{
 "query": "benztropine",
 "ingredient": "benztropine",
 "slug": "benztropine",
 "rxcui": "1424",
 "brands": [],
 "names": [
  "benztropine",
  "benztropine mesylate"
 ],
 "classes": [
  {
   "id": "N04AC",
   "name": "Ethers of tropine or tropine derivatives"
  }
 ],
 "alternatives": [],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 29,
   "INTRAMUSCULAR": 5,
   "INTRAVENOUS": 5
  },
  "boxed_warning": "",
  "indications_and_usage": "INDICATIONS AND USAGE For use as an adjunct in the therapy of all forms of parkinsonism. Useful also in the control of extrapyramidal disorders (except tardive dyskinesia \u2013 see PRECAUTIONS ) due to neuroleptic drugs (e.g., phenothiazines).",
  "contraindications": "CONTRAINDICATIONS Hypersensitivity to benztropine mesylate tablets. Because of its atropine-like side effects, this drug is contraindicated in pediatric patients under three years of age, and should be used with caution in older pediatric patients.",
  "warnings_and_cautions": "",
  "warnings": "WARNINGS Safe use in pregnancy has not been established. Benztropine mesylate may impair mental and/or physical abilities required for performance of hazardous tasks, such as operating machinery or driving a motor vehicle. When benztropine mesylate is given concomitantly with phenothiazines, haloperidol, or other drugs with anticholinergic or antidopaminergic activity, patients should be advised to report gastrointestinal complaints, fever or heat intolerance promptly. Paralytic ileus, hyperthermia and heat stroke, all of which have sometimes been fatal, have occurred in patients taking anticholinergic-type antiparkinsonism drugs, including benztropine mesylate, in combination with phenothiazines and/or tricyclic antidepressants. Since benztropine mesylate contains structural features of atropine, it may produce anhidrosis. For this reason, it should be administered with caution during hot weather, especially when given concomitantly with other atropine-like drugs to the chronically ill, the alcoholic, those who have central nervous system disease, and those who do manual labor in a hot environment. Anhidrosis may occur more readily when some disturbance of sweating already exists....",
  "adverse_reactions": "ADVERSE REACTIONS The adverse reactions below, most of which are anticholinergic in nature, have been reported and within each category are listed in order of decreasing severity. Cardiovascular Tachycardia. Digestive Paralytic ileus, constipation, vomiting, nausea, dry mouth. If dry mouth is so severe that there is difficulty in swallowing or speaking, or loss of appetite and weight, reduce dosage or discontinue the drug temporarily. Slight reduction in dosage may control nausea and still give sufficient relief of symptoms. Vomiting may be controlled by temporary discontinuation, followed by resumption at a lower dosage. Nervous System Toxic psychosis, including confusion, disorientation, memory impairment, visual hallucinations; exacerbation of pre-existing psychotic symptoms; nervousness; depression; listlessness; numbness of fingers. Special Senses Blurred vision, dilated pupils. Urogenital Urinary retention, dysuria. Metabolic/Immune or Skin Occasionally, an allergic reaction, e.g., skin rash, develops. If this cannot be controlled by dosage reduction, the medication should be discontinued. Other Heat stroke, hyperthermia, fever.",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "",
  "spl_medguide": "",
  "clinical_studies": "",
  "brand_name": "Benztropine Mesylate",
  "manufacturer": "Coupler LLC",
  "application_number": "ANDA040715",
  "pharm_class_epc": [],
  "route": [
   "ORAL"
  ],
  "effective_time": "20260424",
  "set_id": "5035534e-e15c-8f06-e063-6294a90a5003",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 8980,
  "serious": 6084,
  "death": 1268,
  "hospitalization": 3137,
  "primary_suspect": 8922,
  "top_reactions": [
   [
    "Drug Ineffective",
    652
   ],
   [
    "Off Label Use",
    589
   ],
   [
    "Toxicity To Various Agents",
    482
   ],
   [
    "Completed Suicide",
    431
   ],
   [
    "Tremor",
    431
   ],
   [
    "Drug Interaction",
    427
   ],
   [
    "Death",
    341
   ],
   [
    "Fatigue",
    322
   ],
   [
    "Fall",
    312
   ],
   [
    "Somnolence",
    305
   ],
   [
    "Weight Increased",
    304
   ],
   [
    "Anxiety",
    297
   ],
   [
    "Nausea",
    289
   ],
   [
    "Dizziness",
    285
   ],
   [
    "Confusional State",
    275
   ]
  ],
  "by_year": {
   "2019": 855,
   "2020": 835,
   "2021": 804,
   "2022": 604,
   "2023": 525,
   "2024": 524,
   "2025": 541,
   "2026": 314
  },
  "by_year_primary": {
   "2019": 853,
   "2020": 831,
   "2021": 800,
   "2022": 591,
   "2023": 520,
   "2024": 512,
   "2025": 530,
   "2026": 307
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20130701",
   "reason": "Presence of particulate matter:  characterized as thin colorless flakes that are visually and chemically consistent with glass delamination observed in reserve sample vials",
   "firm": "Fresenius Kabi USA, LLC",
   "status": "Terminated"
  }
 ],
 "recall_total": 1,
 "drugsfda": {
  "applications": 30,
  "nda": 2,
  "anda": 22,
  "first_approval": "19540305",
  "rems": false,
  "rems_last": "19740701",
  "labeling_supplements": 21,
  "labeling_recent": 0,
  "sponsors": [
   "AIPING PHARM INC",
   "CHARTWELL RX",
   "EPIC PHARMA LLC",
   "FRESENIUS KABI USA",
   "HIKMA",
   "HIKMA FARMACEUTICA",
   "INVAGEN PHARMS",
   "LANNETT CO INC"
  ],
  "unapproved": false,
  "first_approval_fmt": "03/05/1954"
 },
 "trials": {
  "total": 17,
  "completed": 13,
  "terminated": 1,
  "with_results": 7,
  "industry": 5,
  "phase3": 1,
  "results_share": 0.5384615384615384,
  "terminated_share": 0.058823529411764705
 },
 "pubmed": {
  "rct": 9,
  "meta": 0,
  "recent_rct": 1,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "benztropine"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 1944678,
  "beneficiaries": 249349,
  "spend": 23986554.44,
  "by_brand": [
   {
    "brand": "Benztropine Mesylate",
    "claims": 1944678,
    "per_claim": 12.334460738,
    "is_generic": true
   }
  ],
  "per_claim": 12.334460738487298
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 1349,
  "fills": 1944678,
  "per_million": 693.6881067199814,
  "ratio": 0.25052390559647586,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 95,
   "letter": "A",
   "why": [
    "694 FDA reports naming it as the suspect drug per million Medicare fills, 0.3x the median drug on this site",
    "Death appears in 1.6x the FAERS average share of reports (within the margin this measure deserves)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 18,
   "letter": "F",
   "why": [
    "9 randomized trials and 0 systematic reviews/meta-analyses indexed in PubMed",
    "No Cochrane review found (-5)",
    "'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": 70,
   "letter": "C",
   "why": [
    "Generic versions approved (22 applications)",
    "No same-class alternatives found: little leverage to switch (-30)"
   ],
   "weight": 0.1
  }
 },
 "total": 75,
 "grade": "C",
 "questions": [
  "The most-reported problems in FDA's adverse event data are toxicity to various agents, completed suicide. How would we recognize and handle those?",
  "Off-label use is among the most-reported items for this drug. Is my use on-label, and if not, what evidence supports it?",
  "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.)"
 ]
}