{
 "query": "tolterodine",
 "ingredient": "tolterodine",
 "slug": "tolterodine",
 "rxcui": "119565",
 "brands": [
  "Detrol"
 ],
 "names": [
  "tolterodine",
  "tolterodine tartrate"
 ],
 "classes": [
  {
   "id": "G04BD",
   "name": "Drugs for urinary frequency and incontinence"
  }
 ],
 "alternatives": [
  "darifenacin",
  "emepronium",
  "fesoterodine",
  "flavoxate",
  "mirabegron",
  "oxybutynin",
  "propiverine",
  "solifenacin",
  "terodiline",
  "trospium",
  "vibegron"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 17
  },
  "boxed_warning": "",
  "indications_and_usage": "Tolterodine Tartrate Extended-Release Capsules are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency [see CLINICAL STUDIES (14) ] . Tolterodine Tartrate Extended-Release Capsules are an antimuscarinic indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. ( 1 )",
  "contraindications": "Tolterodine Tartrate Extended-Release Capsules are contraindicated in patients with urinary retention, gastric retention, or uncontrolled narrow-angle glaucoma. Tolterodine Tartrate Extended-Release Capsules are also contraindicated in patients with known hypersensitivity to the drug or its ingredients, or to fesoterodine fumarate extended-release tablets which, like Tolterodine Tartrate Extended-Release Capsules, are metabolized to 5-hydroxymethyl tolterodine [see WARNINGS AND PRECAUTIONS (5.2) , (5.3) , (5.4) ]. Tolterodine Tartrate Extended-Release Capsules are contraindicated in patients with urinary retention, gastric retention, or uncontrolled narrow-angle glaucoma. Tolterodine Tartrate Extended-Release Capsules are also contraindicated in patients with known hypersensitivity to the drug or its ingredients, or to fesoterodine fumarate extended-release tablets which, like Tolterodine Tartrate Extended-Release Capsules, are metabolized to 5-hydroxymethyl tolterodine. ( 4 )",
  "warnings_and_cautions": "Anaphylaxis and angioedema requiring hospitalization and emergency medical treatment have occurred with the first or subsequent doses of tolterodine tartrate extended-release capsules. ( 5.1 ) Urinary Retention: use caution in patients with clinically significant bladder outflow obstruction because of the risk of urinary retention. ( 5.2 ) Gastrointestinal Disorders: use caution in patients with gastrointestinal obstructive disorders or decreased gastrointestinal motility because of the risk of gastric retention. ( 5.3 ) Controlled Narrow-Angle Glaucoma: use caution in patients being treated for narrow-angle glaucoma. ( 5.4 ) Central Nervous System Effects: Somnolence has been reported with tolterodine tartrate extended-release capsules. Advise patients not to drive or operate heavy machinery until they know how tolterodine tartrate extended-release capsules affect them ( 5.5 ). Myasthenia Gravis: use caution in patients with myasthenia gravis. ( 5.8 ) QT Prolongation: consider observations from the thorough QT study in clinical decisions to prescribe tolterodine tartrate extended-release capsules to patients with a known history of QT prolongation or to patients who are taking Cla...",
  "warnings": "",
  "adverse_reactions": "Because clinical trials are conducted under widely varying conditions, 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 practice. The most common adverse reactions (incidence \u22654% and >placebo) were dry mouth, headache, constipation, and abdominal pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Slate Run Pharmaceuticals, LLC at 1-888-341-9214 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience The efficacy and safety of tolterodine tartrate extended-release capsules was evaluated in 1,073 patients (537 assigned to tolterodine tartrate extended-release capsules; 536 assigned to placebo) who were treated with 2, 4, 6, or 8 mg/day for up to 15 months. These included a total of 1,012 patients (505 randomized to tolterodine tartrate extended-release capsules 4 mg once daily and 507 randomized to placebo) enrolled in a randomized, placebo-controlled, double-blind, 12-week clinical efficacy and safety study. Adverse events were reported in 52% (n=263) of patients receiving tolterodine tartrate extended-release capsul...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "Advise the patient to read the FDA-approved patient labeling (Patient Information). Antimuscarinic Effects Inform patients that antimuscarinic agents such as tolterodine tartrate extended-release capsules may have side effects including blurred vision, dizziness, or drowsiness. Advise patients not to drive, operate machinery, or do other potentially dangerous activities until they know how tolterodine tartrate extended-release capsules affect them.",
  "spl_medguide": "",
  "clinical_studies": "Tolterodine tartrate extended-release capsules 2 mg were evaluated in 29 patients in a Phase 2 dose-effect study. Tolterodine tartrate extended-release capsules 4 mg were evaluated for the treatment of overactive bladder with symptoms of urge urinary incontinence and frequency in a randomized, placebo-controlled, multicenter, double-blind, Phase 3, 12-week study. A total of 507 patients received tolterodine tartrate extended-release capsules 4 mg once daily in the morning and 508 received placebo. The majority of patients were Caucasian (95%) and female (81%), with a mean age of 61 years (range, 20 to 93 years). In the study, 642 patients (42%) were 65 to 93 years of age. The study included patients known to be responsive to tolterodine immediate release and other anticholinergic medications, however, 47% of patients never received prior pharmacotherapy for overactive bladder. At study entry, 97% of patients had at least 5 urge incontinence episodes per week and 91% of patients had 8 or more micturitions per day. The primary efficacy assessment was change in mean number of incontinence episodes per week at week 12 from baseline. Secondary efficacy measures included change in mean n...",
  "brand_name": "Tolterodine Tartrate",
  "manufacturer": "Slate Run Pharmaceuticals, LLC",
  "application_number": "ANDA213858",
  "pharm_class_epc": [],
  "route": [
   "ORAL"
  ],
  "effective_time": "20260805",
  "set_id": "bbbee85a-e5e2-24ec-e053-2995a90acfd8",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 10557,
  "serious": 6606,
  "death": 650,
  "hospitalization": 2855,
  "primary_suspect": 10509,
  "top_reactions": [
   [
    "Drug Ineffective",
    1005
   ],
   [
    "Fatigue",
    736
   ],
   [
    "Fall",
    685
   ],
   [
    "Diarrhoea",
    570
   ],
   [
    "Nausea",
    493
   ],
   [
    "Dizziness",
    485
   ],
   [
    "Headache",
    479
   ],
   [
    "Off Label Use",
    446
   ],
   [
    "Pain",
    437
   ],
   [
    "Urinary Tract Infection",
    410
   ],
   [
    "Arthralgia",
    393
   ],
   [
    "Dyspnoea",
    383
   ],
   [
    "Asthenia",
    382
   ],
   [
    "Gait Disturbance",
    372
   ],
   [
    "Malaise",
    306
   ]
  ],
  "by_year": {
   "2019": 1175,
   "2020": 1083,
   "2021": 779,
   "2022": 595,
   "2023": 430,
   "2024": 493,
   "2025": 439,
   "2026": 175
  },
  "by_year_primary": {
   "2019": 1174,
   "2020": 1081,
   "2021": 779,
   "2022": 584,
   "2023": 407,
   "2024": 488,
   "2025": 435,
   "2026": 174
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [],
 "recall_total": 0,
 "drugsfda": {
  "applications": 20,
  "nda": 2,
  "anda": 16,
  "first_approval": "19980325",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 21,
  "labeling_recent": 0,
  "sponsors": [
   "AJANTA PHARMA LTD",
   "APOTEX CORP",
   "AUROBINDO PHARMA USA",
   "HETERO LABS LTD III",
   "HETERO LABS LTD V",
   "INVENTIA HLTHCARE",
   "IVAX SUB TEVA PHARMS",
   "MACLEODS PHARMS"
  ],
  "unapproved": false,
  "first_approval_fmt": "03/25/1998"
 },
 "trials": {
  "total": 120,
  "completed": 97,
  "terminated": 9,
  "with_results": 37,
  "industry": 75,
  "phase3": 33,
  "results_share": 0.38144329896907214,
  "terminated_share": 0.075
 },
 "pubmed": {
  "rct": 150,
  "meta": 13,
  "recent_rct": 6,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "tolterodine",
   "Detrol"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 810996,
  "beneficiaries": 215352,
  "spend": 71245597.38,
  "by_brand": [
   {
    "brand": "Tolterodine Tartrate ER",
    "claims": 646179,
    "per_claim": 91.231482763,
    "is_generic": false
   },
   {
    "brand": "Tolterodine Tartrate",
    "claims": 163394,
    "per_claim": 68.15380424,
    "is_generic": true
   },
   {
    "brand": "Detrol La",
    "claims": 1329,
    "per_claim": 808.28025583,
    "is_generic": false
   },
   {
    "brand": "Detrol",
    "claims": 94,
    "per_claim": 889.38223404,
    "is_generic": false
   }
  ],
  "per_claim": 87.84950527499518
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 1097,
  "fills": 810996,
  "per_million": 1352.6577196435,
  "ratio": 0.4885093049420035,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 100,
   "letter": "A",
   "why": [
    "1,353 FDA reports naming it as the suspect drug per million Medicare fills, 0.5x the median drug on this site",
    "Death share in reports is near or below the FAERS average (0.7x)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 47,
   "letter": "F",
   "why": [
    "150 randomized trials and 13 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": 100,
   "letter": "A",
   "why": [
    "No recalls on record since 2016"
   ],
   "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 (16 applications)",
    "11 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 87,
 "grade": "B",
 "questions": [
  "The most-reported problems in FDA's adverse event data are fatigue, fall, diarrhoea. 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.)"
 ]
}