{
 "query": "oxybutynin",
 "ingredient": "oxybutynin",
 "slug": "oxybutynin",
 "rxcui": "32675",
 "brands": [
  "Oxytrol",
  "Gelnique"
 ],
 "names": [
  "oxybutynin",
  "oxybutynin chloride"
 ],
 "classes": [
  {
   "id": "G04BD",
   "name": "Drugs for urinary frequency and incontinence"
  }
 ],
 "alternatives": [
  "darifenacin",
  "emepronium",
  "fesoterodine",
  "flavoxate",
  "mirabegron",
  "propiverine",
  "solifenacin",
  "terodiline",
  "tolterodine",
  "trospium",
  "vibegron"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 81,
   "TRANSDERMAL": 2
  },
  "boxed_warning": "",
  "indications_and_usage": "Oxybutynin chloride extended-release tablets are a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. Oxybutynin chloride extended-release tablets are also indicated for the treatment of pediatric patients aged 6 years and older with symptoms of detrusor overactivity associated with a neurological condition (e.g., spina bifida). Oxybutynin chloride extended-release tablets are a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. (1) Oxybutynin chloride extended-release tablets are also indicated for the treatment of pediatric patients aged 6 years and older with symptoms of detrusor overactivity associated with a neurological condition (e.g., spina bifida). (1)",
  "contraindications": "Oxybutynin chloride extended-release tablets are contraindicated in patients with urinary retention, gastric retention and other severe decreased gastrointestinal motility conditions, uncontrolled narrow-angle glaucoma. Oxybutynin chloride extended-release tablets are also contraindicated in patients who have demonstrated hypersensitivity to the drug substance or other components of the product. There have been reports of hypersensitivity reactions, including anaphylaxis and angiodema. Urinary retention (4) Gastric Retention (4) Uncontrolled narrow angle glaucoma (4) Known hypersensitivity to Oxybutynin chloride extended-release tablets, oxybutynin or any component of Oxybutynin chloride extended-release tablets (4)",
  "warnings_and_cautions": "Angioedema: Angioedema has been reported with oxybutynin. If symptoms of angioedema occur, discontinue Oxybutynin chloride extended-release tablets immediately and initiate appropriate therapy. ( 5.1 ) Central Nervous System (CNS) effects: CNS effects have been reported with oxybutynin. If patient experiences anticholinergic CNS effects, consider dose adjustment or discontinuation of Oxybutynin chloride extended-release tablets. ( 5.2 ) Use with caution due to aggravation of symptoms: Pre-existing dementia in patients treated with cholinesterase inhibitors ( 5.2 ), Parkinson's disease ( 5.2 ), Myasthenia gravis ( 5.3 ), and Decreased gastrointestinal motility in patients with autonomic neuropathy. ( 5.4 ) Urinary Retention: Use with caution in patients with clinically significant bladder outflow obstruction because of the risk of urinary retention ( 5.5 ) Gastrointestinal Adverse Reactions: Use with caution in patients with gastrointestinal obstructive disorders or decreased intestinal motility due to risk of gastric retention. Use with caution in patients with gastroesophageal reflux or in patients concurrently taking drugs that can exacerbate esophagitis. ( 5.6 ) 5.1 Angioedema A...",
  "warnings": "",
  "adverse_reactions": "The most common (incidence \u22655%) adverse reactions were dry mouth, constipation, diarrhea, headache, somnolence, and dizziness. (6) To report SUSPECTED ADVERSE REACTIONS, contact AvKARE, Inc. at 1-855-361-3993 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The safety and efficacy of Oxybutynin chloride extended-release tablets (5 to 30 mg/day) was evaluated in 774 adult subjects who participated in five double-blind, controlled clinical trials. In four of the five studies, Oxybutynin chloride IR (5 to 20 mg/day in 199 subjects) was an active comparator. Adverse reactions reported by \u2265 1% of subjects are shown in Table 1. Table 1: Adverse Drug Reactions Reported by \u2265 1% of Oxybutynin chloride extended-release tablets-treated Adult Subjects in Five Double-blind, Controlled Clinical Trials of Oxybutynin chloride extended-release tablets System/Organ Class Preferred Term Oxybutynin...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "Patients should be informed that oxybutynin may produce angioedema that could result in life threatening airway obstruction. Patients should be advised to promptly discontinue oxybutynin therapy and seek immediate medical attention if they experience swelling of the tongue, edema of the laryngopharynx, or difficulty breathing. Patients should be informed that anticholinergic (antimuscarinic) agents such as Oxybutynin chloride extended-release tablets, may produce clinically significant adverse reactions related to anticholinergic activity such as: Urinary retention and constipation Heat prostration due to decreased sweating. Heat prostration can occur when anticholinergic medicines are administered in the presence of high environmental temperature. Patients should be informed that anticholinergic medicines such as Oxybutynin chloride extended-release tablets may produce drowsiness (somnolence), dizziness or blurred vision. Patients should be advised to exercise caution in decisions to engage in potentially dangerous activities until Oxybutynin chloride extended-release tablets effects have been determined. Patients should be informed that alcohol may enhance the drowsiness caused b...",
  "spl_medguide": "",
  "clinical_studies": "Oxybutynin chloride extended-release tablets were evaluated for the treatment of patients with overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency in three controlled efficacy studies. The majority of patients were Caucasian (89.0%) and female (91.9%) with a mean age of 59 years (range, 18 to 98 years). Entry criteria required that patients have urge or mixed incontinence (with a predominance of urge) as evidenced by \u2265 6 urge incontinence episodes per week and \u2265 10 micturitions per day. Study 1 was a fixed-dose escalation design, whereas the other two studies used a dose-adjustment design in which each patient's final dose was adjusted to a balance between improvement of incontinence symptoms and tolerability of side effects. All three studies included patients known to be responsive to oxybutynin or other anticholinergic medications, and these patients were maintained on a final dose for up to 2 weeks. The efficacy results for the three controlled trials are presented in the following tables and figures. Number of Urge Urinary Incontinence Episodes Per Week Study 1 n Oxybutynin chloride extended-release tablets n Placebo Mean Baseline 34 15.9 16 2...",
  "brand_name": "Oxybutynin Chloride Extended Release",
  "manufacturer": "Aphena Pharma Solutions - Tennessee, LLC",
  "application_number": "ANDA078503",
  "pharm_class_epc": [],
  "route": [
   "ORAL"
  ],
  "effective_time": "20230531",
  "set_id": "02ff3be7-fc5c-4b91-8c67-ecdf6e19c42a",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 34781,
  "serious": 18592,
  "death": 2162,
  "hospitalization": 9282,
  "primary_suspect": 34697,
  "top_reactions": [
   [
    "Drug Ineffective",
    3417
   ],
   [
    "Fatigue",
    2327
   ],
   [
    "Fall",
    2097
   ],
   [
    "Nausea",
    1724
   ],
   [
    "Diarrhoea",
    1591
   ],
   [
    "Headache",
    1555
   ],
   [
    "Off Label Use",
    1535
   ],
   [
    "Urinary Tract Infection",
    1524
   ],
   [
    "Pain",
    1438
   ],
   [
    "Dizziness",
    1435
   ],
   [
    "Asthenia",
    1218
   ],
   [
    "Constipation",
    1102
   ],
   [
    "Gait Disturbance",
    1080
   ],
   [
    "Malaise",
    1010
   ],
   [
    "Dyspnoea",
    1002
   ]
  ],
  "by_year": {
   "2019": 3494,
   "2020": 3054,
   "2021": 2549,
   "2022": 2371,
   "2023": 2131,
   "2024": 1193,
   "2025": 2087,
   "2026": 969
  },
  "by_year_primary": {
   "2019": 3493,
   "2020": 3050,
   "2021": 2548,
   "2022": 2345,
   "2023": 2097,
   "2024": 1190,
   "2025": 2078,
   "2026": 967
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20231019",
   "reason": "Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.",
   "firm": "Zydus Pharmaceuticals (USA) Inc",
   "status": "Completed"
  },
  {
   "class": "Class II",
   "date": "20231019",
   "reason": "Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.",
   "firm": "Zydus Pharmaceuticals (USA) Inc",
   "status": "Completed"
  },
  {
   "class": "Class II",
   "date": "20231019",
   "reason": "Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.",
   "firm": "Zydus Pharmaceuticals (USA) Inc",
   "status": "Completed"
  },
  {
   "class": "Class II",
   "date": "20230921",
   "reason": "Failed Dissolution Specifications",
   "firm": "Zydus Pharmaceuticals (USA) Inc",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20190301",
   "reason": "Failed Dissolution Specifications",
   "firm": "AVKARE Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20190221",
   "reason": "Failed Dissolution Specifications",
   "firm": "Lannett Company Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20181211",
   "reason": "Labeling: Wrong bar code",
   "firm": "KVK-Tech, Inc.",
   "status": "Terminated"
  }
 ],
 "recall_total": 7,
 "drugsfda": {
  "applications": 43,
  "nda": 7,
  "anda": 33,
  "first_approval": "19750716",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 48,
  "labeling_recent": 2,
  "sponsors": [
   "ABBVIE",
   "ABHAI LLC",
   "ACCORD HLTHCARE",
   "ADAPTIS",
   "AIPING PHARM INC",
   "AJANTA PHARMA LTD",
   "ALLERGAN",
   "AMNEAL PHARMS"
  ],
  "unapproved": false,
  "first_approval_fmt": "07/16/1975"
 },
 "trials": {
  "total": 116,
  "completed": 74,
  "terminated": 8,
  "with_results": 28,
  "industry": 48,
  "phase3": 25,
  "results_share": 0.3783783783783784,
  "terminated_share": 0.06896551724137931
 },
 "pubmed": {
  "rct": 160,
  "meta": 9,
  "recent_rct": 22,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "oxybutynin",
   "Oxytrol",
   "Gelnique"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 5422689,
  "beneficiaries": 1476739,
  "spend": 112245784.0,
  "by_brand": [
   {
    "brand": "Oxybutynin Chloride ER",
    "claims": 3420475,
    "per_claim": 22.320454294,
    "is_generic": false
   },
   {
    "brand": "Oxybutynin Chloride",
    "claims": 2000706,
    "per_claim": 17.231277584,
    "is_generic": true
   },
   {
    "brand": "Oxytrol",
    "claims": 1434,
    "per_claim": 962.56281032,
    "is_generic": false
   },
   {
    "brand": "Gelnique",
    "claims": 74,
    "per_claim": 597.19702703,
    "is_generic": false
   }
  ],
  "per_claim": 20.69928480132274
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 4235,
  "fills": 5422689,
  "per_million": 780.9778506567498,
  "ratio": 0.2820484010544655,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 100,
   "letter": "A",
   "why": [
    "781 FDA reports naming it as the suspect drug per million Medicare fills, 0.3x the median drug on this site",
    "Death share in reports is near or below the FAERS average (0.7x)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 46,
   "letter": "F",
   "why": [
    "160 randomized trials and 9 systematic reviews/meta-analyses indexed in PubMed",
    "No Cochrane review found (-5)",
    "Only 38% of completed registered trials posted results (-8)",
    "'Drug ineffective' is the single most-reported item about this drug in FAERS (-5)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 89,
   "letter": "A",
   "why": [
    "Recalls since 2016: 0 Class I, 5 Class II, 2 Class III across 33 generic makers (-7)",
    "2 label changes approved since 2021 (-4)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 100,
   "letter": "A",
   "why": [
    "Pharma paid doctors $0 tied to this drug last year: negligible",
    "Not named in any pending federal MDL"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 100,
   "letter": "A",
   "why": [
    "Generic versions approved (33 applications)",
    "11 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 85,
 "grade": "B",
 "questions": [
  "The most-reported problems in FDA's adverse event data are fatigue, fall, nausea. How would we recognize and handle those?",
  "Why this one over darifenacin, emepronium, fesoterodine? What would make you pick one of those instead?",
  "What result are we expecting, by when, and what is the plan if it does not happen?",
  "If 100 people like me took this drug, how many would actually get better because of it, and how many would be harmed by it? (Doctors call these the number needed to treat and the number needed to harm.)"
 ]
}