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)
Respiratory tract congestion22.02.07.003---
Musculoskeletal discomfort15.03.04.001---
Inappropriate antidiuretic hormone secretion14.05.07.001; 05.03.03.0010.000106%-
Affect lability19.04.01.0010.000106%-
Myoclonic epilepsy17.12.03.0070.000070%-
Transaminases increased13.03.04.036---
Cerebral disorder17.02.10.0170.000070%-
Dysphemia19.19.03.005; 17.02.08.0100.000106%-
Haemorrhage24.07.01.002---
Cognitive disorder19.21.02.001; 17.03.03.0030.000881%
Major depression19.15.01.003---
Skin oedema23.06.04.0010.000070%-
Vasodilation procedure25.03.01.001---
Disturbance in sexual arousal19.08.04.003---
Blood alkaline phosphatase increased13.04.02.004--
Hot flush24.03.01.005; 21.02.02.001; 08.01.03.027--
Deficiency anaemia14.03.02.016; 01.03.01.004---
Feeding disorder19.09.01.003; 14.03.02.0030.000070%-
Infestation23.11.01.002; 11.09.01.001---
Malnutrition14.03.02.004---
Mental disorder19.07.01.0020.000211%-
Abnormal behaviour19.01.01.0010.000845%-
Decreased appetite08.01.09.028; 14.03.01.0050.001733%
Gastrointestinal ulcer07.04.04.0020.000352%-
Ill-defined disorder08.01.03.049---
Lacrimal disorder06.08.02.005---
Parkinson's disease17.01.05.0100.000423%-
Disease recurrence08.01.03.0500.000317%-
Psychotic disorder19.03.01.002--
Hyperlipidaemia14.08.03.001--
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ADReCS-Target
Drug Name ADR Term Target
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