ADVERSE REACTIONS
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 can cause virilization of external genitalia of the female fetus.
Male: Gynecomastia, and excessive frequency and duration of penile erections. Oligospermia may occur at high dosage.
Skin and appendages
Hirsutism, male pattern of baldness, seborrhea, and acne.
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.
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