The FDA label for testosterone cypionate describes an oil-based injection into muscle, approved for testosterone replacement in men whose low testosterone comes from specific testicular, pituitary or hypothalamic causes. The Depo-Testosterone (testosterone cypionate) label also sets out who should not use it, the warnings, and the side effects reported with androgens.
What the drug is
The label describes testosterone cypionate as the oil-soluble 17-beta cyclopentylpropionate ester of testosterone, labeled for intramuscular injection. Its molecular formula is C27H40O3 and its molecular weight is 412.61. PubChem lists the same formula with a molecular weight of 412.6.
It comes in two strengths, 100 mg/mL and 200 mg/mL, dissolved in cottonseed oil with benzyl benzoate and benzyl alcohol as a preservative (9.45 mg per mL). The label says it is absorbed slowly from the oil, so it can be given every two to four weeks, and its half-life after intramuscular injection is about eight days.
The label states it contains testosterone, a Schedule III controlled substance, and the vial is marked CIII. Federal DEA regulations list anabolic steroids, including their salts, esters and ethers, in Schedule III, and name testosterone in that list.
What it is approved for
The label lists two indications in males:
- Primary hypogonadism: testicular failure from causes such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome or orchidectomy.
- Hypogonadotropic hypogonadism: gonadotropin or LHRH deficiency, or pituitary-hypothalamic injury from tumors, trauma or radiation.
The current label states that safety and efficacy in men with age-related (late-onset) hypogonadism have not been established, and a generic cypionate label revised June 2026 carries the same statement. On March 3, 2015, the FDA said benefit and safety had not been established for low testosterone due to aging. The FDA's Testosterone Information page, current as of 06/23/2026, says none of the FDA-approved testosterone products are approved for men with low testosterone who lack an associated medical condition. The same page says the FDA requested label updates in June 2026 that include removing the age-related limitation of use. In the cypionate labels read for this guide, that change had not yet appeared: the current Depo-Testosterone label and a generic label revised in June 2026 still carry the limitation.
Testing and dosing in the label
Before starting, the label says to confirm hypogonadism with morning serum testosterone measured on at least two separate days, both below the normal range. For replacement in hypogonadal males it lists 50 to 400 mg every two to four weeks, with dosage varying by age, sex and diagnosis and adjusted to the patient's response and adverse reactions. A licensed provider sets any dose.
The label says the injection is for intramuscular use only, should not be given intravenously, and should be given deep in the gluteal muscle.
Who should not use it, and the warnings
Contraindications are known hypersensitivity, male breast cancer, known or suspected prostate cancer, pregnancy, and serious cardiac, hepatic or renal disease.
| Warning | What the label says |
|---|---|
| Blood clots | Postmarketing cases of venous thromboembolism, including deep vein thrombosis and pulmonary embolism. Stop treatment if a clot is suspected. |
| Heart events | Studies have been inconclusive on major adverse cardiovascular events; some but not all reported increased risk. Patients should be told of this possible risk. |
| Blood pressure | Testosterone can raise blood pressure. Monitor it; not recommended with uncontrolled hypertension. |
| Red blood cells | Check hemoglobin and hematocrit periodically during long-term therapy to detect polycythemia. |
| Liver | Prolonged high-dose androgen use, mainly 17-alpha alkyl androgens, has been linked with hepatic adenomas, hepatocellular carcinoma and peliosis hepatis. |
| Breast tissue and fluid | Gynecomastia may develop and occasionally persist. Edema may be serious in people with pre-existing cardiac, renal or hepatic disease. |
The label also says testosterone has been abused, typically at higher than recommended doses and with other anabolic steroids, which can lead to serious cardiovascular and psychiatric reactions. Dependence has not been documented at approved doses for approved indications, while people taking supratherapeutic doses may have withdrawal symptoms lasting weeks or months. On October 25, 2016, the FDA approved class-wide labeling changes adding a new Warning and expanding the Abuse and Dependence section.
The AndroGel 1.62% gel label warns that testosterone may worsen sleep apnea in some men, especially with obesity or chronic lung disease. The Depo-Testosterone label does not include this warning.
Side effects the label lists
Adverse reactions listed for androgens include gynecomastia, prolonged erections, acne, hirsutism, male-pattern baldness, nausea, polycythemia, libido changes, headache, anxiety, depression, venous thromboembolism, and pain at the injection site.
What this does not tell you
A label lists approved uses, warnings and reactions that have been reported. It does not say how often a given side effect happens to any one man, and it does not decide whether a man has hypogonadism or what dose fits him. Labels can change after the date they were read. A licensed provider reviews each person's history and blood tests.