ANDROGEL FDA MedWatch Direct Reports Summary

These tables and charts are created from 395 voluntary U.S. reports for ANDROGEL (TESTOSTERONE) reported by individuals to the FDA via the MedWatch Reporting System from 2004 through April 28, 2026.

For a summary of adverse events including mandatory reports submitted by pharmaceutical companies (all countries and all reporter types) to the FAERS database, View FDA FAERS ANDROGEL Report.

Top Adverse Effects Associated with ANDROGEL (from U.S. FDA Medwatch Reports)

	Side Effect	# of FDA Reports
1	HEART ATTACK (MYOCARDIAL INFARCTION)	32
2	PULMONARY EMBOLISM	30
3	THROMBOSIS	29
4	DEEP VEIN THROMBOSIS	18
5	STROKE	15
6	SHORTNESS OF BREATH	15
7	ANXIETY	12
8	PAIN	12
9	PRODUCT SUBSTITUTION ISSUE	12
10	DRUG INEFFECTIVE	11
11	FATIGUE	11
12	INSOMNIA	10
13	STROKE	9
14	CHEST PAIN	8
15	DEATH	8
16	FEELING ABNORMAL	8
17	HEADACHE	8
18	LOCAL SWELLING	8
19	ITCHING	8
20	DEPRESSION	7
21	DIZZINESS	7
22	DRUG DOSE OMISSION	7
23	HOSPITALIZATION	7
24	PULMONARY EMBOLISM	7
25	JOINT PAIN	6

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ANDROGEL Total Medwatch Safety Reports by Patient Sex

Male	Female	Unknown	Total
360	7	35	395

Medwatch Reporter Type	Count
Consumer	115
Physician	18
Pharmacist	54
Other Health Professional	33

Top Indications

Product used for unknown indication
Blood testosterone decreased
Transgender hormonal therapy
Hormone replacement therapy
Gender reassignment therapy

Type of Outcome Reported
Serious: 309
Not Serious: 86
Note: A serious outcome means the adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition.

Suspected Role
Primary Suspect: 395
Concomitant Drugs: 213
Note: A single MedWatch report can list more than one drug. This summary includes ANDROGEL identified as the suspect drug or as a concomitantly taken drug.

FDA Safety-Related Labeling Changes

ANDROGEL (TESTOSTERONE) Rx Drug:
FDA Safety-related Labeling Changes

Warns that cases of venous thromboembolism (VTE) and high blood pressure have been reported.

Have experience (good or bad) with ANDROGEL? Rate ANDROGEL at Ask a Patient.

For serious adverse events, report them to the FDA by contacting the drug manufacturer or report directly through the MedWatch voluntary reporting form.

NOTES

This report, created by AskaPatient.com, is derived from U.S. drug-related adverse event cases that were reported directly to the FDA using the voluntary MedWatch online or paper reporting system. MedWatch is the voluntary FDA system for consumers, physicians, and others to directly report adverse reactions. The Medwatch initiative was launched in 1993 as a voluntary reporting program for consumers, physicians and other healthcare practitioners.

After processing the received forms, the FDA adds the MedWatch reports to the FDA Adverse Events Reporting System(or FAERS database.) Click here for the complete FAERS report summary, which includes mandatory reports submitted by pharmaceutical companies (worldwide) combined with the MedWatch reports. MedWatch Reports only represent about 5% of the FAERS database. For more, read "Does the FDA's Rapidly Growing Database of Adverse Events Improve Drug Safety?"

The data in this report was obtained from Open FDA. Data was last updated to include reports through January 27, 2026. The reactions, side effects, or "adverse events," represent up to the 20 most frequently occuring events in the database for a drug related to the event.

Open FDA states that it only includes the most recent version of a case report. It also adds the disclaimer: "Do not rely on Open FDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated."

FDA uses the "MedDRA" classification system to describe reported adverse reactions. MedDRA is a standardized medical terminology that facilitates sharing of regulatory information internationally. In some cases, "patient friendly" terms for the layman designated by MedDRA have been substituted for medical jargon. Please contact us with questions about this report.