Sabril
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Sabril
Sabril Side Effects Center
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.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Sabril in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: 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 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. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Sabril (Vigabatrin Oral Solution) »
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Sabril FDA Prescribing Information: Side Effects
(Adverse Reactions)
SIDE EFFECTS
SABRIL (vigabatrin oral solution) causes permanent damage to vision in a high percentage of patients [see BOXED WARNING: Vision Loss and WARNINGS AND PRECAUTIONS, Vision Loss].
Adverse Reactions in Clinical Trials
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.
Adverse Reactions in U.S. and Primary Non-U.S. Clinical Studies
In U.S. and primary non-U.S. clinical studies of 4,079 SABRIL (vigabatrin oral solution) treated patients, the most commonly observed ( ≥ 5%) adverse reactions associated with the use of SABRIL (vigabatrin oral solution) in combination with other AEDs were headache (18%), somnolence (17%), fatigue (16%), dizziness (15%), convulsion (11%), nasopharyngitis (10%), weight increased (10%), upper respiratory tract infection (10%), visual field defect (9%), depression (8%), tremor (7%), nystagmus (7%), nausea (7%), diarrhea (7%), memory impairment (7%), insomnia (7%), irritability (7%), coordination abnormal (7%), vision blurred (6%), diplopia (6%), vomiting (6%), influenza (6%), pyrexia (6%), and rash (6%).
The adverse reactions most commonly associated with SABRIL (vigabatrin oral solution) treatment discontinuation in ≥ 1% of patients were convulsion (1.4%) and depression (1.5%).
Most Common Adverse Reactions in Controlled Clinical Trials
Refractory Complex Partial Seizures in Adults
Table 2 lists the treatment emergent adverse reactions that occurred in ≥ 2% and more than one patient per SABRIL (vigabatrin oral solution) -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 2. Treatment Emergent Adverse Reactions Occurring in
≥ 2% and More than One Patient per SABRIL (vigabatrin oral solution) -Treated Group and More Frequently
than in Placebo Patients (Studies 024 and 025)
| Body System Preferred Term | SABRIL (vigabatrin oral solution) 3 g/day (N=134) n(%) |
SABRIL (vigabatrin oral solution) 6 g/day (N=43) n(%) |
Placebo (N=135) n(%) |
| Ear Disorders | |||
| Tinnitus | 3(2) | 0(0) | 2(1) |
| Vertigo | 3(2) | 2(5) | 2(1) |
| Eye Disorders | |||
| Vision blurred | 18(13) | 7(16) | 7(5) |
| Diplopia | 9(7) | 7(16) | 4(3) |
| Asthenopia | 3(2) | 1(2) | 0(0) |
| Eye pain | 0(0) | 2(5) | 0(0) |
| Gastrointestinal Disorders | |||
| Diarrhoea | 14(10) | 7(16) | 10(7) |
| Nausea | 13(10) | 1(2) | 11(8) |
| Vomiting | 9(7) | 4(9) | 8(6) |
| Constipation | 11(8) | 2(5) | 4(3) |
| Abdominal pain upper | 7(5) | 2(5) | 2(1) |
| Dyspepsia | 6(4) | 2(5) | 4(3) |
| Stomach discomfort | 5(4) | 1(2) | 1(1) |
| Abdominal pain | 4(3) | 1(2) | 2(1) |
| Toothache | 3(2) | 2(5) | 3(2) |
| Abdominal distension | 3(2) | 0(0) | 1(1) |
| General Disorders | |||
| Fatigue | 31(23) | 17(40) | 21(16) |
| Gait disturbance | 8(6) | 5(12) | 9(7) |
| Asthenia | 7(5) | 3(7) | 2(1) |
| Oedema peripheral | 7(5) | 3(7) | 1(1) |
| Fever | 6(4) | 3(7) | 4(3) |
| Chest pain | 2(1) | 2(5) | 2(1) |
| Thirst | 3(2) | 0(0) | 0(0) |
| Malaise | 0(0) | 2(5) | 0(0) |
| Infections | |||
| Nasopharyngitis | 19(14) | 4(9) | 14(10) |
| Upper respiratory tract infection | 10(7) | 4(9) | 8(6) |
| Influenza | 7(5) | 3(7) | 5(4) |
| Urinary tract infection | 5(4) | 2(5) | 0(0) |
| Bronchitis | 0(0) | 2(5) | 2(1) |
| Injury | |||
| Contusion | 4(3) | 2(5) | 3(2) |
| Joint sprain | 2(1) | 1(2) | 1(1) |
| Muscle strain | 1(1) | 1(2) | 2(1) |
| Wound secretion | 0(0) | 1(2) | 0(0) |
| Metabolism and Nutrition Disorders | |||
| Increased appetite | 2(1) | 2(5) | 1(1) |
| Weight increased | 8(6) | 6(14) | 4(3) |
| Musculoskeletal Disorders | |||
| Arthralgia | 14(10) | 2(5) | 4(3) |
| Back pain | 6(4) | 3(7) | 3(2) |
| Pain in extremity | 8(6) | 1(2) | 5(4) |
| Myalgia | 4(3) | 2(5) | 2(1) |
| Muscle twitching | 1(1) | 4(9) | 2(1) |
| Muscle spasms | 4(3) | 0(0) | 1(1) |
| Nervous System Disorders | |||
| Headache | 44 (33) | 1 1 (26) | 42(31) |
| Somnolence | 29 (22) | 11 (26) | 18(13) |
| Dizziness | 32 (24) | 11 (26) | 23(17) |
| Nystagmus | 17(13) | 8(19) | 12(9) |
| Tremor | 20(15) | 7(16) | 11(8) |
| Memory impairment | 9(7) | 7(16) | 4(3) |
| Coordination abnormal | 10(7) | 7(16) | 3(2) |
| Disturbance in attention | 12(9) | 0(0) | 1(1) |
| Sensory disturbance | 6(4) | 3(7) | 3(2) |
| Hyporeflexia | 6(4) | 2(5) | 1(1) |
| Paraesthesia | 9(7) | 1(2) | 1(1) |
| Lethargy | 6(4) | 3(7) | 3(2) |
| Hyperreflexia | 5(4) | 1(2) | 4(3) |
| Hypoaesthesia | 5(4) | 2(5) | 2(1) |
| Sedation | 5(4) | 0(0) | 0(0) |
| Status epilepticus | 3(2) | 2(5) | 0(0) |
| Dysarthria | 3(2) | 1(2) | 1(1) |
| Postictal state | 3(2) | 0(0) | 1(1) |
| Sensory loss | 0(0) | 2(5) | 0(0) |
| Psychiatric Disorders | |||
| Irritability | 10(7) | 10(23) | 10(7) |
| Depression | 8(6) | 6(14) | 4(3) |
| Confusional state | 5(4) | 6(14) | 1(1) |
| Anxiety | 6(4) | 0(0) | 4(3) |
| Depressed mood | 7(5) | 0(0) | 1(1) |
| Thinking abnormal | 4(3) | 3(7) | 0(0) |
| Abnormal behaviour | 4(3) | 2(5) | 1(1) |
| Expressive language disorder | 2(1) | 3(7) | 1(1) |
| Nervousness | 3(2) | 2(5) | 3(2) |
| Abnormal dreams | 2(1) | 2(5) | 1(1) |
| Reproductive System | |||
| Dysmenorrhoea | 12(9) | 2(5) | 4(3) |
| Erectile dysfunction | 0(0) | 2(5) | 0(0) |
| Respiratory and Thoracic Disorders | |||
| Pharyngolaryngeal pain | 10(7) | 6(14) | 7(5) |
| Cough | 3(2) | 6(14) | 9(7) |
| Pulmonary congestion | 0(0) | 2(5) | 1(1) |
| Sinus headache | 8(6) | 1(2) | 1(1) |
| Skin and Subcutaneous Tissue Disorders | |||
| Rash | 6(4) | 2(5) | 6(4) |
Post Marketing Experience
The following serious adverse events have been reported since approval and use of SABRIL (vigabatrin oral solution) worldwide. All serious adverse events that are not listed above as adverse events 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. Events 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: Deafness
Endocrine: Delayed puberty
Gastrointestinal: Gastrointestinal hemorrhage, esophagitis
General: Developmental delay, facial edema, malignant hyperthermia, multi-organ failure
Hepatobiliary: Cholestasis
Nervous System: Dystonia, encephalopathy, hypertonia, hypotonia, muscle spasticity, myoclonus, optic neuritis
Psychiatric: Acute psychosis, apathy, delirium, hypomania, neonatal agitation, psychotic disorder
Respiratory: Laryngeal edema, pulmonary embolism, respiratory failure, stridor
Skin and Subcutaneous Tissue: Angioedema, maculo-papular rash, pruritus
Read the entire FDA prescribing information for Sabril (Vigabatrin Oral Solution) »
Additional Sabril Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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