Testosterone cypionate: adverse event reports filed with FDA

3,098

reports as suspect product

0% of all reports · about 149 a year

322

reports, 12 months to June 2026

384 in the 12 months before

39.5%

marked serious by the reporter

61.2% across the class

2.1%

record death among outcomes, as reported

65 reports · not verified by FDA

Reports by month, five years

Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

By year received

2026 covers reports received through June 2026 only.

Reactions recorded in the reports

share of Testosterone cypionate reports recording the termmedian drug in androgen

1. Drug ineffectivethe medicine did not work as expected8.9%277
2. Product deposit8.4%259
3. Product dose omission issuea dose was missed7.8%241
4. Liquid product physical issue7.5%231
5. Poor quality product administered6.9%214
6. Injection site painpain where the injection was given6.5%201
7. Myocardial infarctionheart attack5.9%182
8. Off label useused for a purpose or in a way not on the label5.1%157
9. Pulmonary embolisma blood clot in the lung4.1%128
10. Deep vein thrombosisa blood clot in a deep vein4%123
11. Product use issuea problem in how the product was used3.9%120
12. Cerebrovascular accidentstroke3.8%117
13. Fatiguetiredness3.6%111
14. Multiple use of single-use product3.5%108
15. Astheniaweakness or lack of energy3.1%96
16. Acute myocardial infarction2.8%86
17. Product use in unapproved indicationused for a purpose not on the label2.7%83
18. Painpain, site not specified2.6%82
19. Inappropriate schedule of product administrationthe product was taken at the wrong times2.6%79
20. Injection site swellingswelling where the injection was given2.4%75
21. Blood testosterone decreased2.3%71
22. Product quality issuea problem with the product itself2.3%70
23. Product administration errora mistake in giving the product2.2%67
24. Injection site erythemaredness where the injection was given2%62
25. Inappropriate schedule of drug administrationthe medicine was taken at the wrong times1.9%58
26. Product administered at inappropriate site1.9%58
27. Headachehead pain1.8%57
28. Product with quality issue administered1.8%56
29. Recalled product administered1.8%56
30. Incorrect dose administeredthe wrong dose was given1.7%54

Top 30 of 522 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 8 drugs in the androgen class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Outcomes recorded

Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 20,367 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."

Patients and reporters

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 97.5% of reports give the United States as the country of the event or reporter.

Reason for use recorded

The indication field is filled in by the reporter and is often blank; shares are of all 3,098 reports.

Drugs most often listed in the same reports

Other products listed in reports where Testosterone cypionate is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.

In context

Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Other drugs in the androgen class

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Testosterone cypionate as a suspect or interacting product; reports listing it only as a concomitant medication (2,883) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.