Topiramate adverse event reports that FDA received

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

Name type: Generic name
Also reported as: Topiramate Tablets, Topiramate 100mg, Topiramate Tabs 25mg

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.

Reports on file

From January 2004 to June 2026, FDA received 25,229 adverse event reports that name Topiramate. In these reports the drug is a suspect or interacting product.

In the same period, 24,951 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 2,121 reports in the 12 months to June 2026 and 2,577 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

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 Topiramate 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 1 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.

No update is on record for this page. The record starts when FDA adds the reports of July to September 2026.

In April to June 2026, FDA received 517 reports that name Topiramate.
In January to March 2026, FDA received 417.
In April to June 2025, FDA received 500.

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 1,540 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 25,067 of the 25,229 reports (99.4%).

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 1,540 terms.

Reaction terms in the reports that name Topiramate, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 25,229 reports
Drug ineffectivethe medicine did not work as expected	4,947	19.6%
Off label useused for a purpose or in a way not on the label	3,822	15.1%
Product use in unapproved indicationused for a purpose not on the label	2,034	8.1%
Drug intolerancethe medicine was not tolerated	1,887	7.5%
Headachehead pain	1,767	7%
Nauseafeeling sick	1,514	6%
Migraine	1,460	5.8%
Condition aggravatedthe condition being treated got worse	1,346	5.3%
Fatiguetiredness	1,302	5.2%
Dizzinesslight-headedness or unsteadiness	1,271	5%
Paraesthesiatingling or pins and needles	1,261	5%
Completed suicidedeath by suicide	1,258	5%
Toxicity to various agentspoisoning or toxic effect of one or more substances	1,226	4.9%
Product use issuea problem in how the product was used	1,207	4.8%
Painpain, site not specified	1,138	4.5%
Treatment failurethe treatment did not work	1,129	4.5%
Confusional stateconfusion	1,098	4.4%
Depressionlow mood	1,097	4.3%
Vomitingbeing sick	1,096	4.3%
Maternal exposure during pregnancythe mother took the medicine during pregnancy	1,068	4.2%
Rashskin rash	1,046	4.1%
Weight increasedweight gain	1,046	4.1%
Epilepsy	1,041	4.1%
Seizurea fit or convulsion	1,040	4.1%
Drug interactionan interaction between medicines	1,017	4%
Hypoaesthesianumbness	970	3.8%
Memory impairmentmemory problems	948	3.8%
Dyspnoeashortness of breath	882	3.5%
Diarrhoealoose or frequent stools	878	3.5%
Insomniadifficulty sleeping	871	3.5%
Somnolencedrowsiness	869	3.4%
Alopeciahair loss	860	3.4%
Drug ineffective for unapproved indication	854	3.4%
Gastrooesophageal reflux diseaseacid reflux	853	3.4%
Intentional product use issuedeliberate use not as intended	835	3.3%
Foetal exposure during pregnancythe unborn baby was exposed to the medicine	821	3.3%
Drug hypersensitivityan allergic-type reaction (the term names a medicine)	808	3.2%
Systemic lupus erythematosuslupus, an autoimmune disease	795	3.2%
Arthralgiajoint pain	771	3.1%
Decreased appetitereduced appetite	771	3.1%
Wound	770	3.1%
Wheezing	764	3%
Astheniaweakness or lack of energy	745	3%
Synovitis	739	2.9%
Malaisegeneral feeling of being unwell	737	2.9%
Contraindicated product administered	732	2.9%
Abdominal pain upperupper stomach pain	729	2.9%
Abdominal discomfortstomach discomfort	722	2.9%
Falla fall	721	2.9%
Type 2 diabetes mellitustype 2 diabetes	721	2.9%

Download all 1,540 terms of Topiramate (CSV)

The counts add to more than 25,229 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 Topiramate with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Topiramate (this page)	Generic name	25,229
Topamax	Brand name	13,193
Trokendi XR	Brand name	1,269

Sum of the separately reported names: 39,691. 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 Topiramate, 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	87	77	14	5	33	3	3	31	10
2005	98	90	23	6	42	3	5	30	8
2006	82	78	15	6	33	1	3	32	4
2007	85	79	6	4	34	4	8	36	6
2008	219	208	29	7	51	7	42	108	11
2009	543	505	69	27	82	12	52	323	38
2010	692	640	119	41	153	31	54	381	52
2011	741	700	168	49	188	15	37	390	41
2012	673	646	96	31	158	20	76	393	27
2013	657	617	91	21	124	41	38	416	40
2014	962	923	205	39	247	61	55	521	39
2015	1,336	1,012	213	27	230	32	45	729	324
2016	1,214	938	152	35	233	54	85	670	276
2017	1,118	955	283	52	263	48	50	600	163
2018	1,490	1,287	128	105	448	50	73	962	203
2019	1,699	1,469	147	92	404	74	38	1,112	230
2020	1,518	1,358	185	84	462	40	42	1,028	160
2021	1,608	1,451	207	74	438	48	54	1,144	157
2022	1,757	1,595	214	89	450	28	30	1,293	162
2023	1,853	1,693	159	151	566	90	80	1,381	160
2024	2,674	2,166	515	435	836	389	360	1,841	508
2025	2,697	2,484	880	811	1,198	769	773	2,144	213
2026	1,426	1,346	481	419	584	399	423	1,183	80

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 Topiramate, 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 Topiramate, by the year in which FDA received them
Year	Reports
2004	79
2005	98
2006	80
2007	85
2008	218
2009	561
2010	685
2011	769
2012	795
2013	633
2014	928
2015	1,385
2016	1,244
2017	1,210
2018	1,580
2019	1,799
2020	1,595
2021	1,763
2022	1,760
2023	2,122
2024	2,567
2025	2,335
2026	934

Reports that name Topiramate, 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 Topiramate
Age	Reports	Share
Under 2	680	2.7%
2 to 11	1,253	5%
12 to 17	884	3.5%
18 to 44	8,738	34.6%
45 to 64	4,465	17.7%
65 to 74	768	3%
75 and over	347	1.4%
Age not given	8,094	32.1%

Sex of the patient in the reports that name Topiramate
Sex	Reports	Share
Female	14,635	58%
Male	6,035	23.9%
Unknown or not given	4,559	18.1%

Type of reporter in the reports that name Topiramate
Reporter	Reports	Share
Physician	7,544	29.9%
Pharmacist	1,335	5.3%
Other health professional	11,325	44.9%
Lawyer	33	0.1%
Consumer or non-health professional	4,116	16.3%
Not given	876	3.5%

Age and sex are as the report gives them. The reporter is the primary source in the report. 35.6% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Topiramate record
Indication as recorded (MedDRA)	Reports	Share
Migraine	4,302	17.1%
Epilepsy	2,731	10.8%
Seizure	1,288	5.1%
Migraine prophylaxis	837	3.3%
Partial seizures	427	1.7%
Status epilepticus	388	1.5%

The reporter fills in the indication, and the field is often empty. Each share is of all 25,229 reports.

Drugs in the same reports

Other drugs that the reports of Topiramate name, in any role, in order of name
Drug	Reports that name the two
Acetaminophen	2,355
Aimovig	1,965
Botulinum toxin type a	2,046
Candesartan	1,733
Clobazam	1,700
Lamotrigine	2,810
Levetiracetam	3,137
Naproxen	2,186
Prednisone	1,779
Valproic acid	1,809

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

Topamax same ingredient
Trokendi XR same ingredient
Topicort next in the A to Z list
Topotecan next in the A to Z list
Topotecan hydrochloride next in the A to Z list
Topalgic next in the A to Z list
Toprol Xl next in the A to Z list
Tolvaptan next in the A to Z list
Toprol-Xl next in the A to Z list
Tolterodine tartrate next in the A to Z list
Toradol next in the A to Z list
Tolterodine next in the A to Z list

These links are for navigation. No count selected them.

Official pages

DailyMed labels for TopiramateThe 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. Topiramate: adverse event reports that FDA received. https://reportedreactions.com/drug/topiramate/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of 1 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 1 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 Oct 2026. A class is the pharmacologic class (EPC) of the FDA label.

A report is in the count when it names Topiramate as a suspect or interacting product. The 24,951 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 Topiramate 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 Topiramate?

No. It is a count of what people reported to FDA: 25,229 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 (44.9%), physician (29.9%) and consumer or non-health professional (16.3%). 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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