Sabril Side Effects

Generic name: vigabatrin

Medically reviewed by Philip Thornton, DipPharm. Last updated on Dec 27, 2022.

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

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

Warning

Oral route (Powder for Solution; Tablet)

Vigabatrin can cause permanent bilateral concentric visual field constriction, including tunnel vision that can result in disability. In some cases, vigabatrin may also decrease visual acuity.Risk increases with increasing dose and cumulative exposure, but there is no dose or exposure to vigabatrin known to be free of risk of vision loss.Risk of new and worsening vision loss continues as long as vigabatrin is used, and possibly after discontinuing vigabatrin.Baseline and periodic vision assessment is recommended for patients on vigabatrin. However, this assessment cannot always prevent vision damage.Vigabatrin is available only through a restricted program called the Vigabatrin REMS Program. Further information is available at www.vigabatrinREMS.com or 1-866-244-8175.

Serious side effects of Sabril

Along with its needed effects, vigabatrin (the active ingredient contained in Sabril) 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

Other side effects of Sabril

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.

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]