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, oral powder for solution, oral tablet
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
- Uncontrolled rolling eye movements
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
- Abdominal or stomach pain
- abnormal coordination
- burning, tingling, or prickly sensations
- double vision or seeing double
- increased movement
- joint pain
- mental depression
- sleepiness or unusual drowsiness
- trouble sitting still
- increased saliva
- muscle weakness
- poor concentration
- speech disorder
- thinking abnormal
- trouble sleeping
- weight gain
For Healthcare Professionals
Applies to vigabatrin: oral powder for reconstitution, oral tablet
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 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 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 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 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 side effects including increased weight (up to 14%) and increased appetite (up to 5%) have been reported.
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 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 side effects including dysmenorrhea (up to 9%) and erectile dysfunction (up to 5%) have been reported.
Other side effects including vertigo (up to 5%), tinnitus (up to 2%), and deafness have been reported.
Dermatologic side effects including rash (up to 5%), angioedema, maculopapular rash, pruritus, Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) have been reported.
Renal side effects including urinary tract infection (up to 5%) have been reported.
Endocrine side effects including delayed puberty have been reported.
Hepatic side effects including cholestasis have been reported.
More about Sabril (vigabatrin)
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