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Fluoxymesterone Side Effects

Not all side effects for fluoxymesterone may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to fluoxymesterone: oral tablets

Side effects include:

Males: Gynecomastia, frequent or persistent penile erections.

Females: Amenorrhea, other menstrual irregularities, inhibition of gonadotropin secretion, virilization (e.g., deepening of the voice, clitoral enlargement).

For Healthcare Professionals

Applies to fluoxymesterone: compounding powder, oral tablet


Dermatologic side effects have included hirsutism, seborrhea, and acne. While alopecia usually presents as male pattern baldness, patchy alopecia has also been reported in some female patients.[Ref]


Gastrointestinal side effects have included nausea and vomiting.[Ref]


Hepatic side effects have included cholestatic jaundice, alterations in liver function tests, and rarely hepatocellular neoplasms and peliosis hepatitis. Patients should be instructed to report any changes in skin color, abdominal pain lasting more than a few days, white bowel movements, dark urine, or yellowing of the eyes.[Ref]


Hematologic side effects have included suppression of clotting factors II, V, VII, and X, polycythemia and bleeding in patients on concomitant anticoagulant therapy .[Ref]

Nervous system

Nervous system side effects have included increased or decreased libido, headache, anxiety, depression, and generalized paresthesia.[Ref]


Hypersensitivity side effects have included skin manifestations and anaphylactoid reactions.[Ref]


Renal side effects have included retention of nitrogen, sodium, potassium, chloride, water and phosphorus, and decreased urinary excretion of calcium. Patients should be instructed to report edema.[Ref]


Genitourinary side effects in male patients have included gynecomastia, and excessive frequency and duration of penile erections. Oligospermia has been reported at higher dosages. Male patients should be instructed to report too frequent or persistent erections of the penis. Patients with benign prostatic hypertrophy may develop acute urethral obstruction.

Genitourinary side effects in female patients have included 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. Female patients should be instructed to report any hoarseness, acne, changes in menstrual periods or increase in facial hair.[Ref]


Endocrine side effects have included increases in serum cholesterol. Large doses of exogenous androgens may suppress spermatogenesis through inhibition of pituitary follicle stimulating hormone (FSH).[Ref]


1. "Product Information. Halotestin (fluoxymesterone)." Pharmacia and Upjohn, Kalamazoo, MI.

2. "Multum Information Services, Inc. Expert Review Panel"

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