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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.

APROVEL: 41 Adverse Event Reports & Safety Profile

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41
Total FAERS Reports
7 (17.1%)
Deaths Reported
18
Hospitalizations
41
As Primary/Secondary Suspect
3
Life-Threatening

First Report: 20110209 · Latest Report: 20140607

What Are the Most Common APROVEL Side Effects?

#1 Most Reported
Visual impairment
6 reports (14.6%)
#2 Most Reported
Diabetes mellitus inadequate control
5 reports (12.2%)
#3 Most Reported
Renal failure
4 reports (9.8%)

All APROVEL Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Visual impairment 6 14.6% 0 0
Diabetes mellitus inadequate control 5 12.2% 0 0

Who Reports APROVEL Side Effects? Age & Gender Data

Average age: 68.9 years. Most reports from: FR. View detailed demographics →

Is APROVEL Getting Safer? Reports by Year

YearReportsDeathsHosp.
2011 4 1 1
2012 5 1 3
2013 16 1 7
2014 10 1 5

View full timeline →

What Is APROVEL Used For?

IndicationReports
Hypertension 20
Product used for unknown indication 13

Official FDA Label for APROVEL

Official prescribing information from the FDA-approved drug label.