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.
Nausea, cholestatic jaundice, alterations in liver function tests, rarely hepatocellular
neoplasms and peliosis hepatis (See WARNINGS).
Suppression of clotting factors II, V, VII, and X, bleeding in patients on concomitant anticoagulant therapy, and polycythemia.
Increased or decreased libido, headache, anxiety, depression, and generalized paresthesia.
Hypersensitivity, including skin manifestations and anaphylactoid reactions.
Drug Abuse And Dependence
Controlled Substance Class: Fluoxymesterone is a controlled substance
under the Anabolic Steroids Control Act, and HALOTESTIN (fluoxymesterone) Tablets has been assigned
to Schedule III.
Androgens may increase sensitivity to oral anticoagulants. Dosage of the anticoagulant may require reduction in order to maintain satisfactory therapeutic hypoprothrombinemia.
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.
Drug/Laboratory test interferences
Androgens may decrease levels of thyroxine-binding globulin, resulting in decreased total T4 serum levels and increased resin uptake of T3 and T4. Free thyroid hormone levels remain unchanged, however, and there is no clinical evidence of thyroid dysfunction.