Lamotrigine: Side Effects, Uses & Monitoring
Facts extracted from current FDA product labeling for Lamotrigine. Educational only — not medical advice.
Reported adverse reactions
| Reaction | Highest frequency reported* |
|---|---|
| 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 across placebo-controlled trial tables summarized in current labeling.
Labeled uses
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…
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