Rufinamide Side Effects

Medically reviewed by Philip Thornton, DipPharm. Last updated on Nov 2, 2022.

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]

Frequently asked questions

• What is the mechanism of action of Banzel (rufinamide)?

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.

Medical Disclaimer