FDA label
What is Lamictal used for?
Lamictal contains lamotrigine. The FDA-approved uses below are quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label for Lamictal lists 2 uses: Adjunctive Therapy; Monotherapy.
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Lamictal, tablet, film coated, extended release
Indications and Usage, quoted from the label by GlaxoSmithKline LLC (NDA022115). Cross-references to other label sections are left out.
Adjunctive Therapy
LAMICTAL XR is indicated as adjunctive therapy for primary generalized tonic-clonic (PGTC) seizures and partial-onset seizures with or without secondary generalization in patients aged 13 years and older.
Monotherapy
LAMICTAL XR is indicated for conversion to monotherapy in patients aged 13 years and older with partial-onset seizures who are receiving treatment with a single antiepileptic drug (AED).
Safety and effectiveness of LAMICTAL XR have not been established as initial monotherapy or for simultaneous conversion to monotherapy from 2 or more concomitant AEDs.
Limitation of Use
Safety and effectiveness of LAMICTAL XR for use in patients younger than 13 years have not been established.
Source: DailyMed label, set id 3e2c9a35-6a39-41d7-ad84-3c0bb8894b09, version 44, effective October 10, 2025. NDC 0173-0754, one of 6 listings for this product.
Lamictal, tablet
Indications and Usage, quoted from the label by GlaxoSmithKline LLC (NDA020241). Cross-references to other label sections are left out.
Epilepsy
Adjunctive Therapy
LAMICTAL is indicated as adjunctive therapy for the following seizure types in patients aged 2 years and older:
- partial-onset seizures.
- primary generalized tonic-clonic (PGTC) seizures.
- generalized seizures of Lennox-Gastaut syndrome.
Monotherapy
LAMICTAL is indicated for conversion to monotherapy in adults (aged 16 years and older) with partial-onset seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single antiepileptic drug (AED).
Safety and effectiveness of LAMICTAL have not been established as initial monotherapy; for conversion to monotherapy from AEDs other than carbamazepine, phenytoin, phenobarbital, primidone, or valproate; or for simultaneous conversion to monotherapy from 2 or more concomitant AEDs.
Bipolar Disorder
LAMICTAL is indicated for the maintenance treatment of bipolar I disorder to delay the time to occurrence of mood episodes (depression, mania, hypomania, mixed episodes) in patients treated for acute mood episodes with standard therapy.
Limitations of Use
Treatment of acute manic or mixed episodes is not recommended. Effectiveness of LAMICTAL in the acute treatment of mood episodes has not been established.
Source: DailyMed label, set id d7e3572d-56fe-4727-2bb4-013ccca22678, version 45, effective October 10, 2025. NDC 0173-0633, one of 4 listings for this product.
Questions
What is Lamictal used for?
The FDA label for Lamictal lists 2 uses: Adjunctive Therapy; Monotherapy.
What drug class is Lamictal?
FDA lists lamotrigine in the Anti-epileptic Agent and Mood Stabilizer established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.
More on Lamictal
- Is Lamictal a controlled substance?Federal schedule
- Generic for LamictalFDA Orange Book
- What is Lamotrigine used for?FDA label uses
- Is Lamotrigine a controlled substance?Federal schedule
- Generic for LamliqueFDA Orange Book
- Generic for SubveniteFDA Orange Book
- Generic for Lamictal XRFDA Orange Book
- Generic for Lamictal CDFDA Orange Book
- Generic for Lamictal ODTFDA Orange Book
- Anti-epileptic Agents listFDA drug class
- Mood Stabilizers listFDA drug class
- NDC 0173-0526Lamictal NDC record
- NDC 0173-0527Lamictal NDC record
- NDC 0173-0633Lamictal NDC record