82/100 · Critical
Manufactured by Camber Pharmaceuticals, Inc.
Donepezil Hydrochloride Reports High Incidence of Serious Adverse Events, Particularly Falls and Confusion
69,498 FDA adverse event reports analyzed
Last updated: 2026-05-12
DONEPEZIL HYDROCHLORIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Camber Pharmaceuticals, Inc.. Based on analysis of 69,498 FDA adverse event reports, DONEPEZIL HYDROCHLORIDE has a safety score of 82 out of 100. This score indicates a relatively favorable safety profile, with fewer or less severe adverse events compared to many other tracked medications. The most commonly reported adverse reactions for DONEPEZIL HYDROCHLORIDE include FALL, DEATH, CONFUSIONAL STATE, DIARRHOEA, DIZZINESS. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for DONEPEZIL HYDROCHLORIDE.
Donepezil Hydrochloride has a safety concern score of 82 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 69,498 adverse event reports for this medication, which is primarily manufactured by Camber Pharmaceuticals, Inc..
The most commonly reported adverse events include Fall, Death, Confusional State. Of classified reports, 75.9% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Donepezil hydrochloride reports a high number of serious adverse events, including falls and confusion.
The drug is associated with a wide range of reactions, indicating potential for diverse side effects. Report volume is substantial, with over 69,000 reports, providing a comprehensive dataset for analysis.
Patients taking Donepezil Hydrochloride should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Donepezil hydrochloride is known to interact with other drugs, potentially leading to adverse effects. Patients should be warned about the risk of drug interactions and should consult their healthcare provider before starting any new medications. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Donepezil Hydrochloride received a safety concern score of 82/100 (high concern). This is based on a 75.9% serious event ratio across 35,136 classified reports. The score accounts for 69,498 total adverse event reports and 100 distinct reaction types. This high score reflects a significant proportion of serious adverse events in the reporting data.
Adverse event reports by sex: Female: 17,416, Male: 14,684, Unknown: 64. The most frequently reported age groups are age 80 (1,184 reports), age 79 (1,167 reports), age 83 (1,140 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 35,136 classified reports for DONEPEZIL HYDROCHLORIDE:
The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.
Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.
Donepezil hydrochloride is known to interact with other drugs, potentially leading to adverse effects. Patients should be warned about the risk of drug interactions and should consult their healthcare provider before starting any new medications.
If you are taking Donepezil Hydrochloride, here are important things to know. The most commonly reported side effects include fall, death, confusional state, diarrhoea, dizziness. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Patients should be informed about the potential for serious adverse events such as falls and confusion, and should seek medical attention if these symptoms occur. Regular monitoring of cognitive and physical health is recommended, especially in elderly patients. If you experience a serious adverse reaction, seek emergency medical attention immediately or call 911. You can report side effects to the FDA's MedWatch program at 1-800-FDA-1088.
The FDA continues to monitor the safety of donepezil hydrochloride. Healthcare providers should report any adverse events to the FDA's MedWatch program.
The FDA has received approximately 69,498 adverse event reports associated with Donepezil Hydrochloride. These reports come from healthcare professionals, consumers, and manufacturers through the FDA Adverse Event Reporting System (FAERS). Note that the number of reports does not directly indicate the frequency of side effects, as adverse events are voluntarily reported and may be underrepresented.
The most frequently reported adverse events for Donepezil Hydrochloride include Fall, Death, Confusional State, Diarrhoea, Dizziness. By volume, the top reported reactions are: Fall (2,966 reports), Death (2,018 reports), Confusional State (1,894 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Donepezil Hydrochloride.
Out of 35,136 classified reports, 26,660 (75.9%) were classified as serious and 8,476 as non-serious. The FDA classifies an event as "serious" if it results in death, hospitalization, disability, or other medically significant outcomes. A higher serious-event ratio warrants closer attention but does not necessarily mean the drug is unsafe.
Adverse event reports for Donepezil Hydrochloride break down by patient sex as follows: Female: 17,416, Male: 14,684, Unknown: 64. This distribution reflects reporting patterns rather than actual risk differences between groups. Reporting rates can be influenced by prescribing patterns, disease demographics, and reporting behavior.
The most frequently reported age groups for Donepezil Hydrochloride adverse events are: age 80: 1,184 reports, age 79: 1,167 reports, age 83: 1,140 reports, age 82: 1,096 reports, age 84: 1,067 reports. Age-related reporting patterns can reflect both the demographics of the patient population and potential age-related susceptibility to certain side effects.
The primary manufacturer associated with Donepezil Hydrochloride adverse event reports is Camber Pharmaceuticals, Inc.. Multiple manufacturers may produce generic versions of this drug. The manufacturer listed reflects the most frequently reported brand in FDA adverse event data.
Beyond the most common reactions, other reported adverse events for Donepezil Hydrochloride include: Fatigue, Nausea, Drug Ineffective, Hallucination, Asthenia. Less common side effects can still be clinically significant. Patients should report any unusual symptoms to their healthcare provider.
You can report adverse events from Donepezil Hydrochloride to the FDA through their MedWatch program at www.fda.gov/medwatch, by calling 1-800-FDA-1088, or by completing Form FDA 3500. Healthcare professionals, consumers, and manufacturers can all submit reports. Reporting helps the FDA monitor drug safety after approval.
Donepezil Hydrochloride has a safety concern score of 82 out of 100 (high concern). This score is calculated from the ratio of serious to non-serious adverse events, the diversity of reported reactions, and the overall volume of reports relative to usage. Donepezil hydrochloride reports a high number of serious adverse events, including falls and confusion.
Key safety signals identified in Donepezil Hydrochloride's adverse event data include: Falls (2966 reports). Death (2018 reports). Confusion (1894 reports). These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Donepezil hydrochloride is known to interact with other drugs, potentially leading to adverse effects. Patients should be warned about the risk of drug interactions and should consult their healthcare provider before starting any new medications. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Donepezil Hydrochloride.
Patients should be informed about the potential for serious adverse events such as falls and confusion, and should seek medical attention if these symptoms occur. Regular monitoring of cognitive and physical health is recommended, especially in elderly patients.
Donepezil Hydrochloride has 69,498 adverse event reports on file with the FDA. The drug is associated with a wide range of reactions, indicating potential for diverse side effects. The volume of reports for Donepezil Hydrochloride reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety of donepezil hydrochloride. Healthcare providers should report any adverse events to the FDA's MedWatch program. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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