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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.

SIMULECT: 27 Adverse Event Reports & Safety Profile

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27
Total FAERS Reports
6 (22.2%)
Deaths Reported
12
Hospitalizations
27
As Primary/Secondary Suspect
1
Life-Threatening
1
Disabilities

First Report: 20071129 · Latest Report: 20140319

What Are the Most Common SIMULECT Side Effects?

#1 Most Reported
Kidney transplant rejection
7 reports (25.9%)
#2 Most Reported
Cytomegalovirus infection
5 reports (18.5%)
#3 Most Reported
Drug ineffective
3 reports (11.1%)

All SIMULECT Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Kidney transplant rejection 7 25.9% 1 4
Cytomegalovirus infection 5 18.5% 0 2

Who Reports SIMULECT Side Effects? Age & Gender Data

Average age: 47.7 years. Most reports from: JP. View detailed demographics →

Is SIMULECT Getting Safer? Reports by Year

YearReportsDeathsHosp.
2007 1 0 0
2009 1 0 1
2010 1 0 1
2011 5 0 2
2012 4 1 2
2013 1 1 1
2014 4 0 4

View full timeline →

What Is SIMULECT Used For?

IndicationReports
Renal transplant 17

Official FDA Label for SIMULECT

Official prescribing information from the FDA-approved drug label.