Side Effect Information

Important Safety Information about LAMICTAL and LAMICTAL ODT

Prescription LAMICTAL Tablets are not for everyone. LAMICTAL ODT is another form of LAMICTAL.


LAMICTAL may cause a serious skin rash that may cause you to be hospitalized or to stop LAMICTAL; it may rarely cause death. There is no way to tell if a mild rash will develop into a more serious reaction. These serious skin reactions are more likely to happen when you begin taking LAMICTAL, within the first 2-8 weeks of treatment. But it can happen in people who have taken LAMICTAL for any period of time. Children between 2 to 16 years of age have a higher chance of getting
this serious skin reaction while taking LAMICTAL.

The risk of getting a rash is higher if taking LAMICTAL while taking valproate [Depakene* (valproic acid) or Depakote* (divalproex sodium)], taking a higher starting dose of LAMICTAL than a healthcare provider prescribed or increasing the dose of LAMICTAL faster than prescribed.

LAMICTAL can also cause other types of allergic reactions or serious problems which may affect organs and other parts of your body like the liver or blood cells. You may or may not have a rash with these types of reactions.

Call your healthcare provider right away if you have any of the following: a skin rash, hives, fever, swollen lymph glands, painful sores in the mouth or around your eyes, swelling of your lips or tongue, yellowing of your skin or eyes, unusual bruising or bleeding, severe fatigue or weakness, severe muscle pain or frequent infections. These symptoms may be the first signs of a serious reaction. A healthcare provider should examine you to decide if you should continue taking LAMICTAL.

Like other antiepileptic drugs, LAMICTAL may cause suicidal thoughts or actions in a very small number of people, about 1 in 500.
Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:

• thoughts about suicide or dying
• attempt to commit suicide
• new or worse depression
• new or worse anxiety
• feeling agitated or restless
• panic attacks
• trouble sleeping (insomnia)
• new or worse irritability
• acting aggressive, being angry, or violent
• acting on dangerous impulses
• an extreme increase in activity and talking (mania)
• other unusual changes in behavior or mood

Do not stop LAMICTAL without first talking to a healthcare provider.

• Stopping LAMICTAL suddenly can cause serious problems.
• Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes.

How can I watch for early symptoms of suicidal thoughts and actions?

• Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings.
• Keep all follow-up visits with your healthcare provider as scheduled.
• Call your healthcare provider between visits as needed, especially if you are worried about symptoms.

You should not take LAMICTAL if you have had an allergic reaction to lamotrigine or to any of the inactive ingredients.

Common side effects include dizziness, headache, blurred or double vision, lack of coordination, sleepiness, nausea, vomiting, insomnia, tremor, rash, fever, abdominal pain, back pain, tiredness, and dry mouth. Tell your healthcare provider about any side effect that bothers you or does not go away. Also, tell your healthcare provider if you have any changes in your menstrual pattern, such as breakthrough bleeding, while taking LAMICTAL and birth control pills. These are not all the possible side effects of LAMICTAL.

Before taking LAMICTAL or LAMICTAL ODT, tell your healthcare provider about all of your medical conditions, including if you:

• have had a rash or allergic reaction to another antiseizure medicine.
• have or have had depression, mood problems, or suicidal thoughts or behavior.
• are taking oral contraceptives (birth control pills) or other female hormonal medicines. 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 or starting these medicines may cause side effects (such as dizziness, lack of coordination, or double vision) or lessen how well LAMICTAL and LAMICTAL ODT work.
• are pregnant or plan to become pregnant. It is not known if LAMICTAL or LAMICTAL ODT will harm your unborn baby. If you become pregnant while taking LAMICTAL or LAMICTAL ODT, 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 antiepileptic drugs during pregnancy.
• are breastfeeding. LAMICTAL and LAMICTAL ODT can pass into your breast milk. You and your healthcare provider should decide if you should take LAMICTAL ODT or breastfeed. Breastfeeding while taking LAMICTAL ODT is not recommended.

Tell your healthcare provider about all the medicines you take or if you are planning to take a new medicine, including prescription and non-prescription medicines, vitamins, and herbal supplements. Using LAMICTAL or LAMICTAL ODT with certain other medicines can affect each other, causing side effects.

*Depakene and Depakote are registered trademarks of Abbott Laboratories