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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.

VX-809 FDC: 21 Adverse Event Reports & Safety Profile

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21
Total FAERS Reports
0
Deaths Reported
18
Hospitalizations
21
As Primary/Secondary Suspect

First Report: 20130908 · Latest Report: 20140511

What Are the Most Common VX-809 FDC Side Effects?

#1 Most Reported
Infective pulmonary exacerbation of cystic fibrosis
7 reports (33.3%)
#2 Most Reported
Pneumonia
2 reports (9.5%)
#3 Most Reported
Forced expiratory volume decreased
2 reports (9.5%)

All VX-809 FDC Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Infective pulmonary exacerbation of cystic fibrosis 7 33.3% 0 7

Who Reports VX-809 FDC Side Effects? Age & Gender Data

Average age: 28.9 years. Most reports from: US. View detailed demographics →

Is VX-809 FDC Getting Safer? Reports by Year

YearReportsDeathsHosp.
2013 12 0 10
2014 9 0 8

View full timeline →

What Is VX-809 FDC Used For?

IndicationReports
Cystic fibrosis 21

Official FDA Label for VX-809 FDC

Official prescribing information from the FDA-approved drug label.