May 11, 2022

Dosage, Side Effects, Cost, Uses & More

Sabril can cause mild or severe side effects. The following lists contain some of the main side effects that can occur when taking Sabril. These lists do not include all possible side effects.

For more information about the possible side effects of Sabril, talk to your doctor or pharmacist. They can give you advice on how to deal with side effects that may be concerning or bothersome.

To note: The Food and Drug Administration (FDA) tracks the side effects of drugs it has approved. If you would like to notify the FDA of a side effect you have had with Sabril, you can do so via MedWatch.

Mild side effects

Mild side effects* of Sabril may include:

Most of these side effects may disappear within a few days or weeks. But if they get worse or don’t go away, talk to your doctor or pharmacist.

*This is a partial list of mild Sabril side effects. For more information about other mild side effects, talk to your doctor or pharmacist, or check out Sabril’s prescribing information.
† For more information on this side effect, see “Details of side effects” below.

Serious side effects

Serious side effects from Sabril are not common, but they can occur. Call your doctor right away if you experience any serious side effects. Call 911 or your local emergency number if your symptoms are life-threatening or you think you have a medical emergency.

Serious side effects and their symptoms may include:

* For more information on this side effect, see ‘Details of side effects’ below.
Sabril has a framed warning for this side effect. This is the most serious warning from the Food and Drug Administration (FDA). A boxed warning alerts doctors and patients to potentially dangerous drug effects.

Side effects in children and babies

In children taking Sabril for refractory focal seizures, weight gain was most often reported side effect.

The most common side effects in babies taking Sabril for infantile spasms were:

If you have any questions about side effects that may occur in your child, talk to their doctor.

* For more information on this side effect, see ‘Details of side effects’ below.

Details of side effects

Here are some details about some side effects that this drug can cause. To find out how often side effects occurred in clinical trials, see the prescribing information for Sabril.

Suicidal thoughts and behaviors

Sabril may increase the risk of developing suicidal thoughts or behavior during treatment. This is a known risk with all antiepileptic medicines, including Sabril. This was an uncommon side effect in clinical tests drug.

However, it is important that you are aware of the symptoms that can lead to suicidal thoughts and behaviors. This allows you to immediately report symptoms to your doctor or loved ones. Symptoms may include:

This increased risk can occur as early as 1 week after starting treatment with Sabril.

what you can do

If you have suicidal thoughts or behavior, go to the hospital immediately. However, it is important that you do not suddenly stop taking Sabril without talking to your doctor first. Suddenly stopping this medication may cause a condition called status epilepticus. (With status epilepticus, you have seizures that don’t stop).

If you notice any changes in your or your child’s behavior, tell a doctor immediately. Be sure to keep your follow-up appointments with your doctor. This is how they can watch for any symptoms of mood changes or suicidal thoughts or behaviors.

Drowsiness and fatigue

Sabril can cause drowsiness (drowsiness) and fatigue (low energy) in some people. These symptoms were common side effects reported by people taking Sabril.

what you can do

Because of these possible side effects, you should not drive or use other machinery until you know how Sabril affects you.

If you notice that you feel sleepy or tired after taking Sabril, tell your doctor. They may be able to recommend ways to reduce these symptoms.

Risk of permanent vision loss

Sabril may cause permanent vision loss. Sabril has a framed warning for this side effect. A boxed warning is the most serious warning from the Food and Drug Administration. It alerts physicians and patients to potentially dangerous drug effects. Changes in vision have been commonly reported in clinical tests drug.

Symptoms of vision loss can include:

  • blurred vision
  • vision changes
  • bump into things
  • clumsiness

Some people taking Sabril have developed a condition called tunnel vision. With this condition, you lose your side vision, but you can still see when looking straight ahead.

Vision loss can occur at any time during your Sabril treatment. This includes right after starting the drug or after taking the drug for several years. You have an increased risk of vision loss if you take a higher dose. This risk also increases the longer you take the drug. There is no dose or duration of treatment with Sabril that does not carry the risk of vision loss.

It is important to note that vision loss due to Sabril will usually not improve after stopping treatment. It is even possible that your vision will deteriorate after stopping treatment with Sabril.

what you can do

If you notice any changes in your vision, it is important to tell your doctor immediately.

Because of the risk of vision loss, you can only get Sabril through a special program called the Risk Assessment and Mitigation Strategy (REMS) program. The REMS program ensures that you and your doctor are aware of the risk of vision loss associated with treatment with Sabril. For more information about the REMS program, call 866-244-8175 or visit This site.

Before you start taking Sabril, your doctor will recommend that you have an eye exam. They will also recommend that you have follow-up eye exams at least every 3 months during treatment. And they will recommend that you have another eye exam within 3-6 months of stopping treatment. It is important to note that frequent eye exams will not help prevent vision loss due to treatment with Sabril. However, they can help your doctor determine whether you should continue or stop taking Sabril.

To help prevent vision loss, your doctor will likely prescribe the lowest dose* of Sabril that is right for you.

Due to the risk of vision loss associated with treatment with Sabril, your doctor may recommend that you stop treatment if:

  • your refractory focal seizures do not decrease within 3 months of starting treatment
  • your child’s infantile spasms do not decrease within 2 to 4 weeks of starting treatment

If you have other vision problems or are at increased risk of developing vision problems, your doctor may recommend another treatment option. Also, if you’re taking other medications that may affect your vision, your doctor probably won’t prescribe Sabril for you.

* For Sabril dosing information, see “Sabril Dosage” section above.

Allergic reaction

As with most medicines, some people may have an allergic reaction after taking Sabril. Although allergic reactions have not been reported in the drug clinical teststhey have occurred since Sabril was approved for use.

Symptoms of a mild allergic reaction may include:

A more serious allergic reaction is rare but possible. Symptoms of a severe allergic reaction may include:

  • swelling under the skin, usually in the eyelids, lips, hands, or feet
  • swelling of the tongue, mouth or throat
  • difficulty breathing

Call your doctor right away if you have an allergic reaction to Sabril, as the reaction could become serious. Call 911 or your local emergency number if your symptoms are life-threatening or you think you have a medical emergency.


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