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]