Important Safety Information
Fluoxymesterone is contraindicated in pregnancy (Category X), in men with prostate or male breast cancer, and in patients with severe liver disease. It should not be used in women who may become pregnant due to risk of fetal harm and virilization.
The 17α-alkylated structure confers significant hepatotoxicity. Liver function tests should be obtained periodically during clinical use. Post-marketing reports include cholestatic jaundice, alterations in liver function tests, and rarely hepatocellular neoplasms and peliosis hepatis.
Important
Non-Medical Use
Non-medical use of fluoxymesterone falls outside approved indications and carries substantial risks. The compound is among the most hepatotoxic oral steroids, and product purity does not establish that non-medical use is safe or appropriate for an individual.
Potential Adverse Effects
Hepatotoxicity is the primary adverse effect of fluoxymesterone. Manifestations include cholestatic jaundice, elevated transaminases, and rarely hepatocellular neoplasms and peliosis hepatis. Liver function abnormalities may develop with long-term use.
Cardiovascular effects include severe dyslipidemia with HDL cholesterol dropping 30–50% and LDL rising, hypertension, and polycythemia with increased hematocrit and clot risk. Sodium and water retention may occur and can worsen congestive heart failure in patients with pre-existing cardiac, liver, or kidney disease.
Endocrine effects include complete hypothalamic-pituitary-gonadal axis shutdown, testicular atrophy, oligospermia, and decreased fertility in males. Women may experience virilization including deepening of the voice, clitoral enlargement, and menstrual irregularities.
Conditions Requiring Medical Evaluation
Fluoxymesterone is not appropriate for everyone. Contraindications include pregnancy, prostate cancer, male breast cancer, and severe liver disease. Caution is advised in patients with pre-existing heart conditions, fluid retention, or benign prostatic hypertrophy, as acute urethral obstruction may develop.
Patients should inform their physician of any pre-existing conditions including chicken pox, heart disease, kidney disease, liver disease, or lung disease, as these may worsen with fluoxymesterone treatment.
Monitoring During Therapy
Clinical monitoring for fluoxymesterone includes periodic liver function tests, hemoglobin and hematocrit levels to detect polycythemia, and serum cholesterol. Women with disseminated breast carcinoma should have frequent determination of urine and serum calcium levels during androgen therapy.
Patients should report nausea, vomiting, changes in skin color, and ankle swelling. Males should report too frequent or persistent erections, and females should report hoarseness, acne, changes in menstrual periods, or increased facial hair.
Product Care
Storage & Handling
Store tablets in a cool, dry place in the original packaging. Keep out of reach of children. Inspect tablets before use and do not use if they appear damaged or compromised.
Further Safety Information