Memantine adverse event reports that FDA received

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

Name type: Generic name
Class: N-methyl-D-aspartate receptor antagonist
Also reported as: Memantine Oral Solution, Memantine 20mg, Memantine Tablet

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 3,485 adverse event reports that name Memantine. In these reports the drug is a suspect or interacting product.

In the same period, 7,525 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 246 reports in the 12 months to June 2026 and 317 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, 246 (under 0.1%) name Memantine. Reports for patients 75 and over were 45.7% of the reports that name Memantine 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 Memantine 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 43 reports that name Memantine.
In January to March 2026, FDA received 82.
In April to June 2025, FDA received 56.

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 344 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 3,449 of the 3,485 reports (99%).

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 344 terms.

Reaction terms in the reports that name Memantine, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 3,485 reports
Drug ineffectivethe medicine did not work as expected	323	9.3%
Off label useused for a purpose or in a way not on the label	318	9.1%
Falla fall	209	6%
Condition aggravatedthe condition being treated got worse	195	5.6%
Confusional stateconfusion	189	5.4%
Agitationrestlessness	169	4.8%
Bradycardiaslow heart rate	144	4.1%
Somnolencedrowsiness	136	3.9%
Dizzinesslight-headedness or unsteadiness	132	3.8%
Drug interactionan interaction between medicines	117	3.4%
Aggressionaggressive behaviour	96	2.8%
Fatiguetiredness	95	2.7%
Nauseafeeling sick	92	2.6%
Hallucinationseeing or hearing things that are not there	91	2.6%
Headachehead pain	88	2.5%
Toxicity to various agentspoisoning or toxic effect of one or more substances	88	2.5%
Vomitingbeing sick	85	2.4%
Astheniaweakness or lack of energy	82	2.4%
Product use in unapproved indicationused for a purpose not on the label	82	2.4%
Deliriumsudden confusion	74	2.1%
Hypertensionhigh blood pressure	74	2.1%
Electrocardiogram QT prolongeda QT prolongation on the ECG	73	2.1%
Deaththe patient died; cause not stated by this term	71	2%
Drug ineffective for unapproved indication	71	2%
Pulmonary embolisma blood clot in the lung	70	2%
Myoclonus	68	2%
Insomniadifficulty sleeping	64	1.8%
Seizurea fit or convulsion	63	1.8%
Completed suicidedeath by suicide	62	1.8%
Decreased appetitereduced appetite	60	1.7%
Loss of consciousnesspassing out	60	1.7%
Constipation	58	1.7%
Cognitive disorderproblems with thinking or memory	56	1.6%
Syncopefainting	56	1.6%
Weight increasedweight gain	56	1.6%
Accidental overdosean accidental overdose	55	1.6%
Urinary tract infectionbladder or urinary infection	55	1.6%
Gait disturbancedifficulty walking	54	1.5%
Rashskin rash	54	1.5%
Tremorshaking	54	1.5%
Malaisegeneral feeling of being unwell	53	1.5%
Medication errora mistake in prescribing, dispensing or taking a medicine	53	1.5%
Sedationdrowsiness	53	1.5%
Cellulitisa skin infection	51	1.5%
Abnormal behaviourunusual behaviour	50	1.4%
Anxiety	49	1.4%
Drug intolerancethe medicine was not tolerated	49	1.4%
Hypotensionlow blood pressure	49	1.4%
Hyponatraemialow blood sodium	47	1.3%
Diarrhoealoose or frequent stools	45	1.3%

Download all 344 terms of Memantine (CSV)

The counts add to more than 3,485 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 Memantine with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Memantine (this page)	Generic name	3,485
Memantine hydrochloride	Generic name	1,324

Sum of the separately reported names: 4,809. 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 Memantine, 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	37	30	9	1	17	0	5	7
2005	15	14	5	0	8	1	4	1
2006	5	5	2	0	3	0	2	0
2007	2	2	1	1	2	0	0	0
2008	8	8	4	1	5	0	2	0
2009	5	5	1	0	4	0	1	0
2010	47	43	11	7	25	2	12	4
2011	122	121	20	8	52	4	52	1
2012	101	100	19	6	54	3	33	1
2013	127	124	15	11	52	13	57	3
2014	165	161	18	8	89	12	68	4
2015	213	183	32	11	97	5	74	30
2016	200	191	19	10	116	11	77	9
2017	144	133	17	11	72	10	72	11
2018	202	190	27	1	76	4	136	12
2019	239	215	16	15	89	22	118	24
2020	242	217	2	23	102	26	149	25
2021	249	216	11	2	107	7	163	33
2022	351	311	24	25	162	3	204	40
2023	279	269	10	12	128	8	210	10
2024	334	311	26	19	109	21	232	23
2025	262	239	35	28	96	3	183	23
2026	136	131	41	1	44	11	89	5

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 Memantine, 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 Memantine, by the year in which FDA received them
Year	Reports
2004	32
2005	20
2006	5
2007	2
2008	7
2009	5
2010	46
2011	125
2012	111
2013	138
2014	155
2015	219
2016	202
2017	147
2018	214
2019	254
2020	267
2021	266
2022	337
2023	265
2024	311
2025	232
2026	125

Reports that name Memantine, 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 Memantine
Age	Reports	Share
Under 2	7	0.2%
2 to 11	42	1.2%
12 to 17	20	0.6%
18 to 44	202	5.8%
45 to 64	314	9%
65 to 74	373	10.7%
75 and over	1,592	45.7%
Age not given	935	26.8%

Sex of the patient in the reports that name Memantine
Sex	Reports	Share
Female	1,718	49.3%
Male	1,216	34.9%
Unknown or not given	551	15.8%

Type of reporter in the reports that name Memantine
Reporter	Reports	Share
Physician	797	22.9%
Pharmacist	422	12.1%
Other health professional	1,647	47.3%
Lawyer	1	under 0.1%
Consumer or non-health professional	506	14.5%
Not given	112	3.2%

Age and sex are as the report gives them. The reporter is the primary source in the report. 24.8% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Memantine record
Indication as recorded (MedDRA)	Reports	Share
Dementia alzheimer's type	671	19.3%
Dementia	395	11.3%
Dementia alzheimer's type	131	3.8%
Catatonia	89	2.6%
Cognitive disorder	73	2.1%
Complex regional pain syndrome	71	2%

The reporter fills in the indication, and the field is often empty. Each share is of all 3,485 reports.

Drugs in the same reports

Other drugs that the reports of Memantine name, in any role, in order of name
Drug	Reports that name the two
Amlodipine	215
Aspirin	212
Atorvastatin	224
Donepezil	400
Gabapentin	166
Lorazepam	232
Pregabalin	152
Quetiapine	214
Risperidone	179
Sertraline	172

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

Memantine hydrochloride same ingredient
Memantine hcl same class
Melphalan hydrochloride next in the A to Z list
Melphalan next in the A to Z list
Memantine Hcl - Bp next in the A to Z list
Melperone next in the A to Z list
Melperon next in the A to Z list
Menest next in the A to Z list
Meloxicam next in the A to Z list
Menopur next in the A to Z list
Melatonin next in the A to Z list
Menotropins 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 MemantineThe 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. Memantine: adverse event reports that FDA received. https://reportedreactions.com/drug/memantine/ 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 Memantine as a suspect or interacting product. The 7,525 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 Memantine 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 Memantine?

No. It is a count of what people reported to FDA: 3,485 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 (47.3%), physician (22.9%) and consumer or non-health professional (14.5%). 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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