Home

Attention TOPAMAX® Patients and Medical Professionals
Dispensing errors have been reported between TOPAMAX® (topiramate) tablets and TOPROL-XL® (metoprolol succinate) extended-release tablets.

Please be sure to check your tablets to ensure you are taking the right medicine.

*TOPROL-XL is a registered trademark of the AstraZeneca group of companies.

TOPAMAX® is a prescription medication used:
  • To prevent migraine headaches in adults and adolescents 12 years of age and older. TOPAMAX® is not used to stop a migraine after its starts.


IMPORTANT SAFETY INFORMATION

Warnings and Precautions



TOPAMAX® may cause eye problems. Serious eye problems include: sudden decrease in vision with or without eye pain and redness; blockage of fluid in the eye causing increased pressure in the eye (secondary angle closure glaucoma). These eye problems can lead to permanent loss of vision if not treated. You should call your healthcare professional right away if you have any new eye symptoms.

TOPAMAX® may cause decreased sweating and increased body temperature (fever). People, especially children, should be watched for signs of decreased sweating and fever, especially in hot temperatures. Some people may need to be hospitalized for this condition. Call your healthcare provider right away if you have a high fever, a fever that does not go away, or decreased sweating.

TOPAMAX® can increase the level of acid in your blood (metabolic acidosis). If left untreated, metabolic acidosis can cause brittle or soft bones (osteoporosis, osteomalacia, osteopenia), kidney stones, can slow the rate of growth in children, and may possibly harm your baby if you are pregnant. Metabolic acidosis can happen with or without symptoms. Sometimes people with metabolic acidosis will: feel tired, not feel hungry (loss of appetite), feel changes in heartbeat, or have trouble thinking clearly. Your healthcare provider should do a blood test to measure the level of acid in your blood before and during your treatment with TOPAMAX®. If you are pregnant, you should talk to your healthcare provider about whether you have metabolic acidosis.

Like other antiepileptic drugs, TOPAMAX® may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Pay attention to any changes and call your doctor right away if you have any of these symptoms, especially if they are new, worse, or worry you: thoughts about suicide or dying, attempts 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), or other unusual changes in behavior or mood. Do not stop taking TOPAMAX® without first talking to your doctor. Stopping TOPAMAX® suddenly can cause serious problems.

TOPAMAX® can harm your unborn baby. If you take TOPAMAX® during pregnancy, your baby has a higher risk for birth defects called cleft lip and cleft palate. These defects can begin early in pregnancy, even before you know you are pregnant. There may be other medicines to treat your condition that have a lower chance of birth defects. All women of childbearing age should talk to their healthcare providers about using other possible treatments instead of TOPAMAX®. If the decision is made to use TOPAMAX®, you should use effective birth control (contraception) unless you are planning to become pregnant. Tell your healthcare provider right away if you become pregnant while taking TOPAMAX®. You and your healthcare provider should decide if you will continue to take TOPAMAX® while you are pregnant. Metabolic acidosis may have harmful effects on your baby. Talk to your healthcare provider if TOPAMAX® has caused metabolic acidosis during your pregnancy. If you become pregnant while taking TOPAMAX®, 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.

TOPAMAX® may cause high blood ammonia levels. High ammonia in the blood can affect your mental activities, slow your alertness, make you feel tired, or cause vomiting. Call your Doctor if you develop unexplained tiredness, vomiting or changes in your mental status.

Taking TOPAMAX® when you are also taking valproic acid can cause a drop in body temperature (hypothermia) to less than 95ºF, feeling tired, confusion, or coma.

TOPAMAX® may affect how you think, and cause confusion, problems with concentration, attention, memory, or speech, depression or mood problems, tiredness, and sleepiness.

Topamax® may cause dizziness or loss of muscle coordination.

Do not drink alcohol while taking TOPAMAX®. Using TOPAMAX® and alcohol can affect each other causing side effects such as sleepiness and dizziness.

Do not drive a car or operate heavy machinery until you know how TOPAMAX® affects you. TOPAMAX® can slow your thinking and motor skills and may affect vision.

Adverse Reactions

The most common side effects of TOPAMAX® include: tingling in arms and legs, loss of appetite, nausea, taste change, diarrhea, weight loss, nervousness, upper respiratory tract infection, speech problems, tiredness, dizziness, sleepiness/drowsiness, slow reactions, difficulty with memory, pain in abdomen, fever, abnormal vision.

Tell your doctor about other medications that you are taking or any side effect that bothers you or that does not go away.

These are not all the possible side effects of TOPAMAX®. For more information, ask your healthcare professional or pharmacist.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please see full US Prescribing Information and Medication Guide

Attention TOPAMAX® Patients and Medical Professionals

Dispensing errors have been reported between TOPAMAX® (topiramate) tablets and TOPROL-XL® (metoprolol succinate) extended-release tablets. Please be sure to check your tablets to ensure you are taking the right medicine.

*TOPROL-XL is a registered trademark of the AstraZeneca group of companies.

March 4, 2011 - FDA Drug Safety Communication: TOPAMAX® (topiramate) use during pregnancy can cause fetal harm, including an increased risk for cleft lip and/or cleft palate. For information from the company click here. The FDA announcement can be found at www.fda.gov.
TOPAMAX