Aricept (donepezil hydrochloride) adverse event reports that FDA received

Name: Reaction terms in FDA adverse event reports that name Aricept
Creator: Reported Reactions
License: https://creativecommons.org/publicdomain/zero/1.0/

Name type: Brand name
Generic name: Donepezil hydrochloride
Class: Cholinesterase inhibitor
Also reported as: Aricept /01318901/, Aricept Odt

What a report is

A report is not proof that the drug was the cause of the event.

FDA says:

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview, section "Responsible use of the data". The site read the page on 2 Oct 2026. The data have the reports that FDA received through 30 Jun 2026.

FDA also says:

There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event. The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.
Source: openFDA, Response of the drug event API (meta.disclaimer). The site read the page on 2 Oct 2026.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

Drug reports received through 30 Jun 2026. Device reports have a separate cutoff, 30 Sep 2026. Why a report count is not a rate.

Reports on file

From January 2004 to June 2026, FDA received 4,043 adverse event reports that name Aricept. In these reports the drug is a suspect or interacting product.

In the same period, 11,601 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 43 reports in the 12 months to June 2026 and 34 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Of the 1,332,454 drug reports that FDA received in the 12 months to June 2026, 43 (under 0.1%) name Aricept. Reports for patients 75 and over were 53.5% of the reports that name Aricept and 9.5% of all drug reports.

The number of people who use the product is not in the data. A count is not a rate. A count of reports is not a count of events or of patients, because one event can have more than one report.

There are many instances of duplicative reports and some reports do not contain all the necessary information.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Suspect product

FDA records each drug in a report as suspect, concomitant or interacting. This page counts the reports in which Aricept is suspect or interacting. FDA says:

Any number of the drugs may be marked as suspect if thought to be responsible for one or more of the reactions, but that information is not validated.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Data version

openFDA FAERS release of 29 Oct 2026. Reports received through 30 Jun 2026.

Since the last update

FDA says:

Many factors can influence whether or not an event will be reported, such as the time a product has been marketed and publicity about an event.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The information in these reports cannot be used to estimate the incidence (occurrence rates) of the events reported.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

The latest update of the FDA data, recorded on 28 Oct 2026, changed no count of this page.

In April to June 2026, FDA received 8 reports that name Aricept.
In January to March 2026, FDA received 16.
In April to June 2025, FDA received 3.

April to June 2026 is the latest closed quarter in the data. A closed quarter is a quarter for which the FDA files have most of the reports.

All updates Feed of updates (RSS)

Reaction lookup

These are the reaction terms that the reports record, with the number of reports for each term. Type a term or a plain word to find its count.

What this list leaves out

The table lists the 322 reaction terms that 5 or more reports record. A term with fewer than 5 reports is not in the table.

The site keeps reaction terms for 4,042 of the 4,043 reports (99.9%).

The reports of the other years are not in the counts.

So a count in the table can be lower than the count of FDA.

Find a reaction term

The table shows the first 50 of 322 terms.

Reaction terms in the reports that name Aricept, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 4,043 reports
Falla fall	255	6.3%
Bradycardiaslow heart rate	241	6%
Drug interactionan interaction between medicines	221	5.5%
Nauseafeeling sick	215	5.3%
Vomitingbeing sick	194	4.8%
Diarrhoealoose or frequent stools	193	4.8%
Confusional stateconfusion	188	4.7%
Syncopefainting	181	4.5%
Dizzinesslight-headedness or unsteadiness	168	4.2%
Convulsion	149	3.7%
Somnolencedrowsiness	137	3.4%
Hallucinationseeing or hearing things that are not there	131	3.2%
Malaisegeneral feeling of being unwell	126	3.1%
Loss of consciousnesspassing out	122	3%
Decreased appetitereduced appetite	112	2.8%
Astheniaweakness or lack of energy	111	2.7%
Tremorshaking	111	2.7%
Drug ineffectivethe medicine did not work as expected	109	2.7%
Agitationrestlessness	99	2.4%
Deliriumsudden confusion	99	2.4%
Rhabdomyolysismuscle breakdown	98	2.4%
Aggressionaggressive behaviour	92	2.3%
Memory impairmentmemory problems	92	2.3%
Electrocardiogram QT prolongeda QT prolongation on the ECG	91	2.3%
Depressed level of consciousness	90	2.2%
Dementia	87	2.2%
Insomniadifficulty sleeping	87	2.2%
Dehydration	84	2.1%
Gait disturbancedifficulty walking	78	1.9%
Fatiguetiredness	74	1.8%
Headachehead pain	73	1.8%
Condition aggravatedthe condition being treated got worse	67	1.7%
Hypotensionlow blood pressure	67	1.7%
Abnormal behaviourunusual behaviour	66	1.6%
Pneumonialung infection	66	1.6%
Dyspnoeashortness of breath	61	1.5%
General physical health deteriorationgeneral decline in health	60	1.5%
Overdosea dose above the recommended amount	59	1.5%
Weight decreasedweight loss	58	1.4%
Muscle spasmsmuscle cramps	57	1.4%
Altered state of consciousness	55	1.4%
Depressionlow mood	55	1.4%
Sudden deatha sudden death	55	1.4%
Atrial fibrillationan irregular heart rhythm	54	1.3%
Nightmarenightmares	54	1.3%
Anxiety	52	1.3%
Arrhythmia	52	1.3%
Dementia alzheimer's type	52	1.3%
Cardiac arrestthe heart stopped	49	1.2%
Coma	49	1.2%

Download all 322 terms of Aricept (CSV)

The counts add to more than 4,043 reports, because one report can record more than one term. FDA says:

No individual drug is connected to any individual reaction. When a report lists multiple drugs and multiple reactions, there is no way to conclude from the data therein that a given drug is responsible for a given reaction.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The CSV file has the same rows and the same limits. Its last row is a note that says so.

MedDRA term

The person who codes a report selects the preferred term that agrees best with the description of the reporter. The words under a term are the plain meaning that this site gives.

Not the label

The FDA-approved label of a product lists its adverse reactions. See the official pages at the end of this page.

Same ingredient, other names

Reporters write a brand name or a generic name. Each name has its own page and its own count.

Names of Donepezil with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Donepezil	Generic name	6,388
Donepezil hydrochloride	Generic name	1,569
Aricept (this page)	Brand name	4,043

Sum of the separately reported names: 12,000. A report that names two of these names is in the sum two times. The sum is not the number of reports for the ingredient.

FDA says:

Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Outcomes by year

The table gives the outcomes that the reporters gave, in the terms of FDA.

Outcomes in the reports that name Aricept, by the year of the openFDA file that holds the report

The table continues to the right.

Year of the openFDA file	Reports	Serious	Death	Life-threatening	Hospitalization (initial or prolonged)	Disability or Permanent Damage	Congenital Anomaly/Birth Defect	Other Serious (Important Medical Events)	Not serious
2004	259	213	37	20	162	10	0	20	46
2005	267	230	42	22	144	17	0	56	37
2006	270	231	46	15	156	11	0	52	39
2007	222	202	28	23	136	11	0	49	20
2008	256	226	38	27	133	12	0	54	30
2009	241	186	29	17	113	6	0	54	55
2010	274	260	53	25	134	8	0	85	14
2011	286	276	47	24	144	16	1	113	10
2012	195	182	34	19	113	11	2	72	13
2013	155	143	17	14	85	6	0	57	12
2014	262	181	43	17	91	2	0	79	81
2015	338	275	30	19	160	10	0	107	63
2016	216	139	13	12	79	0	0	55	77
2017	151	110	8	15	69	2	0	44	41
2018	117	85	4	3	52	2	0	31	32
2019	122	79	7	2	33	6	0	48	43
2020	78	60	9	3	39	0	0	25	18
2021	72	59	15	1	28	0	0	30	13
2022	66	57	4	3	28	3	0	32	9
2023	76	69	13	10	41	4	0	31	7
2024	54	44	9	3	25	3	0	17	10
2025	35	30	6	3	14	0	0	16	5
2026	31	28	2	2	14	0	0	16	3

An outcome in a report is not proof that the drug was the cause. The reporter gives the outcome, and FDA does not verify it. FDA says:

The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The six headings with the names of FDA are the outcome terms of FDA. A report can have more than one outcome. The columns Serious and Not serious are the two values of the openFDA field serious. For the value serious, openFDA gives this description:

The adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition
Source: openFDA, Drug adverse event fields (YAML reference). The site read the page on 2 Oct 2026.

The year is the year of the openFDA file that holds the latest version of the report. It is not always the year in which FDA first received the report. The chart of the next section uses the year of first receipt. The latest year is not complete.

Reports by year and month

Reports that name Aricept, by the year in which FDA received them

The column of 2026 has an outline, because the year is not complete. It has the reports that FDA received through June 2026 only.

Show the figures of the chart as a table

Reports that name Aricept, by the year in which FDA received them
Year	Reports
2004	216
2005	254
2006	277
2007	229
2008	278
2009	238
2010	287
2011	269
2012	247
2013	157
2014	253
2015	347
2016	212
2017	154
2018	114
2019	124
2020	74
2021	70
2022	62
2023	71
2024	54
2025	32
2026	24

Reports that name Aricept, by month, five years to June 2026

FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Why a count moves

A count moves for many reasons. The guide gives FDA's words about them.

Patients and reporters

Age of the patient in the reports that name Aricept
Age	Reports	Share
Under 2	2	under 0.1%
2 to 11	1	under 0.1%
12 to 17	0	0%
18 to 44	22	0.5%
45 to 64	231	5.7%
65 to 74	523	12.9%
75 and over	2,164	53.5%
Age not given	1,100	27.2%

Sex of the patient in the reports that name Aricept
Sex	Reports	Share
Female	2,372	58.7%
Male	1,523	37.7%
Unknown or not given	148	3.7%

Type of reporter in the reports that name Aricept
Reporter	Reports	Share
Physician	1,694	41.9%
Pharmacist	345	8.5%
Other health professional	803	19.9%
Lawyer	3	0.1%
Consumer or non-health professional	856	21.2%
Not given	342	8.5%

Age and sex are as the report gives them. The reporter is the primary source in the report. 33% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Aricept record
Indication as recorded (MedDRA)	Reports	Share
Dementia alzheimer's type	841	20.8%
Dementia	576	14.2%
Dementia alzheimer's type	520	12.9%
Amnesia	94	2.3%
Memory impairment	76	1.9%
Cognitive disorder	61	1.5%

The reporter fills in the indication, and the field is often empty. Each share is of all 4,043 reports.

Drugs in the same reports

Other drugs that the reports of Aricept name, in any role, in order of name
Drug	Reports that name the two
Amlodipine	114
Aspirin	313
Furosemide	131
Lasix	93
Lipitor	153
Norvasc	113
Plavix	86
Risperdal	146
Seroquel	102
Zoloft	105

The table has the 10 drug names that these reports name most. Two names in one report says only that the report recorded the two. It says nothing about the part of a product in the event.

FDA says:

Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Pages near this one

Donepezil same ingredient
Donepezil hydrochloride same ingredient
Exelon same class
Galantamine same class
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Arikayce next in the A to Z list
Arestin next in the A to Z list
Arimidex next in the A to Z list
Aredia next in the A to Z list
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Arcoxia next in the A to Z list
Aristada next in the A to Z list

These links are for navigation. No count selected them. The class page lists each drug of the class.

Official pages

DailyMed labels for AriceptThe labels (prescribing information) that have this name, at the National Library of Medicine.
MedWatch Online Voluntary Reporting FormThe online form of FDA for a voluntary report.
MedWatch: The FDA Safety Information and Adverse Event Reporting ProgramThe page of the FDA program that receives reports about drugs and devices.
FDA Adverse Event Monitoring System (AEMS) Public DashboardThe public dashboard of FDA for adverse event reports on drugs and biologics.

The site checked these addresses on 2 Oct 2026. The links open in a new tab.

Cite this page

Reported Reactions. Aricept: adverse event reports that FDA received. https://reportedreactions.com/drug/aricept/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of 29 Oct 2026. Reports received through 30 Jun 2026.

Where the data come from

The counts come from the openFDA Drug Adverse Event (FAERS) bulk files, release of 29 Oct 2026. The files have the reports that FDA received through 30 Jun 2026. A drug name is the name on the report. The site matches it to a brand name or a generic name of the National Drug Code Directory of 2 Nov 2026. A class is the pharmacologic class (EPC) of the FDA label.

A report is in the count when it names Aricept as a suspect or interacting product. The 11,601 reports that name it only as a concomitant medicine are not in the count. The site does not publish a report narrative, a lot number, a detail of a patient or the identity of a reporter. The record of FDA is the authority. See how the site counts reports, the data sources and the corrections page.

Questions

Do these reports show that Aricept was responsible for the reactions?

No. FDA says:

For any given report, there is no certainty that a suspected drug caused the event.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

A reaction can relate to the condition that the drug treats, to other medicines, or to something else.

Is this the list of reactions on the label of Aricept?

No. It is a count of what people reported to FDA: 4,043 reports from January 2004 to June 2026. The FDA-approved label of a product lists its adverse reactions. The official pages at the end of this page link to the labels.

Who sent these reports?

Physician (41.9%), consumer or non-health professional (21.2%) and other health professional (19.9%). These are the types of reporter for the reports that name this drug.

If a manufacturer receives an adverse event report, it is normally required to send the report to FDA.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

How does a person report an adverse event?

FDA runs MedWatch, a program that takes voluntary reports from health professionals, patients and consumers. The guide on how to report has the links.

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