Drug information for FABRAZYME

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
VIAL; INTRAVENOUS 35MG/VIAL Prescription   AGALSIDASE BETA agalsidase beta GENZYME 103979
2011-01-05 Label
2009-01-16 Label
2008-12-29 Letter
2007-01-08 Letter
2007-01-08 Letter
2007-01-08 Letter
2007-01-08 Label
2007-01-08 Label
2007-01-08 Label
2005-03-03 Other
2004-03-15 Letter
2004-03-15 Label
2004-03-15 Review
VIAL; INTRAVENOUS 5MG/VIAL Prescription   AGALSIDASE BETA agalsidase beta GENZYME   "

Drug Adverse Effects information for FABRAZYME

Role code Indications Reaction # Reports
PS ANAEMIA ASTHENIA 2
PS ANAEMIA ATRIAL FLUTTER 2
PS ANAEMIA ATRIOVENTRICULAR BLOCK SECOND DEGREE 2
PS ANAEMIA DIZZINESS 2
PS ANAEMIA HEART RATE INCREASED 2
PS ANTIFUNGAL PROPHYLAXIS DEHYDRATION 1
PS ANTIVIRAL PROPHYLAXIS DEHYDRATION 1
PS ANXIETY ACUTE CORONARY SYNDROME 1
PS ANXIETY ASTHENIA 1
PS ANXIETY ATRIAL FLUTTER 1
PS ANXIETY ATRIOVENTRICULAR BLOCK SECOND DEGREE 1
PS ANXIETY DIZZINESS 1
PS ANXIETY HEART RATE INCREASED 1
PS ASTHMA HYPERTROPHIC CARDIOMYOPATHY 1
PS ASTHMA LEFT VENTRICULAR FAILURE 1
PS DIURETIC THERAPY DEHYDRATION 1
PS FABRY'S DISEASE ABDOMINAL PAIN 3
PS FABRY'S DISEASE ACUTE CORONARY SYNDROME 1
PS FABRY'S DISEASE ANGINA PECTORIS 1
PS FABRY'S DISEASE ANGIOKERATOMA 1
PS FABRY'S DISEASE ANURIA 1
PS FABRY'S DISEASE APHONIA 1
PS FABRY'S DISEASE ASTHENIA 5
PS FABRY'S DISEASE ATRIAL FIBRILLATION 1
PS FABRY'S DISEASE ATRIAL FLUTTER 1
PS FABRY'S DISEASE ATRIOVENTRICULAR BLOCK SECOND DEGREE 1
PS FABRY'S DISEASE CARDIAC ARREST 1
PS FABRY'S DISEASE CARDIAC DISORDER 6
PS FABRY'S DISEASE CARDIAC FAILURE 4
PS FABRY'S DISEASE CARDIAC FAILURE CONGESTIVE 2
PS FABRY'S DISEASE CARDIAC HYPERTROPHY 1
PS FABRY'S DISEASE CARDIAC NEOPLASM UNSPECIFIED 1
PS FABRY'S DISEASE CATARACT 1
PS FABRY'S DISEASE CEREBRAL INFARCTION 4
PS FABRY'S DISEASE CEREBROVASCULAR ACCIDENT 6
PS FABRY'S DISEASE CHEST PAIN 1
PS FABRY'S DISEASE CHOLECYSTITIS INFECTIVE 3
PS FABRY'S DISEASE CLOSTRIDIAL INFECTION 2
PS FABRY'S DISEASE COLONIC POLYP 1
PS FABRY'S DISEASE DEAFNESS NEUROSENSORY 1
PS FABRY'S DISEASE DEAFNESS UNILATERAL 1
PS FABRY'S DISEASE DEATH 5
PS FABRY'S DISEASE DEHYDRATION 1
PS FABRY'S DISEASE DILATATION VENTRICULAR 1
PS FABRY'S DISEASE DISEASE PROGRESSION 1
PS FABRY'S DISEASE DIZZINESS 1
PS FABRY'S DISEASE DYSLALIA 4
PS FABRY'S DISEASE DYSPNOEA 4
PS FABRY'S DISEASE EAR INFECTION FUNGAL 1
PS FABRY'S DISEASE EJECTION FRACTION DECREASED 2
PS FABRY'S DISEASE ERYTHEMA 1
PS FABRY'S DISEASE EYELID OEDEMA 1
PS FABRY'S DISEASE FATIGUE 2
PS FABRY'S DISEASE FIBROSIS 1
PS FABRY'S DISEASE GASTROENTERITIS 1
PS FABRY'S DISEASE GASTROINTESTINAL DISORDER 2
PS FABRY'S DISEASE GASTROINTESTINAL INFLAMMATION 1
PS FABRY'S DISEASE GASTROOESOPHAGEAL REFLUX DISEASE 1
PS FABRY'S DISEASE GENERAL PHYSICAL HEALTH DETERIORATION 1
PS FABRY'S DISEASE HAEMOGLOBIN DECREASED 1
PS FABRY'S DISEASE HAEMORRHAGE 1
PS FABRY'S DISEASE HEART RATE INCREASED 1
PS FABRY'S DISEASE HEMIPLEGIA 1
PS FABRY'S DISEASE HYPERTROPHIC CARDIOMYOPATHY 1
PS FABRY'S DISEASE LEFT VENTRICULAR DYSFUNCTION 1
PS FABRY'S DISEASE LEFT VENTRICULAR FAILURE 1
PS FABRY'S DISEASE LEFT VENTRICULAR HYPERTROPHY 1
PS FABRY'S DISEASE LIP OEDEMA 2
PS FABRY'S DISEASE MULTI-ORGAN FAILURE 5
PS FABRY'S DISEASE MUSCULAR WEAKNESS 4
PS FABRY'S DISEASE MYOCARDIAL INFARCTION 7
PS FABRY'S DISEASE NEOPLASM MALIGNANT 1
PS FABRY'S DISEASE NOSOCOMIAL INFECTION 1
PS FABRY'S DISEASE PAIN 8
PS FABRY'S DISEASE PAIN IN EXTREMITY 2
PS FABRY'S DISEASE PARAESTHESIA 1
PS FABRY'S DISEASE PRURITUS 3
PS FABRY'S DISEASE PYREXIA 3
PS FABRY'S DISEASE RENAL DISORDER 4
PS FABRY'S DISEASE RENAL FAILURE 5
PS FABRY'S DISEASE RENAL IMPAIRMENT 1
PS FABRY'S DISEASE RENAL TRANSPLANT 1
PS FABRY'S DISEASE ROAD TRAFFIC ACCIDENT 1
PS FABRY'S DISEASE SEPSIS 3
PS FABRY'S DISEASE SEPTIC SHOCK 1
PS FABRY'S DISEASE SKIN CANCER 1
PS FABRY'S DISEASE SKULL FRACTURE 1
PS FABRY'S DISEASE SUDDEN DEATH 1
PS FABRY'S DISEASE SURGICAL PROCEDURE REPEATED 1
PS FABRY'S DISEASE SWELLING FACE 1
PS FABRY'S DISEASE SWOLLEN TONGUE 1
PS FABRY'S DISEASE TOOTH DISORDER 1
PS FABRY'S DISEASE TOOTH INFECTION 1
PS FABRY'S DISEASE TRANSIENT ACANTHOLYTIC DERMATOSIS 1
PS FABRY'S DISEASE TRANSIENT ISCHAEMIC ATTACK 2
PS FABRY'S DISEASE TRANSPLANT FAILURE 1
PS FABRY'S DISEASE TROPONIN T INCREASED 1
PS FABRY'S DISEASE TYPE I HYPERSENSITIVITY 1
PS FABRY'S DISEASE URINARY RETENTION 1
PS FABRY'S DISEASE URTICARIA 3
PS FABRY'S DISEASE UTERINE DISORDER 1
PS FABRY'S DISEASE VENTRICULAR FIBRILLATION 2
PS FABRY'S DISEASE WEIGHT DECREASED 2
PS FATIGUE ACUTE CORONARY SYNDROME 1
PS HYPERTENSION ACUTE CORONARY SYNDROME 1
PS HYPERTENSION ASTHENIA 2
PS HYPERTENSION ATRIAL FLUTTER 1
PS HYPERTENSION ATRIOVENTRICULAR BLOCK SECOND DEGREE 1
PS HYPERTENSION DIZZINESS 1
PS HYPERTENSION HEART RATE INCREASED 1
PS HYPERTENSION PAIN 1
PS HYPERTENSION PAIN IN EXTREMITY 1
PS HYPERTENSION URINARY RETENTION 1
PS NEUROPATHY PERIPHERAL ACUTE CORONARY SYNDROME 1
PS OSTEOARTHRITIS ASTHENIA 1
PS OSTEOARTHRITIS ATRIAL FLUTTER 1
PS OSTEOARTHRITIS ATRIOVENTRICULAR BLOCK SECOND DEGREE 1
PS OSTEOARTHRITIS DIZZINESS 1
PS OSTEOARTHRITIS HEART RATE INCREASED 1
PS PAIN ASTHENIA 1
PS PAIN ATRIAL FLUTTER 1
PS PAIN ATRIOVENTRICULAR BLOCK SECOND DEGREE 1
PS PAIN CARDIAC DISORDER 2
PS PAIN DIZZINESS 1
PS PAIN EJECTION FRACTION DECREASED 2
PS PAIN FATIGUE 2
PS PAIN GASTROINTESTINAL DISORDER 2
PS PAIN HEART RATE INCREASED 1
PS PAIN PAIN 2
PS PAIN RENAL FAILURE 2
PS PAIN WEIGHT DECREASED 2
PS PREMEDICATION ASTHENIA 2
PS PREMEDICATION ATRIAL FIBRILLATION 3
PS PREMEDICATION ATRIAL FLUTTER 2
PS PREMEDICATION ATRIOVENTRICULAR BLOCK SECOND DEGREE 2
PS PREMEDICATION CARDIAC FAILURE 3
PS PREMEDICATION DIZZINESS 2
PS PREMEDICATION HEART RATE INCREASED 2
PS PREMEDICATION NOSOCOMIAL INFECTION 3
PS PREMEDICATION SEPTIC SHOCK 3
PS PRODUCT USED FOR UNKNOWN INDICATION ASTHENIA 2
PS PRODUCT USED FOR UNKNOWN INDICATION ATRIAL FIBRILLATION 5
PS PRODUCT USED FOR UNKNOWN INDICATION ATRIAL FLUTTER 2
PS PRODUCT USED FOR UNKNOWN INDICATION ATRIOVENTRICULAR BLOCK SECOND DEGREE 2
PS PRODUCT USED FOR UNKNOWN INDICATION CARDIAC DISORDER 8
PS PRODUCT USED FOR UNKNOWN INDICATION CARDIAC FAILURE 45
PS PRODUCT USED FOR UNKNOWN INDICATION CATARACT 5
PS PRODUCT USED FOR UNKNOWN INDICATION CLOSTRIDIAL INFECTION 2
PS PRODUCT USED FOR UNKNOWN INDICATION COLONIC POLYP 1
PS PRODUCT USED FOR UNKNOWN INDICATION DEAFNESS NEUROSENSORY 1
PS PRODUCT USED FOR UNKNOWN INDICATION DEHYDRATION 12
PS PRODUCT USED FOR UNKNOWN INDICATION DIZZINESS 2
PS PRODUCT USED FOR UNKNOWN INDICATION EJECTION FRACTION DECREASED 8
PS PRODUCT USED FOR UNKNOWN INDICATION FATIGUE 8
PS PRODUCT USED FOR UNKNOWN INDICATION GASTROINTESTINAL DISORDER 8
PS PRODUCT USED FOR UNKNOWN INDICATION HAEMOGLOBIN DECREASED 1
PS PRODUCT USED FOR UNKNOWN INDICATION HAEMORRHAGE 5
PS PRODUCT USED FOR UNKNOWN INDICATION HEART RATE INCREASED 2
PS PRODUCT USED FOR UNKNOWN INDICATION HYPERTROPHIC CARDIOMYOPATHY 2
PS PRODUCT USED FOR UNKNOWN INDICATION LEFT VENTRICULAR FAILURE 2
PS PRODUCT USED FOR UNKNOWN INDICATION MULTI-ORGAN FAILURE 40
PS PRODUCT USED FOR UNKNOWN INDICATION NOSOCOMIAL INFECTION 5
PS PRODUCT USED FOR UNKNOWN INDICATION PAIN 8
PS PRODUCT USED FOR UNKNOWN INDICATION PYREXIA 40
PS PRODUCT USED FOR UNKNOWN INDICATION RENAL DISORDER 44
PS PRODUCT USED FOR UNKNOWN INDICATION RENAL FAILURE 14
PS PRODUCT USED FOR UNKNOWN INDICATION RENAL TRANSPLANT 6
PS PRODUCT USED FOR UNKNOWN INDICATION SEPTIC SHOCK 5
PS PRODUCT USED FOR UNKNOWN INDICATION SURGICAL PROCEDURE REPEATED 6
PS PRODUCT USED FOR UNKNOWN INDICATION TOOTH INFECTION 2
PS PRODUCT USED FOR UNKNOWN INDICATION WEIGHT DECREASED 8
PS PROPHYLAXIS CLOSTRIDIAL INFECTION 2
PS PROPHYLAXIS DEHYDRATION 2
PS PROPHYLAXIS TOOTH DISORDER 1
PS PROPHYLAXIS TOOTH INFECTION 1
PS PROPHYLAXIS AGAINST TRANSPLANT REJECTION DEHYDRATION 3
PS PROPHYLAXIS URINARY TRACT INFECTION DEHYDRATION 1
PS RENAL TRANSPLANT CARDIAC DISORDER 2
PS RENAL TRANSPLANT EJECTION FRACTION DECREASED 2
PS RENAL TRANSPLANT FATIGUE 2
PS RENAL TRANSPLANT GASTROINTESTINAL DISORDER 2
PS RENAL TRANSPLANT PAIN 2
PS RENAL TRANSPLANT RENAL DISORDER 2
PS RENAL TRANSPLANT RENAL FAILURE 2
PS RENAL TRANSPLANT WEIGHT DECREASED 2
PS SLEEP DISORDER ACUTE CORONARY SYNDROME 1
SS ANTIFUNGAL PROPHYLAXIS DEHYDRATION 3
SS ANTIVIRAL PROPHYLAXIS DEHYDRATION 3
SS ANXIETY ACUTE CORONARY SYNDROME 1
SS ASTHMA HYPERTROPHIC CARDIOMYOPATHY 4
SS ASTHMA LEFT VENTRICULAR FAILURE 4
SS DIURETIC THERAPY DEHYDRATION 3
SS FABRY'S DISEASE ACUTE CORONARY SYNDROME 1
SS FABRY'S DISEASE ANURIA 2
SS FABRY'S DISEASE ASTHENIA 4
SS FABRY'S DISEASE CARDIAC DISORDER 2
SS FABRY'S DISEASE CARDIAC FAILURE 2
SS FABRY'S DISEASE CEREBRAL INFARCTION 4
SS FABRY'S DISEASE COLONIC POLYP 1
SS FABRY'S DISEASE DEAFNESS NEUROSENSORY 3
SS FABRY'S DISEASE DEHYDRATION 3
SS FABRY'S DISEASE DYSLALIA 4
SS FABRY'S DISEASE EJECTION FRACTION DECREASED 2
SS FABRY'S DISEASE FATIGUE 2
SS FABRY'S DISEASE GASTROENTERITIS 1
SS FABRY'S DISEASE GASTROINTESTINAL DISORDER 2
SS FABRY'S DISEASE HAEMOGLOBIN DECREASED 1
SS FABRY'S DISEASE HYPERTROPHIC CARDIOMYOPATHY 4
SS FABRY'S DISEASE LEFT VENTRICULAR FAILURE 4
SS FABRY'S DISEASE MULTI-ORGAN FAILURE 2
SS FABRY'S DISEASE MUSCULAR WEAKNESS 4
SS FABRY'S DISEASE MYOCARDIAL INFARCTION 2
SS FABRY'S DISEASE PAIN 7
SS FABRY'S DISEASE PAIN IN EXTREMITY 4
SS FABRY'S DISEASE PYREXIA 3
SS FABRY'S DISEASE RENAL DISORDER 3
SS FABRY'S DISEASE RENAL FAILURE 2
SS FABRY'S DISEASE ROAD TRAFFIC ACCIDENT 1
SS FABRY'S DISEASE SKULL FRACTURE 1
SS FABRY'S DISEASE URINARY RETENTION 2
SS FABRY'S DISEASE WEIGHT DECREASED 2
SS FATIGUE ACUTE CORONARY SYNDROME 1
SS HYPERTENSION ACUTE CORONARY SYNDROME 1
SS HYPERTENSION ASTHENIA 2
SS HYPERTENSION PAIN 2
SS HYPERTENSION PAIN IN EXTREMITY 2
SS HYPERTENSION URINARY RETENTION 2
SS NEUROPATHY PERIPHERAL ACUTE CORONARY SYNDROME 1
SS PAIN CARDIAC DISORDER 2
SS PAIN EJECTION FRACTION DECREASED 2
SS PAIN FATIGUE 2
SS PAIN GASTROINTESTINAL DISORDER 2
SS PAIN PAIN 2
SS PAIN RENAL FAILURE 2
SS PAIN WEIGHT DECREASED 2
SS PRODUCT USED FOR UNKNOWN INDICATION CARDIAC DISORDER 8
SS PRODUCT USED FOR UNKNOWN INDICATION CARDIAC FAILURE 40
SS PRODUCT USED FOR UNKNOWN INDICATION COLONIC POLYP 1
SS PRODUCT USED FOR UNKNOWN INDICATION DEAFNESS NEUROSENSORY 3
SS PRODUCT USED FOR UNKNOWN INDICATION DEHYDRATION 36
SS PRODUCT USED FOR UNKNOWN INDICATION EJECTION FRACTION DECREASED 8
SS PRODUCT USED FOR UNKNOWN INDICATION FATIGUE 8
SS PRODUCT USED FOR UNKNOWN INDICATION GASTROINTESTINAL DISORDER 8
SS PRODUCT USED FOR UNKNOWN INDICATION HAEMOGLOBIN DECREASED 1
SS PRODUCT USED FOR UNKNOWN INDICATION HYPERTROPHIC CARDIOMYOPATHY 8
SS PRODUCT USED FOR UNKNOWN INDICATION LEFT VENTRICULAR FAILURE 8
SS PRODUCT USED FOR UNKNOWN INDICATION MULTI-ORGAN FAILURE 40
SS PRODUCT USED FOR UNKNOWN INDICATION PAIN 8
SS PRODUCT USED FOR UNKNOWN INDICATION PYREXIA 40
SS PRODUCT USED FOR UNKNOWN INDICATION RENAL DISORDER 44
SS PRODUCT USED FOR UNKNOWN INDICATION RENAL FAILURE 8
SS PRODUCT USED FOR UNKNOWN INDICATION WEIGHT DECREASED 8
SS PROPHYLAXIS DEHYDRATION 6
SS PROPHYLAXIS AGAINST TRANSPLANT REJECTION DEHYDRATION 9
SS PROPHYLAXIS URINARY TRACT INFECTION DEHYDRATION 3
SS RENAL TRANSPLANT CARDIAC DISORDER 2
SS RENAL TRANSPLANT EJECTION FRACTION DECREASED 2
SS RENAL TRANSPLANT FATIGUE 2
SS RENAL TRANSPLANT GASTROINTESTINAL DISORDER 2
SS RENAL TRANSPLANT PAIN 2
SS RENAL TRANSPLANT RENAL DISORDER 2
SS RENAL TRANSPLANT RENAL FAILURE 2
SS RENAL TRANSPLANT WEIGHT DECREASED 2
SS SLEEP DISORDER ACUTE CORONARY SYNDROME 1
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