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Sabril

Last reviewed on RxList: 8/14/2019
Sabril Side Effects Center

Last reviewed on RxList 8/14/2019

Sabril (vigabatrin) is an anti-epileptic medication, also called an anticonvulsant, used in combination with other medications to treat complex partial seizures in adults and adolescents who are at least 16 years old. Sabril is usually given after other anti-epileptic medications have been tried without successful control of seizures. The powder form of Sabril is used to treat infantile spasms in babies and children between the ages of 1 month and 2 years. Common side effects of Sabril include:

  • headache,
  • irritability,
  • dizziness,
  • drowsiness,
  • tiredness,
  • memory problems,
  • weight gain,
  • swelling anywhere in your body,
  • numbness/burning pain/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).

Tell your doctor if you have serious side effects of of Sabril including:

  • any change in your vision, no matter how mild;
  • back and forth eye movements you cannot control;
  • tremors;
  • pale skin, lightheadedness, shortness of breath, rapid heart rate, trouble concentrating;
  • worsening seizures; or
  • confusion, mood or behavior changes, depression, or thoughts about suicide or hurting yourself.

The recommended dose of Sabril in adults is 3 g/day (1.5 g twice daily). Sabril may interact with cold or allergy medicines, sedatives, narcotics, sleeping pills, muscle relaxers, medicines for depression or anxiety, amiodarone, clonazepam, deferoxamine, ethambutol, hydroxychloroquine, phenytoin, tamoxifen, or steroids. Tell your doctor all medications and supplements you use. During pregnancy, Sabril should be used only if prescribed. Although Sabril might harm a fetus, having a seizure during pregnancy could harm both mother and baby. If you become pregnant while taking this drug, do not stop taking it without your doctor's advice. If you are pregnant, your name may be listed on a pregnancy registry to track the outcome of the pregnancy and to evaluate any effects of Sabril on the baby. Sabril passes into breast milk and may harm a nursing baby. Breastfeeding is not recommended while you are using this drug.

Our Sabril (vigabatrin) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

QUESTION

If you have had a seizure, it means you have epilepsy. See Answer
Sabril Consumer Information

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Taking vigabatrin can cause permanent vision loss. Tell your doctor right away about any changes in your vision. If a child is taking vigabatrin: Tell the doctor right away if the child shows signs of vision changes, such as bumping into things or being easily startled or surprised.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), depressed, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have:

  • increased or worsening seizures;
  • any change in your vision, no matter how mild;
  • unusual or involuntary eye movements;
  • severe drowsiness, fussiness, or feeding problems (in a baby taking vigabatrin);
  • numbness, tingling, or burning pain in your hands or feet;
  • weight gain with or without swelling;
  • signs of an ear infection--fever, ear pain or full feeling, trouble hearing, drainage from the ear, fussiness in a child; or
  • low red blood cells (anemia)--pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet.

Some babies treated with vigabatrin have had abnormal brain changes seen on magnetic resonance imaging (MRI). It is not known if these changes are caused by vigabatrin or if they are harmful. Tell any doctor who treats your baby that the child is taking vigabatrin.

Common side effects may include:

  • blurred vision or other eye problems;
  • drowsiness, dizziness, feeling tired;
  • problems with walking or coordination;
  • tremors or shaking;
  • aggressive behavior;
  • confusion, problems with thinking or memory;
  • weight gain;
  • joint pain;
  • cold symptoms such as stuffy nose, sneezing, sore throat; or
  • (in babies) fussiness, ear infection, cough, breathing problems.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Sabril (Vigabatrin Oral Solution)

SLIDESHOW

Epilepsy: Symptoms, Causes and Treatment See Slideshow
Sabril Professional Information

SIDE EFFECTS

The following serious and otherwise important adverse reactions are described elsewhere in labeling:

Clinical Trial Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In U.S. and primary non-U.S. clinical studies of 4,079 SABRIL treated patients, the most common (≥5%) adverse reactions associated with the use of SABRIL in combination with other AEDs were headache, somnolence, fatigue, dizziness, convulsion, nasopharyngitis, weight gain, upper respiratory tract infection, visual field defect, depression, tremor, nystagmus, nausea, diarrhea, memory impairment, insomnia, irritability, abnormal coordination, blurred vision, diplopia, vomiting, influenza, pyrexia, and rash.

The adverse reactions most commonly associated with SABRIL treatment discontinuation in ≥1% of patients were convulsion and depression.

In patients with infantile spasms, the adverse reactions most commonly associated with SABRIL treatment discontinuation in ≥1% of patients were infections, status epilepticus, developmental coordination disorder, dystonia, hypotonia, hypertonia, weight gain, and insomnia.

Refractory Complex Partial Seizures

Adults

Table 5 lists the adverse reactions that occurred in ≥2% and more than one patient per SABRIL treated group and that occurred more frequently than in placebo patients from 2 U.S. add-on clinical studies of refractory CPS in adults.

Table 5. Adverse Reactions in Pooled, Add-On Trials in Adults with Refractory Complex Partial Seizures

Body System
  Adverse Reaction
SABRIL dosage (mg/day)
3000
[N=134]
%
6000
[N=43]
%
Placebo
[N=135]
%
Ear Disorders
  Tinnitus 2 0 1
  Vertigo 2 5 1
Eye Disorders
  Blurred vision 13 16 5
  Diplopia 7 16 3
  Asthenopia 2 2 0
  Eye pain 0 5 0
Gastrointestinal Disorders
  Diarrhea 10 16 7
  Nausea 10 2 8
  Vomiting 7 9 6
  Constipation 8 5 3
  Upper abdominal pain 5 5 1
  Dyspepsia 4 5 3
  Stomach discomfort 4 2 1
  Abdominal pain 3 2 1
  Toothache 2 5 2
  Abdominal distension 2 0 1
General Disorders
  Fatigue 23 40 16
  Gait disturbance 6 12 7
  Asthenia 5 7 1
  Edema peripheral 5 7 1
  Fever 4 7 3
  Chest pain 1 5 1
  Thirst 2 0 0
  Malaise 0 5 0
Infections
  Nasopharyngitis 14 9 10
  Upper respiratory tract infection 7 9 6
  Influenza 5 7 4
  Urinary tract infection 4 5 0
  Bronchitis 0 5 1
Injury
  Contusion 3 5 2
  Joint sprain 1 2 1
  Muscle strain 1 2 1
  Wound secretion 0 2 0
Metabolism and Nutrition Disorders
  Increased appetite 1 5 1
  Weight gain 6 14 3
Musculoskeletal Disorders
  Arthralgia 10 5 3
  Back pain 4 7 2
  Pain in extremity 6 2 4
  Myalgia 3 5 1
  Muscle twitching 1 9 1
  Muscle spasms 3 0 1
Nervous System Disorders
  Headache 33 26 31
  Somnolence 22 26 13
  Dizziness 24 26 17
  Nystagmus 13 19 9
  Tremor 15 16 8
  Memory impairment 7 16 3
  Abnormal coordination 7 16 2
  Disturbance in attention 9 0 1
  Sensory disturbance 4 7 2
  Hyporeflexia 4 5 1
  Paraesthesia 7 2 1
  Lethargy 4 7 2
  Hyperreflexia 4 2 3
  Hypoaesthesia 4 5 1
  Sedation 4 0 0
  Status epilepticus 2 5 0
  Dysarthria 2 2 1
  Postictal state 2 0 1
  Sensory loss 0 5 0
Psychiatric Disorders
  Irritability 7 23 7
  Depression 6 14 3
  Confusional state 4 14 1
  Anxiety 4 0 3
  Depressed mood 5 0 1
  Abnormal thinking 3 7 0
  Abnormal behavior 3 5 1
  Expressive language disorder 1 7 1
  Nervousness 2 5 2
  Abnormal dreams 1 5 1
Reproductive System
  Dysmenorrhea 9 5 3
  Erectile dysfunction 0 5 0
Respiratory and Thoracic Disorders
  Pharyngolaryngeal pain 7 14 5
  Cough 2 14 7
  Pulmonary congestion 0 5 1
  Sinus headache 6 2 1
Skin and Subcutaneous Tissue Disorders
  Rash 4 5 4

Pediatrics 10 to 16 Years of Age

Table 6 lists adverse reactions from controlled clinical studies of pediatric patients receiving SABRIL or placebo as add-on therapy for refractory complex partial seizures. Adverse reactions that are listed occurred in at least 2% of SABRIL treated patients and more frequently than placebo. The median SABRIL dose was 49.4 mg/kg (range of 8.0 – 105.9 mg/kg).

Table 6. Adverse Reactions in Pooled, Add-On Trials in Pediatric Patients 10 to 16 Years of Age with Refractory Complex Partial Seizures

Body System
  Adverse Reaction
All SABRIL
[N=109]
%
Placebo
[N=46]
%
Eye Disorders
  Diplopia 5 0
  Blurred vision 3 0
Gastrointestinal Disorders
  Diarrhea 6 2
  Upper abdominal pain 3 0
  Constipation 3 2
General Disorders
  Fatigue 9 4
Infections and Infestations
  Upper respiratory tract infection 10 4
  Influenza 6 2
  Otitis media 6 2
Investigations
  Weight gain 17 2
Nervous System Disorders
  Somnolence 6 2
  Tremor 6 0
  Nystagmus 5 2
  Psychomotor hyperactivity 4 2
Psychiatric Disorders
  Abnormal behavior 6 2
  Aggression 5 0
  Disorientation 4 0
Reproduction and Breast Disorders
  Dysmenorrhea 3 0
Skin and Subcutaneous Tissue Disorders
  Acne 3 0

Infantile Spasms

In a randomized, placebo-controlled IS study with a 5 day double-blind treatment phase (n=40), the adverse reactions that occurred in >5% of patients receiving SABRIL and that occurred more frequently than in placebo patients were somnolence (SABRIL 45%, placebo 30%), bronchitis (SABRIL 30%, placebo 15%), ear infection (SABRIL 10%, placebo 5%), and acute otitis media (SABRIL 10%, placebo 0%).

In a dose response study of low-dose (18-36 mg/kg/day) versus high-dose (100-148 mg/kg/day) SABRIL, no clear correlation between dose and incidence of adverse reactions was observed. The adverse reactions (≥5% in either dose group) are summarized in Table 7.

Table 7. Adverse Reactions in a Placebo-Controlled Trial in Patients with Infantile Spasms

Body System
  Adverse Reaction
SABRIL
Low Dose
[N=114]
%
SABRIL
High Dose
[N=108]
%
Eye Disorders (other than field or acuity changes)
  Strabismus 5 5
  Conjunctivitis 5 2
Gastrointestinal Disorders
  Vomiting 14 20
  Constipation 14 12
  Diarrhea 13 12
General Disorders
  Fever 29 19
Infections
  Upper respiratory tract infection 51 46
  Otitis media 44 30
  Viral infection 20 19
  Pneumonia 13 11
  Candidiasis 8 3
  Ear infection 7 14
  Gastroenteritis viral 6 5
  Sinusitis 5 9
  Urinary tract infection 5 6
  Influenza 5 3
  Croup infectious 5 1
Metabolism & Nutrition Disorders
  Decreased appetite 9 7
Nervous System Disorders
  Sedation 19 17
  Somnolence 17 19
  Status epilepticus 6 4
  Lethargy 5 7
  Convulsion 4 7
  Hypotonia 4 6
Psychiatric Disorders
  Irritability 16 23
  Insomnia 10 12
Respiratory Disorders
  Nasal congestion 13 4
  Cough 3 8
Skin and Subcutaneous Tissue Disorders
  Rash 8 11

Post Marketing Experience

The following adverse reactions have been reported during post approval use of SABRIL worldwide. All adverse reactions that are not listed above as adverse reactions reported in clinical trials, that are not relatively common in the population and are not too vague to be useful are listed in this section. These reactions are reported voluntarily from a population of uncertain size; therefore, it is not possible to estimate their frequency or establish a causal relationship to drug exposure. Adverse reactions are categorized by system organ class.

Birth Defects: 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, talipes

Ear Disorders: Deafness

Endocrine Disorders: Delayed puberty

Gastrointestinal Disorders: Gastrointestinal hemorrhage, esophagitis

General Disorders: Developmental delay, facial edema, malignant hyperthermia, multi-organ failure

Hepatobiliary Disorders: Cholestasis

Nervous System Disorders: Dystonia, encephalopathy, hypertonia, hypotonia, muscle spasticity, myoclonus, optic neuritis, dyskinesia

Psychiatric Disorders: Acute psychosis, apathy, delirium, hypomania, neonatal agitation, psychotic disorder

Respiratory Disorders: Laryngeal edema, pulmonary embolism, respiratory failure, stridor

Skin and Subcutaneous Tissue Disorders: Angioedema, maculo-papular rash, pruritus, Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), alopecia

Read the entire FDA prescribing information for Sabril (Vigabatrin Oral Solution)

IMAGES

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Related Resources for Sabril

© Sabril Patient Information is supplied by Cerner Multum, Inc. and Sabril Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

QUESTION

If you have had a seizure, it means you have epilepsy. See Answer

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