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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.

KALETRA 200/50: 27 Adverse Event Reports & Safety Profile

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27
Total FAERS Reports
3 (11.1%)
Deaths Reported
14
Hospitalizations
27
As Primary/Secondary Suspect
1
Disabilities

First Report: 1999 · Latest Report: 201405

What Are the Most Common KALETRA 200/50 Side Effects?

#1 Most Reported
Diarrhoea
5 reports (18.5%)
#2 Most Reported
Weight decreased
3 reports (11.1%)
#3 Most Reported
Vomiting
3 reports (11.1%)

All KALETRA 200/50 Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Diarrhoea 5 18.5% 1 2

Who Reports KALETRA 200/50 Side Effects? Age & Gender Data

Average age: 44.6 years. Most reports from: COUNTRY NOT SPECIFIED. View detailed demographics →

Is KALETRA 200/50 Getting Safer? Reports by Year

YearReportsDeathsHosp.
2009 1 0 1
2010 2 0 2
2011 1 0 0
2012 1 0 0
2013 7 0 2
2014 8 1 5

View full timeline →

What Is KALETRA 200/50 Used For?

IndicationReports
Antiretroviral therapy 12
Hiv infection 12

Official FDA Label for KALETRA 200/50

Official prescribing information from the FDA-approved drug label.