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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.

PROSCAR: 78 Adverse Event Reports & Safety Profile

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78
Total FAERS Reports
2 (2.6%)
Deaths Reported
14
Hospitalizations
78
As Primary/Secondary Suspect
1
Life-Threatening
12
Disabilities

First Report: 1995 · Latest Report: 20140605

What Are the Most Common PROSCAR Side Effects?

#1 Most Reported
Erectile dysfunction
34 reports (43.6%)
#2 Most Reported
Sexual dysfunction
30 reports (38.5%)
#3 Most Reported
Drug administration error
19 reports (24.4%)

All PROSCAR Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Erectile dysfunction 34 43.6% 0 3
Sexual dysfunction 30 38.5% 0 3
Drug administration error 19 24.4% 0 3
Wrong technique in drug usage process 18 23.1% 0 4
Anxiety 16 20.5% 0 1
Depression 15 19.2% 0 1
Cognitive disorder 12 15.4% 0 2
Libido decreased 12 15.4% 0 0
Gynaecomastia 11 14.1% 0 0
Asthenia 8 10.3% 0 1
Loss of libido 8 10.3% 0 1
Blood testosterone decreased 7 9.0% 0 1
Drug ineffective 7 9.0% 0 3
Ejaculation disorder 7 9.0% 0 0
Headache 7 9.0% 0 1
Fatigue 6 7.7% 0 1
Urinary retention 6 7.7% 0 4
Back pain 5 6.4% 0 0
Ejaculation failure 5 6.4% 0 1
Hypertension 5 6.4% 0 0

Who Reports PROSCAR Side Effects? Age & Gender Data

Average age: 64.4 years. Most reports from: US. View detailed demographics →

Is PROSCAR Getting Safer? Reports by Year

YearReportsDeathsHosp.
2000 5 0 1
2001 4 0 0
2002 1 0 0
2003 3 0 1
2004 2 0 0
2006 1 0 0
2008 2 0 0
2009 6 0 1
2010 1 0 0
2011 2 0 0
2012 3 0 0
2013 12 0 3
2014 16 0 6

View full timeline →

What Is PROSCAR Used For?

IndicationReports
Benign prostatic hyperplasia 22
Androgenetic alopecia 15
Alopecia 11
Prostatomegaly 7

Official FDA Label for PROSCAR

Official prescribing information from the FDA-approved drug label.