82/100 · Critical
Manufactured by GlaxoSmithKline LLC
Lamotrigine Adverse Events: High Serious Reaction Rate
249,683 FDA adverse event reports analyzed
Last updated: 2026-05-12
LAMOTRIGINE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by GlaxoSmithKline LLC. Based on analysis of 249,683 FDA adverse event reports, LAMOTRIGINE has a safety score of 82 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 LAMOTRIGINE include DRUG INEFFECTIVE, RASH, SEIZURE, NAUSEA, FATIGUE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for LAMOTRIGINE.
Lamotrigine has a safety concern score of 82 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 249,683 adverse event reports for this medication, which is primarily manufactured by Glaxosmithkline Llc.
The most commonly reported adverse events include Drug Ineffective, Rash, Seizure. Of classified reports, 71.9% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Severe reactions such as rash, suicidal ideation, and Stevens-Johnson syndrome are common.
Seizures and convulsions are frequent, indicating potential efficacy issues. Psychiatric symptoms like depression and anxiety are notable.
Patients taking Lamotrigine should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Lamotrigine can interact with other drugs, potentially leading to toxicity or altered efficacy. Patients should avoid certain medications and inform healthcare providers of all current medications. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Lamotrigine received a safety concern score of 82/100 (high concern). This is based on a 71.9% serious event ratio across 127,171 classified reports. The score accounts for 249,683 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: 75,506, Male: 35,161, Unknown: 535. The most frequently reported age groups are age 40 (2,102 reports), age 43 (1,902 reports), age 50 (1,522 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 127,171 classified reports for LAMOTRIGINE:
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 interact with other drugs, potentially leading to toxicity or altered efficacy. Patients should avoid certain medications and inform healthcare providers of all current medications.
If you are taking Lamotrigine, here are important things to know. The most commonly reported side effects include drug ineffective, rash, seizure, nausea, fatigue. 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 severe rash, such as blistering or peeling skin, and seek immediate medical attention. Report any suicidal thoughts or behaviors to your healthcare provider immediately. 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 Lamotrigine for safety, particularly for severe rashes and suicidal ideation. Regular follow-ups are recommended for patients.
The FDA has received approximately 249,683 adverse event reports associated with Lamotrigine. 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 Lamotrigine include Drug Ineffective, Rash, Seizure, Nausea, Fatigue. By volume, the top reported reactions are: Drug Ineffective (9,925 reports), Rash (8,408 reports), Seizure (6,527 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Lamotrigine.
Out of 127,171 classified reports, 91,381 (71.9%) were classified as serious and 35,790 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 Lamotrigine break down by patient sex as follows: Female: 75,506, Male: 35,161, Unknown: 535. 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 Lamotrigine adverse events are: age 40: 2,102 reports, age 43: 1,902 reports, age 50: 1,522 reports, age 32: 1,503 reports, age 35: 1,486 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 Lamotrigine adverse event reports is Glaxosmithkline 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 Lamotrigine include: Off Label Use, Dizziness, Headache, Depression, Vomiting. 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 Lamotrigine 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.
Lamotrigine has a safety concern score of 82 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 rash, suicidal ideation, and Stevens-Johnson syndrome are common.
Key safety signals identified in Lamotrigine's adverse event data include: Severe rash, including Stevens-Johnson syndrome, is a key safety signal.. Suicidal ideation and attempts are reported, warranting close monitoring.. Seizure-related events are frequent, indicating potential drug ineffectiveness.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Lamotrigine can interact with other drugs, potentially leading to toxicity or altered efficacy. Patients should avoid certain medications and inform healthcare providers of all current medications. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Lamotrigine.
Monitor for signs of severe rash, such as blistering or peeling skin, and seek immediate medical attention. Report any suicidal thoughts or behaviors to your healthcare provider immediately.
Lamotrigine has 249,683 adverse event reports on file with the FDA. Seizures and convulsions are frequent, indicating potential efficacy issues. The volume of reports for Lamotrigine reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor Lamotrigine for safety, particularly for severe rashes and suicidal ideation. Regular follow-ups are recommended for patients. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
Explore other medications manufactured by GlaxoSmithKline LLC and compare their safety profiles:
The following drugs share commonly reported adverse reactions with LAMOTRIGINE:
Drugs related to LAMOTRIGINE based on therapeutic use, drug class, or shared indications: