ALDURAZYME

Aldurazyme Adverse Events Reported to the FDA Over Time

How are Aldurazyme adverse event reports trending over time?

This graph shows volume of adverse events submitted to the FDA by quarter for Aldurazyme, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Aldurazyme is flagged as the suspect drug causing the adverse event.

Most Common Aldurazyme Adverse Events Reported to the FDA

What are the most common Aldurazyme adverse events reported to the FDA?

Pneumonia	86 (2.56%)
Pyrexia	76 (2.26%)
Infusion Related Reaction	72 (2.14%)
Respiratory Failure	66 (1.96%)
Oxygen Saturation Decreased	53 (1.58%)
Urticaria	50 (1.49%)
Vomiting	45 (1.34%)
Dyspnoea	43 (1.28%)
Disease Progression	40 (1.19%)
Respiratory Distress	39 (1.16%)
Tachycardia	36 (1.07%)
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Cardiac Failure	35 (1.04%)
Cardio-respiratory Arrest	35 (1.04%)
Cyanosis	32 (.95%)
Hydrocephalus	32 (.95%)
Convulsion	30 (.89%)
Cough	30 (.89%)
Hypertension	29 (.86%)
Headache	28 (.83%)
Pallor	28 (.83%)
Cardiac Arrest	27 (.8%)
Chills	27 (.8%)
Death	26 (.77%)
Diarrhoea	26 (.77%)
Tachypnoea	25 (.74%)
Hypotension	23 (.68%)
Irritability	23 (.68%)
Rash	21 (.62%)
Upper Respiratory Tract Infection	21 (.62%)
Mucopolysaccharidosis I	20 (.59%)
Respiratory Disorder	20 (.59%)
Condition Aggravated	19 (.56%)
Respiratory Arrest	19 (.56%)
Sepsis	19 (.56%)
Stem Cell Transplant	19 (.56%)
Bronchopneumonia	18 (.54%)
Graft Versus Host Disease	18 (.54%)
Heart Rate Increased	18 (.54%)
Bone Marrow Transplant	17 (.51%)
Influenza	17 (.51%)
Weight Decreased	17 (.51%)
Hypersensitivity	16 (.48%)
Nausea	16 (.48%)
Bronchospasm	15 (.45%)
Drug Ineffective	15 (.45%)
Anaphylactic Reaction	14 (.42%)
Asthma	14 (.42%)
Cardiac Disorder	14 (.42%)
Pruritus	14 (.42%)
Wheezing	14 (.42%)
Blindness	13 (.39%)
Body Temperature Increased	13 (.39%)
Catheter Related Complication	13 (.39%)
Fall	13 (.39%)
Poor Venous Access	13 (.39%)
Sleep Apnoea Syndrome	13 (.39%)
Viral Infection	13 (.39%)
Device Related Infection	12 (.36%)
Face Oedema	12 (.36%)
Fatigue	12 (.36%)
Spinal Cord Compression	12 (.36%)
Cardiopulmonary Failure	11 (.33%)
Erythema	11 (.33%)
Intracranial Pressure Increased	11 (.33%)
Malaise	11 (.33%)
Post Procedural Complication	11 (.33%)
Procedural Complication	11 (.33%)
Respiratory Syncytial Virus Infecti...	11 (.33%)
Sinusitis	11 (.33%)
Abasia	10 (.3%)
Anaemia	10 (.3%)
Blood Pressure Increased	10 (.3%)
Bradycardia	10 (.3%)
Cardiac Valve Disease	10 (.3%)
Dehydration	10 (.3%)
Drug Exposure During Pregnancy	10 (.3%)
Infection	10 (.3%)
Pneumonia Aspiration	10 (.3%)
Pneumonia Viral	10 (.3%)
Pulmonary Hypertension	10 (.3%)
Renal Failure	10 (.3%)
Abortion Spontaneous	9 (.27%)
Aspiration	9 (.27%)
Decreased Appetite	9 (.27%)
General Physical Health Deteriorati...	9 (.27%)
Hepatomegaly	9 (.27%)
Hypercapnia	9 (.27%)
Moaning	9 (.27%)
Respiratory Rate Increased	9 (.27%)
Tremor	9 (.27%)
Agitation	8 (.24%)
Angioedema	8 (.24%)
Ascites	8 (.24%)
Asthenia	8 (.24%)
Bacterial Infection	8 (.24%)
Blood Pressure Fluctuation	8 (.24%)
Carpal Tunnel Syndrome	8 (.24%)
Corneal Transplant	8 (.24%)
Hypernatraemia	8 (.24%)
Lung Disorder	8 (.24%)
Oedema Peripheral	8 (.24%)

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This graph shows the top adverse events submitted to the FDA for Aldurazyme, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Aldurazyme is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Adverse Event Categories for Aldurazyme

What are the most common Aldurazyme adverse events reported to the FDA?

Respiratory	334 (9.93%)
Infections - Pathogen Unspecified	281 (8.36%)
Cardiac Arrhythmias	125 (3.72%)
Administration Site Reactions	103 (3.06%)
Epidermal And Dermal Conditions	96 (2.85%)
Body Temperature Conditions	80 (2.38%)
Gastrointestinal Signs	75 (2.23%)
Viral Infectious	75 (2.23%)
Procedural And Device Related Injur...	65 (1.93%)
Bronchial Disorders	61 (1.81%)
Heart Failures	61 (1.81%)
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Metabolic, Nutritional And Blood Ga...	59 (1.75%)
Angiedema And Urticaria	58 (1.72%)
Vascular	57 (1.69%)
Cardiac And Vascular Investigations	53 (1.58%)
Neurological	53 (1.58%)
Cardiac Disorder Signs	50 (1.49%)
Physical Examination Topics	49 (1.46%)
Hematological And Lymphoid Tissue T...	46 (1.37%)
Lower Respiratory Tract Disorders	44 (1.31%)
Bacterial Infectious	43 (1.28%)
Increased Intracranial Pressure And...	43 (1.28%)
Seizures	40 (1.19%)
Gastrointestinal Motility And Defec...	39 (1.16%)
Decreased And Nonspecific Blood Pre...	38 (1.13%)
Allergic Conditions	37 (1.1%)
Fatal Outcomes	35 (1.04%)
Immune	35 (1.04%)
Vascular Hypertensive	30 (.89%)
Electrolyte And Fluid Balance Condi...	28 (.83%)
Headaches	28 (.83%)
Therapeutic And Nontherapeutic Effe...	28 (.83%)
Cardiac Valve	27 (.8%)
Myocardial	27 (.8%)
Upper Respiratory Tract Disorders	27 (.8%)
Spinal Cord And Nerve Root	26 (.77%)
Metabolic And Nutritional Disorders...	25 (.74%)
Vision	23 (.68%)
Hematology Investigations	22 (.65%)
Musculoskeletal And Connective Tiss...	22 (.65%)
Musculoskeletal And Connective Tiss...	22 (.65%)
Hepatic And Hepatobiliary	21 (.62%)
Injuries	21 (.62%)
Appetite And General Nutritional	19 (.56%)
Anemias Nonhemolytic And Marrow Dep...	17 (.51%)
Renal Disorders	17 (.51%)
Lifestyle Issues	15 (.45%)
Abdominal Hernias And Other Abdomin...	14 (.42%)
Anxiety Disorders	14 (.42%)
Mood Disorders	13 (.39%)
Hepatobiliary	12 (.36%)
Movement Disorders	12 (.36%)
Arteriosclerosis, Stenosis, Vascula...	11 (.33%)
Chemical Injury And Poisoning	11 (.33%)
Eye	11 (.33%)
Hemolyses And Related Conditions	11 (.33%)
Immunology And Allergy	11 (.33%)
Ocular Infections, Irritations And ...	11 (.33%)
Peripheral Neuropathies	11 (.33%)
Pulmonary Vascular	11 (.33%)
Central Nervous System Vascular	10 (.3%)
Embolism And Thrombosis	10 (.3%)
Tongue Conditions	10 (.3%)
Abortions And Stillbirth	9 (.27%)
Aural	9 (.27%)
Bone Disorders	9 (.27%)
Oral Soft Tissue Conditions	9 (.27%)
Eye Therapeutic Procedures	8 (.24%)
Fungal Infectious	8 (.24%)
Hearing	8 (.24%)
Joint	8 (.24%)
Microbiology And Serology	8 (.24%)
Peritoneal And Retroperitoneal Cond...	8 (.24%)
Pregnancy, Labour, Delivery And Pos...	8 (.24%)
Therapeutic Procedures And Supporti...	8 (.24%)
Changes In Physical Activity	7 (.21%)
Coronary Artery	7 (.21%)
Gastrointestinal Stenosis And Obstr...	7 (.21%)
Gastrointestinal Tract Disorders Co...	7 (.21%)
Muscle	7 (.21%)
Nervous System, Skull And Spine The...	7 (.21%)
Skin Vascular Abnormalities	7 (.21%)
Bone And Joint Injuries	6 (.18%)
Exocrine Pancreas Conditions	6 (.18%)
Glucose Metabolism Disorders	6 (.18%)
Medication Errors	6 (.18%)
Ocular Structural Change, Deposit A...	6 (.18%)
Respiratory Tract Therapeutic Proce...	6 (.18%)
Skin Appendage Conditions	6 (.18%)
Nephropathies	5 (.15%)
Pleural	5 (.15%)
Protein And Chemistry Analyses	5 (.15%)
Schizophrenia And Other Psychotic	5 (.15%)
Cardiac Therapeutic Procedures	4 (.12%)
Coagulopathies And Bleeding Diathes...	4 (.12%)
Cranial Nerve Disorders	4 (.12%)
Gastrointestinal Vascular Condition...	4 (.12%)
Hematopoietic Neoplasms	4 (.12%)
Mental Impairment	4 (.12%)
Neurological, Special Senses And Ps...	4 (.12%)
Sleep Disorders	4 (.12%)

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This graph shows the top categories of adverse events submitted to the FDA for Aldurazyme, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Aldurazyme is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.