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Rufinamide Side Effects

In Summary

Commonly reported side effects of rufinamide include: seizure, dizziness, drowsiness, fatigue, headache, nausea, and vomiting. Other side effects include: status epilepticus, ataxia, blurred vision, diplopia, and skin rash. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to rufinamide: oral suspension, oral tablet

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

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

Nervous system

Very common (10% or more): Somnolence, headache, dizziness

Common (1% to 10%): Status epilepticus, convulsion, abnormal coordination, nystagmus, psychomotor hyperactivity, tremor[Ref]

General

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

References

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

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

Further information

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.

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