85/100 · Critical
Manufactured by Actavis Pharma, Inc.
High Safety Concerns with Lamotrigine, Particularly Seizures and Suicidal Ideation
130,106 FDA adverse event reports analyzed
Last updated: 2026-05-12
LAMOTIRIGINE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Actavis Pharma, Inc.. Based on analysis of 130,106 FDA adverse event reports, LAMOTIRIGINE 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 LAMOTIRIGINE include DRUG INEFFECTIVE, SEIZURE, TOXICITY TO VARIOUS AGENTS, OFF LABEL USE, DRUG INTERACTION. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for LAMOTIRIGINE.
Lamotirigine 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 130,106 adverse event reports for this medication, which is primarily manufactured by Actavis Pharma, Inc..
The most commonly reported adverse events include Drug Ineffective, Seizure, Toxicity To Various Agents. Of classified reports, 81.1% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Seizures and suicidal ideation are the most common serious adverse events.
Drug interactions and intentional overdose are also significant concerns. Falls and confusion are frequent, indicating potential cognitive effects.
Patients taking Lamotirigine should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Lamotrigine can cause drug interactions and should be used with caution in combination with other medications. Intentional overdose is a serious concern. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Lamotirigine received a safety concern score of 85/100 (high concern). This is based on a 81.1% serious event ratio across 68,341 classified reports. The score accounts for 130,106 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: 38,396, Male: 19,660, Unknown: 286. The most frequently reported age groups are age 43 (906 reports), age 32 (862 reports), age 35 (828 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 68,341 classified reports for LAMOTIRIGINE:
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.
Lamotrigine can cause drug interactions and should be used with caution in combination with other medications. Intentional overdose is a serious concern.
If you are taking Lamotirigine, here are important things to know. The most commonly reported side effects include drug ineffective, seizure, toxicity to various agents, off label use, drug interaction. 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 suicidal ideation and behavior, especially in the first few months of treatment. Be aware of potential drug interactions and adjust dosing accordingly. 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 continues to monitor the safety of Lamotrigine and has not issued any new warnings based on this data.
The FDA has received approximately 130,106 adverse event reports associated with Lamotirigine. 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 Lamotirigine include Drug Ineffective, Seizure, Toxicity To Various Agents, Off Label Use, Drug Interaction. By volume, the top reported reactions are: Drug Ineffective (5,956 reports), Seizure (4,094 reports), Toxicity To Various Agents (3,762 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Lamotirigine.
Out of 68,341 classified reports, 55,409 (81.1%) were classified as serious and 12,932 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 Lamotirigine break down by patient sex as follows: Female: 38,396, Male: 19,660, Unknown: 286. 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 Lamotirigine adverse events are: age 43: 906 reports, age 32: 862 reports, age 35: 828 reports, age 25: 820 reports, age 50: 818 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 Lamotirigine 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 Lamotirigine include: Completed Suicide, Fatigue, Dizziness, Nausea, Rash. 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 Lamotirigine 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.
Lamotirigine 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. Seizures and suicidal ideation are the most common serious adverse events.
Key safety signals identified in Lamotirigine's adverse event data include: Seizures and epilepsy are common, with 1783 reports.. Suicidal ideation and suicide attempts are reported in 1446 and 1356 cases respectively.. Drug interactions and intentional overdose are significant, with 3098 and 1744 reports respectively.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Lamotrigine can cause drug interactions and should be used with caution in combination with other medications. Intentional overdose is a serious concern. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Lamotirigine.
Monitor patients for signs of suicidal ideation and behavior, especially in the first few months of treatment. Be aware of potential drug interactions and adjust dosing accordingly.
Lamotirigine has 130,106 adverse event reports on file with the FDA. Drug interactions and intentional overdose are also significant concerns. The volume of reports for Lamotirigine reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety of Lamotrigine and has not issued any new warnings based on this data. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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