{
 "query": "trospium",
 "ingredient": "trospium",
 "slug": "trospium",
 "rxcui": "236778",
 "brands": [],
 "names": [
  "trospium",
  "trospium chloride"
 ],
 "classes": [
  {
   "id": "G04BD",
   "name": "Drugs for urinary frequency and incontinence"
  }
 ],
 "alternatives": [
  "darifenacin",
  "emepronium",
  "fesoterodine",
  "flavoxate",
  "mirabegron",
  "oxybutynin",
  "propiverine",
  "solifenacin",
  "terodiline",
  "tolterodine",
  "vibegron"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 25
  },
  "boxed_warning": "",
  "indications_and_usage": "Trospium Chloride Extended-Release Capsules are a muscarinic antagonist indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency. Trospium Chloride Extended-Release Capsules are a muscarinic antagonist indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency. ( 1 )",
  "contraindications": "Trospium Chloride Extended-Release Capsules are contraindicated in patients with: \u2022 urinary retention \u2022 gastric retention \u2022 uncontrolled narrow-angle glaucoma \u2022 known hypersensitivity to the drug or its ingredients. Angioedema, rash and anaphylactic reaction have been reported. Trospium Chloride Extended-Release Capsules are contraindicated in \u2022 patients with urinary retention, gastric retention, or uncontrolled narrow-angle glaucoma, and in patients who are at risk for these conditions ( 4 ) \u2022 patients with known hypersensitivity ( 4 )",
  "warnings_and_cautions": "\u2022 Trospium Chloride Extended-Release Capsules should be administered with caution to patients with clinically significant bladder outflow obstruction or gastrointestinal obstructive disorders due to risk of urinary or gastric retention. ( 5.1 , 5.3 ) \u2022 Angioedema of the face, lips, tongue and/or larynx has been reported with trospium chloride. ( 5.2 ) \u2022 In patients with narrow-angle glaucoma, Trospium Chloride Extended-Release Capsules should be used only with careful monitoring. ( 5.4 ) \u2022 Central Nervous System Effects: Somnolence has been reported with Trospium Chloride Extended-Release Capsules. Advise patients not to drive or operate heavy machinery until they know how Trospium Chloride Extended-Release Capsules affect them. ( 5.5 ) \u2022 Trospium Chloride Extended-Release Capsules are not recommended for use in patients with severe renal impairment (creatinine clearance < 30 mL/minute). ( 5.6 ) \u2022 Alcohol should not be consumed within 2 hours of Trospium Chloride Extended-Release Capsules administration. ( 5.7 ) 5.1 Risk of Urinary Retention Trospium Chloride Extended-Release Capsules should be administered with caution to patients with clinically significant bladder outflow obstru...",
  "warnings": "",
  "adverse_reactions": "The most common adverse reactions (\u2265 1%) with Trospium Chloride Extended-Release Capsules are dry mouth (10.7%) and constipation (8.5%). (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Padagis at 1-866-634-9120 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 data described below reflect exposure to Trospium Chloride Extended-Release Capsules in 578 patients for 12 weeks in two Phase 3 double-blind, placebo controlled trials (n = 1165). These studies included overactive bladder patients of ages 21 to 90 years, of which 86% were female and 85% were Caucasian. Patients received 60 mg daily doses of Trospium Chloride Extended-Release Capsules. Patients in these studies were eligible to continue treatment with Trospium Chloride Extended-Release Capsules 60 mg for up to one year. From both these controlled trials combined, 769 and 238 patients received treatment with Trospi...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "\"See FDA-approved Patient Labeling ( Patient Information )\" 17.1 Angioedema Patients should be informed that Trospium Chloride Extended-Release Capsules may produce angioedema which could result in life-threatening airway obstruction. Patients should be advised to promptly discontinue Trospium Chloride Extended-Release Capsules therapy and seek immediate medical attention if they experience edema of the tongue, edema of the laryngopharynx, or difficulty breathing. 17.2 When Not to Use Prior to treatment, patients should fully understand the risks and benefits of Trospium Chloride Extended-Release Capsules. In particular, patients should be informed not to take Trospium Chloride Extended-Release Capsules if they: \u2022 have urinary retention; \u2022 gastric retention; \u2022 uncontrolled narrow-angle glaucoma; \u2022 are allergic to any component of Trospium Chloride Extended-Release Capsules. 17.3 Administration Patients should be instructed regarding the recommended dosing and administration of Trospium Chloride Extended-Release Capsules: \u2022 Take one Trospium Chloride Extended-Release Capsule daily in the morning with water. \u2022 Take Trospium Chloride Extended-Release Capsules on an empty stomach or at...",
  "spl_medguide": "",
  "clinical_studies": "Trospium Chloride Extended-Release Capsules were evaluated for the treatment of patients with overactive bladder who had symptoms of urinary frequency, urgency and urge urinary incontinence in two 12-week, randomized, double-blind, placebo-controlled studies. For both studies, entry criteria required the presence of urge incontinence (predominance of urge), at least one incontinence episode per day, and 10 or more micturitions (voids) per day (assessed by 3-day urinary diary). Medical history and data from the baseline urinary diary confirmed the diagnosis. Approximately 88% of the patients enrolled completed the 12-week studies. The mean age was 60 years, and the majority of patients were female (84%) and Caucasian (86%). The co-primary endpoints in the trials were the mean change from baseline to Week 12 in number of voids/24 hours (reductions in urinary frequency) and the mean change from baseline to Week 12 in number of incontinence episodes/24 hours. Secondary endpoints included mean change from baseline to Week 12 in volume per void. Study 1 included 592 patients in both Trospium Chloride Extended-Release Capsules 60 mg and placebo groups. As illustrated in Table 4 and Figure...",
  "brand_name": "Trospium Chloride ER",
  "manufacturer": "Padagis US LLC",
  "application_number": "ANDA201291",
  "pharm_class_epc": [],
  "route": [
   "ORAL"
  ],
  "effective_time": "20221130",
  "set_id": "4574f905-a8c5-4732-b934-d1c7f9e708c9",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 4833,
  "serious": 3446,
  "death": 388,
  "hospitalization": 2057,
  "primary_suspect": 4814,
  "top_reactions": [
   [
    "Fall",
    388
   ],
   [
    "Fatigue",
    293
   ],
   [
    "Drug Ineffective",
    284
   ],
   [
    "Urinary Tract Infection",
    284
   ],
   [
    "Dizziness",
    264
   ],
   [
    "Asthenia",
    208
   ],
   [
    "Dyspnoea",
    206
   ],
   [
    "General Physical Health Deterioration",
    202
   ],
   [
    "Diarrhoea",
    201
   ],
   [
    "Off Label Use",
    186
   ],
   [
    "Gait Disturbance",
    185
   ],
   [
    "Nausea",
    183
   ],
   [
    "Constipation",
    181
   ],
   [
    "Headache",
    169
   ],
   [
    "Acute Kidney Injury",
    168
   ]
  ],
  "by_year": {
   "2019": 443,
   "2020": 467,
   "2021": 401,
   "2022": 409,
   "2023": 327,
   "2024": 340,
   "2025": 391,
   "2026": 199
  },
  "by_year_primary": {
   "2019": 443,
   "2020": 466,
   "2021": 397,
   "2022": 401,
   "2023": 326,
   "2024": 340,
   "2025": 391,
   "2026": 194
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20231101",
   "reason": "Failed Tablets/Capsules specifications; missing/broken/extra tablets within the capsules",
   "firm": "Padagis US LLC",
   "status": "Ongoing"
  }
 ],
 "recall_total": 1,
 "drugsfda": {
  "applications": 14,
  "nda": 2,
  "anda": 12,
  "first_approval": "20040528",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 12,
  "labeling_recent": 0,
  "sponsors": [
   "ACTAVIS LABS FL INC",
   "ALLERGAN",
   "APOTEX",
   "CHARTWELL RX",
   "GLENMARK PHARMS LTD",
   "GRANULES",
   "HERITAGE PHARMS INC",
   "INVAGEN PHARMS"
  ],
  "unapproved": false,
  "first_approval_fmt": "05/28/2004"
 },
 "trials": {
  "total": 74,
  "completed": 39,
  "terminated": 3,
  "with_results": 20,
  "industry": 59,
  "phase3": 26,
  "results_share": 0.5128205128205128,
  "terminated_share": 0.04054054054054054
 },
 "pubmed": {
  "rct": 53,
  "meta": 12,
  "recent_rct": 10,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "trospium"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 576136,
  "beneficiaries": 183196,
  "spend": 46727109.099999994,
  "by_brand": [
   {
    "brand": "Trospium Chloride",
    "claims": 448238,
    "per_claim": 54.295130689,
    "is_generic": true
   },
   {
    "brand": "Trospium Chloride ER",
    "claims": 127898,
    "per_claim": 175.06112926,
    "is_generic": false
   }
  ],
  "per_claim": 81.10430367135537
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 925,
  "fills": 576136,
  "per_million": 1605.5236957940488,
  "ratio": 0.5798312857054313,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 100,
   "letter": "A",
   "why": [
    "1,606 FDA reports naming it as the suspect drug per million Medicare fills, 0.6x the median drug on this site",
    "Death share in reports is near or below the FAERS average (0.9x)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 52,
   "letter": "D",
   "why": [
    "53 randomized trials and 12 systematic reviews/meta-analyses indexed in PubMed",
    "No Cochrane review found (-5)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 99,
   "letter": "A",
   "why": [
    "Recalls since 2016: 0 Class I, 1 Class II, 0 Class III across 12 generic makers (-1)"
   ],
   "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 (12 applications)",
    "11 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 88,
 "grade": "A",
 "questions": [
  "The most-reported problems in FDA's adverse event data are fall, fatigue, urinary tract infection. 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.)"
 ]
}