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Vigabatrin Side Effects

In Summary

Commonly reported side effects of vigabatrin include: arthralgia, blurred vision, confusion, depression, diplopia, fatigue, weight gain, abnormal gait, ataxia, cough, diarrhea, drowsiness, memory impairment, tremor, irritability, and pharyngolaryngeal pain. Other side effects include: status epilepticus, urinary tract infection, pulmonary congestion, abnormality in thinking, asthenia, depressed mood, dysmenorrhea, erectile dysfunction, eye pain, muscle twitching, paresthesia, peripheral edema, sinus headache, abnormal behavior, anemia, back pain, bronchitis, chest pain, constipation, fever, hypoesthesia, hyporeflexia, lethargy, myalgia, nervousness, nystagmus, peripheral neuropathy, sedation, sensory disturbance, toothache, upper abdominal pain, vertigo, malaise, abnormal dreams, bruise, and increased appetite. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to vigabatrin: oral powder, oral powder for solution, oral tablet

Along with its needed effects, vigabatrin 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 vigabatrin:

More common
  • Blue-yellow color blindness
  • blurred vision
  • decreased vision or other vision changes
  • eye pain
  • increase in seizures
  • loss of memory
  • problems with memory
Less common or rare
  • Uncontrolled rolling eye movements

Get emergency help immediately if any of the following symptoms of overdose occur while taking vigabatrin:

Symptoms of overdose
  • Change in or loss of consciousness

Some side effects of vigabatrin 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
  • Agitation
  • burning, tingling, or prickly sensations
  • clumsiness or unsteadiness
  • confusion
  • constipation
  • diarrhea
  • dizziness
  • double vision or seeing double
  • increased movement
  • joint pain
  • mental depression
  • sleepiness or unusual drowsiness
  • stomach pain
  • trembling
  • tremor
  • trouble sitting still
Less common
  • Aggression
  • headache
  • increased saliva
  • muscle weakness
  • nausea
  • poor concentration
  • speech disorder
  • trouble sleeping
  • unusual thoughts
  • vomiting
  • weight gain

For Healthcare Professionals

Applies to vigabatrin: oral powder for reconstitution, oral tablet

Ocular

Very common (10% or more): Visual field defect (30% or more of patients can be affected with bilateral concentric visual field constriction ranging in severity from mild to severe), nystagmus (up to 19%), blurred vision (up to 16%), diplopia (up to 16%)
Common (1% to 10%): Asthenopia, eye pain, strabismus, conjunctivitis
Rare (0.01% to 0.1%): Retinal disorder (such as peripheral retinal atrophy)
Very rare (less than 0.01%): Optic neuritis, optic atrophy[Ref]

Dermatologic

Common (1% to 10%): Acne
Uncommon (0.1% to 1%): Rash
Rare (less than 0.1%): Angioedema, urticaria[Ref]

Gastrointestinal

Very common (10% or more): Diarrhea (up to 16%), nausea (up to 10%)
Common (1% to 10%): Vomiting, abdominal pain, upper abdominal pain, constipation, dyspepsia, stomach discomfort, toothache, abdominal distention, thirst[Ref]

General

-Visual field defects ranging from mild to severe have been reported frequently in patients receiving this drug. Severe cases are potentially disabling. The onset is usually after months to years of therapy. One-third of patients receiving therapy with this drug develop visual field defects.
-Approximately 50% of patients in clinical studies have experienced undesirable effects during treatment. In adults, these were mostly central nervous system related such as sedation, drowsiness, fatigue, and impaired concentration. Excitation or agitation is frequent in children. The incidence of these undesirable effects is generally higher at the beginning of treatment and decreases with time.
-Some patients may experience an increase in seizure frequency, including status epilepticus with this drug. Patients with myoclonic seizures may be particularly liable to this effect. New onset myoclonus and exacerbation of existing myoclonus may occur in rare cases.[Ref]

Genitourinary

Common (1% to 10%): Urinary tract infection, dysmenorrhea, erectile dysfunction[Ref]

Hepatic

Very rare (less than 0.01%): Hepatitis
Frequency not reported: Decreases in ALT and AST[Ref]

Metabolic

Very common (10% or more): Weight gain (up to 14%)
Common (1% to 10%): Increased appetite[Ref]

Musculoskeletal

Very common (10% or more): Arthralgia
Common (1% to 10%): Joint sprain, muscle strain, back pain, pain in extremity, myalgia, muscle twitching, muscle spasms[Ref]

Nervous system

Very common (10% or more): Headache (up to 33%), somnolence (up to 26%), dizziness (up to 26%), tremor (up to 16%), memory impairment (up to 16%), abnormal coordination (up to 16%)
Common (1% to 10%): Speech disorder, sensory disturbance, paresthesia, movement disorder (including dystonia, dyskinesia, and hypertonia), either alone or in association with abnormalities in MRI, hyperreflexia, hyporeflexia, hyperesthesia, hypoesthesia, status epilepticus, dysarthria, postical state, sensory loss
Uncommon (0.1% to 1%): Coordination abnormal (ataxia)
Rare (0.01% to 0.1%): Encephalopathy (e.g., sedation, stupor, confusion)
Very rare (less than 0.01%): Optic neuritis, optic atrophy (see also OCULAR)
Frequency not reported: Increase in seizure frequency[Ref]

Other

Very common (10% or more): Fatigue (up to 40%), gait disturbance (up to 12%)
Common (1% to 10%): Edema, tinnitus, vertigo, peripheral edema[Ref]

Psychiatric

Very common (10% or more): Excitation (children), agitation (children)
Common (1% to 10%): Agitation, aggression, nervousness, depression, paranoid reaction, irritability, asthenia, fever, thirst, malaise, expressive language disorder, abnormal dreams, mental impairment (thought disturbance), lethargy, disturbance in attention
Uncommon (0.1% to 1%): Hypomania, mania, psychotic disorder
Rare (0.01% to 0.1%): Suicide attempt
Very rare (less than 0.01%): Hallucination[Ref]

Respiratory

Very common (10% or more): Upper respiratory tract infection (up to 51%) Nasopharyngitis (up to 14%), pharyngeal pain (up to 14%), cough (up to 14%)
Common (1% to 10%): Bronchitis, pulmonary congestion, sinus headache[Ref]

Cardiovascular

Common (1% to 10%): Chest pain[Ref]

Hematologic

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

Immunologic

Very common (10% or more): Viral infection (up to 20%), pneumonia (up to 13%)
Common (1% to 10%): Influenza
Uncommon (0.1% to 1%): Candidiasis, ear infection, croup infectious[Ref]

References

1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

2. Cerner Multum, Inc. "Australian Product Information." O 0

3. "Product Information. Sabril (vigabatrin)." Lundbeck Inc, Deerfield, IL.

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

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. Drugs.com 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.

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