Drug Safety Information for ARICEPT ODT (Donepezil hydrochloride)

Safety-related Labeling Changes for ARICEPT (DONEPEZIL HYDROCHLORIDE) Rx Drug: FDA Link

Safety-related Labeling Changes for ARICEPT ODT (DONEPEZIL HYDROCHLORIDE) Rx Drug: FDA Link

Safety-related Labeling Changes for NAMZARIC (DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE) Rx Drug: FDA Link

Adverse Drug Reactions for ARICEPT ODT* (Donepezil hydrochloride)

These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).

Top 20 Adverse Effects Associated with ARICEPT ODT
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Fall972
2Confusional state*826
3Dizziness625
4Nausea*611
5Asthenia580
6Diarrhoea*575
7Vomiting547
8Somnolence*532
9Bradycardia519
10Drug interaction513
11Decreased appetite*464
12Fatigue461
13Convulsion451
14Syncope437
15Dehydration414
16Dyspnoea407
17Drug ineffective407
18Pneumonia405
19Agitation405
20Dementia400

* This side effect also appears in "Top 10 Side Effects of ARICEPT ODT " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking ARICEPT ODT
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Dementia alzheimer's type*9299
2Product used for unknown indication5260
3Dementia*4682
4Memory impairment1582
5Amnesia*791
6Cognitive disorder543
7Parkinson's disease336
8Ill-defined disorder325
9Vascular dementia*245
10Dementia with lewy bodies163

*Also a top-10 reason in AskaPatient Review Summary.


Types of Adverse Events for ARICEPT ODT

Total Reports Filed with FDA: 60466


Number of FDA Adverse Event Reports by Patient Age for ARICEPT ODT

Total Reports Filed with FDA: 60466*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Donepezil hydrochloride (Eranz, E2020, Donepezil, Aricept odt, Aricept)

Charts are based on 60466 reports filed with the FDA between 2004 and June 2015.

Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.

Click to go back to search results and ARICEPT ODT Reviews and Review Summary .

Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.

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