Drug information for SABRIL
Form
Dosage
Status
Therapeutic Equivalence
Active Ingred
Ref.
Sponsor
Document
FOR SOLUTION; ORAL
500MG/PACKET
Prescription
(Reference Drug)
VIGABATRIN
Vigabatrin
LUNDBECK INC
22006
2011-02-02 Other
2011-01-25 Label
2011-01-24 Letter
2009-10-16 Review
2009-10-16 Summary Review
2009-10-16 Other
2009-09-02 Medication Guide
2009-08-26 Letter
TABLET; ORAL
500MG
Prescription
(Reference Drug)
VIGABATRIN
Vigabatrin
LUNDBECK INC
20427
2011-02-02 Other
2011-01-25 Label
2011-01-24 Letter
2009-11-23 Review
2009-09-02 Medication Guide
2009-08-26 Label
2009-08-26 Letter
Drug Adverse Effects information for SABRIL
Role code
Indications
Reaction
# Reports
PS
COMPLEX PARTIAL SEIZURES
ANKLE OPERATION
1
PS
COMPLEX PARTIAL SEIZURES
COMPLEX PARTIAL SEIZURES
1
PS
COMPLEX PARTIAL SEIZURES
CONDITION AGGRAVATED
3
PS
COMPLEX PARTIAL SEIZURES
FALL
1
PS
COMPLEX PARTIAL SEIZURES
HYPOTENSION
1
PS
COMPLEX PARTIAL SEIZURES
LACERATION
1
PS
COMPLEX PARTIAL SEIZURES
MALAISE
2
PS
COMPLEX PARTIAL SEIZURES
POST PROCEDURAL COMPLICATION
1
PS
COMPLEX PARTIAL SEIZURES
PSYCHOLOGICAL FACTOR AFFECTING MEDICAL CONDITION
1
PS
COMPLEX PARTIAL SEIZURES
RESPIRATORY DISTRESS
1
PS
COMPLEX PARTIAL SEIZURES
ROAD TRAFFIC ACCIDENT
1
PS
COMPLEX PARTIAL SEIZURES
SEPSIS
1
PS
COMPLEX PARTIAL SEIZURES
SLEEP DISORDER
1
PS
COMPLEX PARTIAL SEIZURES
TEARFULNESS
1
PS
COMPLEX PARTIAL SEIZURES
URINARY TRACT INFECTION
1
PS
CONVULSION
APHASIA
1
PS
CONVULSION
BRADYCARDIA
1
PS
CONVULSION
CONVULSION
1
PS
CONVULSION
DEATH
1
PS
CONVULSION
FALL
1
PS
CONVULSION
GRAND MAL CONVULSION
1
PS
CONVULSION
RETINAL DISORDER
1
PS
CONVULSION
WEIGHT INCREASED
1
PS
EPILEPSY
APHASIA
1
PS
EPILEPSY
BRADYCARDIA
2
PS
EPILEPSY
CARDIAC FAILURE
3
PS
EPILEPSY
CENTRAL NERVOUS SYSTEM LESION
2
PS
EPILEPSY
COMA
1
PS
EPILEPSY
CONVULSION
2
PS
EPILEPSY
DEATH
2
PS
EPILEPSY
DRUG INEFFECTIVE
1
PS
EPILEPSY
FALL
3
PS
EPILEPSY
GRAND MAL CONVULSION
2
PS
EPILEPSY
INCORRECT DOSE ADMINISTERED
1
PS
EPILEPSY
LACERATION
1
PS
EPILEPSY
LOSS OF CONSCIOUSNESS
1
PS
EPILEPSY
PARTIAL SEIZURES
1
PS
EPILEPSY
PSYCHOLOGICAL FACTOR AFFECTING MEDICAL CONDITION
1
PS
EPILEPSY
SLEEP DISORDER
1
PS
EPILEPSY
STATUS EPILEPTICUS
1
PS
EPILEPSY
SUDDEN UNEXPLAINED DEATH IN EPILEPSY
6
PS
EPILEPSY
TEARFULNESS
1
PS
GENERALISED NON-CONVULSIVE EPILEPSY
ABNORMAL BEHAVIOUR
1
PS
GENERALISED NON-CONVULSIVE EPILEPSY
CONVULSION
1
PS
GENERALISED NON-CONVULSIVE EPILEPSY
FEAR
1
PS
GENERALISED NON-CONVULSIVE EPILEPSY
INSOMNIA
1
PS
GENERALISED NON-CONVULSIVE EPILEPSY
INTENTIONAL SELF-INJURY
1
PS
GRAND MAL CONVULSION
DEATH
2
PS
GRAND MAL CONVULSION
LUNG DISORDER
1
PS
INFANTILE SPASMS
ABASIA
1
PS
INFANTILE SPASMS
ABNORMAL BEHAVIOUR
1
PS
INFANTILE SPASMS
ANGER
1
PS
INFANTILE SPASMS
ASPIRATION
1
PS
INFANTILE SPASMS
AUTISM
2
PS
INFANTILE SPASMS
CONVULSION
4
PS
INFANTILE SPASMS
DEATH
3
PS
INFANTILE SPASMS
DECREASED APPETITE
1
PS
INFANTILE SPASMS
DEHYDRATION
1
PS
INFANTILE SPASMS
DIARRHOEA
1
PS
INFANTILE SPASMS
DISEASE COMPLICATION
1
PS
INFANTILE SPASMS
ELECTROENCEPHALOGRAM ABNORMAL
1
PS
INFANTILE SPASMS
FATIGUE
1
PS
INFANTILE SPASMS
GASTROOESOPHAGEAL REFLUX DISEASE
1
PS
INFANTILE SPASMS
HAEMATOCHEZIA
1
PS
INFANTILE SPASMS
HYPOTONIA
1
PS
INFANTILE SPASMS
INCORRECT DOSE ADMINISTERED
1
PS
INFANTILE SPASMS
INFANT
1
PS
INFANTILE SPASMS
IRRITABILITY
1
PS
INFANTILE SPASMS
LETHARGY
1
PS
INFANTILE SPASMS
LOSS OF CONSCIOUSNESS
1
PS
INFANTILE SPASMS
MYDRIASIS
1
PS
INFANTILE SPASMS
PSYCHOMOTOR HYPERACTIVITY
1
PS
INFANTILE SPASMS
RESPIRATORY DISORDER
1
PS
INFANTILE SPASMS
RETINOPATHY
1
PS
INFANTILE SPASMS
STATUS EPILEPTICUS
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
BRONCHIOLITIS
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
CATARACT OPERATION
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
DYSPNOEA
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
FATIGUE
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
HEART RATE INCREASED
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
HYPERSOMNIA
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
HYPERTENSION
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
HYPOPHAGIA
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
LIP DISORDER
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
MENTAL DISORDER
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
NEUTROPENIA
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
PARANOIA
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
PSYCHOTIC DISORDER
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
TONGUE DISORDER
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
TONGUE PARALYSIS
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
VIRAL INFECTION
1
PS
SIMPLE PARTIAL SEIZURES
COMA
1
PS
SIMPLE PARTIAL SEIZURES
DRUG INEFFECTIVE
1
PS
SIMPLE PARTIAL SEIZURES
PARTIAL SEIZURES
1
PS
SIMPLE PARTIAL SEIZURES
STATUS EPILEPTICUS
1
PS
TUBEROUS SCLEROSIS
CARDIAC FAILURE
2
PS
TUBEROUS SCLEROSIS
RETINAL DISORDER
1
SS
COMPLEX PARTIAL SEIZURES
CONDITION AGGRAVATED
2
SS
COMPLEX PARTIAL SEIZURES
MALAISE
2
SS
EPILEPSY
ABDOMINAL PAIN UPPER
2
SS
INFANTILE SPASMS
ABDOMINAL PAIN UPPER
2
SS
MEDICAL INDUCTION OF COMA
DEEP VEIN THROMBOSIS
1
SS
MEDICAL INDUCTION OF COMA
TREATMENT FAILURE
1
SS
STATUS EPILEPTICUS
DEEP VEIN THROMBOSIS
1
SS
STATUS EPILEPTICUS
TREATMENT FAILURE
1
C
ASTROCYTOMA
ACNE
1
C
ASTROCYTOMA
ATONIC SEIZURES
1
C
ASTROCYTOMA
BLOOD PRESSURE DECREASED
1
C
ASTROCYTOMA
COMA
2
C
ASTROCYTOMA
COMPLEX PARTIAL SEIZURES
2
C
ASTROCYTOMA
CONVULSION
1
C
ASTROCYTOMA
COUGH
3
C
ASTROCYTOMA
CYANOSIS
1
C
ASTROCYTOMA
DERMATITIS CONTACT
2
C
ASTROCYTOMA
DIARRHOEA
2
C
ASTROCYTOMA
DISORIENTATION
1
C
ASTROCYTOMA
DYSPNOEA
1
C
ASTROCYTOMA
EAR INFECTION
2
C
ASTROCYTOMA
ELECTROLYTE IMBALANCE
2
C
ASTROCYTOMA
ERYTHEMA
1
C
ASTROCYTOMA
FALL
1
C
ASTROCYTOMA
FLUSHING
1
C
ASTROCYTOMA
FOAMING AT MOUTH
1
C
ASTROCYTOMA
GAIT DISTURBANCE
1
C
ASTROCYTOMA
HERPANGINA
1
C
ASTROCYTOMA
INFANTILE SPASMS
2
C
ASTROCYTOMA
MASS
2
C
ASTROCYTOMA
NASAL CONGESTION
1
C
ASTROCYTOMA
NASOPHARYNGITIS
1
C
ASTROCYTOMA
POLLAKIURIA
1
C
ASTROCYTOMA
PYREXIA
1
C
ASTROCYTOMA
RASH
1
C
ASTROCYTOMA
RASH GENERALISED
1
C
ASTROCYTOMA
SNEEZING
1
C
ASTROCYTOMA
SOMNOLENCE
2
C
ASTROCYTOMA
STOMATITIS
1
C
ASTROCYTOMA
SWELLING FACE
2
C
ASTROCYTOMA
VOMITING
2
C
ASTROCYTOMA, LOW GRADE
CONVULSION
1
C
ASTROCYTOMA, LOW GRADE
INFECTION SUSCEPTIBILITY INCREASED
1
C
ASTROCYTOMA, LOW GRADE
MALAISE
1
C
ASTROCYTOMA, LOW GRADE
QUALITY OF LIFE DECREASED
1
C
BLOOD PRESSURE
ATONIC SEIZURES
2
C
BLOOD PRESSURE
BLOOD PRESSURE DECREASED
2
C
BLOOD PRESSURE
CONVULSION
2
C
BLOOD PRESSURE
COUGH
2
C
BLOOD PRESSURE
CYANOSIS
2
C
BLOOD PRESSURE
DISORIENTATION
2
C
BLOOD PRESSURE
DYSPNOEA
2
C
BLOOD PRESSURE
FALL
2
C
BLOOD PRESSURE
FOAMING AT MOUTH
2
C
BLOOD PRESSURE
GAIT DISTURBANCE
2
C
BLOOD PRESSURE
HERPANGINA
2
C
BLOOD PRESSURE
NASAL CONGESTION
2
C
BLOOD PRESSURE
PYREXIA
2
C
CONVULSION
ATONIC SEIZURES
1
C
CONVULSION
BLOOD PRESSURE DECREASED
1
C
CONVULSION
CONVULSION
1
C
CONVULSION
COUGH
1
C
CONVULSION
CYANOSIS
1
C
CONVULSION
DISORIENTATION
1
C
CONVULSION
DYSPNOEA
1
C
CONVULSION
FALL
1
C
CONVULSION
FOAMING AT MOUTH
1
C
CONVULSION
GAIT DISTURBANCE
1
C
CONVULSION
HERPANGINA
1
C
CONVULSION
NASAL CONGESTION
1
C
CONVULSION
PYREXIA
1
C
EPILEPSY
CONFUSIONAL STATE
3
C
EPILEPSY
DISTURBANCE IN ATTENTION
3
C
EPILEPSY
GENERALISED NON-CONVULSIVE EPILEPSY
3
C
EPILEPSY
HYPERTENSION
3
C
EPILEPSY
LOSS OF CONSCIOUSNESS
3
C
EPILEPSY
SEDATION
3
C
EPILEPSY
TACHYCARDIA
3
C
PROPHYLAXIS
ATONIC SEIZURES
1
C
PROPHYLAXIS
BLOOD PRESSURE DECREASED
1
C
PROPHYLAXIS
CONVULSION
1
C
PROPHYLAXIS
COUGH
1
C
PROPHYLAXIS
CYANOSIS
1
C
PROPHYLAXIS
DISORIENTATION
1
C
PROPHYLAXIS
DYSPNOEA
1
C
PROPHYLAXIS
FALL
1
C
PROPHYLAXIS
FOAMING AT MOUTH
1
C
PROPHYLAXIS
GAIT DISTURBANCE
1
C
PROPHYLAXIS
HERPANGINA
1
C
PROPHYLAXIS
NASAL CONGESTION
1
C
PROPHYLAXIS
PYREXIA
1
C
SCHIZOPHRENIA
CONFUSIONAL STATE
1
C
SCHIZOPHRENIA
DISTURBANCE IN ATTENTION
1
C
SCHIZOPHRENIA
GENERALISED NON-CONVULSIVE EPILEPSY
1
C
SCHIZOPHRENIA
HYPERTENSION
1
C
SCHIZOPHRENIA
LOSS OF CONSCIOUSNESS
1
C
SCHIZOPHRENIA
SEDATION
1
C
SCHIZOPHRENIA
TACHYCARDIA
1
C
TUBEROUS SCLEROSIS
ABSCESS NECK
1
C
TUBEROUS SCLEROSIS
ACNE
1
C
TUBEROUS SCLEROSIS
APHAGIA
1
C
TUBEROUS SCLEROSIS
ATONIC SEIZURES
1
C
TUBEROUS SCLEROSIS
BLOOD PRESSURE DECREASED
1
C
TUBEROUS SCLEROSIS
COMA
2
C
TUBEROUS SCLEROSIS
COMPLEX PARTIAL SEIZURES
2
C
TUBEROUS SCLEROSIS
CONVULSION
2
C
TUBEROUS SCLEROSIS
COUGH
3
C
TUBEROUS SCLEROSIS
CYANOSIS
1
C
TUBEROUS SCLEROSIS
DECREASED APPETITE
1
C
TUBEROUS SCLEROSIS
DERMATITIS CONTACT
2
C
TUBEROUS SCLEROSIS
DIARRHOEA
2
C
TUBEROUS SCLEROSIS
DISORIENTATION
1
C
TUBEROUS SCLEROSIS
DYSPNOEA
1
C
TUBEROUS SCLEROSIS
EAR INFECTION
2
C
TUBEROUS SCLEROSIS
ELECTROLYTE IMBALANCE
2
C
TUBEROUS SCLEROSIS
EPILEPSY
1
C
TUBEROUS SCLEROSIS
ERYTHEMA
1
C
TUBEROUS SCLEROSIS
FALL
1
C
TUBEROUS SCLEROSIS
FEELING ABNORMAL
1
C
TUBEROUS SCLEROSIS
FLUSHING
1
C
TUBEROUS SCLEROSIS
FOAMING AT MOUTH
1
C
TUBEROUS SCLEROSIS
GAIT DISTURBANCE
1
C
TUBEROUS SCLEROSIS
GRAND MAL CONVULSION
1
C
TUBEROUS SCLEROSIS
HERPANGINA
1
C
TUBEROUS SCLEROSIS
HYPOPHAGIA
1
C
TUBEROUS SCLEROSIS
INFANTILE SPASMS
2
C
TUBEROUS SCLEROSIS
IRRITABILITY
1
C
TUBEROUS SCLEROSIS
MASS
2
C
TUBEROUS SCLEROSIS
MOUTH ULCERATION
1
C
TUBEROUS SCLEROSIS
NASAL CONGESTION
2
C
TUBEROUS SCLEROSIS
NASOPHARYNGITIS
1
C
TUBEROUS SCLEROSIS
NAUSEA
1
C
TUBEROUS SCLEROSIS
ORAL PAIN
2
C
TUBEROUS SCLEROSIS
POLLAKIURIA
1
C
TUBEROUS SCLEROSIS
PYREXIA
3
C
TUBEROUS SCLEROSIS
RASH
1
C
TUBEROUS SCLEROSIS
RASH GENERALISED
1
C
TUBEROUS SCLEROSIS
RHINORRHOEA
1
C
TUBEROUS SCLEROSIS
SNEEZING
1
C
TUBEROUS SCLEROSIS
SOMNOLENCE
2
C
TUBEROUS SCLEROSIS
STOMATITIS
2
C
TUBEROUS SCLEROSIS
SWELLING FACE
2
C
TUBEROUS SCLEROSIS
URINARY TRACT INFECTION
1
C
TUBEROUS SCLEROSIS
VOMITING
2
I
EPILEPSY
CONVULSION
3
I
EPILEPSY
DRUG INTERACTION
3
I
INFANTILE SPASMS
CONVULSION
3
I
INFANTILE SPASMS
DRUG INTERACTION
3
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