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

Along with its needed effects, rufinamide 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
  • chills
  • cough producing mucus
  • diarrhea
  • 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
  • runny nose
  • sensation of spinning
  • shakiness and unsteady walk
  • shivering
  • shortness of breath or troubled breathing
  • sore throat
  • stuffy or runny nose
  • sweating
  • tightness in the chest
  • trouble in walking
  • trouble sitting still
  • trouble sleeping
  • unsteadiness, trembling, or other problems with muscle control or coordination
  • unusual tiredness or weakness
  • vomiting
  • wheezing
  • Black, tarry stools
  • bleeding gums
  • blood in the urine or stools
  • burning while urinating
  • chest pain
  • difficult or painful urination
  • 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
  • sores, ulcers, or white spots on the lips or in the mouth
  • swollen glands
  • swollen, painful, or tender lymph glands in the neck, armpit, or groin
  • troubled breathing with exertion
  • unusual bleeding or bruising
  • waking to urinate at night

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
  • Increased appetite

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


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


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


Psychiatric side effects have included anxiety (3%).


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


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


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


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


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

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.