Lamictal ODTlamotrigine
According to the FDA label: LAMICTAL is indicated for: Epilepsy—adjunctive therapy in patients aged 2 years and older: • partial-onset seizures. • primary generalized tonic-clonic (PGTC) seizures. • generalized seizures of Lennox-Gastaut syndrome. ( 1.1 ) Epilepsy—monotherapy in patients aged 16 years and older: Conversion to monotherapy in patients with partial-onset seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single antiepileptic drug.
127,939 adverse event reports submitted to the FDA (2002–2026)
Top Reported Adverse Events
The most frequently reported events in association with Lamictal ODT in the FAERS database. These are events reported by patients taking this medication, not necessarily caused by it. A single report may include multiple events.
Show these terms with plain-language definitions
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Drug Ineffective 9,951 reports
A report that the medication did not work as expected for the person taking it. This is a reporting category, not a sign the drug is defective. It simply means someone felt it was not helping their condition.
Full definition in the glossary →Rash 8,433 reports
An area of irritated, red, or bumpy skin.
Full definition in the glossary → See all drugs reporting this event →Seizure 6,513 reports
A sudden burst of electrical activity in the brain that can cause shaking, altered awareness, or other temporary changes.
Full definition in the glossary →Nausea 6,234 reports
The feeling of sickness in your stomach that often comes before vomiting.
Full definition in the glossary → See all drugs reporting this event →Fatigue 6,000 reports
Extreme tiredness or lack of energy that does not improve with rest.
Full definition in the glossary → See all drugs reporting this event →Off Label Use 5,981 reports
Using a medication for a condition or in a way that the FDA has not officially approved. This is common and often legal, and a report of it does not mean something went wrong. Doctors sometimes prescribe drugs off label based on their judgment.
Full definition in the glossary →Dizziness 5,825 reports
A feeling of being lightheaded, unsteady, or like the room is spinning.
Full definition in the glossary → See all drugs reporting this event →Headache 5,612 reports
Pain in the head or upper neck.
Full definition in the glossary → See all drugs reporting this event →Depression 5,046 reports
A persistent low mood, loss of interest, or feelings of sadness. If you are struggling, the 988 Suicide and Crisis Lifeline (call or text 988 in the US) is available 24 hours a day.
Full definition in the glossary → See all drugs reporting this event →Vomiting 4,623 reports
Throwing up the contents of the stomach.
Full definition in the glossary → See all drugs reporting this event →Pyrexia 4,395 reports
The medical term for fever, meaning a raised body temperature.
Full definition in the glossary → See all drugs reporting this event →Somnolence 4,393 reports
Drowsiness or strong sleepiness.
Full definition in the glossary → See all drugs reporting this event →Anxiety 4,356 reports
A feeling of worry, nervousness, or unease.
Full definition in the glossary → See all drugs reporting this event →Drug Interaction 4,354 reports
A report that two or more medications may have affected each other when taken together.
Full definition in the glossary →Toxicity to Various Agents 4,184 reports
A broad reporting category used when the body has a harmful response, sometimes involving more than one substance.
Full definition in the glossary →
Ranked by frequency of reports, not severity. The most-reported event is not necessarily the most dangerous or the most common in patients taking this drug.
Who Is Reporting
Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.
By Sex
View reporter sex data as a table
| Sex | Reports |
|---|---|
| Female | 75,784 |
| Male | 35,188 |
| Unknown | 529 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 9,974 |
| 18-34 | 21,201 |
| 35-49 | 21,267 |
| 50-64 | 18,116 |
| 65-74 | 6,592 |
| 75+ | 3,480 |
This shows who filed reports, reflecting who takes this drug and who tends to report, not who is at greatest risk.
Reported Outcomes
Outcomes recorded in FAERS reports that included Lamictal ODT. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.
View outcome data as a table
| Outcome | Reports |
|---|---|
| Other Serious | 62,987 |
| Hospitalization | 39,148 |
| Non-Serious | 35,745 |
| Death | 11,003 |
| Life-Threatening | 8,236 |
| Disability | 5,249 |
Serious outcomes are far more likely to be reported than mild ones, so this overstates how often outcomes are serious. A recorded death does not mean the drug caused it.
Report Volume Over Time
Number of FAERS reports received per quarter for Lamictal ODT. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior, not changes in the medication's safety profile.
View report trend as a table
| Year | Reports |
|---|---|
| 2002 | 1 |
| 2004 | 2,016 |
| 2005 | 3,052 |
| 2006 | 3,557 |
| 2007 | 3,882 |
| 2008 | 2,377 |
| 2009 | 4,889 |
| 2010 | 3,760 |
| 2011 | 4,930 |
| 2012 | 5,261 |
| 2013 | 4,636 |
| 2014 | 5,129 |
| 2015 | 7,175 |
| 2016 | 7,478 |
| 2017 | 7,207 |
| 2018 | 8,197 |
| 2019 | 8,579 |
| 2020 | 7,701 |
| 2021 | 7,242 |
| 2022 | 6,632 |
| 2023 | 6,987 |
| 2024 | 7,668 |
| 2025 | 7,827 |
| 2026 (partial) | 1,756 |
The steep increase around 2004 reflects the FDA's move to electronic submission, not a change in this drug's safety. Trends track reporting volume, not risk.
Medications commonly reported with Lamictal ODT
In FDA adverse event reports that mention Lamictal ODT, these medications appeared most often in the same report.
- Levetiracetam (15,024 reports)
- Quetiapine (12,796 reports)
- Clonazepam (11,955 reports)
- Topiramate (9,945 reports)
- Levetiracetam In (9,233 reports)
This reflects co-occurrence in submitted reports, not evidence of drug interaction or combined risk. People often report several medications taken for the same condition or for unrelated reasons. Talk to a doctor or pharmacist about your specific medications.
Related Drugs
Other medications with similar adverse event profiles in FDA FAERS reports.
Data Source
This data is sourced from the FDA's Adverse Event Monitoring System (AEMS), formerly FAERS, via the OpenFDA API. PillSignal is not affiliated with the FDA.
View this data on the FDA website →Data last updated: June 2026