Side Effect Information

Most people who take LAMICTAL tolerate it well. Common side effects with LAMICTAL include dizziness, headache, blurred or double vision, lack of coordination, sleepiness, nausea, vomiting, insomnia, tremor, and rash. LAMICTAL may cause other side effects not listed here. If you develop any side effects or symptoms you are concerned about, or if you need more information, call your doctor.

Although most patients who develop a rash while receiving LAMICTAL have mild to moderate symptoms, some individuals may develop a serious skin reaction that requires hospitalization. It is not possible to predict whether a mild rash will develop into a more serious one. Rarely, deaths have been reported. These serious skin reactions are most likely to happen within the first 8 weeks of treatment with LAMICTAL. Serious skin reactions occur more often in children than in adults.

Rashes may be more likely to occur if you: take LAMICTAL in combination with valproate (brand names are Depakene® (valproic acid)* and Depakote® (divalproex sodium)*), take a higher starting dose of LAMICTAL than your doctor prescribed, or increase your dose of LAMICTAL faster than prescribed.

If you experience any of the following with or without a skin rash, tell your doctor immediately: hives, fever, swollen lymph glands, painful sores in the mouth or around the eyes, or swelling of lips or tongue. These symptoms may be the first signs of a serious reaction. A doctor should evaluate your condition and determine if you should continue taking LAMICTAL.

Serious blood problems or liver problems have been reported with LAMICTAL, so tell your doctor if you develop symptoms such as unusual bruising or bleeding, severe muscle pain, weakness, fatigue, yellowing of the eyes or skin, and/or frequent infections.

You should not take LAMICTAL if you had an allergic reaction to it in the past.

The effects of LAMICTAL during pregnancy are not known at this time. If you are pregnant or are planning to become pregnant, talk to your healthcare provider. Some LAMICTAL passes into breast milk and the effects of this on infants are unknown. Therefore, if you are breast-feeding, you should discuss this with your provider to determine if you should continue to take LAMICTAL.

If you are a woman, do not start or stop using birth control pills or other female hormonal products until you have consulted with your healthcare provider. Stopping or starting these products may cause side effects (such as dizziness, lack of coordination, or double vision) or decrease the effectiveness of LAMICTAL. Tell your provider right away if you experience side effects or changes in your menstrual pattern (such as break-through bleeding) while taking LAMICTAL and birth control pills or other female hormonal products.

If you are taking LAMICTAL to help prevent extreme mood swings, you may not experience the full effect for several weeks. Occasionally, the symptoms of depression or bipolar disorder may include thoughts of harming yourself or committing suicide. Talk with your healthcare provider immediately or go to the nearest hospital if you have any distressing thoughts or experiences during this initial period or at any other time. Also contact your healthcare provider if you experience any worsening of your condition or develop other new symptoms at any time during your treatment.

If you are thinking about suicide:

Call 911. Get help right away before you act on these thoughts.
Talk with your doctor.
Do not stay alone.
Call the National Hopeline Network at 1-800-SUICIDE (1-800-784-2433).
Please call your doctor or therapist for additional information.

LAMICTAL is indicated for the maintenance treatment of bipolar I disorder to delay the time to occurrence of mood episodes in people 18 years of age or older treated for acute mood episodes with standard therapy. The effectiveness of LAMICTAL in the acute treatment of mood episodes has not been established.

*Depakene (valproic acid) and Depakote (divalproex sodium) are registered trademarks of Abbott Laboratories.