{"id":"oxybutynin-immediate-release","rwe":[],"tags":[],"safety":{"boxedWarnings":[],"drugInteractions":["Antidepressants","Antipsychotics","Other anticholinergics"],"commonSideEffects":[{"effect":"Dry mouth","drugRate":"41%","severity":"Mild to moderate"},{"effect":"Constipation","drugRate":"16%","severity":"Mild to moderate"},{"effect":"Dizziness","drugRate":"10%","severity":"Mild to moderate"},{"effect":"Headache","drugRate":"8%","severity":"Mild to moderate"},{"effect":"Nausea","drugRate":"7%","severity":"Mild to moderate"},{"effect":"Fatigue","drugRate":"5%","severity":"Mild to moderate"}],"contraindications":["Urinary retention","Gastric retention","Uncontrolled narrow-angle glaucoma"],"specialPopulations":{"Elderly":"Increased risk of cognitive impairment and falls","Renal Impairment":"Dosage adjustment may be required","Hepatic Impairment":"Dosage adjustment may be required"}},"trials":[],"_chembl":null,"aliases":[],"patents":[{"number":"US5434174A","issueDate":"1995-07-18","expirationDate":"2015-07-18"}],"pricing":[{"market":"United States","source":"CMS National Average Drug Acquisition Cost (NADAC)","asOfDate":"2024-01-03","unitCost":"$0.0597/EA","priceType":"NADAC","sourceUrl":"https://data.medicaid.gov/dataset/4j6z-xnwq","annualCost":"$22","description":"OXYBUTYNIN 5 MG TABLET","retrievedDate":"2026-04-07"}],"_fixedAt":"2026-03-30T13:14:13.552359","offLabel":[],"timeline":[{"date":"1990-01-01","type":"Approval","milestone":"First approval","regulator":"FDA"}],"_dailymed":null,"aiSummary":"Oxybutynin immediate release is used to treat neurogenic detrusor overactivity, a condition associated with spinal cord injuries. It is also studied for its potential use in treating detrusor hyperreflexia and urinary bladder conditions in individuals with spinal cord injuries.","ecosystem":[],"mechanism":{"target":"Muscarinic acetylcholine receptors (M2 and M3)","novelty":"Well-established","modality":"Oral","drugClass":"Anticholinergic","explanation":"By blocking muscarinic receptors, oxybutynin reduces the involuntary contractions of the bladder muscle, which helps to control symptoms of overactive bladder.","oneSentence":"Oxybutynin is an anticholinergic that blocks muscarinic receptors in the bladder, leading to relaxation of the detrusor muscle and increased bladder capacity.","technicalDetail":"Oxybutynin acts as a competitive antagonist at muscarinic acetylcholine receptors, particularly M2 and M3 subtypes, which are found in high concentrations in the bladder detrusor muscle."},"_scrapedAt":"2026-03-27T23:59:15.793Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"commercial":{"yoyGrowth":"Not available without FDA label","launchDate":"Not available without FDA label","annualCostUS":"Not available without FDA label","currentRevenue":"Not available without FDA label","patientPopulation":"Not available without FDA label","peakSalesEstimate":"Not available without FDA label"},"references":[],"biosimilars":[],"competitors":["Tolterodine (Detrol)","Solifenacin (Vesicare)","Darifenacin (Enablex)","Fesoterodine (Toviaz)"],"dataSources":[{"url":"https://data.medicaid.gov/dataset/4j6z-xnwq","name":"CMS National Average Drug Acquisition Cost (NADAC)","fields":["pricing"],"retrievedDate":"2026-04-07"}],"indications":{"approved":["Overactive bladder"],"offLabel":[],"pipeline":[]},"_fixedFields":["pubmed(28)"],"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT06966778","phase":"NA","title":"Oxybutynin ER to Promote Early Continence Recovery After Robotic Prostatectomy: A Randomized Controlled Trial","status":"RECRUITING","sponsor":"National Taiwan University 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Oxybutynin to That of Ditropan® (Immediate-release Oxybutynin) for the Treatment of Patients With Urge or Mixed Urinary Incontinence.","status":"COMPLETED","sponsor":"Alza Corporation, DE, USA","startDate":"1996-07","conditions":"Urge Incontinence","enrollment":100},{"nctId":"NCT00431041","phase":"PHASE4","title":"Study to Compare the Safety and Efficacy of Solifenacin With Oxybutynin for the Treatment of Overactive Bladder (VECTOR)","status":"COMPLETED","sponsor":"Astellas Pharma Inc","startDate":"2006-12","conditions":"Overactive Bladder","enrollment":132}],"_emaApprovals":[],"_faersSignals":[],"genericFilers":["Mylan Pharmaceuticals Inc","Teva Pharmaceutical Industries Ltd","Sandoz Inc","Dr. Reddy's Laboratories Ltd"],"latestUpdates":[],"manufacturing":[],"formularyStatus":[],"_approvalHistory":[],"developmentCodes":[],"ownershipHistory":[],"publicationCount":28,"therapeuticAreas":["Urology"],"biosimilarFilings":[],"recentPublications":[{"date":"2021 Feb","pmid":"32961225","title":"Statewide Price Variation for Generic Benign Prostatic Hyperplasia Medications.","journal":"Urology"},{"date":"2019 Jan-Feb","pmid":"30268971","title":"Antimuscarinic use and discontinuation in an older adult population.","journal":"Archives of gerontology and geriatrics"},{"date":"2018","pmid":"29686801","title":"Cost-effectiveness of solifenacin compared with oral antimuscarinic agents for the treatment of patients with overactive bladder in the UK.","journal":"Journal of market access & health policy"},{"date":"2018 Mar","pmid":"29140559","title":"Comparative efficacy and tolerability of solifenacin 5 mg/day versus other oral antimuscarinic agents in overactive bladder: A systematic literature review and network meta-analysis.","journal":"Neurourology and urodynamics"},{"date":"2013 Oct","pmid":"23885660","title":"Cost-effectiveness analysis of solifenacin versus oxybutynin immediate-release in the treatment of patients with overactive bladder in the United Kingdom.","journal":"Journal of medical economics"}],"companionDiagnostics":[],"genericManufacturerList":[],"phase":"marketed","status":"active","brandName":"oxybutynin immediate release","genericName":"oxybutynin immediate release","companyName":"Astellas Pharma Inc","companyId":"astellas","modality":"Small molecule","firstApprovalDate":"Not available without FDA label","enrichmentLevel":3,"visitCount":0,"regulatoryByCountry":[{"country_code":"CA","regulator":"Health Canada","status":"approved","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}