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Endocrine and Urogenital, Female – The most common side effects of androgen therapy are amenorrhea and other menstrual irregularities, inhibition of gonadotropin secretion, and virilization, including deepening of the voice and clitoral enlargement. The latter usually is not reversible after androgens are discontinued. When administered to a pregnant woman, androgens cause virilization of the external genitalia of the female fetus.

Male – Gynecomastia, and excessive frequency and duration of penile erections. Oligospermia may occur at high dosages (see CLINICAL PHARMACOLOGY).

Skin and Appendages – Hirsutism, male pattern baldness, and acne.

Fluid and Electrolyte Disturbances – Retention of sodium, chloride, water, potassium, calcium (see WARNINGS), and inorganic phosphates.

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

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

Nervous System – Increased or decreased libido, headache, anxiety, depression, and generalized paresthesia.

Metabolic – Increased serum cholesterol.

Vascular Disorders – venous thromboembolism

Miscellaneous – Rarely, anaphylactoid reactions; inflammation and pain at injection site.

Drug Abuse And Dependence

DELATESTRYL® (Testosterone Enanthate Injection, USP) is classified as a controlled substance under the Anabolic Steroids Control Act of 1990 and has been assigned to Schedule III.