Rufinamide Side Effects

Medically reviewed by Philip Thornton, DipPharm. Last updated on Nov 2, 2023.

Applies to rufinamide: oral suspension, oral tablet.

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:

More common

• dizziness
• shakiness in the legs, arms, hands, or feet
• sleepiness or unusual drowsiness
• trembling or shaking of the hands or feet
• uncontrolled eye movements

Less common

• attack, assault, or force
• black, tarry stools
• chest pain
• chills
• cough
• cough producing mucus
• diarrhea
• difficult or painful urination
• difficulty with breathing
• dizziness or lightheadedness
• fear or nervousness
• feeling of constant movement of self or surroundings
• fever
• general feeling of discomfort or illness
• headache
• joint pain
• loss of appetite
• muscle aches and pains
• nausea
• pain or tenderness around the eyes and cheekbones
• rash
• restlessness
• sensation of spinning
• shakiness and unsteady walk
• shivering
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• stuffy or runny nose
• sweating
• swollen glands
• tightness in the chest
• trouble sitting still
• trouble sleeping
• trouble walking
• unsteadiness, trembling, or other problems with muscle control or coordination
• unusual bleeding or bruising
• unusual tiredness or weakness
• vomiting

Rare

• bleeding gums
• blood in the urine or stools
• burning while urinating
• fainting
• frequent urination
• inability to hold urine
• increased urge to urinate during the night
• increased volume of pale, dilute urine
• lower back or side pain
• pale skin
• pinpoint red spots on the skin
• pounding, slow heartbeat
• sore tongue
• swollen, painful, or tender lymph glands in the neck, armpit, or groin
• troubled breathing with exertion
• waking to urinate at night

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:

More common

• blurred vision
• double vision
• seeing double

Less common

• acid or sour stomach
• back pain
• belching
• change in hearing
• decreased appetite
• difficulty having a bowel movement (stool)
• ear drainage
• earache or pain in the ear
• heartburn
• indigestion
• itching skin
• stomach discomfort, upset, or pain
• upper abdominal or stomach pain

Rare

• increased appetite

For healthcare professionals

Applies to rufinamide: oral suspension, oral tablet.

General

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]

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.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer