Medications and Drugs

Brand Names: Banzel

Generic Name: rufinamide (Pronunciation: roo FIN a mide)

What is rufinamide (Banzel)?

Rufinamide is an anti-epileptic medication, also called an anticonvulsant.

Rufinamide is used in combination with other medications to treat seizures caused by Lennox-Gastaut syndrome, a severe form of childhood epilepsy that also causes developmental and behavior problems.

Rufinamide may also be used for purposes not listed in this medication guide.

What are the possible side effects of rufinamide (Banzel)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, depression, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, agitated, hostile, aggressive, restless, irritable, hyperactive, talkative, or have thoughts about suicide or hurting yourself.

Stop using rufinamide and call your doctor at once if you have any of these serious side effects:

fever, swollen glands, body aches, flu symptoms, feeling very weak or tired;
painful sores in or around your eyes or mouth, sore throat, trouble swallowing;
loss of balance or coordination, trouble walking;
skin rash, easy bruising or bleeding, severe tingling, numbness, pain, severe muscle pain or weakness;
upper stomach pain, loss of appetite, dark urine, jaundice (yellowing of the skin or eyes);
chest pain, irregular heart rhythm, feeling short of breath;
confusion, nausea and vomiting, swelling, rapid weight gain;
lower back pain, bloody urine, urinating less than usual;
pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;
new or worsening cough with fever, trouble breathing; or
worsening of seizures.

Less serious side effects may include:

headache;
dizziness, drowsiness;
increased or decreased appetite;
nausea, vomiting;
stuffy nose, sinus pain; or
blurred vision.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about rufinamide (Banzel)?

You should not use this medication if you are allergic to rufinamide, or if you have a genetic heart rhythm disorder called "Short QT syndrome."

Before taking rufinamide, tell your doctor if you have heart disease, liver disease, kidney disease (or if you are on dialysis), or a history of depression, mental illness, or suicidal thoughts or actions.

It is not known whether rufinamide will harm an unborn baby, but having a seizure during pregnancy could harm both the mother and the baby. Tell your doctor right away if you become pregnant while taking rufinamide for seizures. Do not start or stop taking rufinamide during pregnancy without your doctor's advice.

You may have thoughts about suicide while taking this medication. Your doctor will need to check you at regular visits. Do not miss any scheduled appointments.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, depression, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, agitated, hostile, aggressive, restless, irritable, hyperactive, talkative, or have thoughts about suicide or hurting yourself.

Do not stop using rufinamide without first talking to your doctor, even if you feel fine. You may have increased seizures if you stop using rufinamide suddenly. You may need to use less and less before you stop the medication completely.

Contact your doctor if your seizures get worse or you have them more often while taking rufinamide.

What should I discuss with my healthcare provider before taking rufinamide (Banzel)?»

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Report Problems to the Food and Drug Administration

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.