Rufinamide Side Effects

Medically reviewed by Philip Thornton, DipPharm. Last updated on Nov 4, 2024.

Applies to rufinamide: oral suspension, oral tablet.

Precautions

It is very important that your doctor check you or your child's progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

If you or your child develop any unusual or strange thoughts and behavior while taking this medicine, be sure to discuss it with your doctor. Some changes that have occurred in people taking this medicine are like those seen in people who drink too much alcohol. Other changes might be confusion, worsening of depression, hallucinations (seeing, hearing, or feeling things that are not there), suicidal thoughts, and unusual excitement, nervousness, or irritability.

This medicine may cause some people to become dizzy, drowsy, lightheaded, clumsy, unsteady, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert or able to think or see well.

This medicine may cause serious allergic reactions that may affect several parts of the body (eg, liver, kidneys, or heart). Check with your doctor right away if you or your child have more than one of the following symptoms: a fever, dark-colored urine, headache, rash, itching, extra fluid around the face, stomach pain, swollen, painful, or tender lymph glands in neck, armpit, or groin, unusual tiredness, or yellow eyes or skin.

Do not suddenly Stop taking rufinamide without checking first with your doctor. Your seizures may return or occur more often if you stop this medicine suddenly. Your doctor may want you to gradually reduce the amount you are using before stopping it completely.

Check with your doctor if you notice any signs of fever, chills, or sore throat. These could be symptoms of an infection resulting from low white blood cell counts.

Birth control pills may not work as well while you are using this medicine. To keep from getting pregnant, use another form of birth control together with your birth control pills. Other forms include condoms, diaphragms, or contraceptive foams or jellies.

Avoid drinking alcohol while taking this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Serious side effects of rufinamide

Along with its needed effects, rufinamide may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking rufinamide:

Other side effects of rufinamide

Some side effects of rufinamide may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

For healthcare professionals

Applies to rufinamide: oral suspension, oral tablet.

General adverse events

The most commonly reported adverse reactions overall were headache, dizziness, fatigue, and somnolence.^[Ref]

Nervous system

• Very common (10% or more): Somnolence, headache, dizziness
• Common (1% to 10%): Status epilepticus, convulsion, abnormal coordination, nystagmus, psychomotor hyperactivity, tremor^[Ref]

Gastrointestinal

• Very common (10% or more): Nausea, vomiting
• Common (1% to 10%): Upper abdominal pain, constipation, dyspepsia, diarrhea^[Ref]

Ocular

• Common (1% to 10%): Diplopia, blurred vision, nystagmus^[Ref]

Psychiatric

• Common (1% to 10%): Anxiety, insomnia
• Frequency not reported: Suicidal behavior and ideation^[Ref]

Musculoskeletal

• Common (1% to 10%): Back pain^[Ref]

Hematologic

• Very common (10% or more): Anemia
• Uncommon (0.1% to 1%): Lymphadenopathy, leukopenia, neutropenia, iron deficiency anemia, thrombocytopenia^[Ref]

Metabolic

• Common (1% to 10%): Anorexia, eating disorder, decreased appetite, weight loss^[Ref]

Cardiovascular

• Uncommon (0.1% to 1%): Right bundle branch block, first degree atrioventricular block
• Frequency not reported: QT shortening^[Ref]

Dermatologic

• Common (1% to 10%): Rash, acne
• Postmarketing reports: Stevens-Johnson syndrome and other serious skin rashes with mucosal involvement^[Ref]

Genitourinary

• Common (1% to 10%): Oligomenorrhea^[Ref]

Hepatic

• Uncommon (0.1% to 1%): Hepatic enzymes increased^[Ref]

Hypersensitivity

• Frequency not reported: Multi-organ sensitivity reactions (DRESS)
• Postmarketing reports: DRESS^[Ref]

Immunologic

• Common (1% to 10%): Pneumonia, influenza, nasopharyngitis, ear infection sinusitis, rhinitis^[Ref]

Other

• Very common (10% or more): Fatigue
• Common (1% to 10%): Gait disturbance
• Frequency not reported: Head injury, contusion^[Ref]

Respiratory

• Common (1% to 10%): Epistaxis^[Ref]

See also:

Frequently asked questions

• What is the mechanism of action of Banzel (rufinamide)?

Further information

Rufinamide side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer