Banzel Side Effects
Generic name: rufinamide
Note: This document contains side effect information about rufinamide. Some dosage forms listed on this page may not apply to the brand name Banzel.
Applies to rufinamide: oral suspension, oral tablet.
Serious side effects of Banzel
Along with its needed effects, rufinamide (the active ingredient contained in Banzel) 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 Banzel
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
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
More about Banzel (rufinamide)
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Related treatment guides
References
1. Cerner Multum, Inc. UK Summary of Product Characteristics.
2. Product Information. Banzel (rufinamide). Eisai Inc. 2008.
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.