AndroGeltestosterone
According to the FDA label: MALES Androgens are indicated for replacement therapy in conditions associated with a deficiency or absence of endogenous testosterone. a. Primary hypogonadism (congenital or acquired) - testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testes syndrome; or orchiectomy. b. Hypogonadotropic hypogonadism (congenital or acquired) - gonadotropic LHRH deficiency, or pituitary - hypothalamic injury from tumors, trauma or radiation.
38,668 adverse event reports submitted to the FDA (2004–2026)
Top Reported Adverse Events
The most frequently reported events in association with AndroGel in the FAERS database. These are events reported by patients taking this medication, not necessarily caused by it. A single report may include multiple events.
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Myocardial Infarction 3,013 reports
The medical term for a heart attack.
Full definition in the glossary →Drug Ineffective 2,829 reports
A report that the medication did not work as expected for the person taking it. This is a reporting category, not a sign the drug is defective. It simply means someone felt it was not helping their condition.
Full definition in the glossary →Pain 2,208 reports
A general report of physical discomfort, used when no more specific location is given.
Full definition in the glossary →- Blood Testosterone Decreased 1,988 reports
Deep Vein Thrombosis 1,967 reports
A blood clot that forms in a deep vein, usually in the leg. It can be serious if the clot travels to the lungs.
Full definition in the glossary →Fatigue 1,959 reports
Extreme tiredness or lack of energy that does not improve with rest.
Full definition in the glossary → See all drugs reporting this event →Cerebrovascular Accident 1,897 reports
The medical term for a stroke, which happens when blood flow to part of the brain is interrupted.
Full definition in the glossary →Pulmonary Embolism 1,868 reports
A blockage in one of the arteries of the lungs, usually caused by a blood clot. This is a serious condition that needs urgent medical care.
Full definition in the glossary →Anxiety 1,525 reports
A feeling of worry, nervousness, or unease.
Full definition in the glossary → See all drugs reporting this event →Off Label Use 1,471 reports
Using a medication for a condition or in a way that the FDA has not officially approved. This is common and often legal, and a report of it does not mean something went wrong. Doctors sometimes prescribe drugs off label based on their judgment.
Full definition in the glossary →Asthenia 1,380 reports
Physical weakness or lack of strength.
Full definition in the glossary →Nausea 1,137 reports
The feeling of sickness in your stomach that often comes before vomiting.
Full definition in the glossary → See all drugs reporting this event →Economic Problem 1,113 reports
A report noting a financial difficulty, such as trouble affording a medication. This is a non-medical category sometimes recorded in reports.
Full definition in the glossary →Headache 1,110 reports
Pain in the head or upper neck.
Full definition in the glossary → See all drugs reporting this event →Emotional Distress 1,000 reports
A report of emotional suffering such as upset, worry, or anguish. If you are struggling, the 988 Suicide and Crisis Lifeline (call or text 988 in the US) is available 24 hours a day.
Full definition in the glossary →
Ranked by frequency of reports, not severity. The most-reported event is not necessarily the most dangerous or the most common in patients taking this drug.
Who Is Reporting
Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.
By Sex
View reporter sex data as a table
| Sex | Reports |
|---|---|
| Male | 32,360 |
| Female | 3,589 |
| Unknown | 153 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 553 |
| 18-34 | 1,782 |
| 35-49 | 3,771 |
| 50-64 | 7,705 |
| 65-74 | 3,462 |
| 75+ | 1,490 |
This shows who filed reports, reflecting who takes this drug and who tends to report, not who is at greatest risk.
Reported Outcomes
Outcomes recorded in FAERS reports that included AndroGel. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.
View outcome data as a table
| Outcome | Reports |
|---|---|
| Non-Serious | 17,048 |
| Other Serious | 16,230 |
| Hospitalization | 8,257 |
| Death | 1,716 |
| Disability | 1,311 |
| Life-Threatening | 990 |
Serious outcomes are far more likely to be reported than mild ones, so this overstates how often outcomes are serious. A recorded death does not mean the drug caused it.
Report Volume Over Time
Number of FAERS reports received per quarter for AndroGel. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior, not changes in the medication's safety profile.
View report trend as a table
| Year | Reports |
|---|---|
| 2004 | 256 |
| 2005 | 231 |
| 2006 | 250 |
| 2007 | 269 |
| 2008 | 328 |
| 2009 | 609 |
| 2010 | 558 |
| 2011 | 653 |
| 2012 | 2,351 |
| 2013 | 2,385 |
| 2014 | 2,892 |
| 2015 | 4,797 |
| 2016 | 5,553 |
| 2017 | 3,031 |
| 2018 | 2,370 |
| 2019 | 1,901 |
| 2020 | 1,557 |
| 2021 | 1,395 |
| 2022 | 1,601 |
| 2023 | 1,678 |
| 2024 | 1,749 |
| 2025 | 1,790 |
| 2026 (partial) | 464 |
The steep increase around 2004 reflects the FDA's move to electronic submission, not a change in this drug's safety. Trends track reporting volume, not risk.
Medications commonly reported with AndroGel
In FDA adverse event reports that mention AndroGel, these medications appeared most often in the same report.
- Ergocalciferol (3,090 reports)
- Aspirin (3,028 reports)
- Omeprazole (2,455 reports)
- Lisinopril (2,351 reports)
- Levothyroxine (2,178 reports)
This reflects co-occurrence in submitted reports, not evidence of drug interaction or combined risk. People often report several medications taken for the same condition or for unrelated reasons. Talk to a doctor or pharmacist about your specific medications.
Related Drugs
Other medications with similar adverse event profiles in FDA FAERS reports.
Data Source
This data is sourced from the FDA's Adverse Event Monitoring System (AEMS), formerly FAERS, via the OpenFDA API. PillSignal is not affiliated with the FDA.
View this data on the FDA website →Data last updated: June 2026