Sabril is a brand-name prescription medication that’s FDA-approved to treat certain seizure disorders. Seizures are unusual changes in the electrical activity of your brain.
Specifically, Sabril is approved to treat:
- refractory focal onset seizures (seizures that affect one part of the brain)
- infantile spasms (seizures that occur in children under 2 years old)
Refractory focal onset seizures are also known as complex partial seizures. For this condition Sabril is approved for people who’ve already tried other drugs that haven’t worked for their condition. The drug is not approved as a first-time treatment option for refractory focal onset seizures. Sabril can be taken with other seizure medications for this condition.
Sabril is approved for use in adults and in children ages 2 years and older with refractory focal onset seizures. It’s also approved for use in children ages 1 month to 2 years old with infantile spasms.
Drug details
Sabril belongs to a group of medications called antiseizure medications, also known as anticonvulsants.
The drug is available as an oral tablet. It’s also available as a powder packet. The powder is mixed with water to form an oral solution.
Each tablet and packet come in one strength: 500 milligrams (mg).
Effectiveness
For information about the effectiveness of Sabril, see the “Sabril uses” section below.
Sabril is a brand-name drug that contains the active drug vigabatrin. This active drug is also available as a generic medication. A generic drug is an exact copy of the active drug in a brand-name medication.
The generic is considered to be as safe and effective as the original drug. Generics tend to cost less than brand-name drugs.
If you’re interested in taking the generic version of Sabril, talk with your doctor. They can tell you if it comes in forms and strengths that can be prescribed for your condition.
The Sabril dosage your doctor prescribes will depend on several factors. These include:
- the type and severity of the condition you’re taking Sabril to treat
- your age
- the form of Sabril you take
- body weight, when prescribed to children
Typically, your doctor will start you on a low dosage. Then they’ll adjust it over time to reach the amount that’s right for you. Your doctor will ultimately prescribe the smallest dosage that provides the desired effect.
The following information describes dosages that are commonly taken or recommended. However, be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best dosage to fit your needs.
If you have kidney problems, your doctor may recommend a lower dose of Sabril for you. Before starting Sabril treatment, be sure to tell your doctor if you have kidney problems. (For more details about kidney problems and Sabril, see “Can older people take Sabril?” in the “Common questions about Sabril” section below.)
If you’d like to stop taking Sabril, be sure to tell your doctor. They will recommend you slowly decrease the amount of Sabril you’re taking until you’ve stopped treatment. You should not suddenly stop taking this medication. Suddenly stopping Sabril may cause a condition called status epilepticus. (With status epilepticus, you have seizures that don’t stop).
Drug forms
Sabril is available as an oral tablet. It’s also available as a powder packet. The powder is mixed with water to make an oral solution.
Drug strengths: 500 mg
Each tablet and packet come in one strength: 500 milligrams (mg).
Dosage for refractory focal onset seizures
Below is information about Sabril dosages for refractory focal onset seizures in adults and children.
Dosages for refractory focal onset seizures in adults
To treat refractory focal onset seizures in adults, the recommended starting dosage is 500 mg twice daily.
Depending on how well Sabril works for you, your doctor may recommend increasing your dose by 500 mg every week. However, they’ll likely recommend you take the lowest dose of Sabril possible to decrease your risk of side effects. (For more details about side effects, see the “Sabril side effects” section below.)
The recommended maintenance (long-term) dosage of Sabril is typically 1,500 mg twice daily. However, if your seizures don’t decrease within 3 months of starting treatment, your doctor may recommend stopping treatment. They’ll likely prescribe you a different drug.
Dosages for refractory focal onset seizures in children
Sabril is approved to treat refractory focal onset seizures in children ages 2 years and older. For this use, your child’s dosage is based on their body weight in kilograms (kg). (One kg is about 2.2 pounds [lb].)
Your child’s doctor will prescribe a starting dose that’s given twice daily. They may increase your child’s dose every week until the drug is effective for their condition. This will be the maintenance (long-term) dosage. Below is a table of the recommended dosages of Sabril for this use:
| Child’s weight | Starting dosage | Maintenance (long-term) dosage |
| 10 kg to 15 kilograms (kg), or about 22 pounds (lb) to 33 lb | 175 milligrams (mg) twice daily | 525 mg twice daily |
| More than 15 kg to 20 kg, or more than about 33 lb to 44 lb | 225 mg twice daily | 650 mg twice daily |
| More than 20 kg to 25 kg, or more than about 44 lb to 55 lb | 250 mg twice daily | 750 mg twice daily |
| More than 25 kg to 60 kg, or more than about 55 lb to 132 lb | 250 mg twice daily | 1,000 mg twice daily |
| More than 60 kg, or more than 132 lb* | 500 mg twice daily | 1,500 mg twice daily |
* If your child weighs more than 60 kg, they’ll take the same recommended dosage as an adult. For more details, see “Dosage for refractory focal onset seizures in adults” just above.
Dosage for infantile spasms
Sabril is approved to treat infantile spasms in children ages 1 month to 2 years old. For this use, the dosage is based on your child’s body weight. The recommended starting dosage is 50 milligrams per kilogram of body weight per day (mg/kg/day). (One kg is about 2.2 pounds [lb].) This starting dosage will be split into two doses that you’ll give your child throughout the day.
For example, if your child weighs 5 kg (about 11 lb), their recommended starting dosage would be 250 mg/day. This means they’ll take 125 mg twice daily. Your doctor or pharmacist will advise how to give your child their dosage.
Depending on how well-managed your child’s seizures are, their doctor may recommend increasing their dose of Sabril. They may increase the dose by 50 mg/kg/day every 3 days. The maximum recommended dose of Sabril is 150 mg/kg/day.
Your child’s doctor will determine the best dosing schedule for them before they start Sabril treatment. To view a table of recommended dosages based on weight, view Sabril’s prescribing information.
If your child’s seizures do not decrease within 2 to 4 weeks of starting treatment, their doctor may stop Sabril treatment. They may recommend trying a different treatment option.
Children’s dosages
Sabril is approved to treat the following conditions in children:
- refractory focal onset seizures in children ages 2 years and older
- infantile spasms in children ages 1 month to 2 years old
For details about the recommended dosages for these uses, see “Dosages for refractory focal onset seizures in children” above. You can also view “Dosage for infantile spasms” just above.
What if I miss a dose?
If you miss a dose of Sabril, talk with your doctor about when to take the next dose. They’ll recommend what to do before you continue your usual Sabril dosing schedule.
To help make sure that you don’t miss a dose, try using a medication reminder. This can include setting an alarm or using a timer. You could also download a reminder app on your phone.
Will I need to take this drug long term?
Sabril is meant to be taken as a long-term treatment. If you and your doctor determine that Sabril is safe and effective for you, you’ll likely take it long term.
Sabril can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while taking Sabril. These lists do not include all possible side effects.
For more information about the possible side effects of Sabril, talk with your doctor or pharmacist. They can give you tips on how to manage any side effects that may be concerning or bothersome.
Note: The Food and Drug Administration (FDA) tracks side effects of drugs it has approved. If you’d like to notify the FDA about a side effect you’ve had with Sabril, you can do so through MedWatch.
Mild side effects
Mild side effects* of Sabril can include:
- blurry vision
- dizziness
- changes in coordination
- tremor
- swelling in the arms or legs
- weight gain
- headache
- common cold symptoms, such as cough or a runny or stuffy nose
- memory problems
- nausea and vomiting
- nystagmus (involuntary, fast eye movements)
- feeling irritable
- somnolence (sleepiness)†
- fatigue†
Most of these side effects may go away within a few days or a couple of weeks. But if they become more severe or don’t go away, talk with your doctor or pharmacist.
* This is a partial list of mild side effects from Sabril. To learn about other mild side effects, talk with your doctor or pharmacist, or view Sabril’s prescribing information.
† For more information about this side effect, see “Side effect details” below.
Serious side effects
Serious side effects from Sabril aren’t common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.
Serious side effects and their symptoms can include:
- Anemia (low level of red blood cells). Symptoms can include:
- weakness
- paler skin than usual
- irregular heartbeat
- dizziness
- Peripheral neuropathy (a disorder of the nerves outside the central nervous system). Symptoms may include:
- Changes in magnetic resonance imaging (MRI) in some children’s brains. It’s not known what symptoms or side effects these changes may cause.
- Depression. Symptoms can include:
- depressed mood
- loss of interest in activities you typically enjoy
- appetite changes
- weight changes
- trouble concentrating or thinking
- Suicidal thoughts or behaviors.*
- Risk of permanent vision loss.*†
- Allergic reaction.*
* For more information about this side effect, see “Side effect details” below.
† Sabril has a
Side effects in children and babies
In children taking Sabril for refractory focal onset seizures, weight gain was the most commonly reported side effect.
The most common side effects in babies taking Sabril for infantile spasms were:
- somnolence (sleepiness)*
- ear infections
- bronchitis (swelling and inflammation of your lungs’ bronchial tubes)
If you have questions about side effects that may occur in your child, talk with their doctor.
* For more information about this side effect, see “Side effect details” below.
Side effect details
Here’s some detail on certain side effects this drug may cause. To find out how often side effects occurred in clinical trials, see the prescribing information for Sabril.
Suicidal thoughts and behaviors
It’s possible for Sabril to increase the risk of developing suicidal thoughts or behaviors during treatment. This is a known risk with all antiepileptic drugs, including Sabril. This was an uncommon side effect in clinical trials of the drug.
However, it’s important that you’re aware of the symptoms that may lead to suicidal thoughts and behaviors. This is so that you can report symptoms to your doctor or loved ones right away. Symptoms may include:
- depression
- agitation or restlessness
- trouble sleeping
- anger or violence
- anxiety or panic attacks
- irritability
- feeling impulsive
- unusual changes in your mood
- symptoms of mania, such as extreme confidence or feelings
This increased risk can occur as soon as 1 week after starting Sabril treatment.
What you can do
If you experience suicidal thoughts or behaviors, go to the hospital right away. However, it’s important that you do not suddenly stop taking Sabril without first talking with your doctor. Suddenly stopping this drug may cause a condition called status epilepticus. (With status epilepticus, you have seizures that don’t stop).
If you notice any changes in you or your child’s behavior, tell a doctor right away. Be sure to keep your follow-up appointments with your doctor. This is so they can monitor for any symptoms of mood changes or suicidal thoughts or behaviors.
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 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.
Somnolence and fatigue
Sabril can cause some people to feel somnolence (sleepiness) and fatigue (low energy). These symptoms were common side effects reported by people taking Sabril.
What you can do
Due to these possible side effects, you should not drive or operate other machinery until you know how Sabril affects you.
If you notice that you’re feeling sleepy or fatigued after taking Sabril, talk with your doctor. They may be able to recommend ways to decrease these symptoms.
Risk of permanent vision loss
It’s possible for Sabril to cause permanent vision loss. Sabril has a
Symptoms of vision loss may include:
- blurry vision
- changes in vision
- bumping into things
- clumsiness
Some people taking Sabril developed a condition called tunnel vision. With this condition, you lose your side vision, but you can still see when you look straight forward.
Vision loss can happen at any time during your Sabril treatment. This includes right after starting the drug or after you’ve been 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’s no dose or length of treatment with Sabril that doesn’t carry a risk of vision loss.
It’s important to note vision loss from Sabril will not typically improve after you stop taking the medication. It’s even possible for your vision to worsen after you stop Sabril treatment.
What you can do
If you notice any changes in your vision, it’s important to tell your doctor right away.
Due to the risk of vision loss, you can only get Sabril through a special program called a Risk Evaluation and Mitigation Strategy (REMS) program. The REMS program makes sure you and your doctor are aware of the risk of vision loss from Sabril treatment. For more information on the REMS program, call 866-244-8175 or visit this website.
Before you start taking Sabril, your doctor will recommend getting a vision test. They’ll also recommend getting follow-up vision exams at least every 3 months during treatment. And they’ll recommend getting a vision exam once more within 3 to 6 months after stopping treatment. It’s important to note that frequent vision exams will not help prevent vision loss from Sabril treatment. 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 dosage* of Sabril that works for you.
Due to the risk of vision loss with Sabril treatment, your doctor may recommend stopping treatment if:
- your refractory focal onset seizures don’t decrease within 3 months of beginning treatment
- your child’s infantile spasms don’t reduce within 2 to 4 weeks of starting treatment
If you have other vision problems or if you have an increased risk of developing vision problems, your doctor may recommend a different treatment option for you. In addition, if you’re taking other medications that may affect your vision, your doctor will likely not prescribe you Sabril.
* For more information about Sabril’s dosage, see the “Sabril dosage” section above.
Allergic reactionAs with most drugs, some people can have an allergic reaction after taking Sabril. While allergic reactions weren’t reported in the drug’s clinical trials, they have occurred since Sabril was approved for use.
Symptoms of a mild allergic reaction can include:
A more severe allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include:
- swelling under your skin, typically in your eyelids, lips, hands, or feet
- swelling of your tongue, mouth, or throat
- trouble breathing
Call your doctor right away if you have an allergic reaction to Sabril, as the reaction could become severe. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.
As with all medications, the cost of Sabril can vary.
The actual price you’ll pay depends on your insurance plan, your location, and the pharmacy you use.
Keep in mind that you may be able to get a 90-day supply of Sabril. If approved by your insurance company, getting a 90-day supply of the drug could reduce your number of trips to the pharmacy and help lower the cost. If you’re interested in this option, check with your doctor, pharmacist, or insurance company.
It’s important to note that you’ll have to get Sabril at a specialty pharmacy. It’s available either by mail-order or by visiting in person. This type of pharmacy is authorized to carry specialty medications. These are drugs that may be expensive or may require help from healthcare professionals to be taken safely and effectively.
Before approving coverage for Sabril, your insurance company may require you to get prior authorization. This means that your doctor and insurance company will need to communicate about your prescription before the insurance company will cover the drug. The insurance company will review the prior authorization request and decide if the drug will be covered.
If you’re not sure if you’ll need to get prior authorization for Sabril, contact your insurance company.
Financial and insurance assistance
If you need financial support to pay for Sabril, or if you need help understanding your insurance coverage, help is available.
You can search Medicine Assistance Tool and NeedyMeds to find programs that may help decrease Sabril’s cost. To learn more, visit their websites.
For more information about saving money on prescriptions, check out this article.
Generic version
Sabril is available in a generic version called vigabatrin. A generic drug is an exact copy of the active drug in a brand-name medication. The generic is considered to be as safe and effective as the original drug. And generics tend to cost less than brand-name drugs.
If your doctor has prescribed Sabril and you’re interested in taking vigabatrin instead, talk with your doctor. They may prefer one version or the other. You’ll also need to check your insurance plan, as it may only cover one or the other.
The Food and Drug Administration (FDA) approves prescription drugs such as Sabril to treat certain conditions.
Sabril is approved to treat specific seizure disorders. Seizures are unusual changes in the electrical activity of your brain. Specifically, Sabril is approved to treat:
- refractory focal onset seizures, as an add-on therapy with other antiseizure drugs
- infantile spasms
Sabril is approved for use in adults and in children ages 2 years and older with refractory focal onset seizures. It’s also approved for use in children ages 1 month to 2 years old with infantile spasms.
Sabril for refractory focal onset seizures
Focal onset seizures (also called complex partial seizures) are unusual changes in the electrical activity of one part of your brain. Refractory means that your seizures are hard to treat. So, if you have focal onset seizures and have already tried other drugs to treat your condition, your doctor may prescribe you Sabril.
In this case, your doctor will recommend you take Sabril with other seizure medications to treat your condition.
Symptoms of focal onset seizures may include:
- unusual head or eye movements
- vision changes
- muscle spasms
Focal onset seizures may be due to epilepsy, which is a brain condition that causes seizures. In addition, other conditions, such as infection or head injury, can cause focal onset seizures.
Effectiveness for refractory focal onset seizures
Sabril is an effective treatment option for refractory focal onset seizures in adults and children. In fact, the American Academy of Family Physicians recommend Sabril as a treatment option for this use.
For more information on how Sabril performed in clinical trials, see the drug’s prescribing information.
Sabril for infantile spasms
Sabril can be prescribed to treat infantile spasms. Infantile spasms are a type of seizure that can happen in children under 2 years old.
Symptoms of infantile spasms may include:
- stiff muscles
- eyes that roll back
- arched back
It’s not known what causes infantile spasms. But they may be related to problems with brain development, infection, or brain injury.
To learn more about epilepsy and seizures, see our MNT hub for epilepsy and seizures.
Effectiveness for infantile spasms
Sabril is an effective treatment option infantile spasms in children. In fact, Sabril is recommended as a treatment option for this condition in treatment
For more information on how Sabril performed in clinical trials, see the drug’s prescribing information.
Sabril and children
Sabril is approved for use in children:
- ages 2 years and older with refractory focal onset seizures
- ages 1 month to 2 years old with infantile spasms
Sabril is an effective treatment option for the above conditions in children. For more information about the effectiveness of Sabril in children, see the sections just above.
Sabril is typically prescribed with other medications to treat refractory focal onset seizures.
Refractory focal onset seizures are seizures that are not well-managed with other seizure medications. So, your doctor will prescribe Sabril in addition to other treatments to try to manage your focal onset seizures. Sabril is not approved to treat focal onset seizures on its own.
However, if Sabril is prescribed to treat infantile spasms in your child, their doctor will likely prescribe it alone.
If you have more questions about your treatment plan, talk with your doctor. For more information about the conditions that Sabril is approved to treat, see the “Sabril uses” section above.
There are no known interactions that occur between Sabril and alcohol.
However, your doctor may recommend limiting or avoiding alcohol during your Sabril treatment. This is because both Sabril and alcohol can cause similar side effects, such as:
- blurry vision
- sleepiness
- dizziness
- trouble with coordination
Taking Sabril while you’re drinking alcohol may make these side effects worse. (To learn more about side effects with Sabril, see the “Sabril side effects” section above.)
Talk with your doctor to see how much alcohol, if any, is safe for you to drink while you’re taking Sabril.
Sabril can interact with several other medications and lab test results. However, it’s not known to interact with supplements or certain foods.
Different interactions can cause different effects. For instance, some interactions can interfere with how well a drug works. Other interactions can increase side effects or make them more severe.
Sabril and other medications
Below is a list of medications that can interact with Sabril. This list does not contain all drugs that may interact with Sabril.
Before taking Sabril, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you take. Sharing this information can help you avoid potential interactions.
Drugs that may interact with Sabril include:
- Phenytoin (Dilantin). Phenytoin is another medication that may be prescribed to treat seizure disorders. Taking phenytoin and Sabril together may cause phenytoin to be less effective.
- Clonazepam (Klonopin). Clonazepam may be prescribed for seizure disorders or for other conditions, such as anxiety. Taking Sabril and clonazepam together may increase the amount of clonazepam in your body. This may cause you to have more side effects from clonazepam.
If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.
Sabril and herbs and supplements
There aren’t any herbs or supplements that have been specifically reported to interact with Sabril. However, you should still check with your doctor or pharmacist before taking any of these products with Sabril.
Sabril and foods
There aren’t any foods that have been specifically reported to interact with Sabril. If you have any questions about eating certain foods with Sabril, talk with your doctor.
Sabril and lab tests
Taking Sabril may affect certain lab test results. Specifically, it may affect:
- Liver function tests. These tests help determine if you have liver damage. They measure the levels of liver enzymes (certain proteins) in your blood. However, Sabril may decrease these levels or prevent them from being detected. So, if you have a liver problem, it may not be detected as quickly as usual.
- Urine tests for amino acids. Your doctor may recommend this type of test to determine if you have certain genetic conditions. Sabril can increase the amount of amino acids in your urine, which can make your test results inaccurate.
If you need to have any lab tests done while you’re taking Sabril, tell your doctor that you’re taking this drug. They can determine the best way to get the test results they need.
You should take Sabril according to the instructions your doctor gives you.
For refractory focal onset seizures,* your doctor may prescribe your Sabril dose† in either the tablet form or the powder form. And for infantile spasms,* your child’s doctor will prescribe Sabril in powder form.
If your doctor prescribes the tablet, you’ll swallow it whole.
If they prescribe the powder packet, you’ll need to mix the powder with water to form a solution. Be sure to mix your Sabril powder with cold or room-temperature water only. Do not use any other liquids to form the solution. Your doctor or pharmacist will advise how many Sabril packets you’ll need to take for each dose. They’ll also tell you how much water to add to the powder to form the solution.
After forming the solution, you’ll measure your dose using an oral syringe that your pharmacy will provide. You’ll use the syringe to take your dose by mouth. Do not to use a kitchen teaspoon or tablespoon to measure the dose. This is because these spoons can be inaccurate and won’t measure your dose correctly. Be sure to take your dose of Sabril right after you mix it.
For step-by-step instructions on how to mix the Sabril powder packets to form an oral solution, see these instructions for use.
* These are conditions that Sabril is approved to treat. To learn more, see the “Sabril uses” section above.
† For more information about dosage, see the “Sabril dosage” section above.
When to take
Your total Sabril dose will typically be split into two doses that you’ll take daily. Your doctor will likely recommend you take your doses of Sabril at around the same times each day.
To help make sure that you don’t miss a dose, try using a medication reminder. This can include setting an alarm or using a timer. You could also download a reminder app on your phone.
Accessible labels and containers
If your prescription label is hard to read, talk with your doctor. Some pharmacies offer labels that have large print, braille, or a code you scan with a smartphone to convert text to speech. Your doctor can check if there are REMS-approved* pharmacies that can provide this service for Sabril.
If you’re prescribed the oral tablet form of Sabril, and you have trouble opening medication bottles, ask your pharmacist if they can put Sabril in an easy-open container. They also may be able to recommend tools that can make it simpler to open lids.
* Sabril is only available through the Risk Evaluation and Mitigation Strategy (REMS) program. For additional information, see the “What is the Sabril REMS program?” in the “Common questions about Sabril” section below.
Taking Sabril with food
You can take Sabril with or without food.
Can Sabril be crushed, split, or chewed?
Sabril tablets should not be crushed, split, or chewed. They should be swallowed whole. However, if you’re having trouble swallowing Sabril tablets, a powder packet is available. You’ll mix this powder with water to form an oral solution.
If you’re having trouble taking Sabril tablets, talk with your doctor about switching to Sabril powder packets.
Sabril is approved to treat certain seizure disorders. Seizures are unusual changes in the electrical activity of your brain. Specifically, Sabril is prescribed to treat:
- refractory focal onset seizures
- infantile spasms
Focal onset seizures are seizures in one part of your brain. Refractory means that your seizures are hard to treat. So, if you have focal onset seizures and have already tried other drugs to treat your condition, your doctor may prescribe you Sabril.
In addition, Sabril is approved to treat infantile spasms. Infantile spasms are a type of seizure that can happen in babies and children under 2 years old.
The way that Sabril works to treat focal onset seizures and infantile spasms is not known. However, it’s believed that the drug works by increasing the amount of gamma-aminobutyric acid (GABA) in your body.
GABA is a chemical that works in your brain to calm down your nervous system. Since seizures are unusual electrical activity, it’s thought that increasing the amount of GABA in the brain may reduce this activity. So, this may decrease your seizures.
How long does it take to work?
Sabril starts working as soon as you take your first dose. However, it may take time for you to notice a decrease in your seizures. Your doctor will recommend you stop taking Sabril if you do not notice a difference in your seizure activity within:
- 3 months of beginning treatment for refractory complex partial seizures
- 2 to 4 weeks of starting treatment for infantile spasms
For more information about when to expect results from Sabril treatment, talk with your doctor.
It’s not known if Sabril is safe to take during pregnancy. At this time, there isn’t enough safety information about the drug when it’s taken during pregnancy. Clinical trials haven’t shown an increased risk of congenital anomalies (commonly known as “birth defects”) in the fetus.
However, animal studies do show an increased risk of congenital anomalies. However, it’s important to note that animal studies do not always indicate what may happen in humans.
If you become pregnant during your Sabril treatment, your doctor may recommend you enroll in the North American Antiepileptic Drug (NAAED) pregnancy registry. This registry collects information about people who’ve taken Sabril during pregnancy. It also collects information about the effects the drug may have had on the pregnancy or the developing fetus.
You can join the registry by calling 888-233-2334 or by visiting the registry’s website.
If you’re pregnant or plan to become pregnant, talk with your doctor before starting Sabril. They can help determine if this medication may be a safe treatment option for you.
It’s not known if Sabril is safe to take during pregnancy. If you’re sexually active and you or your partner can become pregnant, talk with your doctor about your birth control needs during Sabril treatment.
For more information about taking Sabril during pregnancy, see the “Sabril and pregnancy” section above.
It’s unknown if Sabril is safe to take while breastfeeding. Sabril is known to pass into breastmilk, so a breastfeeding child will be exposed to the drug.
However, it’s not known what effects Sabril may have on a breastfed child. Due to the possible risks, your doctor will not recommend breastfeeding while you’re taking Sabril.
If you have questions about taking Sabril while breastfeeding, talk with your doctor.
Here are answers to some frequently asked questions about Sabril.
Can I mix Sabril with drinks or food, such as formula, milk, juice, or applesauce?
No, you should not mix Sabril powder* with anything except for water. This means that Sabril should not be mixed with formula, milk, juice, or applesauce.
Be sure to mix the powder with the right amount of water that your doctor advises. For step-by-step instructions on how to mix Sabril powder to form an oral solution, see the instructions for use.
* Sabril comes as a powder packet and oral tablet. For more information, see the “How to take Sabril” section above.
What is the Sabril REMS program?
The Sabril Risk Evaluation and Mitigation Strategy (REMS) program alerts you and your doctor about the risks associated with taking the medication. This includes the risk of permanent vision loss* that may occur from Sabril treatment.
The REMS program ensures Sabril is only available if:
- your doctor educates you about the risk of vision loss
- your doctor recommends you have frequent vision exams to monitor for vision loss
- your specialty pharmacy is enrolled in the REMS program so they can dispense Sabril
For more information on the REMS program, call 866-244-8175 or visit this website.
* Sabril has a
Can older people take Sabril?
Yes, it’s possible for older people (ages 65 and older) to take Sabril. However, clinical trials of Sabril did not include enough older adults. So, it isn’t fully known if the drug is safe and effective for this group.
As you age, your kidney function slows down. And if you take Sabril and have reduced kidney function, your body may not process Sabril fast enough. This can expose you to high levels of the drug and cause side effects. For example, it’s possible for older adults taking Sabril to become confused or tired from treatment.
If you are an older adult taking Sabril, your doctor may monitor you more often for side effects* of the drug. In addition, they may recommend starting treatment with a lower dose† of medication until you know how the drug may affect you.
* For more information about side effects, see the “Sabril side effects” section above.
† To learn more about Sabril dosage, see the “Sabril dosage” section above.
This drug comes with several precautions.
FDA warning: Risk of permanent vision loss
This drug has a
It’s possible for Sabril to cause permanent vision loss. Vision loss can happen at any time while you’re taking Sabril. This includes right after you start taking the medication or after taking the drug for several years. Your risk of vision loss with Sabril increases the longer you take the medication and if you take a higher dose.
Due to this risk, your doctor will recommend regular vision exams. They may also recommend you stop treatment if your condition doesn’t improve within a certain time period. Also, they’ll likely recommend taking the lowest dosage of Sabril to help prevent vision loss.
Due to the risks of this medication, you can only get Sabril through a special program called a Risk Evaluation and Mitigation Strategy (REMS) program. The REMS program makes sure you and your doctor are aware of the risk of vision loss from taking Sabril.
For more information about this side effect, see “Sabril side effects” above.
Other precautions
Before taking Sabril, talk with your doctor about your health history. Sabril may not be right for you if you have certain medical conditions or other factors affecting your health. These include:
- Kidney problems. Tell your doctor if you have any kidney problems* before you start taking Sabril. If you have kidney problems and take Sabril, your risk of side effects from the drug may increase. In this case, your doctor may start your Sabril treatment with a low dosage.†
- Anemia. Sabril may cause anemia (low red blood cell levels). If you already have anemia, taking Sabril may worsen your condition. Talk with your doctor to see if Sabril is a safe treatment option for you.
- Mental health conditions. Sabril may increase your risk of depression or suicidal thoughts or behaviors. If you’ve had any mental health conditions, taking Sabril may make your condition worse. Your doctor may monitor you more often throughout your treatment for changes in your mood.
- Allergic reaction. If you’ve had an allergic reaction to Sabril or any of its ingredients, your doctor will likely not prescribe Sabril. Be sure to ask them what other medications are better options for you.
- Pregnancy. It’s not known if Sabril is safe to take during pregnancy. For more information, see the “Sabril and pregnancy” section above.
- Breastfeeding. It’s unknown if Sabril is safe to take while breastfeeding. However, due to the possible risks, your doctor will not recommend you breastfeed while you’re taking this drug. For additional information, see the “Sabril and breastfeeding” section above.
* To learn more about kidney problems and Sabril, see “Can older people take Sabril?” in the “Common questions about Sabril” section above.
† For additional information about Sabril’s dosage, see the “Sabril dosage” section above.
Note: For more information about the potential negative effects of Sabril, see the “Sabril side effects” section above.
Taking more than the recommended dosage of Sabril can lead to serious side effects. Do not take more Sabril than your doctor recommends.
Overdose symptoms
Symptoms of an overdose can include:
- drowsiness
- unconsciousness
- trouble breathing
- slow heart rate
- confusion
- headache
- low blood pressure
- coma
What to do in case of overdose
If you think you’ve taken too much of this drug, call your doctor. You can also call the American Association of Poison Control Centers at 800-222-1222 or use its online tool. But if your symptoms are severe, call 911 or your local emergency number, or go to the nearest emergency room right away.
When you get Sabril from the pharmacy, the pharmacist will add an expiration date to the label on the bottle or packaging. This date is typically 1 year from the date they dispensed the medication.
The expiration date helps guarantee that the medication is effective during this time. The
Storage
How long a medication remains good to take can depend on many factors, including how and where you store the medication.
Sabril tablets and powder packets should be stored at room temperature, between 20°C to 25°C (68°F to 77°F).
Disposal
If you no longer need to take Sabril and have leftover medication, it’s important to dispose of it safely. This helps prevent others, including children and pets, from taking the drug by accident. It also helps keep the drug from harming the environment.
This article provides several useful tips on medication disposal. You can also ask your pharmacist for information about how to dispose of your medication.
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.