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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.

KUVAN: 28 Adverse Event Reports & Safety Profile

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28
Total FAERS Reports
3 (10.7%)
Deaths Reported
12
Hospitalizations
28
As Primary/Secondary Suspect
1
Life-Threatening

First Report: 20101008 · Latest Report: 20140505

What Are the Most Common KUVAN Side Effects?

#1 Most Reported
Convulsion
6 reports (21.4%)
#2 Most Reported
Pneumonia
2 reports (7.1%)
#3 Most Reported
Fall
2 reports (7.1%)

All KUVAN Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Convulsion 6 21.4% 0 1

Who Reports KUVAN Side Effects? Age & Gender Data

Average age: 23.9 years. Most reports from: US. View detailed demographics →

Is KUVAN Getting Safer? Reports by Year

YearReportsDeathsHosp.
2010 1 0 1
2011 2 0 2
2012 1 0 0
2013 2 0 2
2014 8 0 5

View full timeline →

What Is KUVAN Used For?

IndicationReports
Phenylketonuria 24

Official FDA Label for KUVAN

Official prescribing information from the FDA-approved drug label.