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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