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Vigabatrin

More information: STITCH, PubChem and possibly Wikipedia

ATC Code: N03AG04

Side effects

Options: Hide MedDRA Preferred Terms

MedDRA Preferred Term Side effect Data for drug Placebo Labels
1 2 3 4
Otitis media Otitis media 6% - 44% 2% x
Headache Headache common, 26% - 33% 31% x x x x
Dizziness Dizziness common, 24% - 26% 17% x x x x
Viral infection Viral infection 19% - 20% x x
Asthenia Fatigue very common, 9% - 40% 4% - 16% x x x x
Asthenia 5% - 7% 1% x x
Fatigue Fatigue very common, 9% - 40% 4% - 16% x x x x
Somnolence Somnolence very common, 6% - 26% 2% - 13% x x x x
Drowsiness x
Irritability Irritability common, 7% - 23% 7% x x x
Diarrhoea Diarrhoea 6% - 16% 2% - 7% x x
Pneumonia Pneumonia 11% - 13% x
Nasopharyngitis Nasopharyngitis 9% - 14% 10% x
Coordination abnormal Coordination abnormal 7% - 16% 2% x x
Insomnia Insomnia 10% - 12% x x
Ear infection Ear infection 7% - 14% x
Laryngeal pain Pharyngolaryngeal pain 7% - 14% 5% x
Tremor Tremor common, 6% - 16% 0% - 8% x x x x
Arthralgia Arthralgia very common, 5% - 10% 3% x x x x
Musculoskeletal discomfort Arthralgia very common, 5% - 10% 3% x x x x
Myalgia 3% - 5% 1% x
Depression Depression 6% - 14% 3% x x x
Upper respiratory tract infection Upper respiratory tract infection 7% - 51% 4% - 6% x x
Nystagmus Nystagmus common, 5% - 19% 2% - 9% x x x x
Vomiting Vomiting common, 7% - 20% 6% x x x x
Vision blurred Vision blurred common, 3% - 16% 0% - 5% x x x
Gait disturbance Gait disturbance 6% - 12% 7% x x
Nasal congestion Nasal congestion 4% - 13% x
Constipation Constipation 3% - 14% 2% - 3% x x
Decreased appetite Decreased appetite 7% - 9% x
Scotoma Scotoma postmarketing, very common x x x x
Visual field constriction x x
Body temperature increased Body temperature increased postmarketing, 4% - 29% 3% x x
Sinusitis Sinusitis 5% - 9% x x
Memory impairment Memory impairment common, 7% - 16% 3% x x x x
Forgetfulness x
Diplopia Diplopia common, 5% - 16% 0% - 3% x x x x
Lethargy Lethargy 4% - 7% 2% x
Oedema peripheral Oedema peripheral 5% - 7% 1% x
Weight increased Weight increased common, 3% - 17% 2% - 3% x x x x
Back pain Back pain 4% - 7% 2% x x
Sensory disturbance Sensory disturbance 4% - 7% 2% x
Candida infection Candida infection 3% - 8% x
Cough Cough 2% - 14% 7% x x
Viral diarrhoea Viral diarrhoea 5% - 6% x
Aggression Aggression common, 5% 0% x x x x
Aggressive reaction x
Anaemia Anaemia common x x x
Dysmenorrhoea Dysmenorrhoea 3% - 9% 0% - 3% x x
Oedema Oedema common x x x x
Dermatitis Rash uncommon, 4% - 11% 4% x x x x
Rash Rash uncommon, 4% - 11% 4% x x x x
Influenza Influenza 3% - 7% 2% - 4% x
Nausea Nausea common, 2% - 10% 8% x x x x
Nervousness Nervousness common, 2% - 5% 2% x x x x
Tension Nervousness common, 2% - 5% 2% x x x x
Paraesthesia Paraesthesia common, 2% - 7% 1% x x x x
Speech disorder Speech disorder common x x x
Strabismus Strabismus 5% x
Urinary tract infection Urinary tract infection 4% - 6% 0% x x
Paranoia Paranoid reaction common x x
Abdominal pain upper Abdominal pain upper 3% - 5% 0% - 1% x
Disturbance in attention Disturbance in attention common, 0% - 9% 1% x x x
Cerebration impaired x x x
Abnormal behaviour Abnormal behaviour 3% - 6% 1% - 2% x
Thinking abnormal Thinking abnormal common, 3% - 7% 0% x x x x
Mental disability Thinking abnormal common, 3% - 7% 0% x x x x
Mental disability common x x
Cerebration impaired x x x
Mental retardation Mental disability common x x
Muscle twitching Muscle twitching 1% - 9% 1% x
Dyspepsia Dyspepsia 4% - 5% 3% x x
Hypoaesthesia Hypoaesthesia 4% - 5% 1% x x
Agitation Agitation postmarketing — 4% 2% x x x x
Hyperkinesia x
Hyporeflexia Hyporeflexia 4% - 5% 1% x x
Confusional state Confusional state postmarketing, 4% - 14% 1% x x x x
Feeling abnormal Confusional state postmarketing, 4% - 14% 1% x x x x
Malaise 0% - 5% 0% x
Contusion Contusion 3% - 5% 2% x
Hypotonia Hypotonia postmarketing, 4% - 6% x x
Muscle relaxant therapy Hypotonia postmarketing, 4% - 6% x x
Pain in extremity Pain in extremity 2% - 6% 4% x
Convulsion Convulsion postmarketing, 4% - 7% x x x x
Sinus headache Sinus headache 2% - 6% 1% x
Status epilepticus Status epilepticus postmarketing, 2% - 6% 0% x x x x
Myalgia Myalgia 3% - 5% 1% x
Disorientation Disorientation 4% 0% x
Expressive language disorder Expressive language disorder 1% - 7% 1% x
Conjunctivitis Conjunctivitis 2% - 5% x
Toothache Toothache 2% - 5% 2% x
Vertigo Vertigo 2% - 5% 1% x x
Chest pain Chest pain 1% - 5% 1% x x
Increased appetite Increased appetite 1% - 5% 1% x x
Abnormal dreams Abnormal dreams 1% - 5% 1% x
Croup infectious Croup infectious 1% - 5% x
Abdominal pain Abdominal pain common, 2% - 3% 1% x x x x
Gastrointestinal pain Abdominal pain common, 2% - 3% 1% x x x x
Hyperreflexia Hyperreflexia 2% - 4% 3% x
Abdominal discomfort Upset stomach 2% - 4% 1% x
Acne Acne 3% 0% x
Bronchitis Bronchitis 0% - 5% 1% x
Eye pain Eye pain 0% - 5% 0% x x
Malaise Malaise 0% - 5% 0% x
Discomfort Malaise 0% - 5% 0% x
Ill-defined disorder Malaise 0% - 5% 0% x
Pulmonary congestion Pulmonary congestion 0% - 5% 1% x
Respiratory tract congestion Pulmonary congestion 0% - 5% 1% x
Erectile dysfunction Erectile dysfunction 0% - 5% 0% x
Sensory loss Sensory loss 0% - 5% 0% x
Depressed mood Depressed mood 0% - 5% 1% x
Anxiety Anxiety 0% - 4% 3% x x
Asthenopia Asthenopia 2% 0% x
Dysarthria Dysarthria 2% 1% x
Osteoarthritis Dysarthria 2% 1% x
Arthropathy x
Muscle spasms Muscle spasms 0% - 3% 1% x
Muscle strain Muscle strain 1% - 2% 1% x
Ligament sprain Joint sprain 1% - 2% 1% x
Abdominal distension Abdominal distension 0% - 2% 1% x
Thirst Thirst 0% - 2% 0% x
Tinnitus Tinnitus 0% - 2% 1% x
Postictal state Postictal state 0% - 2% 1% x
Wound secretion Wound secretion 0% - 2% 0% x
Ataxia Ataxia uncommon x x x
Mania Mania uncommon x x x
Psychotic disorder Psychotic disorder postmarketing, uncommon x x x x
Hypomania Hypomania postmarketing, uncommon x x x x
Congenital anomaly Congenital anomaly postmarketing x
Developmental delay Congenital anomaly postmarketing x
Developmental delay postmarketing x
Angioedema Angioedema postmarketing, rare x x x x
Mental disorder Mental disorder postmarketing x x x
Cholestasis Cholestasis postmarketing x
Deafness Deafness postmarketing x
Delirium Delirium postmarketing x
Dyskinesia Dyskinesia postmarketing x x
Movement disorder x x
Ear disorder Ear disorder postmarketing x
Endocrine disorder Endocrine disorder postmarketing x
Toxic epidermal necrolysis Toxic epidermal necrolysis postmarketing x
Myoclonic epilepsy Myoclonic epilepsy postmarketing x
Oesophagitis Oesophagitis postmarketing x
Gastrointestinal disorder Gastrointestinal disorder postmarketing x x x
Gastrointestinal haemorrhage Gastrointestinal haemorrhage postmarketing x
Hamartoma Hamartoma postmarketing x
Hypersensitivity Hypersensitivity postmarketing x
Laryngeal oedema Laryngeal oedema postmarketing x
Congenital oral malformation Congenital oral malformation postmarketing x
Multi-organ failure Multi-organ failure postmarketing x
Hypertonia Hypertonia postmarketing x x x
Muscle spasticity Muscle spasticity postmarketing x
Myoclonus Myoclonus postmarketing x x x x
Nervous system disorder Nervous system disorder postmarketing x x x
Optic neuritis Optic neuritis very rare, postmarketing x x x x
Pallor Pallor postmarketing x
Pruritus Pruritus postmarketing x
Delayed puberty Delayed puberty postmarketing x
Pulmonary embolism Pulmonary embolism postmarketing x
Retinal disorder Retinal disorder rare x x
Retinitis Retinitis postmarketing x
Erythema multiforme Stevens-Johnson syndrome postmarketing x
Stevens-Johnson syndrome Stevens-Johnson syndrome postmarketing x
Stridor Stridor postmarketing x
Suicide attempt Suicide attempt rare x x x
Urticaria Urticaria postmarketing, rare x x x
Encephalopathy Encephalopathy postmarketing, rare x x x
Stupor Stupor postmarketing x x x
Depressed level of consciousness Stupor postmarketing x x x
Apathy Apathy postmarketing x
Flat affect Apathy postmarketing x
Dentofacial anomaly Dentofacial anomaly postmarketing x
Congenital genital malformation Congenital genital malformation postmarketing x
Skin disorder Unspecified disorder of skin and subcutaneous tissue postmarketing, common x x x
Skin disorder x
Limb malformation Limb malformation postmarketing x
Haemangioma congenital Haemangioma congenital postmarketing x
Low set ears Low set ears postmarketing x
Limb reduction defect Limb reduction defect postmarketing x
Supernumerary nipple Supernumerary nipple postmarketing x
Congenital hydronephrosis Congenital hydronephrosis postmarketing x
Hepatobiliary disease Hepatobiliary disease postmarketing x
Acute psychosis Acute psychosis postmarketing x
Rash maculo-papular Rash maculo-papular postmarketing x
Congenital vesicoureteric reflux Congenital vesicoureteric reflux postmarketing x
Retinal degeneration Retinal atrophy postmarketing, rare x x x
Face oedema Face oedema postmarketing x
Electroencephalogram abnormal Wave slowing postmarketing x x x
Respiratory failure Respiratory failure postmarketing x
Talipes Talipes postmarketing x
Developmental hip dysplasia Hip dysplasia postmarketing x
Renal aplasia Renal aplasia postmarketing x
Dysmorphism Dysmorphism postmarketing x
Foetal anticonvulsant syndrome Foetal anticonvulsant syndrome postmarketing x
Hallucination Hallucination very rare, postmarketing x x x
Optic atrophy Optic atrophy very rare, postmarketing x x x
Amnesia Amnesia x
Breast disorder Breast disorder x
Infection Infection x
Connective tissue disorder Connective tissue disorder x x
Developmental coordination disorder Developmental coordination disorder x
Ear pain Ear pain x
Eye disorder Eye disorder x x x
Arthropathy Arthropathy x
Menstrual disorder Menstrual disorder x
Movement disorder Movement disorder x x
Musculoskeletal disorder Musculoskeletal disorder x
Pain Pain x
Neuropathy peripheral Neuropathy peripheral x
Personality disorder Personality disorder x
Purpura Purpura x
Vascular purpura Purpura x
Salivary hypersecretion Salivary hypersecretion x
Tooth disorder Tooth disorder x
Mood swings Mood swings x
Affect lability Mood swings x
Malnutrition Malnutrition x
Neurotoxicity Neurotoxicity x
Otitis media acute Otitis media acute x
Atrophy Atrophy x x
Hyperkinesia Hyperkinesia x
Throat irritation Throat irritation x
Infestation Infestation NOS x
Suicidal behaviour Suicidal behaviour x
Cytotoxic oedema Cytotoxic oedema x x
Visual impairment Abnormal vision x

Indications

Information about indications was extracted from the indications and usage sections of the labels.

Vigabatrin / SABRIL TABLETS / SABRIL SACHETS 500 MG

Side effects:61
Source:medicines.org.au

SABRIL TABLETS / Sabril, Film coated tablet

Side effects:62
Source:Medsafe

VIGABATRIN / SABRIL TAB 500MG

Side effects:83
Source:Health Canada

VIGABATRIN

Side effects:162
Source:FDA Structured Product Label

Color scheme:

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    100%
    75%
    50%
    10%
    frequent (1% to 100%)
    infrequent (0.1% to 1%)
    rare (<0.1%)
    postmarketing
    0%
    no frequency information
    not found on label