Banzel (rufinamide) is a brand-name drug prescribed for seizures in adults and certain children with Lennox-Gastaut syndrome. As with other drugs, Banzel can cause side effects. These include sleepiness and dizziness.
Banzel 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 people who took Banzel in clinical trials:
* For more information about this side effect, see “Side effect specifics” below.
Mild side effects can occur with Banzel treatment. This list doesn’t include all possible mild side effects of the drug. For more information, you can refer to Banzel’s prescribing information.
Mild side effects that have been reported with Banzel include:
- nausea
- vomiting
- headache
- fatigue
- dizziness
- sleepiness*
- mild allergic reaction†
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 Banzel and want to tell the FDA about it, visit MedWatch.
* For more information about this side effect, see “Side effect specifics” below.
† An allergic reaction is possible after taking Banzel. To learn more, see the “Side effect specifics” section below.
Banzel 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 Banzel’s prescribing information.
If you develop serious side effects while taking Banzel, 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:
- Status epilepticus (seizures that last for 5 minutes or more). Symptoms can include:
- loss of consciousness
- muscle spasms
- confusion or agitation
- Lack of coordination, which may lead to gait and balance problems. Symptoms can include:
- dizziness
- swaying while standing or walking
- walking at a slower pace than usual
- Low white blood cell count. This condition doesn’t typically cause symptoms but can be detected with a blood test.
- Suicidal thoughts and behaviors.*
- Severe allergic reaction.†
* For more information about this side effect, see “Side effect specifics” below.
† An allergic reaction is possible after taking Banzel. To learn more, see the “Side effect specifics” section below.
Banzel is approved to treat seizures in children ages 1 year or older who have Lennox-Gastaut syndrome.
Many of Banzel’s side effects in children are expected to be the same as in adults. However, certain side effects, such as vomiting, were reported more commonly in children than adults.
In addition, several side effects were only reported in children. These include:
- appetite loss
- flu or flu-like symptoms, such as a runny or stuffy nose
- hyperactivity and difficulty paying attention
- itchiness
In addition, an allergic reaction called drug reaction with eosinophilia and systemic symptoms (DRESS) was reported in children ages 12 years or younger. For details about this allergic reaction, see the “Side effect specifics” section below.
For more information about Banzel’s side effects in children, talk with your child’s doctor or pharmacist.
Banzel may cause several side effects. Here are some frequently asked questions about the drug’s side effects and their answers.
How do side effects of Banzel compare with those seen with Keppra?
Like Banzel, Keppra (levetiracetam) is used to treat seizures in people with epilepsy. These drugs share many of the same side effects. Below are a few examples:
- headache
- fatigue
- dizziness
- lack of coordination, which may lead to gait and balance problems
- sleepiness*
- suicidal thoughts and behaviors*
However, one drug may cause side effects that the other doesn’t. For example, nausea was reported in clinical trials of Banzel, but not in clinical trials of Keppra.
To learn more about how the side effects of Banzel compare with those of Keppra, talk with your doctor or pharmacist.
* For more information about this side effect, see “Side effect specifics” below.
Can Banzel cause withdrawal symptoms?
Yes, Banzel can cause withdrawal symptoms. These are side effects that happen when you suddenly stop taking a drug your body has become used to.
Specifically, you may have new or worsened seizures if you stop Banzel suddenly. This includes a serious type of seizure called status epilepticus, which is a seizure that lasts for 5 minutes or more.
Due to this risk, it’s important that you talk with your doctor before making any changes to your treatment plan. Do not stop taking a medication without talking with your doctor first.
If your doctor agrees with stopping the drug, they’ll lower your Banzel dosage slowly over time to reduce the risk of withdrawal seizures. Your doctor may also prescribe a different treatment for your condition.
If you have other questions about Banzel and withdrawal symptoms, talk with your doctor or pharmacist.
Learn more about some of the side effects that Banzel may cause. To find out how often side effects occurred in clinical trials, see the prescribing information for Banzel.
Sleepiness
Banzel may cause excessive sleepiness. In clinical trials for the drug, this was one of the more commonly reported side effects.
With sleepiness, you may feel sluggish, groggy, or unable to focus.
What you can do
Due to the risk of sleepiness, your doctor may recommend avoiding certain activities until you know how Banzel affects you. Examples include driving or operating other heavy machinery.
It may take several doses to determine whether this sleepiness could be severe enough to interfere with daily activities.
Suicidal thoughts and behaviors
Taking Banzel may lead to suicidal thoughts and behaviors. This side effect wasn’t reported in clinical trials for Banzel. However, this is a known risk of antiepileptic drugs, such as Banzel. (Banzel is used to treat a severe type of epilepsy.)
Symptoms of suicidal thoughts and behaviors may include:
- changes in mood, such as feeling more anxious or agitated than usual
- changes in behavior, such as taking more risks than usual
- thoughts of harming yourself or taking your life
What you can do
Before taking Banzel, tell your doctor if you’ve ever had a mood disorder or experienced suicidal thoughts and behaviors. These factors may increase the risk or severity of this side effect. (Keep in mind that epilepsy itself also carries a risk of depression, which can cause suicidal thoughts and behaviors.) Your doctor can tell you whether Banzel is a safe treatment option.
While taking Banzel, call your doctor right away if you or a loved one notice you having any of the symptoms above.
Allergic reaction
As with most drugs, Banzel can cause an allergic reaction in some people. Specifically, an allergic reaction called drug reaction with eosinophilia and systemic symptoms (DRESS) was reported in the drug’s clinical trials. However, this side effect was rare and was only reported in children ages 12 years or younger.
Symptoms can be mild or serious and can include:
What you can do
For mild symptoms of an allergic reaction, call your doctor right away. They may recommend ways to ease your symptoms and determine whether you should keep taking Banzel. However, if your symptoms are serious and you think you’re having a medical emergency, immediately call 911 or your local emergency number.
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.
Be sure to talk with your doctor about your health history before you take Banzel. This drug may not be the right treatment for you if you have certain medical conditions or other factors that affect your health. These are considered drug-condition or drug-factor interactions. The conditions and factors to consider include:
Severe liver problems. If you have a severe liver problem, such as liver failure, talk with your doctor before taking Banzel. It isn’t known for certain whether the drug is safe to take with severe liver problems. Your doctor can recommend the right treatment options for your condition.
Short QT syndrome. Before taking Banzel, tell your doctor if you have a type of arrhythmia called short QT syndrome. Banzel may worsen QT shortening (a type of irregular heart rhythm) in people with this condition. Due to this risk, doctors typically will not prescribe Banzel for people with short QT syndrome. Your doctor can tell you about safer treatment options.
Mood disorders. Banzel carries a risk of suicidal thoughts and behaviors. If you’ve ever had a mood disorder or experienced suicidal thoughts or behavior, you may have a higher risk of this side effect. Before starting Banzel treatment, tell your doctor if you have a mood disorder. They can tell you whether Banzel is a safe treatment option. For more information about this side effect, see the “Side effect specifics” section above.
Allergic reaction. If you’ve had an allergic reaction to Banzel or any of its ingredients, your doctor will likely not prescribe Banzel. Ask your doctor what other medications may be better options for you.
Pregnancy or breastfeeding. If you’re pregnant or breastfeeding, Banzel may not be safe for you or your child. Talk with your doctor before taking Banzel. They’ll explain the possible effects of taking Banzel during pregnancy or while breastfeeding.
If you do take Banzel during pregnancy, consider enrolling in a pregnancy registry. These registries help collect information about the safety of Banzel and certain other medications when they’re taken during pregnancy. To learn more, talk with your doctor. You can also visit the registry website or call 888-233-2334.
Alcohol consumption. If you drink alcohol, Banzel may not be safe for you to take. Drinking alcohol may worsen certain side effects of the drug, such as sleepiness and dizziness. If you have questions about the safety of Banzel and alcohol consumption, talk with your doctor or pharmacist.
If you’d like to learn more about Banzel, talk with your doctor or pharmacist. They can help answer any questions you have about side effects from taking the drug.
Besides talking with your doctor, you can do some research on your own. These articles might help:
- More information about Banzel. For details about other aspects of Banzel, refer to this article.
- A look at your condition. For details about Lennox-Gastaut syndrome, see our epilepsy and seizures hub.
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.