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Sabril

Last reviewed on RxList: 10/16/2020
Sabril Side Effects Center

What Is Sabril?

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.

What Are Side Effects of Sabril?

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.

Dosage for Sabril

The recommended dose of Sabril in adults is 3 g/day (1.5 g twice daily).

What Drugs, Substances, or Supplements Interact with Sabril?

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.

Sabril During Pregnancy and Breastfeeding

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.

Additional Information

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.

SLIDESHOW

What Is Epilepsy? Symptoms, Causes, and Treatments See Slideshow
Sabril Consumer Information

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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)

QUESTION

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

SIDE EFFECTS

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

  • Permanent Vision Loss [see BOXED WARNING and WARNINGS AND PRECAUTIONS]
  • Magnetic Resonance Imaging (MRI) Abnormalities in Infants [see WARNINGS AND PRECAUTIONS]
  • Neurotoxicity [see WARNINGS AND PRECAUTIONS]
  • Suicidal Behavior and Ideation [see WARNINGS AND PRECAUTIONS]
  • Withdrawal of Antiepileptic Drugs (AEDs) [see WARNINGS AND PRECAUTIONS]
  • Anemia [see WARNINGS AND PRECAUTIONS]
  • Somnolence and Fatigue [see WARNINGS AND PRECAUTIONS]
  • Peripheral Neuropathy [see WARNINGS AND PRECAUTIONS]
  • Weight Gain [see WARNINGS AND PRECAUTIONS]
  • Edema [see WARNINGS AND PRECAUTIONS]

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. adjunctive clinical studies of refractory CPS in adults.

Table 5: Adverse Reactions in Pooled, Adjunctive Trials in Adults with Refractory Complex Partial Seizures

Body System
Adverse Reaction
SABRIL dosage
(mg/day)
Placebo
[N=135] %
3000
[N=134] %
6000
[N=43] %
Ear Disorders
Tinnitus201
Vertigo251
Eye Disorders
Blurred vision13165
Diplopia7163
Asthenopia220
Eye pain050
Gastrointestinal Disorders
Diarrhea10167
Nausea1028
Vomiting796
Constipation853
Upper abdominal pain551
Dyspepsia453
Stomach discomfort421
Abdominal pain321
Toothache252
Abdominal distension201
General Disorders
Fatigue234016
Gait disturbance6127
Asthenia571
Edema peripheral571
Fever473
Chest pain151
Thirst200
Malaise050
Infections
Nasopharyngitis14910
Upper respiratory tract infection796
Influenza574
Urinary tract infection450
Bronchitis051
Injury
Contusion352
Joint sprain121
Muscle strain121
Wound secretion020
Metabolism and Nutrition isorders
Increased appetite151
Weight gain6143
Musculoskeletal Disorders
Arthralgia1053
Back pain472
Pain in extremity624
Myalgia351
Muscle twitching191
Muscle spasms301
Nervous System Disorders
Headache332631
Somnolence222613
Dizziness242617
Nystagmus13199
Tremor15168
Memory impairment7163
Abnormal coordination7162
Disturbance in attention901
Sensory disturbance472
Hyporeflexia451
Paraesthesia721
Lethargy472
Hyperreflexia423
Hypoaesthesia451
Sedation400
Status epilepticus250
Dysarthria221
Postictal state201
Sensory loss050
Psychiatric Disorders
Irritability7237
Depression6143
Confusional state4141
Anxiety403
Depressed mood501
Abnormal thinking370
Abnormal behavior351
Expressive language disorder171
Nervousness252
Abnormal dreams151
Reproductive System
Dysmenorrhea953
Erectile dysfunction050
Respiratory and Thoracic Disorders
Pharyngolaryngeal pain7145
Cough2147
Pulmonary congestion051
Sinus headache621
Skin and Subcutaneous Tissue Disorders
Rash454

Pediatrics 2 To 16 Years Of Age

Table 6 lists adverse reactions from controlled clinical studies of pediatric patients receiving SABRIL or placebo as adjunctive 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, Adjunctive Trials in Pediatric Patients 3 to 16 Years of Age with Refractory Complex Partial Seizures

Body System
Adverse Reaction
All SABRIL
[N=165] %
Placebo
[N=104] %
Eye Disorders
Diplopia32
Blurred vision20
Gastrointestinal Disorders
Upper abdominal pain43
Constipation21
General Disorders
Fatigue107
Infections and Infestations
Upper respiratory tract infection1511
Influenza73
Otitis media64
Streptococcal pharyngitis43
Viral gastroenteritis20
Investigations
Weight gain152
Nervous System Disorders
Somnolence65
Nystagmus43
Tremor42
Status epilepticus21
Psychiatric Disorders
Abnormal behavior76
Aggression62
Disorientation30

Safety of SABRIL for the treatment of refractory CPS in patients 2 years of age is expected to be similar to pediatric patients 3 to 16 years of age.

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)
Strabismus55
Conjunctivitis52
Gastrointestinal Disorders
Vomiting1420
Constipation1412
Diarrhea1312
General Disorders
Fever2919
Infections
Upper respiratory tract infection5146
Otitis media4430
Viral infection2019
Pneumonia1311
Candidiasis83
Ear infection714
Gastroenteritis viral65
Sinusitis59
Urinary tract infection56
Influenza53
Croup infectious51
Metabolism & Nutrition Disorders
Decreased appetite97
Nervous System Disorders
Sedation1917
Somnolence1719
Status epilepticus64
Lethargy57
Convulsion47
Hypotonia46
Psychiatric Disorders
Irritability1623
Insomnia1012
Respiratory Disorders
Nasal congestion134
Cough38
Skin and Subcutaneous Tissue Disorders
Rash811

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of SABRIL. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably 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)

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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.

SLIDESHOW

What Is Epilepsy? Symptoms, Causes, and Treatments See Slideshow

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