82/100 · Critical
Manufactured by Advanz Pharma (US) Corp.
Zonisamide Adverse Events Show High Seriousness and Seizure Risk
26,522 FDA adverse event reports analyzed
Last updated: 2026-05-12
ZONISAMIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Advanz Pharma (US) Corp.. Based on analysis of 26,522 FDA adverse event reports, ZONISAMIDE 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 ZONISAMIDE include DRUG INEFFECTIVE, SEIZURE, OFF LABEL USE, FATIGUE, SOMNOLENCE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ZONISAMIDE.
Zonisamide 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 26,522 adverse event reports for this medication, which is primarily manufactured by Advanz Pharma (Us) Corp..
The most commonly reported adverse events include Drug Ineffective, Seizure, Off Label Use. Of classified reports, 76.1% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Seizures and convulsions are the most common adverse events, with 1574 and 623 reports respectively.
Serious adverse events account for 76.1% of all reports, indicating a high risk of severe outcomes. Fatigue and somnolence are also frequently reported, affecting patient quality of life.
Patients taking Zonisamide should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Zonisamide can cause drug interactions, and patients should be monitored for potential interactions with other medications. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Zonisamide received a safety concern score of 82/100 (high concern). This is based on a 76.1% serious event ratio across 14,203 classified reports. The score accounts for 26,522 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: 6,962, Male: 4,449, Unknown: 46. The most frequently reported age groups are age 3 (170 reports), age 38 (167 reports), age 27 (164 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 14,203 classified reports for ZONISAMIDE:
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.
Zonisamide can cause drug interactions, and patients should be monitored for potential interactions with other medications.
If you are taking Zonisamide, here are important things to know. The most commonly reported side effects include drug ineffective, seizure, off label use, fatigue, somnolence. 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 seizures and convulsions, especially in the first few weeks of treatment. Report any serious adverse events to your healthcare provider. 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 closely monitors Zonisamide's safety, and any unusual symptoms should be reported to healthcare providers immediately.
The FDA has received approximately 26,522 adverse event reports associated with Zonisamide. 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 Zonisamide include Drug Ineffective, Seizure, Off Label Use, Fatigue, Somnolence. By volume, the top reported reactions are: Drug Ineffective (1,636 reports), Seizure (1,574 reports), Off Label Use (872 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Zonisamide.
Out of 14,203 classified reports, 10,806 (76.1%) were classified as serious and 3,397 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 Zonisamide break down by patient sex as follows: Female: 6,962, Male: 4,449, Unknown: 46. 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 Zonisamide adverse events are: age 3: 170 reports, age 38: 167 reports, age 27: 164 reports, age 25: 157 reports, age 50: 150 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 Zonisamide adverse event reports is Advanz Pharma (Us) Corp.. 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 Zonisamide include: Convulsion, Dizziness, Nausea, Headache, Fall. 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 Zonisamide 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.
Zonisamide 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. Seizures and convulsions are the most common adverse events, with 1574 and 623 reports respectively.
Key safety signals identified in Zonisamide's adverse event data include: Seizures and convulsions. High percentage of serious adverse events. Severe outcomes like status epilepticus and death. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Zonisamide can cause drug interactions, and patients should be monitored for potential interactions with other medications. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Zonisamide.
Monitor for signs of seizures and convulsions, especially in the first few weeks of treatment. Report any serious adverse events to your healthcare provider.
Zonisamide has 26,522 adverse event reports on file with the FDA. Serious adverse events account for 76.1% of all reports, indicating a high risk of severe outcomes. The volume of reports for Zonisamide reflects both the drug's usage level and the vigilance of the reporting community.
The FDA closely monitors Zonisamide's safety, and any unusual symptoms should be reported to healthcare providers immediately. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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