85/100 · Critical
Manufactured by UCB, Inc.
Levetiracetam Adverse Events: Seizure and Fatigue Predominate, with High Serious Event Rate
207,510 FDA adverse event reports analyzed
Last updated: 2026-05-12
LEVETIRACETAM is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by UCB, Inc.. Based on analysis of 207,510 FDA adverse event reports, LEVETIRACETAM has a safety score of 85 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 LEVETIRACETAM include SEIZURE, DRUG INEFFECTIVE, OFF LABEL USE, FATIGUE, CONVULSION. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for LEVETIRACETAM.
Levetiracetam has a safety concern score of 85 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 207,510 adverse event reports for this medication, which is primarily manufactured by Ucb, Inc..
The most commonly reported adverse events include Seizure, Drug Ineffective, Off Label Use. Of classified reports, 83.3% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Seizure and drug ineffectiveness are the most common adverse events, with a high serious event rate.
Fatigue and somnolence are also frequently reported, impacting patient quality of life. The drug is associated with a significant number of serious adverse events, particularly seizures and respiratory issues.
Patients taking Levetiracetam should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Levetiracetam can interact with other drugs, and patients should be monitored for potential interactions and adverse effects. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Levetiracetam received a safety concern score of 85/100 (high concern). This is based on a 83.3% serious event ratio across 127,667 classified reports. The score accounts for 207,510 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: 60,645, Male: 50,020, Unknown: 375. The most frequently reported age groups are age 60 (1,331 reports), age 67 (1,301 reports), age 65 (1,295 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 127,667 classified reports for LEVETIRACETAM:
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.
Levetiracetam can interact with other drugs, and patients should be monitored for potential interactions and adverse effects.
If you are taking Levetiracetam, here are important things to know. The most commonly reported side effects include seizure, drug ineffective, off label use, fatigue, convulsion. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Patients should report any new or worsening symptoms to their healthcare provider immediately. Avoid driving or operating heavy machinery until the effects of the drug are known. 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.
Regulatory oversight is ongoing, with a focus on monitoring serious adverse events and ensuring patient safety.
The FDA has received approximately 207,510 adverse event reports associated with Levetiracetam. 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 Levetiracetam include Seizure, Drug Ineffective, Off Label Use, Fatigue, Convulsion. By volume, the top reported reactions are: Seizure (15,308 reports), Drug Ineffective (11,809 reports), Off Label Use (8,948 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Levetiracetam.
Out of 127,667 classified reports, 106,287 (83.3%) were classified as serious and 21,380 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 Levetiracetam break down by patient sex as follows: Female: 60,645, Male: 50,020, Unknown: 375. 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 Levetiracetam adverse events are: age 60: 1,331 reports, age 67: 1,301 reports, age 65: 1,295 reports, age 58: 1,264 reports, age 59: 1,235 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 Levetiracetam adverse event reports is Ucb, 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 Levetiracetam include: Epilepsy, Somnolence, Fall, Headache, Maternal Exposure During Pregnancy. 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 Levetiracetam 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.
Levetiracetam has a safety concern score of 85 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. Seizure and drug ineffectiveness are the most common adverse events, with a high serious event rate.
Key safety signals identified in Levetiracetam's adverse event data include: Seizure and convulsion are the most frequent serious adverse events, indicating potential neurological risks.. Drug ineffectiveness and drug interaction reports suggest variability in treatment outcomes and potential interactions.. Respiratory issues such as pneumonia and respiratory failure are notable, highlighting the need for monitoring.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Levetiracetam can interact with other drugs, and patients should be monitored for potential interactions and adverse effects. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Levetiracetam.
Patients should report any new or worsening symptoms to their healthcare provider immediately. Avoid driving or operating heavy machinery until the effects of the drug are known.
Levetiracetam has 207,510 adverse event reports on file with the FDA. Fatigue and somnolence are also frequently reported, impacting patient quality of life. The volume of reports for Levetiracetam reflects both the drug's usage level and the vigilance of the reporting community.
Regulatory oversight is ongoing, with a focus on monitoring serious adverse events and ensuring patient safety. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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