Sabril Side Effects

Generic name: vigabatrin

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

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

For the Consumer

Applies to vigabatrin: oral powder for reconstitution, oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking vigabatrin (the active ingredient contained in Sabril) hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

• any change in your vision, no matter how mild;

• back and forth eye movements you cannot control;

• tremors;

• pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;

• worsening seizures; or

• confusion, mood or behavior changes, depression, thoughts about suicide or hurting yourself.

Less serious side effects of vigabatrin may include:

• headache, feeling irritable;

• dizziness, drowsiness, tired feeling;

• memory problems;

• weight gain, swelling anywhere in your body;

• numbness, burning pain, or tingly feeling in your hands or feet;

• loss of coordination;

• joint pain;

• cold symptoms such as stuffy nose, fever, sneezing, sore throat;

• nausea, vomiting, diarrhea; or

• sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to vigabatrin: oral powder for reconstitution, oral tablet

General

General side effects including fatigue (up to 40%), gait disturbance (up to 12%), asthenia (up to 7%), peripheral edema (up to 7%), influenza (up to 7%), chest pain (up to 5%), malaise (up to 5%), contusion (up to 5%), wound secretion (up to 2%), thirst (up to 2%), developmental delay, facial edema, malignant hyperthermia, and multi-organ failure have been reported.

Nervous system

Nervous system side effects including headache (up to 33%), somnolence (up to 26%), dizziness (up to 26%), nystagmus (up to 19%), tremor (up to 16%), memory impairment (up to 16%), abnormal coordination (up to 16%), disturbance in attention (up to 9%), sensory disturbance (up to 7%), paraesthesia (up to 7%), lethargy (up to 7%), hypoesthesia (up to 5%), status epilepticus (up to 5%), sensory loss (up to 5%), hyporeflexia (up to 5%), hyperreflexia (up to 4%), sedation (up to 4%), dysarthria (2%), postictal state (up to 2%), dystonia, encephalopathy, hypertonia, hypotonia, and optic neuritis have been reported.

Psychiatric

Psychiatric side effects including irritability (up to 23%), depression (up to 14%), confusional state (up to 14%), expressive language disorder (up to 7%), abnormal thinking (up to 7%), depressed mood (up to 5%), abnormal behavior (up to 5%), nervousness (up to 5%), abnormal dreams (up to 5%), anxiety (up to 4%), acute psychosis, apathy, delirium, hypomania, neonatal agitation, and psychotic disorder have been reported.

Gastrointestinal

Gastrointestinal side effects including diarrhea (up to 16%), nausea (up to 10%), vomiting (up to 9%), constipation (up to 8%), upper abdominal pain (5%), dyspepsia (up to 5%), toothache (up to 5%), stomach discomfort (up to 4%), abdominal pain (up to 3%), abdominal distension (up to 2%), gastrointestinal hemorrhage, and esophagitis have been reported.

Ocular

Ocular side effects including blurred vision (up to 16%), diplopia (up to 16%), eye pain (5%), asthenopia (2%), and changes in color vision have been reported.

Metabolic

Metabolic side effects including increased weight (up to 14%) and increased appetite (up to 5%) have been reported.

Respiratory

Respiratory side effects including nasopharyngitis (up to 14%), pharyngolaryngeal pain (up to 14%), cough (up to 14%), upper respiratory tract infection (up to 9%), sinus headache (up to 6%), pulmonary congestion (up to 5%), bronchitis (up to 5%), laryngeal edema, pulmonary embolism, respiratory failure, and stridor have been reported.

Musculoskeletal

Musculoskeletal side effects including arthralgia (up to 10%), muscle twitching (up to 9%), back pain (up to 7%), pain in extremity (up to 6%), myalgia (up to 5%), muscle spasms (up to 3%), joint sprain (up to 2%), muscle strain (up to 2%), and myoclonus have been reported.

Genitourinary

Genitourinary side effects including dysmenorrhea (up to 9%) and erectile dysfunction (up to 5%) have been reported.

Other

Other side effects including vertigo (up to 5%), tinnitus (up to 2%), and deafness have been reported.

Dermatologic

Dermatologic side effects including rash (up to 5%), angioedema, maculopapular rash, and pruritus have been reported.

Renal

Renal side effects including urinary tract infection (up to 5%) have been reported.

Endocrine

Endocrine side effects including delayed puberty have been reported.

Hepatic

Hepatic side effects including cholestasis have been reported.

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