Topamaxtopiramate
According to the FDA label: Topiramate is indicated for: Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older (1.1); adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox- Gastaut syndrome in patients 2 years of age and older (1.2) Preventive treatment of migraine in patients 12 years of age and older (1.3) 1.1 Monotherapy Epilepsy Topiramate…
89,507 adverse event reports submitted to the FDA (2001–2026)
Top Reported Adverse Events
The most frequently reported events in association with Topamax in the FAERS database. These are events reported by patients taking this medication, not necessarily caused by it. A single report may include multiple events.
Show these terms with plain-language definitions
Tap any term below for a plain-language definition.
Drug Ineffective 10,077 reports
A report that the medication did not work as expected for the person taking it. This is a reporting category, not a sign the drug is defective. It simply means someone felt it was not helping their condition.
Full definition in the glossary →Off Label Use 7,229 reports
Using a medication for a condition or in a way that the FDA has not officially approved. This is common and often legal, and a report of it does not mean something went wrong. Doctors sometimes prescribe drugs off label based on their judgment.
Full definition in the glossary →Headache 6,394 reports
Pain in the head or upper neck.
Full definition in the glossary → See all drugs reporting this event →Nausea 5,735 reports
The feeling of sickness in your stomach that often comes before vomiting.
Full definition in the glossary → See all drugs reporting this event →Fatigue 5,291 reports
Extreme tiredness or lack of energy that does not improve with rest.
Full definition in the glossary → See all drugs reporting this event →Pain 4,512 reports
A general report of physical discomfort, used when no more specific location is given.
Full definition in the glossary →Migraine 4,292 reports
A severe, often throbbing headache, sometimes with nausea or sensitivity to light and sound.
Full definition in the glossary → See all drugs reporting this event →Dizziness 4,103 reports
A feeling of being lightheaded, unsteady, or like the room is spinning.
Full definition in the glossary → See all drugs reporting this event →Seizure 3,754 reports
A sudden burst of electrical activity in the brain that can cause shaking, altered awareness, or other temporary changes.
Full definition in the glossary →Diarrhoea 3,629 reports
Loose or watery bowel movements, often frequent. Also spelled diarrhea in American English.
Full definition in the glossary → See all drugs reporting this event →Vomiting 3,602 reports
Throwing up the contents of the stomach.
Full definition in the glossary → See all drugs reporting this event →Depression 3,566 reports
A persistent low mood, loss of interest, or feelings of sadness. If you are struggling, the 988 Suicide and Crisis Lifeline (call or text 988 in the US) is available 24 hours a day.
Full definition in the glossary → See all drugs reporting this event →Product Use in Unapproved Indication 3,103 reports
Using a medication for a condition it is not officially approved to treat. Like off label use, this is a reporting category and does not by itself mean harm occurred.
Full definition in the glossary →Weight Increased 2,976 reports
Weight Decreased 2,939 reports
Ranked by frequency of reports, not severity. The most-reported event is not necessarily the most dangerous or the most common in patients taking this drug.
Who Is Reporting
Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.
By Sex
View reporter sex data as a table
| Sex | Reports |
|---|---|
| Female | 62,318 |
| Male | 17,618 |
| Unknown | 386 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 6,307 |
| 18-34 | 11,235 |
| 35-49 | 18,172 |
| 50-64 | 14,501 |
| 65-74 | 3,970 |
| 75+ | 1,358 |
This shows who filed reports, reflecting who takes this drug and who tends to report, not who is at greatest risk.
Reported Outcomes
Outcomes recorded in FAERS reports that included Topamax. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.
View outcome data as a table
| Outcome | Reports |
|---|---|
| Other Serious | 45,075 |
| Non-Serious | 27,313 |
| Hospitalization | 23,146 |
| Death | 6,647 |
| Life-Threatening | 4,320 |
| Disability | 4,030 |
Serious outcomes are far more likely to be reported than mild ones, so this overstates how often outcomes are serious. A recorded death does not mean the drug caused it.
Report Volume Over Time
Number of FAERS reports received per quarter for Topamax. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior, not changes in the medication's safety profile.
View report trend as a table
| Year | Reports |
|---|---|
| 2001 | 2 |
| 2002 | 3 |
| 2004 | 1,032 |
| 2005 | 1,462 |
| 2006 | 1,574 |
| 2007 | 1,390 |
| 2008 | 1,612 |
| 2009 | 2,238 |
| 2010 | 2,823 |
| 2011 | 3,118 |
| 2012 | 3,489 |
| 2013 | 3,184 |
| 2014 | 3,698 |
| 2015 | 5,909 |
| 2016 | 6,576 |
| 2017 | 5,198 |
| 2018 | 6,041 |
| 2019 | 6,488 |
| 2020 | 5,711 |
| 2021 | 5,340 |
| 2022 | 5,094 |
| 2023 | 5,154 |
| 2024 | 5,743 |
| 2025 | 5,535 |
| 2026 (partial) | 1,093 |
The steep increase around 2004 reflects the FDA's move to electronic submission, not a change in this drug's safety. Trends track reporting volume, not risk.
Medications commonly reported with Topamax
In FDA adverse event reports that mention Topamax, these medications appeared most often in the same report.
- Gabapentin (11,995 reports)
- Lamotrigine (9,919 reports)
- Levetiracetam (9,785 reports)
- Ergocalciferol (9,452 reports)
- Clonazepam (8,455 reports)
This reflects co-occurrence in submitted reports, not evidence of drug interaction or combined risk. People often report several medications taken for the same condition or for unrelated reasons. Talk to a doctor or pharmacist about your specific medications.
Related Drugs
Other medications with similar adverse event profiles in FDA FAERS reports.
Data Source
This data is sourced from the FDA's Adverse Event Monitoring System (AEMS), formerly FAERS, via the OpenFDA API. PillSignal is not affiliated with the FDA.
View this data on the FDA website →Data last updated: June 2026