May 28, 2017
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"The U.S. Food and Drug Administration today approved Aptiom (eslicarbazepine acetate) as an add-on medication to treat seizures associated with epilepsy.

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Sabril Patient Information Including Side Effects

Brand Names: Sabril

Generic Name: vigabatrin (Pronunciation: vye GA ba trin)

What is vigabatrin (Sabril)?

Vigabatrin is an anti-epileptic medication, also called an anticonvulsant.

Vigabatrin is used in combination with other medications to treat complex partial seizures in adults and adolescents who are at least 16 years old. Vigabatrin is usually given after other anti-epileptic medications have been tried without successful control of seizures.

The powder form of vigabatrin is used to treat infantile spasms in babies and children between the ages of 1 month and 2 years.

Vigabatrin may also be used for purposes not listed in this medication guide.

What are the possible side effects of vigabatrin (Sabril)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • any change in your vision, no matter how mild;
  • back and forth eye movements you cannot control;
  • tremors;
  • pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;
  • worsening seizures; or
  • confusion, mood or behavior changes, depression, thoughts about suicide or hurting yourself.

Less serious side effects may include:

  • headache, feeling irritable;
  • dizziness, drowsiness, tired feeling;
  • memory problems;
  • weight gain, swelling anywhere in your body;
  • numbness, burning pain, or tingly feeling in your hands or feet;
  • loss of coordination;
  • joint pain;
  • cold symptoms such as stuffy nose, fever, sneezing, sore throat;
  • nausea, vomiting, diarrhea; or
  • sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the Sabril (vigabatrin oral solution) Side Effects Center for a complete guide to possible side effects

What is the most important information I should know about vigabatrin (Sabril)?

Before you take vigabatrin, tell your doctor if you have any vision problems, such as retinitis or glaucoma. Some people taking vigabatrin have developed mild to severe vision problems. Vision loss caused by vigabatrin may be permanent, and you must have eye exams on a regular basis while taking this medication.

To be sure vigabatrin is not causing harmful effects on your vision, you will need a thorough eye exam when you start taking the medication and then every 3 months during treatment. If you ever stop taking vigabatrin, you may still need to have eye exams every 3 to 6 months after your treatment ends. Do not miss any follow-up visits to your doctor.

Tell your doctor about all other medications you use.

You may have thoughts about suicide while taking vigabatrin. Your doctor will need to check your progress at regular visits. Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, depression, or thoughts about suicide or hurting yourself.

Vigabatrin is available only under a special program called SHARE. You must be registered in the program and sign documents stating that you understand the risks and benefits of taking this medication and that you agree to have vision exams on a regular basis while you are taking vigabatrin.

Side Effects Centers

Report Problems to the Food and Drug Administration


You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


Find tips and treatments to control seizures.