Sabril Side Effects

Generic name: vigabatrin

Medically reviewed by Philip Thornton, DipPharm. Last updated on Dec 27, 2024.

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.

Precautions

It is very important that your doctor check your or your child's progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

This medicine may cause permanent vision loss. Check with your doctor immediately if blurred vision, difficulty in reading, or any other change in vision occurs during or after treatment. It is very important that your ophthalmologist (eye doctor) check your child's or your eyes within 4 weeks after starting treatment, every 3 months during treatment, and about 3 to 6 months after stopping treatment with this medicine.

Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine (eg, magnetic resonance imaging or MRI).

This medicine may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. Make sure the doctor knows if you have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. Also tell the doctor if you have sudden or strong feelings, such as feeling nervous, angry, restless, violent, or scared. If you, your child, or your caregiver notice any of these side effects, tell your doctor right away.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away. Your doctor may want you to join a pregnancy registry for patients taking a seizure medicine.

This medicine may cause some people to become drowsy, sleepy, tired, or weak than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are drowsy or not alert.

Check with your doctor right away if you or your child are having burning, numbness, tingling, or painful sensations in the arms, hands, legs, or feet. These could be symptoms of a condition called peripheral neuropathy.

This medicine may increase your weight and cause swelling in your hands, ankles, or feet. Your doctor may need to check your weight on a regular basis while you are using this medicine. Talk to your doctor about ways to prevent weight gain.

Do not suddenly Stop taking vigabatrin (the active ingredient contained in Sabril) without checking first with your doctor. Your doctor may want to gradually reduce the amount you are using before stopping it completely. Stopping this medicine suddenly may cause seizures.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Serious side effects of Sabril

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:

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:

For healthcare professionals

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

General adverse events

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]

See also:

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.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer