Side effect information for Vigabatrin

Side effects

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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	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
Somnolence	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
Musculoskeletal discomfort	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
Scotoma	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
Memory impairment	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
Aggression	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
Disturbance in attention	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
Agitation	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
Feeling abnormal	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
Osteoarthritis	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	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
Dyskinesia	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	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

Indication	Labels
Complex partial seizures				x
Convulsion			x
Epilepsy	x	x	x
Infantile spasms		x	x	x
Myoclonic epilepsy	x	x	x
Partial epilepsy			x
Partial seizures		x
Tonic-clonic seizures		x

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

Search results :

Vigabatrin

Side effects

Indications

Vigabatrin / SABRIL TABLETS / SABRIL SACHETS 500 MG

SABRIL TABLETS / Sabril, Film coated tablet

VIGABATRIN / SABRIL TAB 500MG

VIGABATRIN

Color scheme:

		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