How are Donepezil adverse event reports trending over time?
This graph shows volume of adverse events submitted to the FDA by quarter for Donepezil, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Donepezil is flagged as the suspect drug causing the adverse event.
What are the most common Donepezil adverse events reported to the FDA?
Fall | 348 (1.92%) |
Bradycardia | 330 (1.82%) |
Drug Interaction | 275 (1.51%) |
Syncope | 257 (1.41%) |
Vomiting | 238 (1.31%) |
Nausea | 217 (1.19%) |
Convulsion | 216 (1.19%) |
Diarrhoea | 211 (1.16%) |
Confusional State | 197 (1.08%) |
Rhabdomyolysis | 189 (1.04%) |
Somnolence | 160 (.88%) |
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This graph shows the top adverse events submitted to the FDA for Donepezil, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Donepezil is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.
What are the most common Donepezil adverse events reported to the FDA?
Neurological | 1481 (8.15%) |
Cardiac Arrhythmias | 1402 (7.72%) |
Gastrointestinal Signs | 737 (4.06%) |
Movement Disorders | 530 (2.92%) |
Injuries | 484 (2.66%) |
Infections - Pathogen Unspecified | 446 (2.45%) |
Cardiac And Vascular Investigations | 433 (2.38%) |
Deliria | 399 (2.2%) |
Respiratory | 396 (2.18%) |
Therapeutic And Nontherapeutic Effe... | 382 (2.1%) |
Mental Impairment | 351 (1.93%) |
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This graph shows the top categories of adverse events submitted to the FDA for Donepezil, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Donepezil is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.
Why are people taking Donepezil, according to those reporting adverse events to the FDA?
Dementia Alzheimers Type | 2234 |
Dementia | 1170 |
Drug Use For Unknown Indication | 393 |
Product Used For Unknown Indication | 296 |
Memory Impairment | 244 |
Amnesia | 171 |
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Label | Labeler | Effective |
---|---|---|
Aricept | Physicians Total Care, Inc. | 03-NOV-10 |
Aricept | PD-Rx Pharmaceuticals, Inc. | 03-NOV-10 |
Donepezil Hydrochloride Odt | Greenstone LLC | 30-NOV-10 |
Donepezil Hydrochlorideodt | UDL Laboratories, Inc. | 30-NOV-10 |
Donepezil Hydrochloride | Greenstone LLC | 30-NOV-10 |
Donepezil Hydrochloride | Physicians Total Care, Inc. | 17-DEC-10 |
Donepezil Hydrochloride | Sandoz Inc | 11-JAN-11 |
Donepezil Hydrochloride | NCS HealthCare of KY, Inc dba Vangard Labs | 17-JAN-11 |
Donepezil Hydrochloride | Actavis Inc. | 28-JAN-11 |
Donepezil Hydrochloride | Contract Pharmacy Services-PA | 31-JAN-11 |
Donepezil Hydrochloride | American Health Packaging | 01-FEB-11 |
Donepezil Hydrochloride | WOCKHARDT LIMITED | 19-APR-11 |
Donepezil Hydrochloride | WOCKHARDT USA LLC | 19-APR-11 |
Donepezil Hydrochloride | Hikma Pharmaceutical | 02-MAY-11 |
Donepezil Hydrochloride | Zydus Pharmaceuticals (USA) Inc. | 11-MAY-11 |
Donepezil Hydrochloride | Cadila Healthcare Limited | 11-MAY-11 |
Donepezil Hydrochloride | Zydus Pharmaceuticals (USA) Inc. | 20-MAY-11 |
Donepezil Hydrochloride | Cadila Healthcare Limited | 20-MAY-11 |
Donepezil Hydrochloride | Unit Dose Services | 31-MAY-11 |
Donepezil Hydrochloride | Unit Dose Services | 31-MAY-11 |
Donepezil Hydrochloride | Sandoz Inc | 31-MAY-11 |
Donepezil Hydrochloride | Sun Pharmaceutical Industries Limited | 01-JUN-11 |
Donepezil Hydrochloride | INDICUS PHARMA LLC | 07-JUL-11 |
Donepezil Hydrochloride | Torrent Pharmaceuticals Limited | 10-AUG-11 |
Donepezil Hydrochloride | Accord Healthcare, Inc. | 01-SEP-11 |
Donepezil Hydrochloride | Contract Pharmacy Services-PA | 04-OCT-11 |
Donepezil Hydrochloride | Solco Healthcare US LLC | 16-OCT-11 |
Aricept | Eisai Inc. | 29-FEB-12 |
Ariceptodt | Eisai Inc. | 29-FEB-12 |
Donepezil Hydrochloride | NCS HealthCare of KY, Inc dba Vangard Labs | 15-MAR-12 |
Aricept | Cardinal Health | 26-APR-12 |
Donepezil Hydrochloride | Jubilant Cadista Pharmaceuticals Inc. | 25-JUN-12 |
Donepezil Hydrochloride | Aurobindo Pharma Limited | 02-JUL-12 |
Donepezil Hydrochloride | Major Pharmaceuticals | 23-JUL-12 |
Donepezil Hydrochloride | Preferred Pharmaceuticals, Inc. | 06-SEP-12 |
Donepezil Hydrochloride | West-ward Pharmaceutical Corp | 19-SEP-12 |
Donepezil Hydrochloride | Rebel Distributors Corp | 26-SEP-12 |
Donepezil Hydrochloride | Dr. Reddys Laboratories Limited | 02-NOV-12 |
Donepezil Hydrochloride | Ranbaxy Pharmaceuticals Inc. | 09-NOV-12 |
Donepezil Hydrochloride | Mylan Pharmaceuticals Inc. | 13-DEC-12 |
Donepezil Hydrochloride | Macleods Pharmaceuticals Limited | 04-JAN-13 |
Donepezil Hydrochloride | Macleods Pharmaceuticals Limited | 09-JAN-13 |
Aricept | Bryant Ranch Prepack | 17-JAN-13 |
Donepezil Hydrochloride | Bryant Ranch Prepack | 21-JAN-13 |
Donepezil Hydrochloride | Teva Pharmaceuticals USA Inc | 14-FEB-13 |
Donepezil Hydrochloride | McKesson Packaging Services a business unit of McKesson Corporation | 26-FEB-13 |
Donepezil Hydrochloride | McKesson Packaging Services a business unit of McKesson Corporation | 05-MAR-13 |
Donepezil Hydrochloride | Cardinal Health | 08-MAR-13 |
Donepezil Hydrochloride5 Mg | NorthStar RxLLC | 26-MAR-13 |
Donepezil Hydrochloride10 Mg | NorthStar RxLLC | 26-MAR-13 |
Donepezil Hydrochloride | McKesson Contract Packaging | 10-APR-13 |
What Donepezil safety concerns are being reported by doctors and researchers in the medical literature?
This report contains aggregated drug side effects and adverse events for Donepezil. The data has been pulled from the United States Food and Drug Administration's (US FDA) Adverse Event Reporting System (AERS), a database containing more than 4,000,000 adverse event reports.
DrugCite expands your query using the Unified Medical Language System (UMLS) to include generic drugs and primary active ingredients. While the core of DrugCite's advanced drug filtering algorithm is based on the industry standard UMLS, DrugCite's proprietary filtering system also includes dozens of additional steps to reconcile malformed drug names in the FDA's data.
DrugCite only counts a drug if the submitter of the adverse event indicates that the drug is suspected to have caused the adverse event.
Depending on how the data is aggregated, different counts may occur. When someone submits an adverse event to the FDA, the submitter can attribute multiple adverse events to one or more drugs. For example, an individual taking Paxil could submit the adverse events "anxiety" and "suicidal ideation" for the same individual safety report (ISR). This means when DrugCite aggregates by adverse event, two distinct adverse events are counted in the adverse event graph; once for "anxiety" and again for "suicidal ideation". However, when DrugCite aggregates by individual safety reports irrespective of the details of the adverse events contained within the safety report, the report is only counted once.
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