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Overview: Rufinamide is used to treat seizures associated with Lennox-Gastaut syndrome. Common side effects include dizziness, drowsiness, nausea, and headache. Do not drive or do other activities that require alertness or coordination until you know how rufinamide affects you. Call your health care provider right away if you get a rash, unusual bleeding, sore throat, or changes in your mood or behavior. Do not stop this medicine without talking with your health care provider. This medicine is available as a liquid if you have trouble swallowing tablets.

Uses

What is rufinamide used for?

Rufinamide is commonly used to treat seizures associated with Lennox-Gastaut syndrome.

Rufinamide may also be used for other conditions as determined by your health care provider.

How does rufinamide work (mechanism of action)?

Seizures happen when too many nerve signals are sent between brain cells too quickly. Rufinamide is thought to work by slowing down overactive brain signals and making seizures less likely.

How is rufinamide supplied (dosage forms)?

Brands and other names

  • Banzel

Dosage forms and strengths

  • 200 mg oral tablets
  • 400 mg oral tablets
  • 40 mg/mL oral suspension

How should I store rufinamide?

Oral Tablets. Rufinamide tablets should be stored at 77 F (25 C). It can be exposed to temperatures between 59 F and 86 F (15 C and 30 C) for shorter periods of time, such as when transporting it. Protect from moisture. 

Oral Liquid. Rufinamide liquid should be stored at 77 F (25 C). It can be exposed to temperatures between 59 F and 86 F (15 C and 30 C) for shorter periods of time, such as when transporting it. Protect from moisture. Tightly close the cap after use. Store the bottle upright. Throw any unused medicine away 90 days after you first open the bottle. 

Side Effects

What are the most common side effects of rufinamide?

The most common side effects of rufinamide are listed below. Tell your health care provider if you have any of these side effects that bother you.

  • Headache
  • Dizziness
  • Feeling tired
  • Drowsiness
  • Nausea or vomiting

There may be other side effects of rufinamide that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of rufinamide?

While less common, the most serious side effects of rufinamide are described below, along with what to do if they happen.

Suicidal Thoughts and Actions. Rufinamide may cause suicidal thoughts or actions in a small number of people. If you are about to harm yourself, call 911 or call or text 988, the Suicide & Crisis Lifeline. Call your health care provider right away if you have any of the following symptoms.

  • New or increased thoughts of suicide or death
  • Suicide attempt
  • New or increased feelings of anxiety, depression, or other unusual changes in mood or behavior

Nervous System Problems. Rufinamide can make you dizzy, weak, tired, or sleepy. It can also slow your thinking and cause trouble walking and may affect your balance or coordination. Do not drive or do other activities that require alertness or coordination until you know how rufinamide affects you.

Severe Allergic Reactions. Rufinamide may cause allergic reactions, including a specific type of allergic reaction called DRESS. DRESS stands for drug reaction with eosinophilia and systemic symptoms. It is also sometimes called multiorgan hypersensitivity. This is a reaction that can affect multiple parts of the body, including your liver, kidneys, and heart. Get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Itching, skin rash, or pale red bumps on the skin called hives
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Shortness of breath, trouble swallowing, or throat tightness
  • Swelling in your feet, ankles, or legs
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain
  • Dark-colored pee
  • Your skin or the whites of your eyes turning yellowish in color (also called jaundice)

Low White Blood Cell Levels (Leukopenia). Rufinamide can cause low white blood cell levels (leukopenia). Get help right away if you have any of the following symptoms.

  • Fever
  • Shortness of breath
  • Frequent infections
  • Unusual weakness or tiredness

Warnings & Precautions

Who should not use rufinamide?

Allergies to Ingredients. People who are allergic to any of the following should not take rufinamide.

  • Banzel
  • Rufinamide
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in the specific rufinamide products they stock.

Familial Short QT Syndrome. Rufinamide should not be used in people with familial short QT syndrome, a rare inherited condition that causes irregular heart rhythms.

What should I know about rufinamide before using it?

Do not take rufinamide unless it has been prescribed to you by a health care provider. Take it as prescribed. Take each dose with food.

If you are taking the liquid, read and follow the “Instructions for Use” that comes with your medicine. U​se the adapter and dosing syringe that comes with your medicine to measure your dose. A household spoon is not an accurate measuring device and may cause you to take the wrong dose. Shake the bottle well before measuring each dose. 

If you have trouble swallowing the tablets whole, you can cut them in half or crush them. 

Do not share rufinamide with other people, even if they have the same condition as you. It may harm them.

Keep rufinamide out of the reach of children.

While rufinamide helps make seizures less likely, it does not cure them. Do not stop taking rufinamide without talking to your health care provider. Stopping rufinamide suddenly may cause an increase in seizure activity, which can be serious.

Rufinamide can affect your alertness or coordination. Do not drive or do other activities that require alertness or coordination until you know how rufinamide affects you.

While taking rufinamide, some birth control may not work as well. Talk with your health care provider about the best birth control options for you.

What should I tell my health care provider before using rufinamide?

Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if rufinamide is right for you.

In particular, make sure that you discuss any of the following.

Current and Past Health Conditions. Tell your health care provider if you have any of the following.

  • Liver problems
  • Heart problems
  • Blood problems
  • Mental health problems

Other Medicines and Supplements. Rufinamide may interact with other medicines and supplements. Before taking rufinamide, tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.

Pregnancy. It is not known if or how rufinamide could affect pregnancy or harm a fetus. Tell your health care provider if you are pregnant or plan to become pregnant. Your health care provider will let you know if you should take rufinamide while you are pregnant or trying to get pregnant. If you become pregnant while taking rufinamide, you can sign up for the North American Antiepileptic Drug Pregnancy Registry by calling 888-233-2334 or at www.aedpregnancyregistry.org. This registry collects safety information about the use of seizure medicines during pregnancy.

Breastfeeding. It is not known if rufinamide passes into breast milk. Tell your health care provider if you are breastfeeding or plan to breastfeed. Your health care provider will let you know if you should take rufinamide while breastfeeding.

Interactions

Does rufinamide interact with foods or drinks?

There are no known interactions between rufinamide and foods or drinks.

It is unknown if drinking alcohol will affect rufinamide. The risk of dizziness and drowsiness may increase if you drink alcohol while taking rufinamide. It is best to avoid drinking alcohol while you are taking this medicine.

Does rufinamide interact with other medicines (drug interactions)?

Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

In particular, make sure that you discuss if you are using any of the following before taking rufinamide.

  • Divalproex sodium, valproate sodium (Depakote and others), valproic acid, which are medicines used for seizures and other conditions
  • A birth control pill, patch, vaginal ring, implant, injection, or intrauterine device (IUD) that contains hormones
  • Any other medicine that causes dizziness and sleepiness, such as prescription pain medicines, sleep medicines, or medicines for anxiety

Some other medicines may alter the blood levels of rufinamide, and vice versa. Tell your health care provider about all medicines that you take or have recently taken.

This may not be a complete list of medicines that can interact with rufinamide. Always check with your health care provider.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much rufinamide?

If you or someone else has used too much rufinamide, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of rufinamide?

If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and only take the next dose. Do not take double or extra doses.