Sabril (vigabatrin) is a brand-name drug that’s prescribed for certain types of seizures in adults and children. As with other drugs, Sabril can cause side effects, such as dizziness and tremor.

Sabril has a boxed warning. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). For details, see the “Side effect specifics” section.

Sabril can cause certain side effects, some of which are more common than others. These side effects may be temporary, lasting a few days to weeks. However, if the side effects last longer than that, bother you, or become severe, be sure to talk with your doctor or pharmacist.

These are just a few of the more common side effects reported by adults who took Sabril in clinical trials:

  • blurry vision
  • dizziness
  • tremor
  • changes in coordination
  • sleepiness and fatigue (see “Side effect specifics”)

Mild side effects can occur with Sabril use. This list doesn’t include all possible mild side effects of the drug. For more information, you can refer to Sabril’s prescribing information.

Mild side effects that have been reported with Sabril for complex partial seizures in adults include:

  • dizziness
  • tremor
  • blurry vision
  • headache
  • tiredness
  • nausea and vomiting
  • memory problems
  • changes in coordination
  • unexpected weight gain
  • sleepiness and fatigue (see “Side effect specifics”)

Mild side effects in children that have been reported with Sabril for complex partial seizures include:

Mild side effects in children that have been reported with Sabril for infantile spasms include:

These side effects may be temporary, lasting a few days to weeks. However, if the side effects last longer than that, bother you, or become severe, be sure to talk with your doctor or pharmacist.

Note: After the Food and Drug Administration (FDA) approves a drug, it tracks and reviews side effects of the medication. If you develop a side effect while taking Sabril and want to tell the FDA about it, visit MedWatch.

Sabril may cause serious side effects. The list below may not include all possible serious side effects of the drug. For more information, you can refer to Sabril’s prescribing information.

If you develop serious side effects while taking Sabril, call your doctor right away. If the side effects seem life threatening or you think you’re having a medical emergency, immediately call 911 or your local emergency number.

Serious side effects that have been reported and their symptoms include:

* For more information about this side effect, see “Side effect specifics” below.

ALLERGIC REACTION

For some people, Sabril can cause an allergic reaction.

But this side effect wasn’t reported in the drug’s studies.

In general, symptoms of allergic reaction can be mild or serious.

Ways to manage

For mild allergic reaction symptoms, such as a mild rash, call your doctor right away. They may recommend treatments to help manage your symptoms. They’ll also let you know whether you should keep taking the medication.

For severe allergic reaction symptoms, such as swelling or trouble breathing, call 911 or your local emergency number right away. These symptoms require immediate medical care because they can become life threatening. If you’ve had a serious allergic reaction to Sabril, your doctor may recommend taking a different medication instead.

Sabril may cause several side effects. Here are some frequently asked questions about the drug’s side effects and their answers.

Can Sabril (vigabatrin) cause withdrawal symptoms?

Yes. Similar to any other seizure medication, Sabril can cause withdrawal symptoms if you suddenly stop taking it. Withdrawal symptoms are caused by stopping a medication that your body is used to and needs for you to function as usual. The most common withdrawal symptom of stopping Sabril is an increase in seizures. Other symptoms of withdrawal may include:

  • insomnia (trouble sleeping)
  • anxiety
  • irritability or agitation
  • tremor
  • muscle weakness
  • mood changes

Do not stop taking Sabril without talking with your doctor first. If you and your doctor decide it’s safe for you to stop taking Sabril, they’ll likely suggest that you slowly decrease your dosage before stopping it completely.

How do side effects of Sabril in children compare with side effects seen in adults?

Many of the side effects in children are similar to those seen in adults. However, when used in children under 2 years of age for infantile spasms, side effects not seen in adults were commonly reported, such as bronchitis and ear infections. In children ages 3 to 16 years, unexpected weight gain was the most common side effect of treatment with Sabril.

Serious side effects, such as MRI changes in the brain, were reported in children but not seen in adults.

Talk with your child’s doctor if you have questions about the side effects your child may experience while taking Sabril.

Learn more about some of the side effects that Sabril may cause. To find out how often side effects occurred in clinical trials, see the prescribing information for Sabril.

Risk of permanent vision loss

Sabril has a boxed warning about the risk of permanent vision loss. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). A boxed warning alerts doctors and patients about drug effects that may be dangerous.

Vision changes were a common side effect reported in clinical trials of Sabril. Some people taking the drug may experience blurry vision or difficulty seeing things that aren’t directly in front of them (also known as tunnel vision). It can also cause a loss of vision. Vision loss can occur at any time while taking Sabril, including right after you start taking it or after months or years. Loss of vision is permanent and may still get worse, even after you stop taking Sabril. Symptoms of vision loss may include:

  • double vision
  • blurry vision
  • eye strain
  • difficulty seeing out of the corner of your eyes

The risk of vision loss is increased if you take a higher dosage or the longer you take the medication. Taking Sabril with other drugs that have serious eye side effects may also raise the risk of eye problems.

What you can do

Before starting treatment with Sabril, your doctor will recommend getting a vision test. They’ll likely want you to continue getting follow-up vision exams every 3 months during treatment with Sabril. It’s also recommended that you get another vision test 3 to 6 months after you stop taking Sabril. While regular vision exams may not prevent vision loss, they can help your doctor determine if it’s safe for you to continue taking Sabril. If you notice any changes in your vision, tell your doctor right away.

To help reduce the risk of vision loss, your doctor may suggest that you stop taking Sabril if it isn’t working to treat your seizures within the first 3 months. They’ll gradually reduce your dose when stopping treatment.

If your infant or child is taking Sabril for infantile spams, their doctor may suggest they stop taking the drug if it isn’t working to treat their condition in the first 2 to 4 weeks. They’ll recommend a dosing schedule to slowly decrease the dose until your child isn’t taking the medication anymore.

Due to the risks of vision loss, Sabril is only available through a special program called the Vigabatrin Risk Evaluation and Mitigation Strategy (REMS) program. This is to make sure your doctor understands the risks of using Sabril and the medication is prescribed safely.

If you have certain vision problems, are at high risk of vision problems, or are taking medications that can also cause serious vision side effects, your doctor may recommend an alternative treatment for you.

Peripheral neuropathy

Some people experience peripheral neuropathy while taking Sabril. This wasn’t a common side effect reported in the drug’s clinical studies. Peripheral neuropathy is caused by nerve damage outside the brain and spinal cord. Symptoms of peripheral neuropathy may include:

  • numbness in your hands or feet
  • feeling of pins and needles
  • decreased sensitivity to pain

It’s possible that peripheral neuropathy can occur in infants and children, but Sabril’s clinical trials weren’t designed to evaluate if the symptoms occurred and how often.

What you can do

Talk with your doctor right away if you have symptoms of peripheral neuropathy while taking Sabril. Your doctor may recommend ways to manage this side effect or suggest a different treatment option. It isn’t known if symptoms of peripheral neuropathy will go away after you stop taking Sabril.

If you have any questions about peripheral neuropathy during treatment with Sabril, talk with your doctor or pharmacist.

Sleepiness and fatigue

Extreme sleepiness and fatigue were commonly reported by people taking Sabril in the drug’s clinical studies. These side effects can affect your ability to focus, think, or react. The risk of these side effects is higher if you also take certain other medications that can cause drowsiness, such as benzodiazepines or muscle relaxers.

What you can do

Don’t drive a car or operate heavy machinery until you know how Sabril affects you. If you feel too sleepy from taking Sabril, talk with your doctor. They may suggest ways to help you manage this side effect or recommend a different treatment option for you.

Suicide prevention

If you know someone at immediate risk of self-harm, suicide, or hurting another person:

  • Ask the tough question: “Are you considering suicide?”
  • Listen to the person without judgment.
  • Call 911 or the local emergency number, or text TALK to 741741 to communicate with a trained crisis counselor.
  • Stay with the person until professional help arrives.
  • Try to remove any weapons, medications, or other potentially harmful objects if it’s safe to do so.

If you or someone you know is having thoughts of suicide, a prevention hotline can help. The 988 Suicide and Crisis Lifeline is available 24 hours a day at 988. During a crisis, people who are hard of hearing can use their preferred relay service or dial 711 then 988.

Find more links and local resources.

Below is important information you should consider before taking Sabril.

Sabril has a boxed warning. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). For details, see the “Side effect specifics” section above.

Other precautions

Before taking Sabril, discuss your health history with your doctor. Sabril may not be right for you if you have certain medical conditions or other factors affecting your health. Be sure to talk with your doctor if any of the following apply to you:

  • history of mental health problems
  • vision problems
  • anemia (low red blood cell levels)
  • kidney problems
  • previous allergic reaction to Sabril or a similar drug
  • pregnancy
  • breastfeeding
  • alcohol consumption

Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.