Pharmacologic class (EPC) · 8 drug pages

Androgen: adverse event reports filed with FDA

20,367 reports list a drug in this class as a suspect or interacting product, 2004–2026.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event." The information in these reports "cannot be used to estimate the incidence of these events."

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.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

20,367
reports across the class: 0.1% of all reports; 1,524
reports, 12 months to June 2026: 1,197 in the 12 months before; 61.2%
marked serious by the reporter: 57.4% across all reports; 8
drugs with a page: brand and generic names counted separately

Androgen is a pharmacologic class (an FDA Established Pharmacologic Class) with 8 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 20,367 adverse event reports received by FDA, 0.1% of the database, from January 2004 to June 2026.

1,524 reports arrived in the 12 months to June 2026, up 27% from 1,197 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 61.2% of the class's reports are marked serious, 5.2% record death among the outcomes and 29.5% record hospitalisation, as reported.

Across the class the reactions recorded most often are myocardial infarction (10%), deep vein thrombosis (8.1%) and cerebrovascular accident (8%). The class median share shown beside each term is the middle value across the member drugs; it is the comparison used on every drug page in this class.

The members table is 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."

Drugs in the class

Drug	Name type	Reports	Latest 12 months	Marked serious	Top term recorded
Testosterone	generic	7,072	778	55.9%	Drug ineffective
Testosterone cypionate	generic	3,098	322	39.5%	Drug ineffective
TestimTestosterone	brand	3,085	4	86.9%	Myocardial infarction
Depo-TestosteroneTestosterone cypionate	brand	2,787	10	80.1%	Myocardial infarction
TestopelTestosterone	brand	1,442	21	70.8%	Deep vein thrombosis
AveedTestosterone undecanoate	brand	1,290	108	57.9%	Drug ineffective
XyostedTestosterone enanthate	brand	980	240	2.7%	Product dose omission issue
Danazol	generic	613	41	93.8%	Drug ineffective

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."

Reports by month, five years

FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

Reactions recorded across the class

share of class reports recording the termmedian drug in the class

Myocardial infarctionheart attack10%2,044
Deep vein thrombosisa blood clot in a deep vein8.1%1,645
Cerebrovascular accidentstroke8%1,632
Drug ineffectivethe medicine did not work as expected7.7%1,571
Pulmonary embolisma blood clot in the lung7.5%1,533
Off label useused for a purpose or in a way not on the label4.9%994
Painpain, site not specified4.8%979
Thrombosis4.1%841
Anxietyanxiety3.9%791
Acute myocardial infarction3.3%678
Product dose omission issuea dose was missed3.3%677
Cardiovascular disorder3%613
Cardiac failure congestivecongestive heart failure2.9%582
Fatiguetiredness2.7%546
Injection site painpain where the injection was given2.5%506
Blood testosterone decreased2.4%486
Astheniaweakness or lack of energy2.3%473
Product deposit2.2%455
Coronary artery disease2.2%441
Drug abusemisuse of a medicine2.1%421
Quality of life decreasedreduced quality of life1.9%395
Dyspnoeashortness of breath1.9%383
Infarction1.9%382
Polycythaemia1.9%379
Deaththe patient died; cause not stated by this term1.8%376

Solid bar: share of all class reports. Hollow bar: the median share across the 8 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death5.2%1,059

Life-threatening3.1%624

Hospitalisation (initial or prolonged)29.5%6,000

Disability8.9%1,804

Congenital anomaly0%4

Other serious45.1%9,181

Not serious38.8%7,907

Patient age

Under 20.2%34

2 to 110.4%78

12 to 171%204

18 to 4414.7%2,995

45 to 6427.1%5,510

65 to 748.4%1,707

75 and over2.6%529

Age not given45.7%9,310

Who reported

Physician14.7%2,985

Pharmacist6.7%1,358

Other health professional15.6%3,185

Lawyer26%5,299

Consumer or non-health professional34.6%7,043

Not given2.4%497

Grey bar: all 20,646,523 reports in the database. Outcome flags are as the reporter set them and are not verified by FDA.

Questions about Androgen reports

Which drugs are in the Androgen class on this site?

Testosterone, Testosterone cypionate, Testim, Depo-Testosterone, Testopel and Aveed and 2 more. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

20,367 reports through June 2026, 1,524 of them in the latest 12 months. A report listing two drugs of the class counts once for each.

What reactions are recorded most often?

myocardial infarction (10%), deep vein thrombosis (8.1%), cerebrovascular accident (8%), drug ineffective (7.7%) and pulmonary embolism (7.5%).

Can the members table be used to rank the drugs?

No. 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." Drugs differ in how many people take them, in the conditions they treat, in time on the market and in how diligently reports are collected.

How do I report an adverse event?

Through FDA MedWatch (Form FDA 3500, or 1-800-FDA-1088) or to the manufacturer. See the guide on how to report.

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 class is the Established Pharmacologic Class most often attached to a drug's reports by openFDA's label harmonisation, or from the NDC Directory where reports carry none. 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.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.