{
 "query": "donepezil",
 "ingredient": "donepezil",
 "slug": "donepezil",
 "rxcui": "135447",
 "brands": [
  "Adlarity",
  "Aricept"
 ],
 "names": [
  "donepezil",
  "donepezil hydrochloride"
 ],
 "classes": [
  {
   "id": "N06DA",
   "name": "Anticholinesterases"
  }
 ],
 "alternatives": [
  "benzgalantamine",
  "galantamine",
  "rivastigmine",
  "tacrine"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 53
  },
  "boxed_warning": "",
  "indications_and_usage": "Donepezil hydrochloride tablet is an acetylcholinesterase inhibitor indicated for the treatment of dementia of the Alzheimer's type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer's Disease ( 1 ). Donepezil hydrochloride tablet is indicated for the treatment of dementia of the Alzheimer's type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer's disease.",
  "contraindications": "Known hypersensitivity to donepezil hydrochloride or to piperidine derivatives ( 4 ) Donepezil hydrochloride is contraindicated in patients with known hypersensitivity to donepezil hydrochloride or to piperidine derivatives.",
  "warnings_and_cautions": "Cholinesterase inhibitors are likely to exaggerate succinylcholine-type muscle relaxation during anesthesia ( 5.1 ) Cholinesterase inhibitors may have vagotonic effects on the sinoatrial and atrioventricular nodes manifesting as bradycardia or heart block ( 5.2 ) Donepezil hydrochloride can cause vomiting. Patients should be observed closely at initiation of treatment and after dose increases ( 5.3 ) Patients should be monitored closely for symptoms of active or occult gastrointestinal (GI) bleeding, especially those at increased risk for developing ulcers ( 5.4 ) The use of donepezil hydrochloride in a dose of 23 mg once daily is associated with weight loss ( 5.5 ) Cholinomimetics may cause bladder outflow obstructions ( 5.6 ) Cholinomimetics are believed to have some potential to cause generalized convulsions ( 5.7 ) Cholinesterase inhibitors should be prescribed with care to patients with a history of asthma or obstructive pulmonary disease ( 5.8 ) 5.1 Anesthesia Donepezil hydrochloride, as a cholinesterase inhibitor, is likely to exaggerate succinylcholine-type muscle relaxation during anesthesia. 5.2 Cardiovascular Conditions Because of their pharmacological action, cholineste...",
  "warnings": "",
  "adverse_reactions": "Most common adverse reactions in clinical studies of donepezil hydrochloride are nausea, diarrhea, insomnia, vomiting, muscle cramps, fatigue, and anorexia ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceuticals, Inc. at 1-800-399-2561 or FDA at 1-800-FDA-1088 or www.fda.gov/ medwatch . The following serious adverse reactions are described below and elsewhere in the labeling: Cardiovascular Conditions [ see Warnings and Precautions ( 5.2 ) ]. Nausea and Vomiting [ see Warnings and Precautions ( 5.3 ) ]. Peptic Ulcer Disease and GI Bleeding [ see Warnings and Precautions ( 5.4 ) ]. Weight Loss [ see Warnings and Precautions ( 5.5 ) ]. Genitourinary Conditions [ see Warnings and Precautions ( 5.6 ) ]. Neurological Conditions: Seizures [ see Warnings and Precautions ( 5.7 ) ]. Pulmonary Conditions [ see Warnings and Precautions ( 5.8 ) ]. 6.1 Clinical Trials Experience 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. Donepezil hydrochloride has been adm...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "Advise the patient to read the FDA-approved patient labeling (Patient Information). Instruct patients and caregivers to take donepezil hydrochloride only once per day, as prescribed. Instruct patients and caregivers that donepezil hydrochloride can be taken with or without food. Donepezil hydrochloride 23 mg tablets should be swallowed whole without the tablets being split, crushed or chewed. Advise patients and caregivers that donepezil hydrochloride may cause nausea, diarrhea, insomnia, vomiting, muscle cramps, fatigue, and decreased appetite. Advise patients to notify their healthcare provider if they are pregnant or plan to become pregnant. LUPIN and the are registered trademarks of Lupin Pharmaceuticals, Inc. Manufactured for: Lupin Pharmaceuticals, Inc. Naples, FL 34108 United States. Manufactured by: Lupin Limited Goa 403 722 INDIA. Revised: November 2024 ID#: 279137 Image",
  "spl_medguide": "",
  "clinical_studies": "14.1 Mild to Moderate Alzheimers Disease The effectiveness of donepezil hydrochloride as a treatment for mild to moderate Alzheimer's disease is demonstrated by the results of two randomized, double-blind, placebo-controlled clinical investigations in patients with Alzheimer's disease (diagnosed by NINCDS and DSM III-R criteria, Mini-Mental State Examination \u226510 and \u226426 and Clinical Dementia Rating of 1 or 2). The mean age of patients participating in donepezil hydrochloride trials was 73 years with a range of 50 to 94. Approximately 62% of patients were women and 38% were men. The racial distribution was white 95%, black 3%, and other races 2%. The higher dose of 10 mg did not provide a statistically significantly greater clinical benefit than 5 mg. There is a suggestion, however, based upon order of group mean scores and dose trend analyses of data from these clinical trials, that a daily dose of 10 mg of donepezil hydrochloride might provide additional benefit for some patients. Accordingly, whether or not to employ a dose of 10 mg is a matter of prescriber and patient preference. Study Outcome Measures In each study, the effectiveness of treatment with donepezil hydrochloride w...",
  "brand_name": "DONEPEZIL HYDROCHLORIDE",
  "manufacturer": "Lupin Pharmaceuticals, Inc.",
  "application_number": "ANDA202782",
  "pharm_class_epc": [],
  "route": [
   "ORAL"
  ],
  "effective_time": "20241129",
  "set_id": "03e26183-3e07-45e8-a414-a8bad32483e2",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 28762,
  "serious": 21693,
  "death": 4612,
  "hospitalization": 11112,
  "primary_suspect": 28608,
  "top_reactions": [
   [
    "Fall",
    2515
   ],
   [
    "Death",
    1967
   ],
   [
    "Diarrhoea",
    1523
   ],
   [
    "Fatigue",
    1442
   ],
   [
    "Confusional State",
    1413
   ],
   [
    "Dizziness",
    1386
   ],
   [
    "Drug Ineffective",
    1385
   ],
   [
    "Hallucination",
    1320
   ],
   [
    "Nausea",
    1288
   ],
   [
    "Asthenia",
    1165
   ],
   [
    "Vomiting",
    1043
   ],
   [
    "Off Label Use",
    1029
   ],
   [
    "Somnolence",
    1008
   ],
   [
    "Decreased Appetite",
    998
   ],
   [
    "Drug Interaction",
    961
   ]
  ],
  "by_year": {
   "2019": 2741,
   "2020": 2647,
   "2021": 2083,
   "2022": 2147,
   "2023": 2053,
   "2024": 1787,
   "2025": 2520,
   "2026": 1239
  },
  "by_year_primary": {
   "2019": 2740,
   "2020": 2641,
   "2021": 2076,
   "2022": 2093,
   "2023": 2020,
   "2024": 1775,
   "2025": 2490,
   "2026": 1235
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20220126",
   "reason": "CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.",
   "firm": "CARDINAL HEALTHCARE",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20220126",
   "reason": "CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.",
   "firm": "CARDINAL HEALTHCARE",
   "status": "Terminated"
  }
 ],
 "recall_total": 2,
 "drugsfda": {
  "applications": 53,
  "nda": 5,
  "anda": 47,
  "first_approval": "19961125",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 25,
  "labeling_recent": 0,
  "sponsors": [
   "ACCORD HLTHCARE",
   "ACTAVIS ELIZABETH",
   "AIPING PHARM INC",
   "ALEMBIC PHARMS LTD",
   "APOTEX",
   "AUROBINDO",
   "CADILA PHARMS LTD",
   "CHARTWELL RX"
  ],
  "unapproved": false,
  "first_approval_fmt": "11/25/1996"
 },
 "trials": {
  "total": 375,
  "completed": 252,
  "terminated": 46,
  "with_results": 99,
  "industry": 220,
  "phase3": 56,
  "results_share": 0.39285714285714285,
  "terminated_share": 0.12266666666666666
 },
 "pubmed": {
  "rct": 294,
  "meta": 52,
  "recent_rct": 33,
  "cochrane": [
   {
    "pmid": "29923184",
    "title": "Donepezil for dementia due to Alzheimer's disease",
    "year": "2018"
   },
   {
    "pmid": "19160328",
    "title": "Donepezil for dementia in people with Down syndrome",
    "year": "2009"
   },
   {
    "pmid": "16856114",
    "title": "Donepezil for mild cognitive impairment",
    "year": "2006"
   },
   {
    "pmid": "16437430",
    "title": "Donepezil for dementia due to Alzheimer's disease",
    "year": "2006"
   },
   {
    "pmid": "14974068",
    "title": "Donepezil for vascular cognitive impairment",
    "year": "2004"
   },
   {
    "pmid": "12917900",
    "title": "Donepezil for dementia due to Alzheimer's disease",
    "year": "2003"
   },
   {
    "pmid": "11034704",
    "title": "Donepezil for mild and moderate Alzheimer's disease",
    "year": "2000"
   },
   {
    "pmid": "10796620",
    "title": "Donepezil for mild and moderate Alzheimer's disease",
    "year": "2000"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "donepezil",
   "Adlarity",
   "Aricept"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 8118215,
  "beneficiaries": 1569150,
  "spend": 103312122.57,
  "by_brand": [
   {
    "brand": "Donepezil HCl",
    "claims": 8063081,
    "per_claim": 12.17955005,
    "is_generic": true
   },
   {
    "brand": "Donepezil HCl ODT",
    "claims": 48849,
    "per_claim": 28.850349444,
    "is_generic": false
   },
   {
    "brand": "Adlarity",
    "claims": 4882,
    "per_claim": 515.08563908,
    "is_generic": false
   },
   {
    "brand": "Aricept",
    "claims": 1403,
    "per_claim": 843.52470421,
    "is_generic": false
   }
  ],
  "per_claim": 12.725965322426173
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": {
  "section": "Infectious diseases",
  "names": [
   "donepezil",
   "galantamine",
   "rivastigmine"
  ],
  "reason": "The cholinesterase inhibitors donepezil, galantamine and rivastigmine ( d) can provoke gastrointestinal disorders (including sometimes severe vomiting), neuropsychiatric disorders (including depression and insomnia), anorexia, and cardiac disorders (including rhythm and conduction disorders, bradycardia, faintness and syncope). Donepezil can also cause compulsive sexual behaviour ( Prescrire Int n\u00b0 162, 166, 192, 204, 243, 265; Rev Prescrire n\u00b0 337 , 340, 344, 349, 398, 416).",
  "edition": "2026",
  "qualifier": null,
  "qualified": false,
  "matched": "donepezil"
 },
 "eml": {
  "listed": false,
  "status": "ApplicationRejected",
  "name": "donepezil",
  "matched": "donepezil",
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 5500,
  "fills": 8118215,
  "per_million": 677.4888322124999,
  "ratio": 0.2446735739011079,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 87,
   "letter": "B",
   "why": [
    "Listed by the independent review Prescrire as a drug to avoid (2026 edition) (-10)",
    "677 FDA reports naming it as the suspect drug per million Medicare fills, 0.2x the median drug on this site",
    "Death appears in 1.8x the share of reports seen across all of FAERS (-3)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 61,
   "letter": "D",
   "why": [
    "294 randomized trials and 52 systematic reviews/meta-analyses indexed in PubMed",
    "Prescrire's independent reviewers find its harm-benefit balance unfavourable versus alternatives (-10)",
    "8 independent Cochrane review(s) exist",
    "Only 39% of completed registered trials posted results (-8)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 97,
   "letter": "A",
   "why": [
    "Recalls since 2016: 0 Class I, 2 Class II, 0 Class III across 47 generic makers (-3)"
   ],
   "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 (47 applications)",
    "4 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 85,
 "grade": "B",
 "questions": [
  "An independent reviewer (Prescrire) lists this as a drug to avoid because the harms outweigh the benefits versus alternatives. What is your view on that?",
  "The most-reported problems in FDA's adverse event data are fall, death, diarrhoea, fatigue. How would we recognize and handle those?",
  "Why this one over benzgalantamine, galantamine, rivastigmine? 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.)"
 ]
}