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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.

ANDROGEL: 1,542 Adverse Event Reports & Safety Profile

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1,542
Total FAERS Reports
24 (1.6%)
Deaths Reported
151
Hospitalizations
1,542
As Primary/Secondary Suspect
70
Life-Threatening
38
Disabilities

First Report: 2000 · Latest Report: 20140602

What Are the Most Common ANDROGEL Side Effects?

#1 Most Reported
Blood testosterone decreased
232 reports (15.0%)
#2 Most Reported
Drug ineffective
165 reports (10.7%)
#3 Most Reported
Pain
125 reports (8.1%)

All ANDROGEL Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Blood testosterone decreased 232 15.1% 1 1
Drug ineffective 165 10.7% 0 3
Pain 125 8.1% 8 43
Emotional distress 99 6.4% 7 38
Injury 94 6.1% 6 28
Drug administered at inappropriate site 85 5.5% 0 2
Asthenia 81 5.3% 1 2
Economic problem 81 5.3% 5 26
Fatigue 79 5.1% 0 0
Myocardial infarction 79 5.1% 14 29
Anxiety 62 4.0% 2 18
Incorrect dose administered 59 3.8% 0 3
Blood testosterone increased 54 3.5% 0 3
Cerebrovascular accident 54 3.5% 0 22
Physical disability 50 3.2% 0 20
Pulmonary embolism 48 3.1% 3 38
Thrombosis 47 3.1% 0 21
Deep vein thrombosis 45 2.9% 1 26
Prostatic specific antigen increased 42 2.7% 0 1
Drug dose omission 39 2.5% 0 1

Who Reports ANDROGEL Side Effects? Age & Gender Data

Average age: 57.9 years. Most reports from: US. View detailed demographics →

Is ANDROGEL Getting Safer? Reports by Year

YearReportsDeathsHosp.
2000 1 0 0
2001 2 0 0
2002 2 0 1
2004 2 0 1
2005 3 0 0
2006 5 0 2
2007 6 1 2
2008 4 0 3
2009 7 0 1
2010 33 0 16
2011 66 2 13
2012 112 11 24
2013 535 6 49
2014 155 1 18

View full timeline →

What Is ANDROGEL Used For?

IndicationReports
Blood testosterone decreased 915
Product used for unknown indication 493
Hypogonadism 35
Testicular failure 22
Fatigue 18
Exposure via partner 15
Asthenia 12
Sexual dysfunction 11
Weight increased 11
Libido decreased 10

ANDROGEL vs Alternatives: Which Is Safer?

ANDROGEL vs ANETHOLTRITHION ANDROGEL vs ANGIOTENSIN II ANDROGEL vs ANHYDROUS CITRIC ACID\ASPIRIN\SODIUM BICARBONATE ANDROGEL vs ANHYDROUS CITRIC ACID\MAGNESIUM\SODIUM PICOSULFATE ANDROGEL vs ANIDULAFUNGIN ANDROGEL vs ANIFROLUMAB ANDROGEL vs ANIFROLUMAB-FNIA ANDROGEL vs ANTHOXANTHUM ODORATUM POLLEN\DACTYLIS GLOMERATA POLLEN\LOLIUM PERENNE POLLEN\PHLEUM PRATENSE POLLEN\POA PRATENSIS POLLEN ANDROGEL vs ANTI-INHIBITOR COAGULANT COMPLEX ANDROGEL vs ANTIHEMOPHILIC FACTOR HUMAN

Official FDA Label for ANDROGEL

Official prescribing information from the FDA-approved drug label.