Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Donepezil hydrochloride
Drug ID BADD_D00707
Description In 2016, the global burden of dementia was estimated to be 43.8 million, demonstrating a significant increase from a global prevalence of 20.2 million in 1990.[A182411] Donepezil, also known as Aricept, is a piperidine derivative acetylcholinesterase inhibitor used in the management of the dementia of Alzheimer's Disease, and in some cases, is used to manage other types of dementia. Donepezil was first approved by the FDA in 1996, and its extended-release form was approved in combination with [Memantine] in 2014 to manage moderate and severe forms of Alzheimer's dementia.[L7916,L7937] Though it does not alter the progression of Alzheimer's disease, donepezil is effective in managing the symptoms of its associated dementia.[T668]
Indications and Usage Donepezil is indicated for the management of mild to moderate Alzheimer’s Disease at doses of 5 mg or 10 mg.[L7916] It is also indicated for the management of moderate to severe Alzheimer’s Disease in a higher dose of 10 mg or 23 mg administered once daily.[L7916] Off-label uses include the management of vascular dementia, Parkinson's Disease-associated dementia, and Lewy body dementia, among others.[A182333,T668] When combined with memantine, the extended-release form of donepezil is indicated to treat the symptoms of moderate to severe dementia.[L7937]
Marketing Status approved
ATC Code N06DA02
DrugBank ID DB00843
KEGG ID D00670
MeSH ID D000077265
PubChem ID 5741
TTD Drug ID D0NS6H
NDC Product Code 65862-326; 16571-778; 31722-738; 43063-659; 43547-275; 55154-7882; 63629-1118; 65841-722; 71335-0900; 0615-7951; 53747-026; 60510-613; 13668-102; 29300-250; 29300-251; 33342-028; 63187-401; 70518-1666; 71335-2065; 82009-120; 11071-871; 62147-0011; 65862-429; 24979-004; 29300-249; 50228-140; 65841-750; 68071-3198; 55154-7883; 62856-246; 68382-521; 71093-128; 71335-0416; 71335-0582; 71335-2093; 53104-7728; 60510-614; 64220-101; 66577-022; 62756-194; 68180-527; 68788-8208; 69844-038; 70518-0452; 0615-8313; 0781-5276; 0904-6477; 58623-0116; 33342-027; 46708-295; 50090-2627; 55111-357; 60429-321; 60687-292; 62856-247; 64380-907; 64380-908; 65038-056; 65841-749; 68382-346; 70771-1320; 71335-0792; 65096-0109; 65862-325; 16571-779; 33342-061; 43547-276; 55111-302; 60429-322; 61919-692; 63629-1117; 68071-1523; 71093-127; 71335-0876; 72189-031; 0781-5277; 0904-6478; 53104-7729; 62147-0050; 13668-103; 43547-382; 46708-296; 50228-139; 62332-093; 65841-721; 71205-948; 71209-020; 72189-265; 55486-1590; 51407-320; 55111-356; 60687-303; 62332-092; 63629-8483; 71209-019; 71335-2022; 58032-0137; 65841-163; 29300-248; 33342-030; 50090-3537; 50090-6329; 62856-245; 65038-055; 68382-347; 69844-037; 82009-119; 31722-737; 33342-029; 50090-2910
UNII 3O2T2PJ89D
Synonyms Donepezil | Eranz | Donepezilium Oxalate Trihydrate | E 2020 | E2020 | E-2020 | Donepezil Hydrochloride | 1-Benzyl-4-((5,6-dimethoxy-1-indanon)-2-yl)methylpiperidine hydrochloride | Aricept
Chemical Information
Molecular Formula C24H30ClNO3
CAS Registry Number 120011-70-3
SMILES COC1=C(C=C2C(=C1)CC(C2=O)CC3CCN(CC3)CC4=CC=CC=C4)OC.Cl
Chemical Structure
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice.
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Irritable bowel syndrome07.02.04.003; 19.24.01.003---
Jaundice01.06.04.004; 09.01.01.004; 23.03.03.030---
Leukocytosis01.02.01.002--
Libido decreased19.08.03.001; 21.03.02.005--
Libido increased19.08.03.002; 21.03.02.007--
Listless08.01.01.012; 19.04.04.003---
Liver function test abnormal13.03.04.030---
Malaise08.01.01.003--
Mastitis11.01.02.001; 21.05.03.002--
Melaena07.12.02.004; 24.07.02.013---
Micturition urgency20.02.02.006--
Motion sickness04.04.01.001; 17.02.12.001---
Muscle contractions involuntary15.05.03.008; 17.05.03.001---
Muscle spasms15.05.03.004--
Muscular weakness15.05.06.001; 17.05.03.005--
Myalgia15.05.02.001--
Myocardial infarction02.02.02.007; 24.04.04.009--
Nausea07.01.07.001--
Nervousness19.06.02.003---
Neuralgia17.02.07.005--
Neurodermatitis23.03.04.007---
Neuroleptic malignant syndrome08.05.01.005; 12.03.01.003; 15.05.04.015; 17.05.02.003---
Night sweats08.01.03.031; 23.02.03.006---
Nocturia20.02.03.001---
Nystagmus06.05.02.006; 17.02.02.006--
Oedema08.01.07.006; 14.05.06.010---
Oedema peripheral02.05.04.007; 08.01.07.007; 14.05.06.011--
Oesophagitis07.08.05.001--
Orthostatic hypotension17.05.01.020; 24.06.03.004---
Osteoarthritis15.01.04.001---
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