85/100 · Critical
Manufactured by Advagen Pharma Limited
Severe Reactions Common in Lamotrigine Extended-Release Adverse Events
130,110 FDA adverse event reports analyzed
Last updated: 2026-05-12
LAMOTRIGINE EXTENDED RELEASE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Advagen Pharma Limited. Based on analysis of 130,110 FDA adverse event reports, LAMOTRIGINE EXTENDED RELEASE 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 LAMOTRIGINE EXTENDED RELEASE 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 LAMOTRIGINE EXTENDED RELEASE.
Lamotrigine Extended-Release 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 130,110 adverse event reports for this medication, which is primarily manufactured by Advagen Pharma Limited.
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. Severe reactions such as suicidal ideation, intentional overdose, and death are frequently reported.
Seizures and epilepsy are common, indicating the drug's intended use but also highlighting potential risks. Skin reactions like Stevens-Johnson syndrome and toxic epidermal necrolysis are rare but serious.
Patients taking Lamotrigine Extended-Release should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Lamotrigine extended-release can interact with other drugs, potentially increasing the risk of toxicity. Warnings include avoiding certain drugs that can cause severe skin reactions. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Lamotrigine Extended-Release received a safety concern score of 85/100 (high concern). This is based on a 81.1% serious event ratio across 68,342 classified reports. The score accounts for 130,110 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: 19,661, 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 68,342 classified reports for LAMOTRIGINE EXTENDED RELEASE:
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 extended-release can interact with other drugs, potentially increasing the risk of toxicity. Warnings include avoiding certain drugs that can cause severe skin reactions.
If you are taking Lamotrigine Extended-Release, 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 for signs of suicidal ideation and behavior, especially in the first few months of treatment. Be cautious when combining Lamotrigine with other drugs that can cause severe skin reactions. 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 Lamotrigine extended-release due to its high serious event rate. Regular monitoring and dose adjustments are recommended.
The FDA has received approximately 130,110 adverse event reports associated with Lamotrigine Extended-Release. 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 Extended-Release 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 Lamotrigine Extended-Release.
Out of 68,342 classified reports, 55,410 (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 Lamotrigine Extended-Release break down by patient sex as follows: Female: 38,396, Male: 19,661, 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 Lamotrigine Extended-Release 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 Lamotrigine Extended-Release adverse event reports is Advagen Pharma Limited. 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 Extended-Release 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 Lamotrigine Extended-Release 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 Extended-Release 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 suicidal ideation, intentional overdose, and death are frequently reported.
Key safety signals identified in Lamotrigine Extended-Release's adverse event data include: Suicidal ideation and attempts. Seizures and epilepsy. Stevens-Johnson syndrome and toxic epidermal necrolysis. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Lamotrigine extended-release can interact with other drugs, potentially increasing the risk of toxicity. Warnings include avoiding certain drugs that can cause severe skin reactions. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Lamotrigine Extended-Release.
Monitor for signs of suicidal ideation and behavior, especially in the first few months of treatment. Be cautious when combining Lamotrigine with other drugs that can cause severe skin reactions.
Lamotrigine Extended-Release has 130,110 adverse event reports on file with the FDA. Seizures and epilepsy are common, indicating the drug's intended use but also highlighting potential risks. The volume of reports for Lamotrigine Extended-Release reflects both the drug's usage level and the vigilance of the reporting community.
The FDA closely monitors Lamotrigine extended-release due to its high serious event rate. Regular monitoring and dose adjustments are recommended. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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