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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.

ADVATE: 37 Adverse Event Reports & Safety Profile

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37
Total FAERS Reports
0
Deaths Reported
5
Hospitalizations
37
As Primary/Secondary Suspect

First Report: 2000 · Latest Report: 20140624

What Are the Most Common ADVATE Side Effects?

#1 Most Reported
Haemarthrosis
9 reports (24.3%)
#2 Most Reported
Haemorrhage
7 reports (18.9%)
#3 Most Reported
Factor viii inhibition
5 reports (13.5%)

All ADVATE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Haemarthrosis 9 24.3% 0 1
Haemorrhage 7 18.9% 0 2
Drug ineffective 5 13.5% 0 0
Factor viii inhibition 5 13.5% 0 1

Who Reports ADVATE Side Effects? Age & Gender Data

Average age: 15.8 years. Most reports from: US. View detailed demographics →

Is ADVATE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2000 1 0 0
2005 1 0 0
2010 4 0 1
2012 1 0 1
2013 5 0 2
2014 5 0 1

View full timeline →

What Is ADVATE Used For?

IndicationReports
Factor viii deficiency 13
Haemophilia 10
Product used for unknown indication 10
Prophylaxis 7

Official FDA Label for ADVATE

Official prescribing information from the FDA-approved drug label.