85/100 · Critical
Manufactured by Amneal Pharmaceuticals LLC
Levetiracetam Oral Adverse Events: High Seriousness and Diverse Reactions
117,347 FDA adverse event reports analyzed
Last updated: 2026-05-12
LEVETIRACETAM ORAL is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Amneal Pharmaceuticals LLC. Based on analysis of 117,347 FDA adverse event reports, LEVETIRACETAM ORAL 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 ORAL include DRUG INEFFECTIVE, SEIZURE, OFF LABEL USE, MATERNAL EXPOSURE DURING PREGNANCY, EPILEPSY. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for LEVETIRACETAM ORAL.
Levetiracetam Oral 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 117,347 adverse event reports for this medication, which is primarily manufactured by Amneal Pharmaceuticals Llc.
The most commonly reported adverse events include Drug Ineffective, Seizure, Off Label Use. Of classified reports, 88.9% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. High percentage of serious adverse events (88.9%) indicates significant safety concerns.
Seizure-related reactions are common, with multiple types of seizures reported. Multiple drug interactions and pregnancy-related issues are frequent.
Patients taking Levetiracetam Oral should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Levetiracetam can cause drug interactions and should be used with caution in combination with other medications. Warnings are also issued for its use during pregnancy. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Levetiracetam Oral received a safety concern score of 85/100 (high concern). This is based on a 88.9% serious event ratio across 73,469 classified reports. The score accounts for 117,347 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: 33,758, Male: 28,551, Unknown: 212. The most frequently reported age groups are age 3 (873 reports), age 67 (832 reports), age 65 (784 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 73,469 classified reports for LEVETIRACETAM ORAL:
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 cause drug interactions and should be used with caution in combination with other medications. Warnings are also issued for its use during pregnancy.
If you are taking Levetiracetam Oral, here are important things to know. The most commonly reported side effects include drug ineffective, seizure, off label use, maternal exposure during pregnancy, epilepsy. 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 other neurological symptoms, especially in patients with a history of such conditions. Be aware of potential drug interactions and inform your healthcare provider of all medications you are taking. 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 Levetiracetam for safety, and patients should report any adverse events to their healthcare provider immediately. Regular monitoring is recommended for patients with pre-existing conditions.
The FDA has received approximately 117,347 adverse event reports associated with Levetiracetam Oral. 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 Oral include Drug Ineffective, Seizure, Off Label Use, Maternal Exposure During Pregnancy, Epilepsy. By volume, the top reported reactions are: Drug Ineffective (8,648 reports), Seizure (8,485 reports), Off Label Use (6,066 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 Oral.
Out of 73,469 classified reports, 65,335 (88.9%) were classified as serious and 8,134 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 Oral break down by patient sex as follows: Female: 33,758, Male: 28,551, Unknown: 212. 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 Oral adverse events are: age 3: 873 reports, age 67: 832 reports, age 65: 784 reports, age 4: 773 reports, age 60: 756 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 Oral adverse event reports is Amneal Pharmaceuticals Llc. 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 Oral include: Foetal Exposure During Pregnancy, Drug Interaction, Fatigue, Condition Aggravated, Status Epilepticus. 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 Oral 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 Oral 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. High percentage of serious adverse events (88.9%) indicates significant safety concerns.
Key safety signals identified in Levetiracetam Oral's adverse event data include: Seizure events are the most common reaction, with various types reported.. High number of serious adverse events, particularly related to neurological and cardiovascular systems.. Multiple drug interactions and pregnancy-related warnings are present.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Levetiracetam can cause drug interactions and should be used with caution in combination with other medications. Warnings are also issued for its use during pregnancy. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Levetiracetam Oral.
Monitor for signs of seizures and other neurological symptoms, especially in patients with a history of such conditions. Be aware of potential drug interactions and inform your healthcare provider of all medications you are taking.
Levetiracetam Oral has 117,347 adverse event reports on file with the FDA. Seizure-related reactions are common, with multiple types of seizures reported. The volume of reports for Levetiracetam Oral reflects both the drug's usage level and the vigilance of the reporting community.
The FDA closely monitors Levetiracetam for safety, and patients should report any adverse events to their healthcare provider immediately. Regular monitoring is recommended for patients with pre-existing conditions. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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