Banzel Side Effects

Generic Name: rufinamide

Note: This page contains information about the side effects of rufinamide. Some of the dosage forms included on this document may not apply to the brand name Banzel.

Not all side effects for Banzel may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to rufinamide: oral suspension, oral tablet

In addition to its needed effects, some unwanted effects may be caused by rufinamide (the active ingredient contained in Banzel). In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when 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
  • chills
  • cough producing mucus
  • diarrhea
  • 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
  • runny nose
  • sensation of spinning
  • shakiness and unsteady walk
  • shivering
  • shortness of breath or troubled breathing
  • sore throat
  • stuffy or runny nose
  • sweating
  • tightness in the chest
  • trouble in walking
  • trouble sitting still
  • trouble sleeping
  • unsteadiness, trembling, or other problems with muscle control or coordination
  • unusual tiredness or weakness
  • vomiting
  • wheezing
  • Black, tarry stools
  • bleeding gums
  • blood in the urine or stools
  • burning while urinating
  • chest pain
  • difficult or painful urination
  • 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
  • sores, ulcers, or white spots on the lips or in the mouth
  • swollen glands
  • swollen, painful, or tender lymph glands in the neck, armpit, or groin
  • troubled breathing with exertion
  • unusual bleeding or bruising
  • waking to urinate at night

Some of the side effects that can occur with rufinamide may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

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

Nervous system side effects have included headache (27%), dizziness (19%), somnolence (11%), tremor (6%), ataxia (4%), gait disturbance (3%), vertigo (3%), status epilepticus, seizures, insomnia, and psychomotor hyperactivity.[Ref]


General side effects have included fatigue (16%) and upper abdominal pain (3%).[Ref]


Gastrointestinal side effects have included nausea (12%), vomiting (5%), constipation (3%), dyspepsia (3%), abdominal pain, diarrhea, and decreased appetite.[Ref]


Ocular side effects have included diplopia (9%), blurred vision (6%), and nystagmus (6%).[Ref]


Psychiatric side effects have included anxiety (3%).[Ref]


Musculoskeletal side effects have included back pain (3%).[Ref]


Hematologic side effects including anemia have been reported frequently. Lymphadenopathy, leukopenia, neutropenia, iron deficiency anemia, and thrombocytopenia have been reported infrequently.


Renal side effects including pollakiuria have been reported frequently. Urinary incontinence, dysuria, hematuria, nephrolithiasis, polyuria, enuresis, nocturia, and incontinence have been reported infrequently.


Metabolic side effects including decreased appetite and increased appetite have been reported frequently.


Cardiovascular side effects including right bundle branch block and first degree atrioventricular block have been reported infrequently.


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

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