Rufinamide Side Effects
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. Continue reading for a comprehensive list of adverse effects.
Applies to rufinamide: oral suspension, oral tablets.
Side effects include:
Adjunctive therapy in pediatric patients: Somnolence, headache, fatigue, dizziness, influenza, nasopharyngitis, nausea, vomiting, decreased appetite, constipation, stomach pain, decreased weight, cough, sinusitis, bronchitis, pneumonia, otitis media, rash, pruritus, ataxia, diplopia, aggression, hyperactivity, disturbance in attention.
Adjunctive therapy in adults: Headache, dizziness, fatigue, somnolence, diplopia, tremor, nystagmus, blurred vision, nausea, vomiting, stomach pain, constipation, dyspepsia, ataxia, anxiety, back pain, gait disturbance, vertigo.
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]
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References
1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
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.