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DONEPEZIL HYDROCHLORIDE


DIR Classification


Classification:Ambiguous
Severity Score:1.0

Description in Drug Labeling: View Full Labeling: SPL in DailyMed | PDF

  • ADVERSE REACTIONS
  • Postmarketing Experience
  • The following adverse reactions have been identified during post-approval use donepezil hydrochloride. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
  • Abdominal pain, agitation, aggression, cholecystitis, confusion, convulsions, hallucinations, heart block (all types), hemolytic anemia, hepatitis, hyponatremia, neuroleptic malignant syndrome, pancreatitis, rash, rhabdomyolysis, QTc prolongation, and torsade de pointes.

Postmarketing Surveillance

Contingency Table:

Current Drug
Other Drugs
QT Prolongation
272
23820
Other ADRs
20257
38361330

Odds Ratio = 21.625

Drug Property Information



ATC Code(s):
  • N06DA02 - donepezil hydrochloride
    • N06DA - Anticholinesterases
    • N06D - ANTI-DEMENTIA DRUGS
    • N06 - PSYCHOANALEPTICS
    • N - NERVOUS SYSTEM
Active Ingredient:DONEPEZIL HYDROCHLORIDE
Active Ingredient UNII:3O2T2PJ89D
Drugbank ID:DB00843
PubChem Compound:3152
CTD ID:D000077265
PharmGKB:PA449394
CAS Number:120014-06-4
Dosage Form(s):tablet, film coated
Route(s) Of Administrator:oral
Daily Dose:
  • 7.5 mg/day N06DA02
Chemical Structure:
SMILE Code:
COC1=C(OC)C=C2C(=O)C(CC3CCN(CC4=CC=CC=C4)CC3)CC2=C1

Reference

1: Analysis of electropharmacological and proarrhythmic effects of donepezil using the halothane-anesthetized intact dogs and the conscious chronic atrioventricular block ones.

[Hagiwara-Nagasawa Mihoko,Kambayashi Ryuichi,Goto Ai,Nunoi Yoshio,Izumi-Nakaseko Hiroko,Chiba Koki,Wada Takeshi,Takei Yoshinori,Matsumoto Akio,Sugiyama Atsushi]
Naunyn Schmiedebergs Arch Pharmacol,2021 Apr;394(4):581-589. PMID: 33064166

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