Ariceptdonepezil
19,463 adverse event reports submitted to the FDA (2003–2026)
Top Reported Adverse Events
The most frequently reported events in association with Aricept in the FAERS database. These are events reported by patients taking this medication, not necessarily caused by it. A single report may include multiple events.
Show these terms with plain-language definitions
Tap any term below for a plain-language definition.
Fall 1,571 reports
A report that the person fell down. Falls are tracked because they can signal issues like dizziness, weakness, or balance problems.
Full definition in the glossary →Confusional State 1,108 reports
A state of being confused, disoriented, or unable to think clearly.
Full definition in the glossary →Dizziness 985 reports
A feeling of being lightheaded, unsteady, or like the room is spinning.
Full definition in the glossary → See all drugs reporting this event →Nausea 930 reports
The feeling of sickness in your stomach that often comes before vomiting.
Full definition in the glossary → See all drugs reporting this event →Death 927 reports
A report that the person died. A death appearing in reports for a drug does not mean the drug caused it. Reports record that a death occurred while the medication was being used, which can happen for many unrelated reasons.
Full definition in the glossary →Diarrhoea 921 reports
Loose or watery bowel movements, often frequent. Also spelled diarrhea in American English.
Full definition in the glossary → See all drugs reporting this event →Fatigue 896 reports
Extreme tiredness or lack of energy that does not improve with rest.
Full definition in the glossary → See all drugs reporting this event →Asthenia 820 reports
Physical weakness or lack of strength.
Full definition in the glossary →Drug Ineffective 768 reports
A report that the medication did not work as expected for the person taking it. This is a reporting category, not a sign the drug is defective. It simply means someone felt it was not helping their condition.
Full definition in the glossary →Hallucination 754 reports
Seeing, hearing, or sensing things that are not actually there. The term records what was reported and does not establish that a medication was the cause.
Full definition in the glossary →Somnolence 746 reports
Drowsiness or strong sleepiness.
Full definition in the glossary → See all drugs reporting this event →Vomiting 685 reports
Throwing up the contents of the stomach.
Full definition in the glossary → See all drugs reporting this event →Pneumonia 611 reports
An infection that inflames the air sacs in the lungs, which can cause cough, fever, and difficulty breathing.
Full definition in the glossary →- Dementia 605 reports
Urinary Tract Infection 589 reports
An infection in the bladder, urethra, or kidneys, often called a UTI.
Full definition in the glossary → See all drugs reporting this event →
Ranked by frequency of reports, not severity. The most-reported event is not necessarily the most dangerous or the most common in patients taking this drug.
Who Is Reporting
Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.
By Sex
View reporter sex data as a table
| Sex | Reports |
|---|---|
| Female | 10,469 |
| Male | 8,018 |
| Unknown | 30 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 94 |
| 18-34 | 66 |
| 35-49 | 304 |
| 50-64 | 1,310 |
| 65-74 | 2,788 |
| 75+ | 9,131 |
This shows who filed reports, reflecting who takes this drug and who tends to report, not who is at greatest risk.
Reported Outcomes
Outcomes recorded in FAERS reports that included Aricept. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.
View outcome data as a table
| Outcome | Reports |
|---|---|
| Hospitalization | 7,888 |
| Other Serious | 7,207 |
| Non-Serious | 5,136 |
| Death | 2,962 |
| Life-Threatening | 901 |
| Disability | 581 |
Serious outcomes are far more likely to be reported than mild ones, so this overstates how often outcomes are serious. A recorded death does not mean the drug caused it.
Report Volume Over Time
Number of FAERS reports received per quarter for Aricept. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior, not changes in the medication's safety profile.
View report trend as a table
| Year | Reports |
|---|---|
| 2003 | 1 |
| 2004 | 1,108 |
| 2005 | 792 |
| 2006 | 805 |
| 2007 | 577 |
| 2008 | 692 |
| 2009 | 710 |
| 2010 | 948 |
| 2011 | 953 |
| 2012 | 955 |
| 2013 | 748 |
| 2014 | 853 |
| 2015 | 1,211 |
| 2016 | 1,076 |
| 2017 | 1,098 |
| 2018 | 920 |
| 2019 | 816 |
| 2020 | 707 |
| 2021 | 661 |
| 2022 | 888 |
| 2023 | 864 |
| 2024 | 914 |
| 2025 | 941 |
| 2026 (partial) | 225 |
The steep increase around 2004 reflects the FDA's move to electronic submission, not a change in this drug's safety. Trends track reporting volume, not risk.
Medications commonly reported with Aricept
In FDA adverse event reports that mention Aricept, these medications appeared most often in the same report.
- Aspirin (3,221 reports)
- Furosemide (2,084 reports)
- Ergocalciferol (1,929 reports)
- Atorvastatin (1,781 reports)
- Quetiapine (1,689 reports)
This reflects co-occurrence in submitted reports, not evidence of drug interaction or combined risk. People often report several medications taken for the same condition or for unrelated reasons. Talk to a doctor or pharmacist about your specific medications.
Related Drugs
Other medications with similar adverse event profiles in FDA FAERS reports.
Data Source
This data is sourced from the FDA's Adverse Event Monitoring System (AEMS), formerly FAERS, via the OpenFDA API. PillSignal is not affiliated with the FDA.
View this data on the FDA website →Data last updated: June 2026