Galantamine adverse event reports that FDA received

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

Name type: Generic name
Class: Cholinesterase inhibitor
Also reported as: Galantamine Tablets, Galantamine Unspecified, Galantamine Er

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 789 adverse event reports that name Galantamine. In these reports the drug is a suspect or interacting product.

In the same period, 921 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 37 reports in the 12 months to June 2026 and 59 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, 37 (under 0.1%) name Galantamine. Reports for patients 75 and over were 56.1% of the reports that name Galantamine 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 Galantamine 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 9 reports that name Galantamine.
In January to March 2026, FDA received 15.
In April to June 2025, FDA received 12.

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 103 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 734 of the 789 reports (93%).

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 103 terms.

Reaction terms in the reports that name Galantamine, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 789 reports
Falla fall	300	38%
Cognitive disorderproblems with thinking or memory	273	34.6%
Balance disorderproblems with balance	256	32.4%
Constipation	256	32.4%
Orthostatic hypotension	255	32.3%
Hypotensionlow blood pressure	251	31.8%
Sedationdrowsiness	248	31.4%
Depressed level of consciousness	231	29.3%
Painpain, site not specified	228	28.9%
Toxicity to various agentspoisoning or toxic effect of one or more substances	228	28.9%
Sedation complication	223	28.3%
Creatinine renal clearance decreased	218	27.6%
Blood calcium decreased	217	27.5%
Mobility decreasedreduced ability to move about	217	27.5%
Drug interactionan interaction between medicines	105	13.3%
Off label useused for a purpose or in a way not on the label	72	9.1%
Dyspnoeashortness of breath	61	7.7%
Product use in unapproved indicationused for a purpose not on the label	49	6.2%
Renal function test abnormal	48	6.1%
Overdosea dose above the recommended amount	47	6%
Drug ineffectivethe medicine did not work as expected	44	5.6%
Multiple drug therapy	41	5.2%
Drug abusemisuse of a medicine	39	4.9%
Condition aggravatedthe condition being treated got worse	35	4.4%
Creatinine renal clearance increased	31	3.9%
Anticholinergic syndrome	27	3.4%
Dementia	22	2.8%
Dizzinesslight-headedness or unsteadiness	21	2.7%
Confusional stateconfusion	15	1.9%
Dysphagiadifficulty swallowing	14	1.8%
Arrhythmia	13	1.6%
Bradycardiaslow heart rate	13	1.6%
Electrocardiogram QT prolongeda QT prolongation on the ECG	13	1.6%
Myoclonus	13	1.6%
Drug ineffective for unapproved indication	12	1.5%
Syncopefainting	12	1.5%
Transient ischaemic attack	12	1.5%
Anxiety	11	1.4%
Aphasiadifficulty with language	11	1.4%
Headachehead pain	11	1.4%
Hypertensionhigh blood pressure	11	1.4%
Seizurea fit or convulsion	11	1.4%
Abdominal pain upperupper stomach pain	10	1.3%
Angina pectoris	10	1.3%
Bladder disorder	10	1.3%
Decreased appetitereduced appetite	10	1.3%
Diarrhoealoose or frequent stools	10	1.3%
Fatiguetiredness	10	1.3%
Nauseafeeling sick	10	1.3%
Agitationrestlessness	9	1.1%

Download all 103 terms of Galantamine (CSV)

The counts add to more than 789 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 Galantamine with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Galantamine (this page)	Generic name	789
Galantamine hydrobromide	Generic name	1,163

Sum of the separately reported names: 1,952. 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 Galantamine, 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	33	33	8	2	21	1	0	6	0
2005	11	11	3	1	6	2	0	2	0
2006	11	11	2	0	9	0	0	3	0
2008	3	2	0	0	0	0	0	2	1
2009	3	2	1	0	0	0	0	1	1
2010	4	4	2	0	4	0	0	2	0
2011	0	0	0	0	0	0	0	0	0
2012	15	15	6	0	5	0	0	8	0
2013	22	20	0	0	8	0	1	13	2
2014	36	34	8	3	18	0	0	17	2
2015	20	10	1	0	3	1	0	6	10
2016	24	19	0	0	6	0	0	15	5
2017	32	30	1	8	19	2	0	22	2
2018	45	41	4	1	22	4	0	25	4
2019	40	38	3	2	17	2	0	30	2
2020	53	53	1	3	44	0	0	32	0
2021	115	115	9	2	96	0	0	106	0
2022	120	119	1	8	100	1	0	110	1
2023	41	39	0	14	25	0	0	38	2
2024	65	62	17	22	26	1	0	53	3
2025	60	58	12	18	21	0	0	49	2
2026	36	34	13	11	16	0	0	23	2

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 Galantamine, 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 Galantamine, by the year in which FDA received them
Year	Reports
2004	32
2005	12
2006	9
2007	1
2008	5
2009	3
2010	4
2012	16
2013	22
2014	36
2015	23
2016	24
2017	38
2018	46
2019	50
2020	67
2021	120
2022	113
2023	44
2024	57
2025	43
2026	24

Reports that name Galantamine, 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 Galantamine
Age	Reports	Share
Under 2	0	0%
2 to 11	0	0%
12 to 17	0	0%
18 to 44	14	1.8%
45 to 64	43	5.4%
65 to 74	93	11.8%
75 and over	443	56.1%
Age not given	196	24.8%

Sex of the patient in the reports that name Galantamine
Sex	Reports	Share
Female	470	59.6%
Male	184	23.3%
Unknown or not given	135	17.1%

Type of reporter in the reports that name Galantamine
Reporter	Reports	Share
Physician	179	22.7%
Pharmacist	58	7.4%
Other health professional	407	51.6%
Lawyer	0	0%
Consumer or non-health professional	127	16.1%
Not given	18	2.3%

Age and sex are as the report gives them. The reporter is the primary source in the report. 14.4% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Galantamine record
Indication as recorded (MedDRA)	Reports	Share
Dementia	254	32.2%
Dementia alzheimer's type	108	13.7%
Corticobasal degeneration	22	2.8%
Cognitive disorder	10	1.3%
Memory impairment	8	1%
Dementia with lewy bodies	5	0.6%

The reporter fills in the indication, and the field is often empty. Each share is of all 789 reports.

Drugs in the same reports

Other drugs that the reports of Galantamine name, in any role, in order of name
Drug	Reports that name the two
Acetaminophen	267
Carbamazepine	283
Furosemide	287
Lactulose	277
Levofloxacin	256
Magnesium hydroxide	277
Nitroglycerin	267
Omeprazole	280
Oxazepam	281
Tiotropium bromide	264

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

Galantamine hydrobromide same ingredient
Exelon same class
Donepezil hydrochloride same class
Mestinon same class
Aricept same class
Namzaric same class
Galafold next in the A to Z list
Gadovist next in the A to Z list
Galcanezumab next in the A to Z list
Gadolinium in Drug next in the A to Z list
Galvus next in the A to Z list
Gadolinium 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 GalantamineThe 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. Galantamine: adverse event reports that FDA received. https://reportedreactions.com/drug/galantamine/ 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 Galantamine as a suspect or interacting product. The 921 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 Galantamine 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 Galantamine?

No. It is a count of what people reported to FDA: 789 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?

Other health professional (51.6%), physician (22.7%) and consumer or non-health professional (16.1%). 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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