82/100 · Critical
Manufactured by Janssen Pharmaceuticals, Inc.
Topiramate Adverse Events: High Seriousness and Diverse Reactions
203,737 FDA adverse event reports analyzed
Last updated: 2026-05-12
TOPIRAMATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Janssen Pharmaceuticals, Inc.. Based on analysis of 203,737 FDA adverse event reports, TOPIRAMATE has a safety score of 82 out of 100. This score indicates a relatively favorable safety profile, with fewer or less severe adverse events compared to many other tracked medications. The most commonly reported adverse reactions for TOPIRAMATE include DRUG INEFFECTIVE, OFF LABEL USE, HEADACHE, NAUSEA, FATIGUE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for TOPIRAMATE.
Topiramate has a safety concern score of 82 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 203,737 adverse event reports for this medication, which is primarily manufactured by Janssen Pharmaceuticals, Inc..
The most commonly reported adverse events include Drug Ineffective, Off Label Use, Headache. Of classified reports, 68.6% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Topiramate reports include a high percentage of serious adverse events, particularly related to neurological and psychiatric effects.
A wide range of reactions are reported, indicating diverse safety concerns. Weight changes and gastrointestinal issues are among the most frequently reported side effects.
Patients taking Topiramate should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Topiramate can cause drug interactions, and patients should be aware of potential interactions with other medications. It is important to follow the prescribed dosage and consult a healthcare provider if any side effects occur. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Topiramate received a safety concern score of 82/100 (high concern). This is based on a 68.6% serious event ratio across 90,055 classified reports. The score accounts for 203,737 total adverse event reports and 100 distinct reaction types. This high score reflects a significant proportion of serious adverse events in the reporting data.
Adverse event reports by sex: Female: 62,982, Male: 17,678, Unknown: 389. The most frequently reported age groups are age 40 (1,883 reports), age 43 (1,731 reports), age 53 (1,394 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 90,055 classified reports for TOPIRAMATE:
The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.
Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.
Topiramate can cause drug interactions, and patients should be aware of potential interactions with other medications. It is important to follow the prescribed dosage and consult a healthcare provider if any side effects occur.
If you are taking Topiramate, here are important things to know. The most commonly reported side effects include drug ineffective, off label use, headache, nausea, fatigue. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Monitor for signs of depression, suicidal thoughts, and other psychiatric symptoms, especially in the first few months of use. Be aware of potential drug interactions, particularly with other anticonvulsants and mood stabilizers. If you experience a serious adverse reaction, seek emergency medical attention immediately or call 911. You can report side effects to the FDA's MedWatch program at 1-800-FDA-1088.
The FDA continues to monitor Topiramate for safety, and updates are regularly issued based on new data. Patients should report any adverse events to their healthcare provider and the FDA's MedWatch program.
The FDA has received approximately 203,737 adverse event reports associated with Topiramate. These reports come from healthcare professionals, consumers, and manufacturers through the FDA Adverse Event Reporting System (FAERS). Note that the number of reports does not directly indicate the frequency of side effects, as adverse events are voluntarily reported and may be underrepresented.
The most frequently reported adverse events for Topiramate include Drug Ineffective, Off Label Use, Headache, Nausea, Fatigue. By volume, the top reported reactions are: Drug Ineffective (10,123 reports), Off Label Use (7,199 reports), Headache (6,463 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Topiramate.
Out of 90,055 classified reports, 61,741 (68.6%) were classified as serious and 28,314 as non-serious. The FDA classifies an event as "serious" if it results in death, hospitalization, disability, or other medically significant outcomes. A higher serious-event ratio warrants closer attention but does not necessarily mean the drug is unsafe.
Adverse event reports for Topiramate break down by patient sex as follows: Female: 62,982, Male: 17,678, Unknown: 389. This distribution reflects reporting patterns rather than actual risk differences between groups. Reporting rates can be influenced by prescribing patterns, disease demographics, and reporting behavior.
The most frequently reported age groups for Topiramate adverse events are: age 40: 1,883 reports, age 43: 1,731 reports, age 53: 1,394 reports, age 45: 1,283 reports, age 42: 1,265 reports. Age-related reporting patterns can reflect both the demographics of the patient population and potential age-related susceptibility to certain side effects.
The primary manufacturer associated with Topiramate adverse event reports is Janssen Pharmaceuticals, Inc.. Multiple manufacturers may produce generic versions of this drug. The manufacturer listed reflects the most frequently reported brand in FDA adverse event data.
Beyond the most common reactions, other reported adverse events for Topiramate include: Pain, Migraine, Dizziness, Seizure, Diarrhoea. Less common side effects can still be clinically significant. Patients should report any unusual symptoms to their healthcare provider.
You can report adverse events from Topiramate to the FDA through their MedWatch program at www.fda.gov/medwatch, by calling 1-800-FDA-1088, or by completing Form FDA 3500. Healthcare professionals, consumers, and manufacturers can all submit reports. Reporting helps the FDA monitor drug safety after approval.
Topiramate has a safety concern score of 82 out of 100 (high concern). This score is calculated from the ratio of serious to non-serious adverse events, the diversity of reported reactions, and the overall volume of reports relative to usage. Topiramate reports include a high percentage of serious adverse events, particularly related to neurological and psychiatric effects.
Key safety signals identified in Topiramate's adverse event data include: Seizures and convulsions are reported in a significant number of cases.. Psychiatric symptoms such as depression, anxiety, and suicidal ideation are common.. Neurological issues like dizziness and headache are frequently reported.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Topiramate can cause drug interactions, and patients should be aware of potential interactions with other medications. It is important to follow the prescribed dosage and consult a healthcare provider if any side effects occur. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Topiramate.
Monitor for signs of depression, suicidal thoughts, and other psychiatric symptoms, especially in the first few months of use. Be aware of potential drug interactions, particularly with other anticonvulsants and mood stabilizers.
Topiramate has 203,737 adverse event reports on file with the FDA. A wide range of reactions are reported, indicating diverse safety concerns. The volume of reports for Topiramate reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor Topiramate for safety, and updates are regularly issued based on new data. Patients should report any adverse events to their healthcare provider and the FDA's MedWatch program. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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