Endocrine And Urogenital
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 external
genitalia of the female fetus.
Gynecomastia, and excessive frequency and duration of
penile erections. Oligospermia may occur at high dosage (see CLINICAL
Skin and Appendages: Hirsutism, male pattern of
baldness, and acne.
Cardiovascular Disorders: Myocardial infarction,
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 neoplasma and
peliosis hepatis (see WARNINGS).
Hematologic: Suppression of clotting factors II,
V, VII, and X, bleeding in patients on concomitant anticoagulant therapy, and
Nervous System: Increased or decreased libido, headache,
anxiety, depression, and generalized paresthesia.
Metabolic: Increased serum cholesterol.
Vascular Disorders: Venous thromboembolism.
Miscellaneous: Rarely, anaphylactoid reactions.
To report SUSPECTED ADVERSE REACTIONS, contact IMPAX
Laboratories , Inc. at 1-800- 934-6729 or FDA at 1-800-FDA-1088 or
Drug Abuse And Dependence
Controlled Substance Class
METHYLTESTOSTERONE Tablets are classified as controlled
substances under the Anabolic Steroids Control Act of 1990 and have been
assigned to Schedule III.