Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Donepezil
Drug ID BADD_D00706
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 D07869
MeSH ID D000077265
PubChem ID 3152
TTD Drug ID D0NS6H
NDC Product Code 65085-0046
UNII 8SSC91326P
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 C24H29NO3
CAS Registry Number 120014-06-4
SMILES COC1=C(C=C2C(=C1)CC(C2=O)CC3CCN(CC3)CC4=CC=CC=C4)OC
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)
Stupor17.02.04.007; 19.02.05.0040.000070%-
Sudden death02.03.04.013; 08.04.01.0030.000211%
Suicide attempt19.12.01.0040.000599%
Supraventricular extrasystoles02.03.03.0110.000296%-
Supraventricular tachycardia02.03.03.012--
Suspiciousness19.05.01.0130.000211%-
Swelling face08.01.03.100; 10.01.05.018; 23.04.01.018---
Swollen tongue07.14.02.003; 10.01.05.015; 23.04.01.0140.000190%-
Syncope02.11.04.015; 17.02.04.008; 24.06.02.0120.003445%
Tension19.06.02.005---
Thirst08.01.09.021; 14.03.02.007---
Thrombocytopenia01.08.01.002---
Thrombocytosis01.08.02.001---
Tinnitus04.04.01.002; 17.04.07.004--
Tongue disorder07.14.01.002---
Tongue oedema07.14.02.007; 10.01.05.008; 23.04.01.009---
Tooth abscess07.09.01.003; 11.01.04.003---
Toothache07.09.06.001--
Torsade de pointes02.03.04.0050.000599%-
Torticollis15.05.04.003; 17.01.03.0030.000493%-
Transient ischaemic attack17.08.04.001; 24.04.06.005--
Tremor17.01.06.0020.000909%
Unresponsive to stimuli17.02.05.0310.000282%-
Upper gastrointestinal haemorrhage07.12.02.006; 24.07.02.0240.000282%
Urethral disorder20.07.01.002---
Urinary incontinence17.05.01.008; 20.02.02.0100.000810%
Urinary retention20.02.02.0110.000359%
Urinary tract disorder20.08.01.001---
Urinary tract infection11.01.14.004; 20.08.02.001--
Urticaria10.01.06.001; 23.04.02.001--
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ADReCS-Target
Drug Name ADR Term Target
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