SIDE EFFECTS
Associated with Estrogens (See WARNINGS regarding induction
of neoplasia, adverse effects on the fetus, increased incidence
of gallbladder disease, and adverse effects similar to those
of oral contraceptives, including thromboembolism). The
following additional adverse reactions have been reported
with estrogenic therapy, including oral contraceptives:
- Genitourinary system.
Breakthrough bleeding, spotting, change in menstrual
flow.
Dysmenorrhea.
Premenstrual-like syndrome.
Amenorrhea during and after treatment.
Increase in size of uterine fibromyomata.
Vaginal candidiasis.
Change in cervical erosion and in degree of cervical
secretion.
Cystitis-like syndrome.
- Breasts.
Tenderness, enlargement, secretion.
- Gastrointestinal.
Nausea, vomiting.
Abdominal cramps, bloating.
Cholestatic jaundice.
- Skin.
Chloasma or melasma which may persist when drug is discontinued.
Erythema multiforme.
Erythema nodosum.
Hemorrhagic eruption.
Loss of scalp hair.
Hirsutism.
- Eyes.
Steepening of corneal curvature.
Intolerance to contact lenses.
- CNS.
Headache, migraine, dizziness.
Mental depression.
Chorea.
- Miscellaneous.
Increase or decrease in weight.
Reduced carbohydrate tolerance.
Aggravation of porphyria.
Edema.
Changes in libido.
Associated with Methyltestosterone
A. 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 external genitalia of
the female fetus.
- Skin and Appendages: Hirsutism, male pattern
of baldness, and acne.
- Fluid and Electrolyte Disturbances: Retention
of sodium, chloride, water, potassium, calcium, and
inorganic phosphates.
- Gastrointestinal: Nausea, cholestatic jaundice,
alterations in liver function test, 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.
- Metabolic: Increased serum cholesterol.
- Miscellaneous:: Inflammation and pain at the
site of intramuscular injection or subcutaneous implantation
of testosterone containing pellets, stomatitis with
buccal preparations, and rarely anaphylactoid reactions.
DRUG INTERACTIONS
- Anticoagulants C-17 substituted derivatives
of testosterone, such as methandrostenolone, have been
reported to decrease the anticoagulant requirements
of patients receiving oral anticoagulants. Patients
receiving oral anticoagulant therapy require close monitoring,
especially when androgens are started or stopped.
- Oxyphenbutazone. Concurrent administration
of oxyphenbutazone and androgens may result in elevated
serum levels of oxyphenbutazone.
- Insulin. In diabetic patients the metabolic
effects of androgens may decrease blood glucose and
insulin requirements.
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