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NAGLAZYME

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Naglazyme Adverse Events Reported to the FDA Over Time

How are Naglazyme adverse event reports trending over time?

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

Most Common Naglazyme Adverse Events Reported to the FDA

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

Pneumonia
116 (6.01%)
Spinal Cord Compression
67 (3.47%)
Infusion Related Reaction
46 (2.38%)
Cardio-respiratory Arrest
33 (1.71%)
Convulsion
29 (1.5%)
Oxygen Saturation Decreased
23 (1.19%)
Cervical Cord Compression
22 (1.14%)
Intracranial Pressure Increased
22 (1.14%)
Vomiting
22 (1.14%)
Dyspnoea
18 (.93%)
Pulmonary Hypertension
18 (.93%)
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Condition Aggravated
17 (.88%)
Disease Progression
17 (.88%)
Disease Recurrence
16 (.83%)
Hydrocephalus
15 (.78%)
Respiratory Failure
15 (.78%)
Sepsis
15 (.78%)
Sleep Apnoea Syndrome
15 (.78%)
Urticaria
15 (.78%)
Bronchospasm
14 (.73%)
Influenza
14 (.73%)
Mitral Valve Incompetence
14 (.73%)
Abdominal Pain
13 (.67%)
Cardiac Failure Congestive
13 (.67%)
Carpal Tunnel Syndrome
13 (.67%)
Fall
13 (.67%)
Gait Disturbance
13 (.67%)
Hypertension
13 (.67%)
Death
12 (.62%)
Headache
12 (.62%)
Hypotonia
12 (.62%)
Muscular Weakness
12 (.62%)
Pyrexia
12 (.62%)
Cardiac Failure
11 (.57%)
Gastrointestinal Haemorrhage
11 (.57%)
Muscle Spasticity
11 (.57%)
Nephritic Syndrome
11 (.57%)
Respiratory Distress
11 (.57%)
Abasia
10 (.52%)
Activated Partial Thromboplastin Ti...
10 (.52%)
Cervical Spinal Stenosis
10 (.52%)
Myelopathy
10 (.52%)
Nephrotic Syndrome
10 (.52%)
Obstructive Airways Disorder
10 (.52%)
Upper Respiratory Tract Infection
10 (.52%)
Aortic Valve Incompetence
9 (.47%)
Drug Dose Omission
9 (.47%)
Tachycardia
9 (.47%)
Acute Respiratory Failure
8 (.41%)
Device Related Infection
8 (.41%)
Hypotension
8 (.41%)
Mastoiditis
8 (.41%)
Mucopolysaccharidosis Vi
8 (.41%)
Pyramidal Tract Syndrome
8 (.41%)
Bronchopneumonia
7 (.36%)
Cardiac Arrest
7 (.36%)
Choking
7 (.36%)
Clonus
7 (.36%)
Cyanosis
7 (.36%)
Deafness
7 (.36%)
Glomerulonephritis Membranous
7 (.36%)
Hyperreflexia
7 (.36%)
Malaise
7 (.36%)
Multi-organ Failure
7 (.36%)
Pallor
7 (.36%)
Respiratory Tract Infection
7 (.36%)
Umbilical Hernia
7 (.36%)
Acute Respiratory Distress Syndrome
6 (.31%)
Bronchial Obstruction
6 (.31%)
Cardiac Valve Disease
6 (.31%)
Chest Pain
6 (.31%)
Diarrhoea
6 (.31%)
Hepatomegaly
6 (.31%)
Hypoxia
6 (.31%)
Infection
6 (.31%)
Malignant Hypertension
6 (.31%)
Oedema Peripheral
6 (.31%)
Pain
6 (.31%)
Rash Erythematous
6 (.31%)
Respiratory Arrest
6 (.31%)
Staphylococcal Infection
6 (.31%)
Tonsillectomy
6 (.31%)
Tracheal Stenosis
6 (.31%)
Tracheostomy
6 (.31%)
Upper Airway Obstruction
6 (.31%)
Viral Infection
6 (.31%)
Angioedema
5 (.26%)
Asthma
5 (.26%)
Bacterial Infection
5 (.26%)
Bradycardia
5 (.26%)
Bronchitis
5 (.26%)
Cardiopulmonary Failure
5 (.26%)
Cervical Myelopathy
5 (.26%)
Chills
5 (.26%)
Cough
5 (.26%)
Dizziness
5 (.26%)
General Physical Health Deteriorati...
5 (.26%)
Increased Bronchial Secretion
5 (.26%)
Nausea
5 (.26%)
Nephrolithiasis
5 (.26%)
Paraesthesia
5 (.26%)

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

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

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This graph shows the top categories of adverse events submitted to the FDA for Naglazyme, 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 Naglazyme 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 Naglazyme According to Those Reporting Adverse Events

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

Mucopolysaccharidosis Vi
540
Product Used For Unknown Indication
38
Mucopolysaccharidosis Iv
17
Mucopolysaccharidosis
8
Viral Infection
2

Drug Labels

LabelLabelerEffective
Naglazyme BioMarin Pharmaceutical Inc.15-MAR-13

Naglazyme Case Reports

What Naglazyme 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 Naglazyme. 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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