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Rufinamide Side Effects

It is possible that some side effects of rufinamide may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to rufinamide: oral suspension, oral tablet

As well as its needed effects, rufinamide may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking rufinamide, check with your doctor immediately:

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
  • 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

Some rufinamide side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned 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
  • Increased appetite

For Healthcare Professionals

Applies to rufinamide: oral suspension, oral tablet

Nervous system

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


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


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


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


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


Common (1% to 10%): Back pain[Ref]


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


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


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


Common (1% to 10%): Rash, acne[Ref]


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


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


Frequency not reported: Multi-organ sensitivity reactions[Ref]


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


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


Common (1% to 10%): Epistaxis[Ref]


1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

2. "Product Information. Banzel (rufinamide)." Eisai Inc, Teaneck, NJ.

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