Rufinamide Side Effects

Some side effects of rufinamide may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to rufinamide: oral suspension, oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking rufinamide: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, depression, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, agitated, hostile, aggressive, restless, irritable, hyperactive, talkative, or have thoughts about suicide or hurting yourself.

Stop using rufinamide and call your doctor at once if you have any of these serious side effects:

• fever, swollen glands, body aches, flu symptoms, feeling very weak or tired;

• painful sores in or around your eyes or mouth, sore throat, trouble swallowing;

• loss of balance or coordination, trouble walking;

• skin rash, easy bruising or bleeding, severe tingling, numbness, pain, severe muscle pain or weakness;

• upper stomach pain, loss of appetite, dark urine, jaundice (yellowing of the skin or eyes);

• chest pain, irregular heart rhythm, feeling short of breath;

• confusion, nausea and vomiting, swelling, rapid weight gain;

• lower back pain, bloody urine, urinating less than usual;

• pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;

• new or worsening cough with fever, trouble breathing; or

• worsening of seizures.

Less serious side effects of rufinamide may include:

• headache;

• dizziness, drowsiness;

• increased or decreased appetite;

• nausea, vomiting;

• stuffy nose, sinus pain; or

• blurred vision.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

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.

General

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

Gastrointestinal

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

Ocular

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

Psychiatric

Psychiatric side effects have included anxiety (3%).

Musculoskeletal

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

Hematologic

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

Renal

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

Metabolic

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

Cardiovascular

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

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