Vigabatrin
Side effects
Options:
Show MedDRA Preferred Terms
Side effect
|
Data for drug
|
Placebo
|
Labels
|
|
1
|
2
|
3
|
4
|
Otitis media
|
6% - 44%
|
2%
|
|
|
|
x
|
Headache
|
common, 26% - 33%
|
31%
|
x
|
x
|
x
|
x
|
Dizziness
|
common, 24% - 26%
|
17%
|
x
|
x
|
x
|
x
|
Viral infection
|
19% - 20%
|
|
|
|
x
|
x
|
Fatigue
|
very common, 9% - 40%
|
4% - 16%
|
x
|
x
|
x
|
x
|
Somnolence
|
very common, 6% - 26%
|
2% - 13%
|
x
|
x
|
x
|
x
|
Irritability
|
common, 7% - 23%
|
7%
|
x
|
x
|
|
x
|
Diarrhoea
|
6% - 16%
|
2% - 7%
|
|
|
x
|
x
|
Pneumonia
|
11% - 13%
|
|
|
|
|
x
|
Nasopharyngitis
|
9% - 14%
|
10%
|
|
|
|
x
|
Coordination abnormal
|
7% - 16%
|
2%
|
|
|
x
|
x
|
Insomnia
|
10% - 12%
|
|
|
|
x
|
x
|
Ear infection
|
7% - 14%
|
|
|
|
|
x
|
Pharyngolaryngeal pain
|
7% - 14%
|
5%
|
|
|
|
x
|
Tremor
|
common, 6% - 16%
|
0% - 8%
|
x
|
x
|
x
|
x
|
Arthralgia
|
very common, 5% - 10%
|
3%
|
x
|
x
|
x
|
x
|
Depression
|
6% - 14%
|
3%
|
x
|
x
|
|
x
|
Upper respiratory tract infection
|
7% - 51%
|
4% - 6%
|
|
|
x
|
x
|
Nystagmus
|
common, 5% - 19%
|
2% - 9%
|
x
|
x
|
x
|
x
|
Vomiting
|
common, 7% - 20%
|
6%
|
x
|
x
|
x
|
x
|
Vision blurred
|
common, 3% - 16%
|
0% - 5%
|
x
|
x
|
|
x
|
Gait disturbance
|
6% - 12%
|
7%
|
|
|
x
|
x
|
Nasal congestion
|
4% - 13%
|
|
|
|
|
x
|
Constipation
|
3% - 14%
|
2% - 3%
|
|
|
x
|
x
|
Decreased appetite
|
7% - 9%
|
|
|
|
|
x
|
Scotoma
|
postmarketing, very common
|
|
x
|
x
|
x
|
x
|
Body temperature increased
|
postmarketing, 4% - 29%
|
3%
|
|
|
x
|
x
|
Sinusitis
|
5% - 9%
|
|
|
|
x
|
x
|
Memory impairment
|
common, 7% - 16%
|
3%
|
x
|
x
|
x
|
x
|
Asthenia
|
5% - 7%
|
1%
|
|
|
x
|
x
|
Diplopia
|
common, 5% - 16%
|
0% - 3%
|
x
|
x
|
x
|
x
|
Lethargy
|
4% - 7%
|
2%
|
|
|
|
x
|
Oedema peripheral
|
5% - 7%
|
1%
|
|
|
|
x
|
Weight increased
|
common, 3% - 17%
|
2% - 3%
|
x
|
x
|
x
|
x
|
Back pain
|
4% - 7%
|
2%
|
|
|
x
|
x
|
Sensory disturbance
|
4% - 7%
|
2%
|
|
|
|
x
|
Candida infection
|
3% - 8%
|
|
|
|
|
x
|
Cough
|
2% - 14%
|
7%
|
|
|
x
|
x
|
Viral diarrhoea
|
5% - 6%
|
|
|
|
|
x
|
Aggression
|
common, 5%
|
0%
|
x
|
x
|
x
|
x
|
Anaemia
|
common
|
|
x
|
x
|
|
x
|
Dysmenorrhoea
|
3% - 9%
|
0% - 3%
|
|
|
x
|
x
|
Oedema
|
common
|
|
x
|
x
|
x
|
x
|
Rash
|
uncommon, 4% - 11%
|
4%
|
x
|
x
|
x
|
x
|
Influenza
|
3% - 7%
|
2% - 4%
|
|
|
|
x
|
Nausea
|
common, 2% - 10%
|
8%
|
x
|
x
|
x
|
x
|
Nervousness
|
common, 2% - 5%
|
2%
|
x
|
x
|
x
|
x
|
Paraesthesia
|
common, 2% - 7%
|
1%
|
x
|
x
|
x
|
x
|
Speech disorder
|
common
|
|
x
|
x
|
x
|
|
Strabismus
|
5%
|
|
|
|
|
x
|
Urinary tract infection
|
4% - 6%
|
0%
|
|
|
x
|
x
|
Paranoid reaction
|
common
|
|
x
|
x
|
|
|
Abdominal pain upper
|
3% - 5%
|
0% - 1%
|
|
|
|
x
|
Disturbance in attention
|
common, 0% - 9%
|
1%
|
x
|
x
|
|
x
|
Abnormal behaviour
|
3% - 6%
|
1% - 2%
|
|
|
|
x
|
Thinking abnormal
|
common, 3% - 7%
|
0%
|
x
|
x
|
x
|
x
|
Mental disability
|
common
|
|
x
|
x
|
|
|
Muscle twitching
|
1% - 9%
|
1%
|
|
|
|
x
|
Dyspepsia
|
4% - 5%
|
3%
|
|
|
x
|
x
|
Hypoaesthesia
|
4% - 5%
|
1%
|
|
|
x
|
x
|
Agitation
|
postmarketing — 4%
|
2%
|
x
|
x
|
x
|
x
|
Hyporeflexia
|
4% - 5%
|
1%
|
|
|
x
|
x
|
Confusional state
|
postmarketing, 4% - 14%
|
1%
|
x
|
x
|
x
|
x
|
Contusion
|
3% - 5%
|
2%
|
|
|
|
x
|
Hypotonia
|
postmarketing, 4% - 6%
|
|
|
|
x
|
x
|
Pain in extremity
|
2% - 6%
|
4%
|
|
|
|
x
|
Convulsion
|
postmarketing, 4% - 7%
|
|
x
|
x
|
x
|
x
|
Sinus headache
|
2% - 6%
|
1%
|
|
|
|
x
|
Status epilepticus
|
postmarketing, 2% - 6%
|
0%
|
x
|
x
|
x
|
x
|
Myalgia
|
3% - 5%
|
1%
|
|
|
|
x
|
Disorientation
|
4%
|
0%
|
|
|
|
x
|
Expressive language disorder
|
1% - 7%
|
1%
|
|
|
|
x
|
Conjunctivitis
|
2% - 5%
|
|
|
|
|
x
|
Toothache
|
2% - 5%
|
2%
|
|
|
|
x
|
Vertigo
|
2% - 5%
|
1%
|
|
|
x
|
x
|
Chest pain
|
1% - 5%
|
1%
|
|
|
x
|
x
|
Increased appetite
|
1% - 5%
|
1%
|
|
|
x
|
x
|
Abnormal dreams
|
1% - 5%
|
1%
|
|
|
|
x
|
Croup infectious
|
1% - 5%
|
|
|
|
|
x
|
Abdominal pain
|
common, 2% - 3%
|
1%
|
x
|
x
|
x
|
x
|
Hyperreflexia
|
2% - 4%
|
3%
|
|
|
|
x
|
Upset stomach
|
2% - 4%
|
1%
|
|
|
|
x
|
Acne
|
3%
|
0%
|
|
|
|
x
|
Bronchitis
|
0% - 5%
|
1%
|
|
|
|
x
|
Eye pain
|
0% - 5%
|
0%
|
|
|
x
|
x
|
Malaise
|
0% - 5%
|
0%
|
|
|
|
x
|
Pulmonary congestion
|
0% - 5%
|
1%
|
|
|
|
x
|
Erectile dysfunction
|
0% - 5%
|
0%
|
|
|
|
x
|
Sensory loss
|
0% - 5%
|
0%
|
|
|
|
x
|
Depressed mood
|
0% - 5%
|
1%
|
|
|
|
x
|
Anxiety
|
0% - 4%
|
3%
|
|
|
x
|
x
|
Asthenopia
|
2%
|
0%
|
|
|
|
x
|
Dysarthria
|
2%
|
1%
|
|
|
|
x
|
Muscle spasms
|
0% - 3%
|
1%
|
|
|
|
x
|
Muscle strain
|
1% - 2%
|
1%
|
|
|
|
x
|
Joint sprain
|
1% - 2%
|
1%
|
|
|
|
x
|
Abdominal distension
|
0% - 2%
|
1%
|
|
|
|
x
|
Thirst
|
0% - 2%
|
0%
|
|
|
|
x
|
Tinnitus
|
0% - 2%
|
1%
|
|
|
|
x
|
Postictal state
|
0% - 2%
|
1%
|
|
|
|
x
|
Wound secretion
|
0% - 2%
|
0%
|
|
|
|
x
|
Ataxia
|
uncommon
|
|
x
|
x
|
x
|
|
Mania
|
uncommon
|
|
x
|
x
|
x
|
|
Psychotic disorder
|
postmarketing, uncommon
|
|
x
|
x
|
x
|
x
|
Hypomania
|
postmarketing, uncommon
|
|
x
|
x
|
x
|
x
|
Congenital anomaly
|
postmarketing
|
|
|
|
|
x
|
Angioedema
|
postmarketing, rare
|
|
x
|
x
|
x
|
x
|
Mental disorder
|
postmarketing
|
|
x
|
x
|
|
x
|
Cholestasis
|
postmarketing
|
|
|
|
|
x
|
Deafness
|
postmarketing
|
|
|
|
|
x
|
Delirium
|
postmarketing
|
|
|
|
|
x
|
Dyskinesia
|
postmarketing
|
|
|
x
|
|
x
|
Ear disorder
|
postmarketing
|
|
|
|
|
x
|
Endocrine disorder
|
postmarketing
|
|
|
|
|
x
|
Toxic epidermal necrolysis
|
postmarketing
|
|
|
|
|
x
|
Myoclonic epilepsy
|
postmarketing
|
|
|
|
x
|
|
Oesophagitis
|
postmarketing
|
|
|
|
|
x
|
Gastrointestinal disorder
|
postmarketing
|
|
x
|
x
|
|
x
|
Gastrointestinal haemorrhage
|
postmarketing
|
|
|
|
|
x
|
Hamartoma
|
postmarketing
|
|
|
|
|
x
|
Hypersensitivity
|
postmarketing
|
|
|
|
x
|
|
Laryngeal oedema
|
postmarketing
|
|
|
|
|
x
|
Congenital oral malformation
|
postmarketing
|
|
|
|
|
x
|
Multi-organ failure
|
postmarketing
|
|
|
|
|
x
|
Hypertonia
|
postmarketing
|
|
x
|
x
|
|
x
|
Muscle spasticity
|
postmarketing
|
|
|
|
|
x
|
Myoclonus
|
postmarketing
|
|
x
|
x
|
x
|
x
|
Nervous system disorder
|
postmarketing
|
|
x
|
x
|
|
x
|
Optic neuritis
|
very rare, postmarketing
|
|
x
|
x
|
x
|
x
|
Pallor
|
postmarketing
|
|
|
|
x
|
|
Pruritus
|
postmarketing
|
|
|
|
|
x
|
Delayed puberty
|
postmarketing
|
|
|
|
|
x
|
Pulmonary embolism
|
postmarketing
|
|
|
|
|
x
|
Retinal disorder
|
rare
|
|
x
|
x
|
|
|
Retinitis
|
postmarketing
|
|
|
|
|
x
|
Stevens-Johnson syndrome
|
postmarketing
|
|
|
|
|
x
|
Stridor
|
postmarketing
|
|
|
|
|
x
|
Suicide attempt
|
rare
|
|
x
|
x
|
x
|
|
Urticaria
|
postmarketing, rare
|
|
x
|
x
|
x
|
|
Encephalopathy
|
postmarketing, rare
|
|
x
|
x
|
|
x
|
Stupor
|
postmarketing
|
|
x
|
x
|
x
|
|
Apathy
|
postmarketing
|
|
|
|
|
x
|
Dentofacial anomaly
|
postmarketing
|
|
|
|
|
x
|
Congenital genital malformation
|
postmarketing
|
|
|
|
|
x
|
Unspecified disorder of skin and subcutaneous tissue
|
postmarketing, common
|
|
x
|
x
|
|
x
|
Limb malformation
|
postmarketing
|
|
|
|
|
x
|
Haemangioma congenital
|
postmarketing
|
|
|
|
|
x
|
Low set ears
|
postmarketing
|
|
|
|
|
x
|
Limb reduction defect
|
postmarketing
|
|
|
|
|
x
|
Supernumerary nipple
|
postmarketing
|
|
|
|
|
x
|
Congenital hydronephrosis
|
postmarketing
|
|
|
|
|
x
|
Hepatobiliary disease
|
postmarketing
|
|
|
|
|
x
|
Acute psychosis
|
postmarketing
|
|
|
|
|
x
|
Rash maculo-papular
|
postmarketing
|
|
|
|
|
x
|
Developmental delay
|
postmarketing
|
|
|
|
|
x
|
Congenital vesicoureteric reflux
|
postmarketing
|
|
|
|
|
x
|
Retinal atrophy
|
postmarketing, rare
|
|
x
|
x
|
x
|
|
Face oedema
|
postmarketing
|
|
|
|
|
x
|
Wave slowing
|
postmarketing
|
|
x
|
x
|
x
|
|
Respiratory failure
|
postmarketing
|
|
|
|
|
x
|
Talipes
|
postmarketing
|
|
|
|
|
x
|
Hip dysplasia
|
postmarketing
|
|
|
|
|
x
|
Renal aplasia
|
postmarketing
|
|
|
|
|
x
|
Dysmorphism
|
postmarketing
|
|
|
|
|
x
|
Foetal anticonvulsant syndrome
|
postmarketing
|
|
|
|
|
x
|
Hallucination
|
very rare, postmarketing
|
|
x
|
x
|
x
|
|
Optic atrophy
|
very rare, postmarketing
|
|
x
|
x
|
x
|
|
Amnesia
|
|
|
|
|
x
|
|
Breast disorder
|
|
|
|
|
|
x
|
Infection
|
|
|
|
|
|
x
|
Connective tissue disorder
|
|
|
x
|
x
|
|
|
Developmental coordination disorder
|
|
|
|
|
|
x
|
Drowsiness
|
|
|
|
|
x
|
|
Ear pain
|
|
|
|
|
x
|
|
Eye disorder
|
|
|
x
|
x
|
|
x
|
Arthropathy
|
|
|
|
|
x
|
|
Menstrual disorder
|
|
|
|
|
x
|
|
Movement disorder
|
|
|
x
|
x
|
|
|
Musculoskeletal disorder
|
|
|
|
|
|
x
|
Pain
|
|
|
|
|
x
|
|
Neuropathy peripheral
|
|
|
|
|
|
x
|
Personality disorder
|
|
|
|
|
x
|
|
Purpura
|
|
|
|
|
x
|
|
Salivary hypersecretion
|
|
|
|
|
x
|
|
Skin disorder
|
|
|
|
|
x
|
|
Tooth disorder
|
|
|
|
|
x
|
|
Mood swings
|
|
|
|
|
x
|
|
Malnutrition
|
|
|
|
|
|
x
|
Neurotoxicity
|
|
|
|
|
|
x
|
Visual field constriction
|
|
|
x
|
x
|
|
|
Cerebration impaired
|
|
|
x
|
x
|
x
|
|
Otitis media acute
|
|
|
|
|
|
x
|
Atrophy
|
|
|
x
|
x
|
|
|
Hyperkinesia
|
|
|
|
|
x
|
|
Forgetfulness
|
|
|
|
|
x
|
|
Throat irritation
|
|
|
|
|
x
|
|
Infestation NOS
|
|
|
|
|
|
x
|
Blood and lymphatic system disorders
|
|
|
x
|
x
|
|
|
Aggressive reaction
|
|
|
|
|
x
|
|
Suicidal behaviour
|
|
|
|
|
|
x
|
Cytotoxic oedema
|
|
|
x
|
x
|
|
|
Abnormal vision
|
|
|
|
|
x
|
|
Indications
Information about indications was extracted from the indications and usage sections of the labels.
Side effects: | 61 |
Source: | medicines.org.au |
---|
Side effects: | 62 |
Source: | Medsafe |
---|
Side effects: | 83 |
Source: | Health Canada |
---|
Side effects: | 162 |
Source: | FDA Structured Product Label |
---|
Color scheme:
standard – alternative
|
|
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
|