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Ezogabine Side Effects

For the Consumer

Applies to ezogabine: oral tablet

Along with its needed effects, ezogabine 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 ezogabine:

More common
  • Decrease in the frequency of urination
  • decrease in the urine volume
  • difficulty with passing urine (dribbling)
  • painful urination
  • shakiness in the legs, arms, hands, or feet
Less common
  • Bloating or swelling of the face, arms, hands, lower legs, or feet
  • blood in the urine
  • burning while urinating
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • difficult urination
  • general feeling of discomfort or illness
  • muscle twitching or jerking
  • rapid weight gain
  • rhythmic movement of the muscles
  • tingling of the hands or feet
  • unusual tiredness or weakness
  • unusual weight gain or loss
Incidence not known
  • Agitation
  • back pain
  • black, tarry stools
  • bleeding gums
  • blurred vision
  • change in consciousness
  • chest pain
  • chills
  • cloudy urine
  • confusion
  • cough
  • difficult or labored breathing
  • dizziness
  • drowsiness
  • fainting
  • fever
  • headache
  • irritability
  • loss of consciousness
  • pain in the lower back or side
  • pinpoint red spots on the skin
  • sore throat
  • sores, ulcers, or white spots on the lips or in the mouth
  • stiff neck
  • swollen glands
  • tightness in the chest
  • unusual bleeding or bruising
  • vomiting

Some side effects of ezogabine 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
  • Being forgetful
  • clumsiness or unsteadiness
  • dizziness or lightheadedness
  • double vision
  • feeling of constant movement of self or surroundings
  • seeing double
  • sensation of spinning
  • sleepiness or unusual drowsiness
Less common
  • Absence of or decrease in the body movement
  • acid or sour stomach
  • belching
  • changes in patterns and rhythms of speech
  • confusion about identity, place, and time
  • cough
  • diarrhea
  • difficulty having a bowel movement (stool)
  • difficulty with swallowing
  • dry mouth
  • feeling that others are watching you or controlling your behavior
  • feeling that others can hear your thoughts
  • feeling, seeing, or hearing things that are not there
  • heartburn
  • increased appetite
  • increased sweating
  • indigestion
  • joint pain
  • lack or loss of strength
  • loss of appetite
  • loss of memory
  • muscle aches and pains
  • problems with speech or speaking
  • runny nose
  • severe mood or mental changes
  • shivering
  • slurred speech
  • stomach discomfort, upset, or pain
  • sweating
  • trouble sleeping
  • trouble walking
  • unusual behavior
  • weight gain
Incidence not known
  • False or unusual sense of wellbeing
  • hair loss or thinning of the hair
  • muscle spasms
  • rash
  • uncontrolled eye movements

For Healthcare Professionals

Applies to ezogabine: oral tablet

Ocular

Very common (10% or more): Retinal pigmentary abnormalities (up to 30%)
Common (1% to 10%): Diplopia, blurred vision
Frequency not reported: Decreased visual acuity, nystagmus
Postmarketing reports: Acquired vitelliform lesions[Ref]

Dermatologic

Very common (10% or more): Discoloration of the skin, palate, scleral, nail, conjunctiva, lip, and/or mucous membrane (up to 40%)
Uncommon (0.1% to 1%): Hyperhidrosis, skin rash
Frequency not reported: Alopecia[Ref]

Psychiatric

Common (1% to 10%): Confusional state, psychotic disorders, hallucinations, anxiety, disorientation
Frequency not reported: Euphoric mood[Ref]

Nervous system

Very common (10% or more): Dizziness (up to 23%), somnolence (up to 22%)
Common (1% to 10%): Memory impairment, tremor, vertigo, abnormal coordination, disturbance in attention, gait disturbance, aphasia, dysarthria, balance disorder, paresthesia, amnesia, myoclonus
Frequency not reported: Syncope, coma, encephalopathy[Ref]

Genitourinary

Common (1% to 10%): Urinary retention, urinary hesitation, dysuria, hematuria, chromaturia[Ref]

Gastrointestinal

Common (1% to 10%): Nausea, constipation, dyspepsia, dry mouth
Uncommon (0.1% to 1%): Dysphasia[Ref]

Hematologic

Frequency not reported: Leukopenia, neutropenia, thrombocytopenia[Ref]

Hepatic

Common (1% to 10%): Increased liver enzymes (less than 2%)
Frequency not reported: Nephrolithiasis[Ref]

Immunologic

Common (1% to 10%): Influenza[Ref]

Metabolic

Common (1% to 10%): Increased weight, increased appetite[Ref]

Musculoskeletal

Uncommon (0.1% to 1%): Hypokinesia
Frequency not reported: Muscle spasms[Ref]

Other

Very common (10% or more): Fatigue (up to 15%)
Common (1% to 10%): Asthenia, malaise, peripheral edema[Ref]

Renal

Uncommon (0.1% to 1%): Nephrolithiasis
Frequency not reported: Renal colic[Ref]

Respiratory

Frequency not reported: Dyspnea[Ref]

References

1. "Product Information. Potiga (ezogabine)." GlaxoSmithKline, Research Triangle Park, NC.

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

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