypotension","enrollment":389},{"nctId":"NCT00240812","phase":"PHASE2","title":"A Study to Determine if Ibuprofen in Combination With Pseudoephedrine HCl is More Effective Than Each Drug Alone in the Treatment of Nighttime Bedwetting","status":"COMPLETED","sponsor":"Johnson & Johnson Consumer and Personal Products Worldwide","startDate":"","conditions":"Enuresis","enrollment":318},{"nctId":"NCT01132222","phase":"PHASE1","title":"Bioequivalence Study of Ibuprofen 200 mg + Pseudoephedrine HCL 30 mg Tablets Under Fed Conditions","status":"COMPLETED","sponsor":"Dr. Reddy's Laboratories Limited","startDate":"2004-09","conditions":"Healthy","enrollment":34},{"nctId":"NCT01131780","phase":"PHASE1","title":"Bioequivalency Study of Ibuprofen 200 mg and Pseudoephedrine HCL 30 mg Tablets of Dr. Reddy's Under Fasting Conditions","status":"COMPLETED","sponsor":"Dr. Reddy's Laboratories Limited","startDate":"2004-10","conditions":"Healthy","enrollment":32}],"_emaApprovals":[],"_faersSignals":[{"count":99,"reaction":"DRUG INEFFECTIVE"},{"count":62,"reaction":"JOINT SWELLING"},{"count":57,"reaction":"ARTHRALGIA"},{"count":42,"reaction":"ARTHROPATHY"},{"count":40,"reaction":"FATIGUE"},{"count":39,"reaction":"PAIN IN EXTREMITY"},{"count":38,"reaction":"MUSCULOSKELETAL STIFFNESS"},{"count":37,"reaction":"INFECTION"},{"count":36,"reaction":"DRUG INTOLERANCE"},{"count":34,"reaction":"CONDITION AGGRAVATED"}],"_approvalHistory":[],"publicationCount":12,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Advil® Cold and Sinus"],"phase":"marketed","status":"active","brandName":"Ibuprofen + Pseudoephedrine Hydrochloride","genericName":"Ibuprofen + Pseudoephedrine Hydrochloride","companyName":"Dr. Reddy's Laboratories Limited","companyId":"dr-reddy-s-laboratories-limited","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Ibuprofen reduces inflammation and pain by inhibiting cyclooxygenase enzymes, while pseudoephedrine constricts blood vessels in the nasal passages to relieve congestion. Used for Relief of pain, fever, and nasal congestion associated with common cold and flu.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}