75/100 · Elevated
Manufactured by UCB, Inc.
Seizure and Dizziness Are Common Adverse Events for Lacosamide
64,711 FDA adverse event reports analyzed
Last updated: 2026-05-12
LACOSAMIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by UCB, Inc.. Based on analysis of 64,711 FDA adverse event reports, LACOSAMIDE has a safety score of 75 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 LACOSAMIDE include SEIZURE, DRUG INEFFECTIVE, OFF LABEL USE, DIZZINESS, SOMNOLENCE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for LACOSAMIDE.
Lacosamide has a safety concern score of 75 out of 100, placing it in the elevated concern category based on analysis of FDA adverse event data. The FDA has received approximately 64,711 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, 78.9% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Seizure and dizziness are the most common adverse events reported for Lacosamide, with over 6,500 and 1,610 reports respectively.
Serious adverse events, including death and status epilepticus, account for 78.9% of all reports. Drug interactions and ineffective drug use are also significant concerns, with 956 and 3,936 reports respectively.
Patients taking Lacosamide should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Lacosamide can interact with other drugs, and its ineffectiveness for unapproved indications is a concern. Always consult a healthcare provider before combining medications. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Lacosamide received a safety concern score of 75/100 (elevated concern). This is based on a 78.9% serious event ratio across 35,340 classified reports. The score accounts for 64,711 total adverse event reports and 100 distinct reaction types. This elevated score indicates a notable proportion of serious adverse events and warrants careful monitoring.
Adverse event reports by sex: Female: 16,239, Male: 13,348, Unknown: 162. The most frequently reported age groups are age 26 (353 reports), age 63 (346 reports), age 29 (339 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 35,340 classified reports for LACOSAMIDE:
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.
Lacosamide can interact with other drugs, and its ineffectiveness for unapproved indications is a concern. Always consult a healthcare provider before combining medications.
If you are taking Lacosamide, here are important things to know. The most commonly reported side effects include seizure, drug ineffective, off label use, dizziness, somnolence. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Always follow the prescribed dosage and instructions for Lacosamide to avoid potential adverse events. Be aware of the risk of seizures and dizziness, and seek medical attention if these symptoms occur. 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 Lacosamide's safety profile, and any new or worsening symptoms should be reported to a healthcare provider immediately.
The FDA has received approximately 64,711 adverse event reports associated with Lacosamide. 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 Lacosamide include Seizure, Drug Ineffective, Off Label Use, Dizziness, Somnolence. By volume, the top reported reactions are: Seizure (6,507 reports), Drug Ineffective (3,936 reports), Off Label Use (3,757 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Lacosamide.
Out of 35,340 classified reports, 27,888 (78.9%) were classified as serious and 7,452 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 Lacosamide break down by patient sex as follows: Female: 16,239, Male: 13,348, Unknown: 162. 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 Lacosamide adverse events are: age 26: 353 reports, age 63: 346 reports, age 29: 339 reports, age 27: 337 reports, age 50: 333 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 Lacosamide 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 Lacosamide include: Fatigue, Epilepsy, Fall, Status Epilepticus, Overdose. 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 Lacosamide 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.
Lacosamide has a safety concern score of 75 out of 100 (elevated 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 dizziness are the most common adverse events reported for Lacosamide, with over 6,500 and 1,610 reports respectively.
Key safety signals identified in Lacosamide's adverse event data include: Seizure. Death. Drug Interaction. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Lacosamide can interact with other drugs, and its ineffectiveness for unapproved indications is a concern. Always consult a healthcare provider before combining medications. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Lacosamide.
Always follow the prescribed dosage and instructions for Lacosamide to avoid potential adverse events. Be aware of the risk of seizures and dizziness, and seek medical attention if these symptoms occur.
Lacosamide has 64,711 adverse event reports on file with the FDA. Serious adverse events, including death and status epilepticus, account for 78.9% of all reports. The volume of reports for Lacosamide reflects both the drug's usage level and the vigilance of the reporting community.
The FDA closely monitors Lacosamide's safety profile, and any new or worsening symptoms should be reported to a healthcare provider immediately. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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