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Medication Guide — Lamotrigine

Patient-friendly FDA guidance and safety information.

Last updated · May 13, 2026Source: DailyMed ↗
Boxed Warning

LAMICTAL XR can cause serious rashes requiring hospitalization and discontinuation of treatment. The incidence of these rashes, which have included Stevens-Johnson syndrome, is approximately 0.8% (8 per 1,000) in pediatric patients (aged 2 to 16 years) receiving immediate-release lamotrigine as adjunctive therapy for epilepsy and 0.3% (3 per 1,000) in adults on adjunctive therapy for epilepsy. In a prospectively followed cohort of 1,983 pediatric patients (aged 2 to 16 years) with epilepsy taking adjunctive immediate release lamotrigine, there was 1 rash-related death. LAMICTAL XR is not approved for patients younger than 13 years. In worldwide postmarketing experience, rare cases of toxic epidermal necrolysis and/or rash-related death have been reported in adult and pediatric patients, but their numbers are too few to permit a precise estimate of the rate.

The risk of serious rash caused by treatment with LAMICTAL XR is not expected to differ from that with immediate-release lamotrigine. However, the relatively limited treatment experience with LAMICTAL XR makes it difficult to characterize the frequency and risk of serious rashes caused by treatment with LAMICTAL XR.

In addition to age, factors that may increase the risk of occurrence or the severity of rash caused by LAMICTAL XR include (1) coadministration of LAMICTAL XR with valproate (includes valproic acid and divalproex sodium), (2) exceeding the recommended initial dose of LAMICTAL XR, (3) exceeding the recommended dose escalation for LAMICTAL XR., or (4) the presence of the HLA-B*1502 allele. However, cases have occurred in the absence of these factors.

Nearly all cases of life-threatening rashes caused by immediate-release lamotrigine have occurred within 2 to 8 weeks of treatment initiation. However, isolated cases have occurred after prolonged treatment (e.g., 6 months). Accordingly, duration of therapy cannot be relied upon as means to predict the potential risk heralded by the first appearance of a rash.

Although benign rashes are also caused by LAMICTAL XR, it is not possible to predict reliably which rashes will prove to be serious or life threatening. Accordingly, LAMICTAL XR should ordinarily be discontinued at the first sign of rash, unless the rash is clearly not drug related. Discontinuation of treatment may not prevent a rash from becoming life threatening or permanently disabling or disfiguring .

WARNING: SERIOUS SKIN RASHES

See full prescribing information for complete boxed warning.

  • Cases of life-threatening serious rashes, including Stevens-Johnson syndrome and toxic epidermal necrolysis, and/or rash-related death have been caused by lamotrigine. The rate of serious rash is greater in pediatric patients than in adults. Additional factors that may increase the risk of rash include:
    • coadministration with valproate.
    • exceeding recommended initial dose of LAMICTAL XR.
    • exceeding recommended dose escalation for LAMICTAL XR.
    • presence of the HLA-B*1502 allele.
  • Benign rashes are also caused by lamotrigine; however, it is not possible to predict which rashes will prove to be serious or life threatening. LAMICTAL XR should be discontinued at the first sign of rash, unless the rash is clearly not drug related.

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This Medication Guide has been approved by the U.S. Food and Drug Administration           Revised: October 2025

25 mg tab 50 mg tab 100 mg tab 200 mg tab 250 mg tab 300 mg tab

MEDICATION GUIDE

LAMICTAL (la-MIK-tal) XR (lamotrigine) extended-release tablets

What is the most important information I should know about LAMICTAL XR?

  1. 1. LAMICTAL XR may cause a serious skin rash that may cause you to be hospitalized or even cause death.
    There is no way to tell if a mild rash will become more serious. A serious skin rash can happen at any time during your treatment with LAMICTAL XR, but is more likely to happen within the first 2 to 8 weeks of treatment. Children aged between 2 and 16 years have a higher chance of getting this serious skin rash while taking LAMICTAL XR. LAMICTAL XR is not approved for use in children younger than 13 years.
    The risk of getting a serious skin rash is higher if you:
    1. •take LAMICTAL XR while taking valproate [DEPAKENE (valproic acid) or DEPAKOTE (divalproex sodium)].
    2. •take a higher starting dose of LAMICTAL XR than your healthcare provider prescribed.
    3. •increase your dose of LAMICTAL XR faster than prescribed.

      The risk of serious skin reactions may be associated with a variant in genes called HLA‑B*1502 in people from Asian origin (mainly of Han Chinese and Thai origin). See “Before taking LAMICTAL XR, tell your healthcare provider about all of your health conditions”.

      Call your healthcare provider right away if you have any of the following:

LAMICTAL XR (lamotrigine) extended-release tablets

25 mg, yellow

with white center

Imprinted with

LAMICTAL

XR 25

50 mg, green

with white center

Imprinted with

LAMICTAL

XR 50

100 mg, orange

with white center

Imprinted with

LAMICTAL

XR 100

200 mg, blue

with white center

Imprinted with

LAMICTAL

XR 200

250 mg, purple

with white center

Imprinted with

LAMICTAL

XR 250

300 mg, gray

with white center

Imprinted with

LAMICTAL

XR 300

What is LAMICTAL XR?

  • •LAMICTAL XR is a prescription medicine used:
    • otogether with other medicines to treat primary generalized tonic-clonic seizures and partial-onset seizures in people aged 13 years and older.
    • oalone when changing from 1 other medicine used to treat partial-onset seizures in people aged 13 years and older.
  • •It is not known if LAMICTAL XR is safe or effective in children younger than 13 years. Other forms of LAMICTAL can be used in children aged 2 to 12 years.
  • •It is not known if LAMICTAL XR is safe or effective when used alone as the first treatment of seizures.

Do not take LAMICTAL XR:

  • •if you have had an allergic reaction to lamotrigine or to any of the inactive ingredients in LAMICTAL XR. See the end of this leaflet for a complete list of ingredients in LAMICTAL XR.

Before taking LAMICTAL XR, tell your healthcare provider about all of your health conditions, including if you:

  • •have had a rash or allergic reaction to another antiseizure medicine.
  • •are of Asian origin. have had HLA testing before, and know you are carrying the genetic variant, HLA‑B*1502.
  • •have or have had depression, mood problems, or suicidal thoughts or behavior.
  • •have a history of heart problems or irregular heart beats or any of your family members have any heart problem, including genetic abnormalities.
  • •have had aseptic meningitis after taking LAMICTAL (lamotrigine) or LAMICTAL XR.
  • •are taking estrogen-containing products, including oral contraceptives (birth control pills) or other female hormonal medicines (such as hormone replacement therapy). Do not start or stop taking birth control pills or other female hormonal medicine until you have talked with your healthcare provider. Tell your healthcare provider if you have any changes in your menstrual pattern such as breakthrough bleeding. Stopping these medicines while you are taking LAMICTAL XR may cause side effects (such as dizziness, lack of coordination, or double vision). Starting these medicines may lessen how well LAMICTAL XR works.
  • •are pregnant or plan to become pregnant. It is not known if LAMICTAL XR may harm your unborn baby. If you become pregnant while taking LAMICTAL XR, talk to your healthcare provider about registering with the North American Antiepileptic Drug Pregnancy Registry. You can enroll in this registry by calling 1-888-233-2334. The purpose of this registry is to collect information about the safety of AEDs during pregnancy.
  • •are breastfeeding. LAMICTAL XR passes into breast milk and may cause side effects in a breastfed baby. If you breastfeed while taking LAMICTAL XR, watch your baby closely for trouble breathing, episodes of temporarily stopping breathing, sleepiness, or poor sucking. Call your baby’s healthcare provider right away if you see any of these problems. Talk to your healthcare provider about the best way to feed your baby if you take LAMICTAL XR.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. LAMICTAL XR and certain other medicines may interact with each other. This may cause serious side effects.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

How should I take LAMICTAL XR?

  • •Take LAMICTAL XR exactly as prescribed.
  • •Your healthcare provider may change your dose. Do not change your dose without talking to your healthcare provider.
  • •Do not stop taking LAMICTAL XR without talking to your healthcare provider. Stopping LAMICTAL XR suddenly may cause serious problems. For example, if you have epilepsy and you stop taking LAMICTAL XR suddenly, you may have seizures that do not stop. Talk with your healthcare provider about how to stop LAMICTAL XR slowly.
  • •If you miss a dose of LAMICTAL XR, take it as soon as you remember. If it is almost time for your next dose, just skip the missed dose. Take the next dose at your regular time. Do not take 2 doses at the same time.
  • •If you take too much LAMICTAL XR, call your healthcare provider or your local Poison Control Center or go to the nearest hospital emergency room right away.
  • •You may not feel the full effect of LAMICTAL XR for several weeks.
  • •If you have epilepsy, tell your healthcare provider if your seizures get worse or if you have any new types of seizures.
  • •LAMICTAL XR can be taken with or without food.
  • •Do not chew, crush, or divide LAMICTAL XR.
  • •Swallow LAMICTAL XR tablets whole.
  • •If you have trouble swallowing LAMICTAL XR tablets, tell your healthcare provider because there may be another form of LAMICTAL you can take.
  • •If you receive LAMICTAL XR in a blister pack, examine the blister pack before use. Do not use if blisters are torn, broken, or missing.

What should I avoid while taking LAMICTAL XR?

Do not drive, operate machinery, or do other dangerous activities until you know how LAMICTAL XR affects you.

What are the possible side effects of LAMICTAL XR?

LAMICTAL XR can cause serious side effects.

See “What is the most important information I should know about LAMICTAL XR?”

Common side effects of LAMICTAL XR include:

  • •dizziness
  • •tremor
  • •double vision
  • •nausea
  • •vomiting
  • •trouble with balance and coordination
  • •anxiety

Other common side effects that have been reported with another form of LAMICTAL include headache, sleepiness, blurred vision, runny nose, and rash.

These are not all the possible side effects of LAMICTAL XR.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store LAMICTAL XR?

  • •Store LAMICTAL XR at room temperature between 59°F and 86°F (15°C and 30°C).

Keep LAMICTAL XR and all medicines out of the reach of children.

General information about the safe and effective use of LAMICTAL XR

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use LAMICTAL XR for a condition for which it was not prescribed. Do not give LAMICTAL XR to other people, even if they have the same symptoms that you have. It may harm them.

If you take a urine drug screening test, LAMICTAL XR may make the test result positive for another drug. If you require a urine drug screening test, tell the healthcare professional administering the test that you are taking LAMICTAL XR.

You can ask your healthcare provider or pharmacist for information about LAMICTAL XR that is written for health professionals.

What are the ingredients in LAMICTAL XR?

Active ingredient: lamotrigine.

Inactive ingredients: glycerol monostearate, hypromellose, lactose monohydrate, magnesium stearate, methacrylic acid copolymer dispersion, polyethylene glycol 400, polysorbate 80, silicon dioxide (25- and 50-mg tablets only), titanium dioxide, triethyl citrate, carmine (250-mg tablet only), iron oxide black (50-, 250-, and 300-mg tablets only), iron oxide yellow (25-, 50-, and 100-mg tablets only), iron oxide red (100-mg tablet only), FD&C Blue No. 2 Aluminum Lake (200- and 250-mg tablets only). Tablets are printed with edible black ink.

For more information about LAMICTAL XR, call 1-888-825-5249.

LAMICTAL XR is a trademark owned by or licensed to the GSK group of companies. The other brands listed are trademarks owned by or licensed to their respective owners and are not owned by or licensed to the GSK group of companies. The makers of these brands are not affiliated with and do not endorse the GSK group of companies or its products.

Distributed by GlaxoSmithKline, Durham, NC 27701

©2025 GSK group of companies or its licensor.

LXR:22MG

Sources

RxCUI: 850087

NDC: 65162-949

Last fetched: May 13, 2026

Source: DailyMed ↗

⚠️ Disclaimer

This information is for educational purposes only and is not medical advice. Always consult your doctor, pharmacist, or other licensed healthcare professional before starting, stopping, or changing any medicine. Read full medical disclaimer.