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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

NAGLAZYME: 414 Adverse Event Reports & Safety Profile

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414
Total FAERS Reports
18 (4.3%)
Deaths Reported
88
Hospitalizations
414
As Primary/Secondary Suspect
4
Life-Threatening
3
Disabilities

First Report: 20061010 · Latest Report: 20141202

What Are the Most Common NAGLAZYME Side Effects?

#1 Most Reported
Pyrexia
46 reports (11.1%)
#2 Most Reported
Cough
25 reports (6.0%)
#3 Most Reported
Pneumonia
23 reports (5.6%)

All NAGLAZYME Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Pyrexia 46 11.1% 1 7
Cough 25 6.0% 0 2
Pneumonia 23 5.6% 5 18
Influenza 17 4.1% 0 1
Nasopharyngitis 17 4.1% 0 0
Dyspnoea 14 3.4% 0 5
Upper respiratory tract infection 12 2.9% 0 0
Carpal tunnel syndrome 11 2.7% 0 5
Nasal congestion 11 2.7% 0 0
Bronchitis 10 2.4% 0 1
Diarrhoea 10 2.4% 0 0
Ear infection 10 2.4% 0 2
Cyanosis 8 1.9% 1 3
Sinusitis 8 1.9% 0 0
Fall 7 1.7% 0 2
Malaise 7 1.7% 0 1
Oxygen saturation decreased 7 1.7% 2 3
Pruritus 7 1.7% 0 0
Rhinorrhoea 7 1.7% 0 0
Umbilical hernia 7 1.7% 0 1

Who Reports NAGLAZYME Side Effects? Age & Gender Data

Average age: 12.2 years. Most reports from: BR. View detailed demographics →

Is NAGLAZYME Getting Safer? Reports by Year

YearReportsDeathsHosp.
2006 1 0 1
2007 2 0 2
2008 4 0 1
2009 5 0 1
2010 4 0 0
2011 10 0 7
2012 28 1 4
2013 133 7 27
2014 88 5 25

View full timeline →

What Is NAGLAZYME Used For?

IndicationReports
Mucopolysaccharidosis vi 369
Product used for unknown indication 33
Mucopolysaccharidosis 6

NAGLAZYME vs Alternatives: Which Is Safer?

NAGLAZYME vs NALBUPHINE NAGLAZYME vs NALDEMEDINE NAGLAZYME vs NALMEFENE NAGLAZYME vs NALOXEGOL OXALATE NAGLAZYME vs NALOXONE NAGLAZYME vs NALOXONE\OXYCODONE NAGLAZYME vs NALOXONE\TILIDINE NAGLAZYME vs NALTREXONE NAGLAZYME vs NAPHAZOLINE\PHENIRAMINE NAGLAZYME vs NAPROXEN

Official FDA Label for NAGLAZYME

Official prescribing information from the FDA-approved drug label.