85/100 · Critical
Manufactured by Actavis Pharma, Inc.
Levetiracetam Safety Profile: Severe Reactions Common, Warnings for Seizures and Fatigue
117,343 FDA adverse event reports analyzed
Last updated: 2026-05-12
LEVETIRACETAM IN SODIUM CHLORIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Actavis Pharma, Inc.. Based on analysis of 117,343 FDA adverse event reports, LEVETIRACETAM IN SODIUM CHLORIDE 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 IN SODIUM CHLORIDE 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 IN SODIUM CHLORIDE.
Levetiracetam In Sodium Chloride 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 117,343 adverse event reports for this medication, which is primarily manufactured by Actavis Pharma, Inc..
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. Severe reactions such as death, status epilepticus, and pneumonia are common, indicating significant safety concerns.
Seizures and fatigue are frequently reported, highlighting the need for careful monitoring in patients. The drug is often ineffective for unapproved indications, suggesting potential misuse. Serious adverse events account for 88.9% of all reports, indicating a high risk profile. Multiple drug interactions and warnings are present, necessitating caution in concurrent medication use.
Patients taking Levetiracetam In Sodium Chloride should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Levetiracetam can interact with various drugs, and patients should be monitored for potential side effects such as seizures and fatigue. Warnings are issued for its use in unapproved indications. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Levetiracetam In Sodium Chloride received a safety concern score of 85/100 (high concern). This is based on a 88.9% serious event ratio across 73,468 classified reports. The score accounts for 117,343 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: 28,550, 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 73,468 classified reports for LEVETIRACETAM IN SODIUM CHLORIDE:
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 various drugs, and patients should be monitored for potential side effects such as seizures and fatigue. Warnings are issued for its use in unapproved indications.
If you are taking Levetiracetam In Sodium Chloride, 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 patients for signs of severe reactions such as seizures, pneumonia, and status epilepticus. Be cautious when using levetiracetam for unapproved indications, as it may be ineffective. Report any adverse events to your healthcare provider promptly. 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 frequent updates to the drug's labeling to address emerging safety concerns. Patients should report any adverse events to their healthcare provider immediately.
The FDA has received approximately 117,343 adverse event reports associated with Levetiracetam In Sodium Chloride. 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 In Sodium Chloride 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 (6,065 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 In Sodium Chloride.
Out of 73,468 classified reports, 65,334 (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 In Sodium Chloride break down by patient sex as follows: Female: 33,758, Male: 28,550, 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 In Sodium Chloride 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 In Sodium Chloride adverse event reports is Actavis Pharma, 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 In Sodium Chloride 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 In Sodium Chloride 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 In Sodium Chloride 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. Severe reactions such as death, status epilepticus, and pneumonia are common, indicating significant safety concerns.
Key safety signals identified in Levetiracetam In Sodium Chloride's adverse event data include: Status epilepticus and pneumonia are among the most serious reactions reported.. Seizures and fatigue are frequently reported, indicating potential side effects.. Death and multiple drug interactions are key safety signals.. The drug is often ineffective for unapproved indications, suggesting potential misuse.. Severe reactions such as thrombocytopenia and rhabdomyolysis are also reported.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Levetiracetam can interact with various drugs, and patients should be monitored for potential side effects such as seizures and fatigue. Warnings are issued for its use in unapproved indications. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Levetiracetam In Sodium Chloride.
Monitor patients for signs of severe reactions such as seizures, pneumonia, and status epilepticus. Be cautious when using levetiracetam for unapproved indications, as it may be ineffective. Report any adverse events to your healthcare provider promptly.
Levetiracetam In Sodium Chloride has 117,343 adverse event reports on file with the FDA. Seizures and fatigue are frequently reported, highlighting the need for careful monitoring in patients. The volume of reports for Levetiracetam In Sodium Chloride reflects both the drug's usage level and the vigilance of the reporting community.
Regulatory oversight is ongoing, with frequent updates to the drug's labeling to address emerging safety concerns. Patients should report any adverse events to their healthcare provider immediately. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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