{"id":"solifenacin-plus-tamsulosin","safety":{"commonSideEffects":[{"rate":"20-30","effect":"Dry mouth"},{"rate":"10-20","effect":"Constipation"},{"rate":"5-10","effect":"Dizziness"},{"rate":"5-10","effect":"Headache"},{"rate":"5-10","effect":"Blurred vision"},{"rate":"1-5","effect":"Urinary retention"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Solifenacin is an anticholinergic agent that selectively antagonizes M3 muscarinic receptors on bladder detrusor muscle, decreasing involuntary contractions and urinary urgency. Tamsulosin is an alpha-1A adrenergic receptor antagonist that relaxes smooth muscle in the prostate and bladder neck, reducing urinary obstruction and improving flow rate. Together, they address both storage and voiding symptoms in benign prostatic hyperplasia with concurrent overactive bladder.","oneSentence":"Solifenacin blocks muscarinic receptors in the bladder to reduce overactive bladder symptoms, while tamsulosin relaxes smooth muscle in the prostate and urethra to improve urinary flow.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:08:47.856Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Overactive bladder with urinary urgency, frequency, and incontinence in patients with benign prostatic hyperplasia"},{"name":"Lower urinary tract symptoms associated with benign prostatic hyperplasia"}]},"trialDetails":[{"nctId":"NCT06528613","phase":"","title":"Real World Study in Greek Patients with BPH for Disease Control and QoL Under FDC Treatment with Solifenacin/Tamsulosin.","status":"RECRUITING","sponsor":"Elpen Pharmaceutical Co. Inc.","startDate":"2024-10-23","conditions":"Benign Prostatic Hyperplasia","enrollment":450},{"nctId":"NCT01021332","phase":"PHASE3","title":"Long Term Study of Solifenacin Succinate and Tamsulosin Hydrochloride Oral Controlled Absorption System (OCAS) in Males With Lower Urinary Tract Symptoms","status":"COMPLETED","sponsor":"Astellas Pharma Europe B.V.","startDate":"2010-04-26","conditions":"Lower Urinary Tract Symptoms, Benign Prostatic Hyperplasia","enrollment":1067},{"nctId":"NCT01018511","phase":"PHASE3","title":"Study of Solifenacin Succinate and Tamsulosin Hydrochloride OCAS in Males With Lower Urinary Tract Symptoms","status":"COMPLETED","sponsor":"Astellas Pharma Europe B.V.","startDate":"2010-01-11","conditions":"Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms","enrollment":1334},{"nctId":"NCT05494567","phase":"PHASE4","title":"Efficacy of Tadalafil/Solifenacin VS Tamsulosin/Solifenacin Combination Therapy for BPH/OAB","status":"UNKNOWN","sponsor":"Mansoura 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Hyperplasia","status":"UNKNOWN","sponsor":"IlDong Pharmaceutical Co Ltd","startDate":"2016-01","conditions":"Benign Prostate Hyperplasia","enrollment":588},{"nctId":"NCT02715024","phase":"PHASE4","title":"Study to Evaluate the Clinical Efficacy and Safety of Tamsulosin Alone or in Combination With Solifenacin for the Treatment in Men With Lower Urinary Tract Symptoms Including Overactive Bladder Symptoms","status":"COMPLETED","sponsor":"Astellas Pharma Taiwan, Inc.","startDate":"2007-09","conditions":"Lower Urinary Tract Symptoms, Overactive Bladder, Benign Prostatic Hyperplasia (BPH)","enrollment":52},{"nctId":"NCT00699049","phase":"PHASE4","title":"A Study Comparing the Efficacy of an Alpha Blocker Versus an Alpha Blocker Plus Solifenacin in Men With Overactive Bladder","status":"COMPLETED","sponsor":"KYU-SUNG LEE","startDate":"2008-06","conditions":"Urinary Bladder, Overactive","enrollment":94},{"nctId":"NCT00884104","phase":"PHASE4","title":"A Study to Evaluate Add on Effect of Solifenacin in Men With Overactive Bladder Symptoms After Tamsulosin Monotherapy for 4 Weeks","status":"COMPLETED","sponsor":"KYU-SUNG LEE","startDate":"2009-03","conditions":"Overactive Bladder","enrollment":307},{"nctId":"NCT01533597","phase":"PHASE4","title":"The Efficacy of Solifenacin With or Without Tamsulosin in Adult Women With Overactive Bladder (OAB)","status":"COMPLETED","sponsor":"Soonchunhyang University Hospital","startDate":"2010-12","conditions":"Overactive Bladder","enrollment":70},{"nctId":"NCT00333112","phase":"PHASE4","title":"A Study to Evaluate Solifenacin Succinate in Combination With Tamsulosin for the Treatment of Residual Overactive Bladder Symptoms (OAB) in Men.","status":"COMPLETED","sponsor":"Astellas Pharma Inc","startDate":"2006-05","conditions":"Urinary Incontinence","enrollment":398},{"nctId":"NCT02169713","phase":"PHASE1","title":"Study to Evaluate the Effect of Solifenacin and Mirabegron on the Tamsulosin Hydrochloride (HCl) Concentrations in Blood in Healthy Male Subjects","status":"COMPLETED","sponsor":"Astellas Pharma Europe B.V.","startDate":"2014-05","conditions":"Healthy Subjects, Pharmacokinetics, Drug-Drug Interaction (DDI)","enrollment":20},{"nctId":"NCT00510406","phase":"PHASE2","title":"A Study With Combination Treatment (Tamsulosin Hydrochloride and Solifenacin Succinate) in Male Patients With LUTS/BPH","status":"COMPLETED","sponsor":"Astellas Pharma Inc","startDate":"2007-01","conditions":"Lower Urinary Tract Symptoms, Prostatic Hyperplasia","enrollment":919},{"nctId":"NCT00507455","phase":"PHASE2","title":"Solifenacin Succinate With Tamsulosin HCl in Males With Lower Urinary Tract Symptoms and Bladder Outlet Obstruction","status":"COMPLETED","sponsor":"Astellas Pharma Inc","startDate":"2007-06","conditions":"Lower Urinary Tract Symptoms, Bladder Outlet Obstruction","enrollment":222},{"nctId":"NCT00771394","phase":"PHASE4","title":"Solifenacin as Add-on Therapy for Overactive Bladder Symptoms in Men Treated for Benign Prostatic Hyperplasia","status":"COMPLETED","sponsor":"Astellas Pharma Inc","startDate":"2008-10","conditions":"Benign Prostatic Hyperplasia, Benign Prostatic Hypertrophy, Overactive Bladder","enrollment":638}],"_emaApprovals":[],"_faersSignals":[{"count":1,"reaction":"DIZZINESS"},{"count":1,"reaction":"FALL"}],"_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":["Vesicare","Harnal"],"phase":"marketed","status":"active","brandName":"Solifenacin plus Tamsulosin","genericName":"Solifenacin plus Tamsulosin","companyName":"Soonchunhyang University Hospital","companyId":"soonchunhyang-university-hospital","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Solifenacin blocks muscarinic receptors in the bladder to reduce overactive bladder symptoms, while tamsulosin relaxes smooth muscle in the prostate and urethra to improve urinary flow. Used for Overactive bladder with urinary urgency, frequency, and incontinence in patients with benign prostatic hyperplasia, Lower urinary tract symptoms associated with benign prostatic hyperplasia.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}