Important Safety Information for Testosterone Therapy

Atlas HRT safety summary derived from the FDA-approved Prescribing Information for testosterone cypionate injection (Depo-Testosterone, Pharmacia and Upjohn) revised 09/2025. Last reviewed September 11, 2026.

This page is about testosterone cypionate injection, the testosterone product an independent physician may prescribe through Atlas HRT. Its FDA-approved label carries no Medication Guide; the headings below are questions, and every answer is the label’s own wording.

What is testosterone cypionate injection approved for?

DEPO-Testosterone Injection is indicated for replacement therapy in the male in conditions associated with symptoms of deficiency or absence of endogenous testosterone.

1. Primary hypogonadism (congenital or acquired)-testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome; or orchidectomy.

2. Hypogonadotropic hypogonadism (congenital or acquired) – gonadotropin or LHRH deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation.

Safety and efficacy of DEPO-Testosterone (testosterone cypionate) in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established.

Blood pressure and heart risk

Testosterone can increase blood pressure which can increase cardiovascular (CV) risk over time. Monitor blood pressure periodically in men using testosterone products, especially in men with hypertension. Testosterone products are not recommended for use in patients with uncontrolled hypertension.

Long term clinical safety trials have not been conducted to assess the cardiovascular outcomes of testosterone replacement therapy in men. To date, epidemiologic studies and randomized controlled trials have been inconclusive for determining the risk of major adverse cardiovascular events (MACE), such as non-fatal myocardial infarction, non-fatal stroke, and cardiovascular death, with the use of testosterone compared to non-use. Some studies, but not all, have reported an increased risk of MACE in association with use of testosterone replacement therapy in men. Patients should be informed of this possible risk when deciding whether to use or to continue to use DEPO-Testosterone (testosterone cypionate).

There have been postmarketing reports of venous thromboembolic events, including deep vein thrombosis (DVT) and pulmonary embolism (PE), in patients using testosterone products, such as testosterone cypionate. Evaluate patients who report symptoms of pain, edema, warmth and erythema in the lower extremity for DVT and those who present with acute shortness of breath for PE. If a venous thromboembolic event is suspected, discontinue treatment with testosterone cypionate and initiate appropriate workup and management.

Do not use testosterone cypionate if you have:

• Known hypersensitivity to the drug
• Males with carcinoma of the breast
• Males with known or suspected carcinoma of the prostate gland
• Women who are pregnant (see PRECAUTIONS, Pregnancy)
• Patients with serious cardiac, hepatic or renal disease (see WARNINGS)

What does the label say to monitor?

Hemoglobin and hematocrit levels (to detect polycythemia) should be checked periodically in patients receiving long-term androgen administration.

Serum cholesterol may increase during androgen therapy.

Patients with benign prostatic hypertrophy may develop acute urethral obstruction. Priapism or excessive sexual stimulation may develop. Oligospermia may occur after prolonged administration or excessive dosage.

Geriatric patients treated with androgens may be at an increased risk of developing prostatic hypertrophy and prostatic carcinoma although conclusive evidence to support this concept is lacking.

Edema, with or without congestive heart failure, may be a serious complication in patients with pre-existing cardiac, renal or hepatic disease.

Gynecomastia may develop and occasionally persists in patients being treated for hypogonadism.

Patients should be instructed to report any of the following: nausea, vomiting, changes in skin color, ankle swelling, too frequent or persistent erections of the penis.

What side effects have been reported?

The following adverse reactions in the male have occurred with some androgens:

Endocrine and urogenital: Gynecomastia and excessive frequency and duration of penile erections. Oligospermia may occur at high dosages.

Skin and appendages: Hirsutism, male pattern of baldness, seborrhea, and acne.

Cardiovascular Disorders: myocardial infarction, stroke.

Fluid and electrolyte disturbances: Retention of sodium, chloride, water, potassium, calcium, and inorganic phosphates.

Gastrointestinal: Nausea, cholestatic jaundice, alterations in liver function tests, rarely hepatocellular neoplasms and peliosis hepatis (see WARNINGS).

Hematologic: Suppression of clotting factors II, V, VII, and X, bleeding in patients on concomitant anticoagulant therapy, and polycythemia.

Nervous system: Increased or decreased libido, headache, anxiety, depression, and generalized paresthesia.

Allergic: Hypersensitivity, including skin manifestations and anaphylactoid reactions.

Vascular disorders: Venous thromboembolism.

Special senses: Rare cases of central serous chorioretinopathy (CSCR).

Miscellaneous: Inflammation and pain at the site of intramuscular injection.

Medicines that interact with testosterone

Androgens may increase sensitivity to oral anticoagulants.

Concurrent administration of oxyphenbutazone and androgens may result in elevated serum levels of oxyphenbutazone.

In diabetic patients, the metabolic effects of androgens may decrease blood glucose and, therefore, insulin requirements.

Pregnancy and breastfeeding

The use of testosterone in women who are pregnant is contraindicated. Testosterone is teratogenic and may cause fetal harm. Testosterone is known to cause virilization of the female fetus when administrated to pregnant women.

DEPO-Testosterone is not recommended for use in nursing mothers.

Abuse, dependence and controlled-substance status

DEPO-Testosterone Injection contains testosterone, a Schedule III controlled substance in the Controlled Substances Act.

Testosterone has been subject to abuse, typically at doses higher than recommended for the approved indication and in combination with other anabolic androgenic steroids. Anabolic androgenic steroid abuse can lead to serious cardiovascular and psychiatric adverse reactions (see DRUG ABUSE AND DEPENDENCE).

This drug has not been shown to be safe and effective for the enhancement of athletic performance. Because of the potential risk of serious adverse health effects, this drug should not be used for such purpose.