FDA Adverse Events Reports (FAERS) Summary for ANDROGEL

These tables and charts are based on 22,144 total reports for ANDROGEL (TESTOSTERONE) received by the FDA Adverse Event Reporting System (FAERS) from 2004 through April 28, 2026.

This FAERS total includes 21,749 pharmaceutical company-submitted and non-U.S. FAERS reports and 395 U.S. consumer or healthcare provider-submitted MedWatch reports. For a separate summary of the 395 U.S. reports filed via the FDA MedWatch voluntary reporting system, view our FDA MedWatch ANDROGEL summary report. (See notes section below for explanation of FDA’s mandatory and voluntary reporting system.)

Top 20 Adverse Effects Associated with ANDROGEL (reported in FAERS Database)

	Side Effect	# of FDA Reports
1	HEART ATTACK (MYOCARDIAL INFARCTION)	2821
2	BLOOD TESTOSTERONE DECREASED	1883
3	DEEP VEIN THROMBOSIS	1757
4	STROKE	1751
5	PULMONARY EMBOLISM	1619
6	DRUG INEFFECTIVE	1616
7	PAIN	1526
8	ECONOMIC PROBLEM	1072
9	ANXIETY	990
10	FATIGUE	956
11	INJURY	935
12	LACK OF STRENGTH AND ENERGY (ASTHENIA)	883
13	EMOTIONAL DISTRESS	846
14	THROMBOSIS	809
15	HEART ATTACK	549
16	DRUG ADMINISTERED AT INAPPROPRIATE SITE	511
17	OFF LABEL USE	474
18	IMPAIRED WORK ABILITY	471
19	LOSS OF ALL PLEASURE	465
20	SHORTNESS OF BREATH	419
21	BLOOD TESTOSTERONE INCREASED	416
22	HEADACHE	401
23	PHYSICAL DISABILITY	385
24	DEPRESSION	375
25	CARDIOVASCULAR DISORDER	369
26	DIZZINESS	366
27	ERECTILE DYSFUNCTION	366
28	DEATH	365
29	NAUSEA	362
30	INCORRECT DOSE ADMINISTERED	361
31	INSOMNIA	360
32	LIBIDO DECREASED	354
33	JOINT PAIN	337
34	WEIGHT INCREASED	330
35	WEIGHT DECREASED	322
36	SOCIAL PROBLEM	314
37	RASH	296
38	FEAR	295
39	CHEST PAIN	287
40	CONGESTIVE HEART FAILURE	284
41	HIGH BLOOD PRESSURE	282
42	CORONARY ARTERY DISEASE	279
43	FEELING ABNORMAL	275
44	PAIN IN EXTREMITY	272
45	STROKE	270
46	DIARRHEA	266
47	ATRIAL FIBRILLATION	263
48	BLOOD TESTOSTERONE ABNORMAL	256
49	ITCHING	249
50	PROSTATIC SPECIFIC ANTIGEN INCREASED	245
51	HAIR LOSS	244
52	ACNE	241
53	DRUG DOSE OMISSION	241
54	BLOOD PRESSURE INCREASED	235
55	EXCESS SWEATING	228
56	MALAISE	225
57	ACCIDENTAL EXPOSURE TO PRODUCT	221
58	EMOTIONAL DISORDER	208
59	HAIR GROWTH ABNORMAL	204
60	FALL	200
61	MUSCLE PAIN	199
62	BACK PAIN	198
63	PNEUMONIA	180
64	DRUG EFFECT INCREASED	177
65	PRODUCT QUALITY ISSUE	170
66	CARDIAC DISORDER	167
67	HOT FLUSH	164
68	SWELLING OF LIMBS	164
69	APPLICATION SITE RASH	162
70	SKIN REDNESS	160
71	BLOOD GLUCOSE INCREASED	158
72	LOSS OF EMPLOYMENT	158
73	JOINT SWELLING	156
74	DROWSINESS	154
75	INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION	153
76	MEMORY IMPAIRMENT	153
77	UNEVALUABLE EVENT	153
78	MUSCULOSKELETAL PAIN	151
79	KIDNEY FAILURE	151
80	CHRONIC KIDNEY DISEASE	150
81	PROSTATE CANCER	147
82	INFARCTION	146
83	APPLICATION SITE ITCHING	145
84	QUALITY OF LIFE DECREASED	144
85	CARDIAC ARREST	142
86	VOMITING	142
87	MUSCLE SPASMS	141
88	SLEEP APNEA	138
89	GAIT DISTURBANCE	135
90	ACUTE KIDNEY INJURY	133
91	ISCHAEMIA	133
92	PINS AND NEEDLES	127
93	DEPRESSED MOOD	126
94	ABDOMINAL PAIN	124
95	FLUSHING	124
96	FEVER	123
97	LOWER LIMBS SWELLING	122
98	NUMBNESS	121
99	IRRITABILITY	121
100	PALPITATIONS	119

Latest Known Outcomes for Reactions Reported for ANDROGEL

	Latest Known Outcome for Reported Reactions	Number of Cases
1	Unknown Outcome	12145
2	Patient has not recovered/symtoms have not resolved	7138
3	Patient recovered	2871
4	Patient is recovering/symptoms resolving	975
5	Patient died	869
6	Patient has recovered but has consequent health issues	39

Search all MedWatch and FAERS by keyword:

ANDROGEL Total Reports

Male	Female	Unknown	Total
20599	771	774	22,144

Top Countries Reporting

	Country	Number of Reports
1	United States	18571
2	Canada	265
3	Netherlands	43
4	United Kingdom	31
5	France	23
6	Brazil	18
7	EU	18
8	Puerto Rico	18
9	Australia	14
10	Russia	7

Outcomes for Reports

Serious: 11743
Not Serious: 10401
Note: A serious outcome means the adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition.

Top Indications

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

Top Companies Reporting

ASCEND THERAPEUTICS US, LLC
ASCEND

Safety-Related FDA Updates

FDA Approval Date: 2000-02-28

ANDROGEL (TESTOSTERONE) Rx Drug:
Warns that cases of venous thromboembolism (VTE) and high blood pressure have been reported. Safety-related Labeling Changes

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 the cases for ANDROGEL reported to the United States Food and Drug Administration (FDA) FDA Safety Information and Adverse Event Reporting System (FAERS) and obtained from Open FDA. Data was last updated with reports received through April 28, 2026.

This summary includes ALL reports where the drug is a "primary OR secondary OR suspected interacting" drug. Typically, reports are filed for the most serious type or "event" and do not represent incidental or minor side effects. The majority of these reports are mandatory reports submitted by pharmaceutical companies, who receive complaints from consumers. 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. This report also features counts of latest known outcomes associated with reported side effects, but does not provide the specific outcomes for specific adverse events.

Adverse Event Reports are submitted to the FAERS database by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers). Health care providers such as doctors (voluntary reporting), and patients themselves (voluntary reporting) report to the FDA directly through the MedWatch program. Those MedWatch reports are coded and included in the FAERS database. This report mainly consists of the mandatory reports, because the MedWatch reports are a small percentage (3 - 5%) of total reports. Link to the MedWatch summary report at the top of the page for a summary of the directly reported (voluntary) adverse events for this drug.The number of reports included here might differ somewhat from the number of reports in the downloadable quarterly FAERS reports and in the online FAERS dashboard, due to lags in reporting, drug name differences, duplicates, and other factors. Open FDA states that it only includes the most recent version of a case report. It also adds the disclaimer: "Do not rely on openFDA 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 or comments about this report.