Donepezil hydrochloride adverse event reports that FDA received

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

Name type: Generic name
Class: Cholinesterase inhibitor
Also reported as: Donepezil Hydrochloride Tablets 10mg, Donepezil Hydrochloride Tablets 5mg, Donepezil Hydrochloride Tablets

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 April 2004 to June 2026, FDA received 1,569 adverse event reports that name Donepezil hydrochloride. In these reports the drug is a suspect or interacting product.

In the same period, 2,854 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 136 reports in the 12 months to June 2026 and 208 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, 136 (under 0.1%) name Donepezil hydrochloride. Reports for patients 75 and over were 47.7% of the reports that name Donepezil hydrochloride 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 Donepezil hydrochloride 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 29 reports that name Donepezil hydrochloride.
In January to March 2026, FDA received 51.
In April to June 2025, FDA received 37.

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 218 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 1,476 of the 1,569 reports (94.1%).

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 218 terms.

Reaction terms in the reports that name Donepezil hydrochloride, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 1,569 reports
Drug interactionan interaction between medicines	206	13.1%
Falla fall	181	11.5%
Dizzinesslight-headedness or unsteadiness	175	11.2%
Nauseafeeling sick	152	9.7%
Diarrhoealoose or frequent stools	146	9.3%
Fatiguetiredness	122	7.8%
Syncopefainting	111	7.1%
Confusional stateconfusion	106	6.8%
Decreased appetitereduced appetite	106	6.8%
Head discomfortdiscomfort in the head	105	6.7%
Insomniadifficulty sleeping	104	6.6%
Vomitingbeing sick	103	6.6%
Haemorrhagic stroke	102	6.5%
Altered state of consciousness	101	6.4%
Dyspnoeashortness of breath	94	6%
Abdominal painstomach or belly pain	93	5.9%
Cardio-respiratory arrestthe heart and breathing stopped	93	5.9%
Arthralgiajoint pain	92	5.9%
Headachehead pain	92	5.9%
Pruritusitching	92	5.9%
Chillschills or shivering	91	5.8%
Coma	91	5.8%
Sepsisa severe body-wide response to infection	91	5.8%
Somnolencedrowsiness	89	5.7%
Amaurosis fugax	85	5.4%
Haematemesis	85	5.4%
Blindnessloss of sight	84	5.4%
Bradycardiaslow heart rate	83	5.3%
Eye pain	81	5.2%
Tachycardiafast heart rate	81	5.2%
Malaisegeneral feeling of being unwell	79	5%
Ocular discomfort	79	5%
Astheniaweakness or lack of energy	78	5%
Ascitesfluid in the abdomen	77	4.9%
Abdominal pain upperupper stomach pain	71	4.5%
Anticholinergic syndrome	65	4.1%
Toxicity to various agentspoisoning or toxic effect of one or more substances	64	4.1%
Blood pressure increaseda raised blood pressure reading	62	4%
Generalised oedema	62	4%
Tinnitusringing in the ears	62	4%
Deliriumsudden confusion	61	3.9%
Cough	60	3.8%
Pyrexiafever	59	3.8%
Haematuriablood in the urine	58	3.7%
Off label useused for a purpose or in a way not on the label	57	3.6%
Presyncope	57	3.6%
Urinary tract disorder	56	3.6%
Diplopiadouble vision	54	3.4%
Myalgiamuscle pain	54	3.4%
Cognitive disorderproblems with thinking or memory	53	3.4%

Download all 218 terms of Donepezil hydrochloride (CSV)

The counts add to more than 1,569 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 (this page)	Generic name	1,569
Aricept	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 Donepezil hydrochloride, 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	Other Serious (Important Medical Events)	Not serious
2004	1	1	0	0	1	0	0	0
2005	3	3	0	0	3	0	0	0
2006	3	3	2	0	1	0	1	0
2009	6	6	0	0	4	0	3	0
2010	6	5	0	0	4	0	1	1
2011	20	20	0	3	9	2	12	0
2012	41	37	2	2	14	2	27	4
2013	63	62	6	7	30	2	35	1
2014	67	67	2	3	36	5	34	0
2015	76	71	12	4	40	0	36	5
2016	58	45	4	2	15	2	34	13
2017	50	39	3	1	17	0	27	11
2018	74	61	18	2	26	2	35	13
2019	89	78	9	3	48	4	40	11
2020	79	71	8	7	43	4	37	8
2021	98	86	16	4	36	5	66	12
2022	163	149	22	15	65	4	121	14
2023	187	173	26	7	61	8	122	14
2024	214	207	79	16	63	5	153	7
2025	169	160	35	5	58	4	113	9
2026	102	99	24	9	61	10	72	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 Donepezil hydrochloride, 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 Donepezil hydrochloride, by the year in which FDA received them
Year	Reports
2004	1
2005	3
2006	1
2007	2
2008	1
2009	6
2010	6
2011	23
2012	43
2013	63
2014	67
2015	78
2016	55
2017	54
2018	81
2019	97
2020	96
2021	91
2022	167
2023	192
2024	220
2025	142
2026	80

Reports that name Donepezil hydrochloride, 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 Donepezil hydrochloride
Age	Reports	Share
Under 2	9	0.6%
2 to 11	12	0.8%
12 to 17	0	0%
18 to 44	23	1.5%
45 to 64	117	7.5%
65 to 74	203	12.9%
75 and over	748	47.7%
Age not given	457	29.1%

Sex of the patient in the reports that name Donepezil hydrochloride
Sex	Reports	Share
Female	709	45.2%
Male	538	34.3%
Unknown or not given	322	20.5%

Type of reporter in the reports that name Donepezil hydrochloride
Reporter	Reports	Share
Physician	424	27%
Pharmacist	204	13%
Other health professional	609	38.8%
Lawyer	2	0.1%
Consumer or non-health professional	302	19.2%
Not given	28	1.8%

Age and sex are as the report gives them. The reporter is the primary source in the report. 28.4% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Donepezil hydrochloride record
Indication as recorded (MedDRA)	Reports	Share
Dementia	260	16.6%
Dementia alzheimer's type	242	15.4%
Cognitive disorder	59	3.8%
Memory impairment	35	2.2%
Ill-defined disorder	17	1.1%
Dementia with lewy bodies	13	0.8%

The reporter fills in the indication, and the field is often empty. Each share is of all 1,569 reports.

Drugs in the same reports

Other drugs that the reports of Donepezil hydrochloride name, in any role, in order of name
Drug	Reports that name the two
Acetaminophen	150
Aspirin	204
Diltiazem hydrochloride	116
Hydrochlorothiazide	126
Mirtazapine	210
Pregabalin	144
Simvastatin	193
Tamsulosin hydrochloride	133
Telmisartan	135
Tramadol hydrochloride	114

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
Aricept same ingredient
Exelon same class
Galantamine same class
Galantamine hydrobromide same class
Donepezil hcl next in the A to Z list
Donepezil/Donepezil Hydrochloride next in the A to Z list
Dopamine next in the A to Z list
Donanemab next in the A to Z list
Dopamine hydrochloride next in the A to Z list
Domperidone maleate next in the A to Z list
Doptelet 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 Donepezil hydrochlorideThe 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. Donepezil hydrochloride: adverse event reports that FDA received. https://reportedreactions.com/drug/donepezil-hydrochloride/ 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 Donepezil hydrochloride as a suspect or interacting product. The 2,854 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 Donepezil hydrochloride 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 Donepezil hydrochloride?

No. It is a count of what people reported to FDA: 1,569 reports from April 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?

Other health professional (38.8%), physician (27%) and consumer or non-health professional (19.2%). 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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