Drug information for ZAVESCA

Form	Dosage	Status	Therapeutic Equivalence	Active Ingred	Ref.	Sponsor	Document
CAPSULE; ORAL	100MG	Prescription	(Reference Drug)	MIGLUSTAT	miglustat	ACTELION PHARMS LTD	21348 2010-11-29 Letter 2010-11-23 Label 2008-03-05 Label 2008-03-04 Letter 2003-12-15 Review 2003-08-15 Label 2003-08-15 Letter

Drug Adverse Effects information for ZAVESCA

Role code	Indications	Reaction	# Reports
PS	GAUCHER'S DISEASE	ABDOMINAL PAIN	2
PS	GAUCHER'S DISEASE	AFFECTIVE DISORDER	1
PS	GAUCHER'S DISEASE	AMENORRHOEA	1
PS	GAUCHER'S DISEASE	ANAEMIA	1
PS	GAUCHER'S DISEASE	ANXIETY	1
PS	GAUCHER'S DISEASE	ARTHRALGIA	2
PS	GAUCHER'S DISEASE	ASTHENIA	1
PS	GAUCHER'S DISEASE	BACK PAIN	2
PS	GAUCHER'S DISEASE	BONE INFARCTION	1
PS	GAUCHER'S DISEASE	BONE LESION	2
PS	GAUCHER'S DISEASE	BONE PAIN	2
PS	GAUCHER'S DISEASE	CACHEXIA	1
PS	GAUCHER'S DISEASE	CHITOTRIOSIDASE INCREASED	1
PS	GAUCHER'S DISEASE	CONCOMITANT DISEASE AGGRAVATED	2
PS	GAUCHER'S DISEASE	CONDITION AGGRAVATED	1
PS	GAUCHER'S DISEASE	CONSTIPATION	1
PS	GAUCHER'S DISEASE	DELIRIUM	1
PS	GAUCHER'S DISEASE	DEPRESSION	2
PS	GAUCHER'S DISEASE	DIARRHOEA	4
PS	GAUCHER'S DISEASE	DRUG INTOLERANCE	1
PS	GAUCHER'S DISEASE	DRY SKIN	1
PS	GAUCHER'S DISEASE	ELECTROENCEPHALOGRAM ABNORMAL	1
PS	GAUCHER'S DISEASE	ELECTROMYOGRAM ABNORMAL	1
PS	GAUCHER'S DISEASE	EPILEPSY	1
PS	GAUCHER'S DISEASE	ERECTILE DYSFUNCTION	1
PS	GAUCHER'S DISEASE	GAIT DISTURBANCE	1
PS	GAUCHER'S DISEASE	GASTROOESOPHAGEAL REFLUX DISEASE	1
PS	GAUCHER'S DISEASE	HEADACHE	2
PS	GAUCHER'S DISEASE	HEPATIC NEOPLASM MALIGNANT	1
PS	GAUCHER'S DISEASE	HEPATOMEGALY	1
PS	GAUCHER'S DISEASE	HYPERSENSITIVITY	1
PS	GAUCHER'S DISEASE	HYPOAESTHESIA	1
PS	GAUCHER'S DISEASE	INSOMNIA	1
PS	GAUCHER'S DISEASE	INTERVERTEBRAL DISC PROTRUSION	1
PS	GAUCHER'S DISEASE	LIBIDO DECREASED	1
PS	GAUCHER'S DISEASE	LOSS OF CONSCIOUSNESS	1
PS	GAUCHER'S DISEASE	MEMORY IMPAIRMENT	1
PS	GAUCHER'S DISEASE	MONOCLONAL IMMUNOGLOBULIN PRESENT	1
PS	GAUCHER'S DISEASE	MOOD ALTERED	1
PS	GAUCHER'S DISEASE	MUSCLE ATROPHY	1
PS	GAUCHER'S DISEASE	MUSCLE CONTRACTIONS INVOLUNTARY	1
PS	GAUCHER'S DISEASE	MUSCULAR WEAKNESS	1
PS	GAUCHER'S DISEASE	MYOCLONUS	1
PS	GAUCHER'S DISEASE	NAUSEA	1
PS	GAUCHER'S DISEASE	NECK PAIN	1
PS	GAUCHER'S DISEASE	NO THERAPEUTIC RESPONSE	1
PS	GAUCHER'S DISEASE	OSTEOLYSIS	1
PS	GAUCHER'S DISEASE	OSTEONECROSIS	1
PS	GAUCHER'S DISEASE	OSTEOPENIA	1
PS	GAUCHER'S DISEASE	PAIN IN EXTREMITY	1
PS	GAUCHER'S DISEASE	PARESIS	1
PS	GAUCHER'S DISEASE	PARKINSONISM	1
PS	GAUCHER'S DISEASE	PERIPHERAL SENSORY NEUROPATHY	1
PS	GAUCHER'S DISEASE	PERONEAL NERVE PALSY	1
PS	GAUCHER'S DISEASE	PLATELET COUNT DECREASED	2
PS	GAUCHER'S DISEASE	PNEUMONIA	1
PS	GAUCHER'S DISEASE	POLYNEUROPATHY	2
PS	GAUCHER'S DISEASE	PYREXIA	1
PS	GAUCHER'S DISEASE	SCAB	1
PS	GAUCHER'S DISEASE	SPEECH DISORDER	1
PS	GAUCHER'S DISEASE	SPLENOMEGALY	2
PS	GAUCHER'S DISEASE	STATUS EPILEPTICUS	1
PS	GAUCHER'S DISEASE	THERAPEUTIC RESPONSE DECREASED	1
PS	GAUCHER'S DISEASE	THROMBOCYTOPENIA	1
PS	GAUCHER'S DISEASE	TREMOR	4
PS	GAUCHER'S DISEASE	WEIGHT DECREASED	1
PS	GLYCOGEN STORAGE DISEASE TYPE II	ALANINE AMINOTRANSFERASE INCREASED	1
PS	GLYCOGEN STORAGE DISEASE TYPE II	ASPARTATE AMINOTRANSFERASE INCREASED	1
PS	GLYCOGEN STORAGE DISEASE TYPE II	CHEST X-RAY ABNORMAL	1
PS	GLYCOGEN STORAGE DISEASE TYPE II	HEADACHE	1
PS	GLYCOGEN STORAGE DISEASE TYPE II	PNEUMONIA	1
PS	GLYCOGEN STORAGE DISEASE TYPE II	PYREXIA	1
PS	GLYCOGEN STORAGE DISEASE TYPE II	RED BLOOD CELL SEDIMENTATION RATE INCREASED	1
PS	LIPIDOSIS	LIPIDOSIS	1
PS	NIEMANN-PICK DISEASE	ABDOMINAL PAIN	1
PS	NIEMANN-PICK DISEASE	APPETITE DISORDER	1
PS	NIEMANN-PICK DISEASE	COAGULATION FACTOR DECREASED	1
PS	NIEMANN-PICK DISEASE	CONCOMITANT DISEASE AGGRAVATED	2
PS	NIEMANN-PICK DISEASE	CONDITION AGGRAVATED	1
PS	NIEMANN-PICK DISEASE	CONSTIPATION	1
PS	NIEMANN-PICK DISEASE	CONVULSION	2
PS	NIEMANN-PICK DISEASE	CROHN'S DISEASE	1
PS	NIEMANN-PICK DISEASE	DIARRHOEA	3
PS	NIEMANN-PICK DISEASE	DISEASE PROGRESSION	1
PS	NIEMANN-PICK DISEASE	DYSENTERY	1
PS	NIEMANN-PICK DISEASE	DYSPHAGIA	1
PS	NIEMANN-PICK DISEASE	EAR HAEMORRHAGE	1
PS	NIEMANN-PICK DISEASE	FLUID INTAKE REDUCED	1
PS	NIEMANN-PICK DISEASE	GROWTH RETARDATION	3
PS	NIEMANN-PICK DISEASE	INFLAMMATORY BOWEL DISEASE	1
PS	NIEMANN-PICK DISEASE	LIVER DISORDER	1
PS	NIEMANN-PICK DISEASE	MALAISE	1
PS	NIEMANN-PICK DISEASE	MENTAL IMPAIRMENT	1
PS	NIEMANN-PICK DISEASE	MULTI-ORGAN FAILURE	1
PS	NIEMANN-PICK DISEASE	NIEMANN-PICK DISEASE	2
PS	NIEMANN-PICK DISEASE	NO ADVERSE EVENT	1
PS	NIEMANN-PICK DISEASE	PLATELET COUNT DECREASED	1
PS	NIEMANN-PICK DISEASE	RECTAL HAEMORRHAGE	1
PS	NIEMANN-PICK DISEASE	REFUSAL OF TREATMENT BY PATIENT	1
PS	NIEMANN-PICK DISEASE	RESPIRATORY FAILURE	1
PS	NIEMANN-PICK DISEASE	TRANSAMINASES INCREASED	1
PS	NIEMANN-PICK DISEASE	WEIGHT DECREASED	6
PS	PRODUCT USED FOR UNKNOWN INDICATION	DEATH	1
PS	TAY-SACHS DISEASE	BEDRIDDEN	1
PS	TAY-SACHS DISEASE	DISEASE PROGRESSION	1
PS	TAY-SACHS DISEASE	NEUROLOGICAL DECOMPENSATION	1
PS	TAY-SACHS DISEASE	TAY-SACHS DISEASE	1
SS	GAUCHER'S DISEASE	ABDOMINAL PAIN	4
SS	GAUCHER'S DISEASE	AMENORRHOEA	1
SS	GAUCHER'S DISEASE	ASTHENIA	2
SS	GAUCHER'S DISEASE	BACK PAIN	4
SS	GAUCHER'S DISEASE	BONE LESION	1
SS	GAUCHER'S DISEASE	BONE PAIN	4
SS	GAUCHER'S DISEASE	CONSTIPATION	1
SS	GAUCHER'S DISEASE	DEPRESSION	1
SS	GAUCHER'S DISEASE	DIARRHOEA	4
SS	GAUCHER'S DISEASE	EPILEPSY	4
SS	GAUCHER'S DISEASE	ERECTILE DYSFUNCTION	2
SS	GAUCHER'S DISEASE	HEADACHE	1
SS	GAUCHER'S DISEASE	HEPATIC NEOPLASM MALIGNANT	1
SS	GAUCHER'S DISEASE	HYPERSENSITIVITY	4
SS	GAUCHER'S DISEASE	INSOMNIA	1
SS	GAUCHER'S DISEASE	LIBIDO DECREASED	2
SS	GAUCHER'S DISEASE	MEMORY IMPAIRMENT	1
SS	GAUCHER'S DISEASE	MONOCLONAL IMMUNOGLOBULIN PRESENT	4
SS	GAUCHER'S DISEASE	MOOD ALTERED	1
SS	GAUCHER'S DISEASE	MYOCLONUS	4
SS	GAUCHER'S DISEASE	OSTEOPENIA	4
SS	GAUCHER'S DISEASE	PARKINSONISM	1
SS	GAUCHER'S DISEASE	PERIPHERAL SENSORY NEUROPATHY	4
SS	GAUCHER'S DISEASE	PLATELET COUNT DECREASED	6
SS	GAUCHER'S DISEASE	POLYNEUROPATHY	4
SS	GAUCHER'S DISEASE	PYREXIA	4
SS	GAUCHER'S DISEASE	SPLENOMEGALY	4
SS	GAUCHER'S DISEASE	STATUS EPILEPTICUS	4
SS	GAUCHER'S DISEASE	TREMOR	6
SS	GAUCHER'S DISEASE	WEIGHT DECREASED	1
SS	NIEMANN-PICK DISEASE	APPETITE DISORDER	1
SS	NIEMANN-PICK DISEASE	COAGULATION FACTOR DECREASED	1
SS	NIEMANN-PICK DISEASE	CONCOMITANT DISEASE AGGRAVATED	1
SS	NIEMANN-PICK DISEASE	CONDITION AGGRAVATED	1
SS	NIEMANN-PICK DISEASE	CONVULSION	1
SS	NIEMANN-PICK DISEASE	DIARRHOEA	3
SS	NIEMANN-PICK DISEASE	DYSPHAGIA	1
SS	NIEMANN-PICK DISEASE	EAR HAEMORRHAGE	1
SS	NIEMANN-PICK DISEASE	GROWTH RETARDATION	4
SS	NIEMANN-PICK DISEASE	MENTAL IMPAIRMENT	1
SS	NIEMANN-PICK DISEASE	NIEMANN-PICK DISEASE	1
SS	NIEMANN-PICK DISEASE	PLATELET COUNT DECREASED	1
SS	NIEMANN-PICK DISEASE	WEIGHT DECREASED	5
C	DYSTONIA	ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED	1
C	DYSTONIA	COAGULATION FACTOR V LEVEL DECREASED	1
C	DYSTONIA	COAGULATION FACTOR VII LEVEL DECREASED	1
C	DYSTONIA	NEUTROPENIA	1
C	DYSTONIA	PROTHROMBIN TIME RATIO DECREASED	1
C	DYSTONIA	THROMBOCYTOPENIA	1
C	EPILEPSY	ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED	2
C	EPILEPSY	COAGULATION FACTOR V LEVEL DECREASED	2
C	EPILEPSY	COAGULATION FACTOR VII LEVEL DECREASED	2
C	EPILEPSY	NEUTROPENIA	2
C	EPILEPSY	PROTHROMBIN TIME RATIO DECREASED	2
C	EPILEPSY	THROMBOCYTOPENIA	2
C	PRODUCT USED FOR UNKNOWN INDICATION	ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED	1
C	PRODUCT USED FOR UNKNOWN INDICATION	COAGULATION FACTOR V LEVEL DECREASED	1
C	PRODUCT USED FOR UNKNOWN INDICATION	COAGULATION FACTOR VII LEVEL DECREASED	1
C	PRODUCT USED FOR UNKNOWN INDICATION	NEUTROPENIA	1
C	PRODUCT USED FOR UNKNOWN INDICATION	PROTHROMBIN TIME RATIO DECREASED	1
C	PRODUCT USED FOR UNKNOWN INDICATION	THROMBOCYTOPENIA	1

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