Drug information for ALDURAZYME

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
VIAL 2.9MG/ML Prescription   LARONIDASE Iduronidase BIOMARIN 125058
2011-01-03 Label

2009-10-01 Label

2009-06-29 Label

2009-06-29 Label

2009-06-10 Letter

2009-06-10 Letter

2008-05-28 Letter

2004-03-10 Review

2004-03-10 Letter

2004-03-10 Label

Drug Adverse Effects information for ALDURAZYME

Role code Indications Reaction # Reports
PS MUCOPOLYSACCHARIDOSIS BACTERAEMIA 1
PS MUCOPOLYSACCHARIDOSIS CARDIAC ARREST 1
PS MUCOPOLYSACCHARIDOSIS CARDIAC FAILURE 1
PS MUCOPOLYSACCHARIDOSIS CHEST PAIN 1
PS MUCOPOLYSACCHARIDOSIS CITROBACTER TEST POSITIVE 1
PS MUCOPOLYSACCHARIDOSIS DEVICE RELATED INFECTION 1
PS MUCOPOLYSACCHARIDOSIS DISEASE PROGRESSION 1
PS MUCOPOLYSACCHARIDOSIS DIZZINESS 1
PS MUCOPOLYSACCHARIDOSIS ENTEROBACTER TEST POSITIVE 1
PS MUCOPOLYSACCHARIDOSIS FEBRILE NEUTROPENIA 1
PS MUCOPOLYSACCHARIDOSIS INFARCTION 1
PS MUCOPOLYSACCHARIDOSIS INFUSION RELATED REACTION 1
PS MUCOPOLYSACCHARIDOSIS KLEBSIELLA TEST POSITIVE 1
PS MUCOPOLYSACCHARIDOSIS LOSS OF CONSCIOUSNESS 1
PS MUCOPOLYSACCHARIDOSIS MALAISE 1
PS MUCOPOLYSACCHARIDOSIS SINUSITIS 1
PS MUCOPOLYSACCHARIDOSIS STEM CELL TRANSPLANT 1
PS MUCOPOLYSACCHARIDOSIS TACHYPNOEA 1
PS MUCOPOLYSACCHARIDOSIS VERTIGO 1
PS MUCOPOLYSACCHARIDOSIS I ACUTE RESPIRATORY FAILURE 1
PS MUCOPOLYSACCHARIDOSIS I AGITATION 2
PS MUCOPOLYSACCHARIDOSIS I ARTHROPATHY 1
PS MUCOPOLYSACCHARIDOSIS I ASTHMA 1
PS MUCOPOLYSACCHARIDOSIS I BACTERAEMIA 1
PS MUCOPOLYSACCHARIDOSIS I CARDIAC ARREST 3
PS MUCOPOLYSACCHARIDOSIS I CARDIAC DISORDER 2
PS MUCOPOLYSACCHARIDOSIS I CARDIAC FAILURE 1
PS MUCOPOLYSACCHARIDOSIS I CARDIAC FAILURE ACUTE 1
PS MUCOPOLYSACCHARIDOSIS I CARDIO-RESPIRATORY ARREST 2
PS MUCOPOLYSACCHARIDOSIS I CARDIOMYOPATHY 1
PS MUCOPOLYSACCHARIDOSIS I CONSTIPATION 1
PS MUCOPOLYSACCHARIDOSIS I COUGH 3
PS MUCOPOLYSACCHARIDOSIS I CYANOSIS 2
PS MUCOPOLYSACCHARIDOSIS I DEATH 1
PS MUCOPOLYSACCHARIDOSIS I DEVICE RELATED INFECTION 3
PS MUCOPOLYSACCHARIDOSIS I DISEASE PROGRESSION 2
PS MUCOPOLYSACCHARIDOSIS I DROOLING 2
PS MUCOPOLYSACCHARIDOSIS I ENDOTRACHEAL INTUBATION COMPLICATION 1
PS MUCOPOLYSACCHARIDOSIS I ENGRAFTMENT SYNDROME 1
PS MUCOPOLYSACCHARIDOSIS I EYELID OEDEMA 2
PS MUCOPOLYSACCHARIDOSIS I FALL 1
PS MUCOPOLYSACCHARIDOSIS I FEBRILE NEUTROPENIA 1
PS MUCOPOLYSACCHARIDOSIS I GENERAL PHYSICAL HEALTH DETERIORATION 1
PS MUCOPOLYSACCHARIDOSIS I HAEMOTHORAX 2
PS MUCOPOLYSACCHARIDOSIS I HYPOTENSION 2
PS MUCOPOLYSACCHARIDOSIS I INFUSION RELATED REACTION 3
PS MUCOPOLYSACCHARIDOSIS I LARYNGOSPASM 1
PS MUCOPOLYSACCHARIDOSIS I LIP SWELLING 2
PS MUCOPOLYSACCHARIDOSIS I LUNG ADENOCARCINOMA 1
PS MUCOPOLYSACCHARIDOSIS I METASTASES TO PLEURA 1
PS MUCOPOLYSACCHARIDOSIS I MUCOPOLYSACCHARIDOSIS I 2
PS MUCOPOLYSACCHARIDOSIS I OEDEMA PERIPHERAL 2
PS MUCOPOLYSACCHARIDOSIS I PAPULE 3
PS MUCOPOLYSACCHARIDOSIS I PERICARDIAL EFFUSION 1
PS MUCOPOLYSACCHARIDOSIS I PNEUMONIA 1
PS MUCOPOLYSACCHARIDOSIS I PNEUMONIA ASPIRATION 1
PS MUCOPOLYSACCHARIDOSIS I POOR VENOUS ACCESS 2
PS MUCOPOLYSACCHARIDOSIS I PULMONARY HYPERTENSION 1
PS MUCOPOLYSACCHARIDOSIS I PYREXIA 2
PS MUCOPOLYSACCHARIDOSIS I RASH 3
PS MUCOPOLYSACCHARIDOSIS I RESPIRATORY ARREST 1
PS MUCOPOLYSACCHARIDOSIS I RESPIRATORY FAILURE 2
PS MUCOPOLYSACCHARIDOSIS I RESPIRATORY SYNCYTIAL VIRUS TEST POSITIVE 2
PS MUCOPOLYSACCHARIDOSIS I ROTAVIRUS TEST POSITIVE 2
PS MUCOPOLYSACCHARIDOSIS I SECRETION DISCHARGE 1
PS MUCOPOLYSACCHARIDOSIS I SENSORY DISTURBANCE 3
PS MUCOPOLYSACCHARIDOSIS I SKIN TEST POSITIVE 1
PS MUCOPOLYSACCHARIDOSIS I SLEEP APNOEA SYNDROME 1
PS MUCOPOLYSACCHARIDOSIS I SOMNOLENCE 2
PS MUCOPOLYSACCHARIDOSIS I SPINAL DISORDER 1
PS MUCOPOLYSACCHARIDOSIS I STAPHYLOCOCCAL BACTERAEMIA 1
PS MUCOPOLYSACCHARIDOSIS I STEM CELL TRANSPLANT 2
PS MUCOPOLYSACCHARIDOSIS I STREPTOCOCCAL BACTERAEMIA 1
PS MUCOPOLYSACCHARIDOSIS I SUDDEN DEATH 1
PS MUCOPOLYSACCHARIDOSIS I SUPRAVENTRICULAR TACHYCARDIA 1
PS MUCOPOLYSACCHARIDOSIS I TRANSPLANT FAILURE 2
PS MUCOPOLYSACCHARIDOSIS I UMBILICAL HERNIA 1
PS MUCOPOLYSACCHARIDOSIS I URTICARIA 1
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