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Myozyme Adverse Events Reported to the FDA Over Time

How are Myozyme adverse event reports trending over time?

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

Most Common Myozyme Adverse Events Reported to the FDA

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

Respiratory Failure
287 (2.89%)
Infusion Related Reaction
203 (2.05%)
Pyrexia
187 (1.88%)
Disease Progression
169 (1.7%)
Pneumonia
147 (1.48%)
Respiratory Distress
128 (1.29%)
Muscular Weakness
123 (1.24%)
Tachycardia
118 (1.19%)
Cardiac Failure
107 (1.08%)
Dyspnoea
106 (1.07%)
Death
104 (1.05%)
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Oxygen Saturation Decreased
103 (1.04%)
Urticaria
98 (.99%)
Rash
96 (.97%)
Cyanosis
95 (.96%)
Bradycardia
87 (.88%)
Vomiting
86 (.87%)
Drug Ineffective
77 (.78%)
Staphylococcal Infection
75 (.76%)
Diarrhoea
73 (.74%)
General Physical Health Deteriorati...
73 (.74%)
Cardiac Arrest
72 (.73%)
Cardio-respiratory Arrest
71 (.72%)
Atelectasis
68 (.69%)
Hypotension
68 (.69%)
Flushing
63 (.64%)
Pallor
63 (.64%)
Bronchospasm
62 (.62%)
Hypersensitivity
62 (.62%)
Pseudomonas Infection
60 (.6%)
Respiratory Disorder
59 (.59%)
Hypotonia
58 (.58%)
Respiratory Tract Infection
58 (.58%)
Condition Aggravated
57 (.57%)
Erythema
57 (.57%)
Asthenia
56 (.56%)
No Therapeutic Response
56 (.56%)
Dysphagia
53 (.53%)
Heart Rate Increased
51 (.51%)
Nausea
51 (.51%)
Central Line Infection
49 (.49%)
Glycogen Storage Disease Type Ii
49 (.49%)
Pneumonia Aspiration
49 (.49%)
Tachypnoea
49 (.49%)
Wheezing
49 (.49%)
Hypertrophic Cardiomyopathy
48 (.48%)
Aspiration
47 (.47%)
Aspartate Aminotransferase Increase...
45 (.45%)
Chills
45 (.45%)
Respiratory Arrest
43 (.43%)
Headache
42 (.42%)
Hyperhidrosis
41 (.41%)
Alanine Aminotransferase Increased
40 (.4%)
Blood Creatine Phosphokinase Increa...
39 (.39%)
Blood Immunoglobulin G Increased
39 (.39%)
Fatigue
39 (.39%)
Supraventricular Tachycardia
38 (.38%)
Therapeutic Response Decreased
38 (.38%)
Viral Infection
38 (.38%)
Convulsion
35 (.35%)
Cough
35 (.35%)
Lobar Pneumonia
35 (.35%)
Urinary Tract Infection
35 (.35%)
Blood Pressure Decreased
34 (.34%)
Lung Infection
33 (.33%)
Oedema Peripheral
33 (.33%)
Pruritus
33 (.33%)
Chest Discomfort
32 (.32%)
Hypoxia
32 (.32%)
Sepsis
32 (.32%)
Disease Recurrence
31 (.31%)
Infection
31 (.31%)
Irritability
31 (.31%)
Candidiasis
30 (.3%)
Cardiopulmonary Failure
30 (.3%)
Blood Pressure Increased
29 (.29%)
Cardiac Disorder
29 (.29%)
Cardiomyopathy
29 (.29%)
Nystagmus
29 (.29%)
Body Temperature Increased
28 (.28%)
Myalgia
28 (.28%)
Tracheitis
28 (.28%)
Apnoea
27 (.27%)
Catheter Related Infection
27 (.27%)
Fall
27 (.27%)
Hypercapnia
27 (.27%)
Collapse Of Lung
26 (.26%)
Hypertension
26 (.26%)
Parainfluenzae Virus Infection
26 (.26%)
Respiratory Rate Increased
26 (.26%)
Retching
26 (.26%)
Feeding Disorder
25 (.25%)
Influenza
25 (.25%)
Motor Dysfunction
25 (.25%)
Lower Respiratory Tract Infection
24 (.24%)
Respiratory Syncytial Virus Infecti...
24 (.24%)
Tremor
24 (.24%)
Acute Respiratory Failure
23 (.23%)
Agitation
23 (.23%)
Anaphylactic Reaction
23 (.23%)
Dizziness
23 (.23%)

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This graph shows the top adverse events submitted to the FDA for Myozyme, 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 Myozyme 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 Myozyme

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

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This graph shows the top categories of adverse events submitted to the FDA for Myozyme, 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 Myozyme 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.

Common Uses of Myozyme According to Those Reporting Adverse Events

Why are people taking Myozyme, according to those reporting adverse events to the FDA?

Glycogen Storage Disease Type Ii
1617
Fabrys Disease
3
Mucopolysaccharidosis I
2
Drug Use For Unknown Indication
1

Drug Labels

LabelLabelerEffective
MyozymeGenzyme Corporation09-JUL-12

Myozyme Case Reports

What Myozyme safety concerns are being reported by doctors and researchers in the medical literature?

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About Results

This report contains aggregated drug side effects and adverse events for Myozyme. The data has been pulled from the United States Food and Drug Administration's (US FDA) Adverse Event Reporting System (AERS), a database containing more than 4,000,000 adverse event reports.

DrugCite expands your query using the Unified Medical Language System (UMLS) to include generic drugs and primary active ingredients. While the core of DrugCite's advanced drug filtering algorithm is based on the industry standard UMLS, DrugCite's proprietary filtering system also includes dozens of additional steps to reconcile malformed drug names in the FDA's data.

DrugCite only counts a drug if the submitter of the adverse event indicates that the drug is suspected to have caused the adverse event.

Depending on how the data is aggregated, different counts may occur. When someone submits an adverse event to the FDA, the submitter can attribute multiple adverse events to one or more drugs. For example, an individual taking Paxil could submit the adverse events "anxiety" and "suicidal ideation" for the same individual safety report (ISR). This means when DrugCite aggregates by adverse event, two distinct adverse events are counted in the adverse event graph; once for "anxiety" and again for "suicidal ideation". However, when DrugCite aggregates by individual safety reports irrespective of the details of the adverse events contained within the safety report, the report is only counted once.

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