Sabril Side Effects

Generic name: vigabatrin

Medically reviewed by Philip Thornton, DipPharm. Last updated on Dec 27, 2023.

Note: This document provides detailed information about Sabril Side Effects associated with vigabatrin. Some dosage forms listed on this page may not apply specifically to the brand name Sabril.

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

Important warnings This medicine can cause some serious health issues

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 liquid, 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

• 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]

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]

Nervous system

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]

• 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]

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

• Postmarketing reports: Birth Defects, delayed puberty, developmental delay

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.

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]

Frequently asked questions

• How long does vigabatrin (Sabril) take to work?
• What is the vigabatrin REMS Program?

Further information

Sabril side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer