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Vigabatrin solution may cause permanent vision loss in a high percentage of patients. This effect may occur within weeks or sooner after starting treatment. It may also occur after months or years. The risk may increase with higher doses and prolonged use, but it may occur with any dose or length of use. Vision loss may continue to worsen after stopping vigabatrin solution.
Vision loss may not be detected until it is severe. Parents or caregivers may not be able to recognize the symptoms of vision loss. Eye exams will be performed at the start of treatment and at least every 3 months during treatment. They will also be performed for 3 to 6 months after treatment stops. Some patients may develop severe vision loss even with monitoring.
Tell the doctor if the patient has or is at risk for developing another type of permanent vision loss. Tell the doctor if the patient uses other medicines that may cause serious vision problems (eg, retinopathy, glaucoma). Vigabatrin solution should not be used in these patients unless the benefit outweighs the risks.
Use the lowest dose of vigabatrin solution for the shortest time needed. Talk with your doctor about how long you should take vigabatrin solution.
Treating infantile spasms (IS) in children 1 month to 2 years old. It is also used to treat refractory complex partial seizures (CPS) that have not responded to several other treatments. It may also be used for other conditions as determined by your doctor.
Vigabatrin solution is an antiepileptic. Exactly how it works is not known, but it may work by blocking certain enzymes in the brain.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with vigabatrin solution. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
Some MEDICINES MAY INTERACT with vigabatrin solution. Tell your health care provider if you are taking any other medicines, especially any of the following:
This may not be a complete list of all interactions that may occur. Ask your health care provider if vigabatrin solution may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
Use vigabatrin solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use vigabatrin solution.
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Constipation; cough; decreased appetite; diarrhea; dizziness; drowsiness; headache; irritability; joint pain; nausea; sore throat; stomach pain or upset; stuffy or runny nose; tiredness; trouble sleeping; vomiting; weakness; weight gain.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); burning, numbness, or tingling of the hands or feet; confusion; decreased coordination; ear pain or discharge; fever, chills, or persistent sore throat; increased or painful urination; memory or attention problems; new or worsening mental, mood, or behavior changes (eg, aggressiveness, agitation, depression, exaggerated feeling of well-being, hostility, impulsiveness, irritability, panic attacks, restlessness, or inability to sit still); new or worsening seizures; painful menstrual period; suicidal thoughts or actions; tremor; trouble walking; uncontrolled eye movements; unusual swelling (eg, of the hands or feet); unusual tiredness or weakness; vision changes (eg, blurred vision, double vision); vision loss (eg, loss of the outer edges of your vision).
This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.Proper storage of vigabatrin solution:
Store vigabatrin solution at room temperature, between 68 and 77 degrees F (20 and 25 degrees C), in the original container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep vigabatrin solution out of the reach of children and away from pets
This information should not be used to decide whether or not to take vigabatrin solution or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about vigabatrin solution. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to vigabatrin solution. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using vigabatrin solution.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.
It is possible that some side effects of vigabatrin may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.
Applies to vigabatrin: oral powder, oral powder for solution, oral tablet
As well as its needed effects, vigabatrin may cause unwanted side effects that require medical attention.
If any of the following side effects occur while taking vigabatrin, check with your doctor immediately:More common
Some vigabatrin side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:More common
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.[Ref]
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.[Ref]
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.[Ref]
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.[Ref]
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.[Ref]
Metabolic side effects including increased weight (up to 14%) and increased appetite (up to 5%) have been reported.[Ref]
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.[Ref]
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.[Ref]
Genitourinary side effects including dysmenorrhea (up to 9%) and erectile dysfunction (up to 5%) have been reported.[Ref]
Other side effects including vertigo (up to 5%), tinnitus (up to 2%), and deafness have been reported.[Ref]
Dermatologic side effects including rash (up to 5%), angioedema, maculopapular rash, pruritus, Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) have been reported.[Ref]
Renal side effects including urinary tract infection (up to 5%) have been reported.[Ref]
Endocrine side effects including delayed puberty have been reported.[Ref]
Hepatic side effects including cholestasis have been reported.[Ref]
1. "Product Information. Sabril (vigabatrin)." Lundbeck Inc, Deerfield, IL.
2. Mecarelli O, Rinalduzzi S, Accornero N "Changes in color vision after a single dose of vigabatrin or carbamazepine in healthy volunteers." Clin Neuropharmacol 24 (2001): 23-6
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