Fluoxymesterone Side Effects

Some side effects of fluoxymesterone may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to fluoxymesterone: oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking fluoxymesterone: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using fluoxymesterone and call your doctor at once if you have a serious side effect such as:

• feeling short of breath, even with mild exertion;

• swelling in your ankles, rapid weight gain;

• increased or ongoing erection of the penis;

• nausea, vomiting, loss of appetite, increased thirst, muscle weakness, confusion, and feeling tired or restless; or

• upper stomach pain, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Women receiving fluoxymesterone may develop male characteristics, which could be irreversible if testosterone treatment is continued. Stop taking this medication and call your doctor at once if you notice any of these signs of excess testosterone:

• changes in menstrual periods;

• male-pattern hair growth (such as on the chin or chest);

• hoarse voice; or

• enlarged clitoris.

Less serious side effects (in men or women) may include:

• acne, changes in skin color;

• increased hair growth;

• male pattern baldness;

• increased or decreased interest in sex;

• breast swelling;

• headache, anxiety, depression; or

• numbness, burning, pain, or tingly feeling.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to fluoxymesterone: compounding powder, oral tablet

Dermatologic

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.

Gastrointestinal

Gastrointestinal side effects have included nausea and vomiting.

Hepatic

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.

Hematologic

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

Nervous system

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

Hypersensitivity

Hypersensitivity side effects have included skin manifestations and anaphylactoid reactions.

Renal

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.

Genitourinary

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.

Endocrine

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).

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