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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