Lamotrigine: Side Effects, Uses & Monitoring
1.1 Epilepsy Adjunctive Therapy: Lamotrigine tablets are indicated as adjunctive therapy for the following seizure types in patients ≥ 2 years of age: partial seizures primary generalized tonic-clonic seizures generalize
- Data source
- FDA labeling via NIH DailyMed (label b71ea970…)
- Label version
- current
- Last reviewed
- 2026
Reported adverse reactions
Reactions listed in current FDA labeling, with the highest frequency reported across summarized placebo-controlled trials.
| Adverse reaction (as reported in labeling) | Reported frequency* |
|---|---|
| Dizziness | 38% |
| Headache | 29% |
| Diplopia | 28% |
| Ataxia | 22% |
| Nausea | 19% |
| Blurred vision | 16% |
| Somnolence | 14% |
| Rhinitis | 14% |
| Accidental injury | 14% |
| Pharyngitis | 10% |
| Rash | 10% |
| Vomiting | 9% |
| Cough increased | 8% |
| Asthenia | 8% |
| Back pain | 8% |
| Fatigue | 8% |
| Flu syndrome | 7% |
| Dysmenorrhea | 7% |
| Coordination abnormality | 7% |
| Bronchitis | 7% |
*Highest percentage reported for the active moiety across placebo-controlled trial tables in current FDA labeling. Values reflect trial reporting, not your individual risk.
Labeled uses (from FDA prescribing information)
1.1 Epilepsy Adjunctive Therapy: Lamotrigine tablets are indicated as adjunctive therapy for the following seizure types in patients ≥ 2 years of age: partial seizures primary generalized tonic-clonic seizures generalized seizures of Lennox-Gastaut syndrome Monotherapy: Lamotrigine tablets are indicated for conversion to monotherapy in adults (≥16 years of age) with partial seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single antiepileptic drug (AED). Safety and effectiveness of lamotrigine tablets have not been established (1) as initial monotherapy; (2) for conversion to monotherapy from AEDs other than carbamazepine, phenytoin, phenobarbital, primidone, or valproate; or (3) for simultaneous conversion to monotherapy from 2 or more concomitant AEDs. 1.2 Bipolar Disorder Lamotrigine tablets are indicated for the maintenance treatment of Bipolar I Disorder to delay the time to occurrence of mood episodes (depression, mania, hypomania, mixed episodes) in adults (≥18 years of age) treated for acute mood episodes with standard therapy. The effectiveness of lamotrigine tablets in the acute treatment of mood episodes ha…
Conditions associated with Lamotrigine in labeling
Bipolar Disorder
A mood disorder characterized by alternating periods of mania/hypomania and depression....
Depression
A common but serious mood disorder causing persistent sadness, loss of interest, and changes in sleep, appetit...
Epilepsy
A neurological disorder characterized by recurrent, unprovoked seizures. Management focuses on seizure control...
Lennox-Gastaut syndrome
Lennox-Gastaut syndrome is a medical condition that may be associated with various symptoms and signs....
Frequently Asked Questions
What is Lamotrigine used for?
FDA labeling lists the approved uses shown above under "Labeled uses." This summary is informational; only a qualified prescriber can determine whether a medication is appropriate for you.
What are the most commonly reported side effects of Lamotrigine?
The table above shows adverse reactions and the highest frequencies reported in placebo-controlled trials summarized in current FDA labeling for Lamotrigine. Individual risk varies.
Does Lamotrigine require lab monitoring?
Monitoring needs vary. Ask your healthcare provider whether any lab tests apply while taking Lamotrigine.
Where does this information come from?
All clinical facts on this page were extracted from the current FDA-registered product labeling for this ingredient, published by manufacturers through NIH DailyMed. See the source link below.
Medical disclaimer: Educational content extracted from public FDA labeling. Not medical advice. Always consult a qualified healthcare professional before starting, stopping, or changing any medication.