Note: This document contains side effect information about vigabatrin. Some dosage forms listed on this page may not apply to the brand name Vigadrone.

Summary

Common side effects of Vigadrone 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, abnormal sensory symptoms, anemia, back pain, bronchitis, chest pain, constipation, fever, hypoesthesia, hyporeflexia, lethargy, myalgia, nervousness, nystagmus disorder, peripheral neuropathy, sedated state, toothache, upper abdominal pain, vertigo, malaise, abnormal dreams, bruise, and increased appetite. Continue reading for a comprehensive list of adverse effects.

Applies to vigabatrin: oral powder for oral solution, oral tablets.

Side effects include:

Causes permanent vision damage in a high percentage of patients. (See Permanent Vision Loss under Boxed Warning and also under Cautions.)

Adults (>16 years of age) with refractory complex partial seizures: Headache, fatigue, somnolence, dizziness, nystagmus, tremor, convulsion, nasopharyngitis, blurred vision, diplopia, memory impairment, insomnia, irritability, upper respiratory tract infection, abnormal coordination, pharyngolaryngeal pain, diarrhea, nausea, vomiting, constipation, upper abdominal pain, increased weight, dysmenorrhea, depression, confusional state, asthenia, peripheral edema, fever/pyrexia, influenza, arthralgia, back pain, pain in extremities, disturbance in attention, sensory disturbance, hyporeflexia, paresthesia.

Pediatric patients 10–16 years of age with refractory complex partial seizures: Increased weight, upper respiratory tract infection, fatigue, abnormal behavior, diarrhea, influenza, otitis media, somnolence, tremor, aggression, diplopia, nystagmus.

Pediatric patients with infantile spasms: Somnolence, bronchitis, ear infection, acute otitis media.

For Healthcare Professionals

Applies to vigabatrin: oral powder for reconstitution, oral tablet.

General

The more commonly reported adverse reactions have included headache, somnolence, fatigue, dizziness, weight gain, tremor and visual field defects. This drug can cause permanent vision loss.^[Ref]

Ocular

Based on adult studies, 30 percent or more of patients can be affected with bilateral concentric visual field constriction ranging in severity from mild to severe. Severe cases may be characterized by tunnel vision to within 10 degrees of visual fixation, which can result in disability. In some cases, damage can occur to the central retina and may decrease visual acuity.^[Ref]

Very common (10% or more): Visual field defect (30% or more), 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]

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)

Frequency not reported: Increase in seizure frequency

Postmarketing reports: Dystonia, encephalopathy, hypertonia, hypotonia, muscle spasticity, myoclonus, optic neuritis, dyskinesia^[Ref]

Magnetic Resonance Imaging (MRI) Abnormalities in Infants:

-Abnormal MRI signal changes characterized by increased T2 signal and restricted diffusion in a symmetric pattern involving the thalamus, basal ganglia, brain stem, and cerebellum have been observed in some infants treated with this drug for infantile spasms. Some infants exhibited coincident motor abnormalities, but no causal relationship has been established.^[Ref]

Dermatologic

Common (1% to 10%): Acne

Uncommon (0.1% to 1%): Rash

Rare (less than 0.1%): Angioedema, urticaria

Postmarketing reports: Facial edema, angioedema, maculo-papular rash, pruritus, Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), alopecia^[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

Postmarketing reports: Acute psychosis, apathy, delirium, hypomania, neonatal agitation, psychotic disorder^[Ref]

Metabolic

Very common (10% or more): Weight gain (up to 14%)

Common (1% to 10%): Increased appetite^[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

Postmarketing reports: Deafness, malignant hyperthermia, multi-organ failure^[Ref]

Hematologic

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

Endocrine

The following birth defects have been reported during the postmarketing period: congenital cardiac defects, congenital external ear anomaly, congenital hemangioma, congenital hydronephrosis, congenital male genital malformation, congenital oral malformation, congenital vesicoureteric reflux, dentofacial anomaly, dysmorphism, fetal anticonvulsant syndrome, hamartomas, hip dysplasia, limb malformation, limb reduction defect, low set ears, renal aplasia, retinitis pigmentosa, supernumerary nipple, and talipes.

Postmarketing reports: Birth Defects, delayed puberty, developmental delay

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

Postmarketing reports: Gastrointestinal hemorrhage, esophagitis^[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

Postmarketing reports: Cholestasis^[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]

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

Postmarketing reports: Laryngeal edema, pulmonary embolism, respiratory failure, stridor^[Ref]

Cardiovascular

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