Oreton Methyl Side Effects
Generic Name: methyltestosterone
Note: This document contains side effect information about methyltestosterone. Some of the dosage forms listed on this page may not apply to the brand name Oreton Methyl.
For the Consumer
Applies to methyltestosterone: oral capsules, 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 methyltestosterone: compounding powder, oral capsule, oral tablet
Endocrine side effects have included gynecomastia. Cautious use is recommended in patients with existing gynecomastia.
During exogenous administration of androgens, endogenous testosterone release is inhibited through feedback inhibition of pituitary luteinizing hormone (LH). Large doses of exogenous androgens may suppress spermatogenesis through inhibition of pituitary follicle stimulating hormone (FSH).
Androgens may decrease levels of thyroxine-binding globulin resulting in decreased total T4 serum levels and increased resin uptake of T3 and T4. Free thyroid hormone levels remain unchanged and there is no clinical evidence of thyroid dysfunction.[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]
Hepatic side effects have included life-threatening peliosis hepatitis and hepatic abnormalities including hepatic neoplasms and hepatocellular carcinomas following prolonged therapy with high doses of androgen. Tumor regression did not occur in all cases following medication withdrawal.
Genitourinary side effects have included oligospermia and decreased ejaculatory volume following chronic administration and/or large dosages of androgens. Elderly male patients may experience prostatic enlargement resulting in urinary obstruction. Priapism and excessive stimulation may develop. Methyltestosterone should be discontinued if any of these effects occur. If continued therapy is necessary, resume methyltestosterone (the active ingredient contained in Oreton Methyl) at a lower dosage.
In female patients the use of androgens has resulted in virilization, including deepening voice, hirsutism, acne, clitomegaly (not reversible), and menstrual abnormalities. Discontinuation of methyltestosterone at signs of mild virilization may prevent irreversible virilization.[Ref]
Metabolic side effects have included osteolytic-induced hypercalcemia in immobilized patients or those with metastatic breast disease.
Androgens affect electrolyte balance, nitrogen retention, and urinary calcium excretion. Edema, with and without congestive heart failure has occurred during testosterone therapy.
Androgens have precipitated acute intermittent porphyria.
Increased cholesterol levels have occurred during androgen therapy.[Ref]
Testosterone is involved in termination of linear bone growth by closure of the epiphyseal growth centers. Monitoring of bone age is recommended during methyltestosterone (the active ingredient contained in Oreton Methyl) treatment in healthy males with delayed puberty.
Myalgia and pain have been reported.[Ref]
Hypersensitivity side effects have included rare reports of rash and anaphylactoid reactions.[Ref]
Local side effects have included inflammation and pain at injection or dermal application site.[Ref]
Oncologic side effects have included hepatic neoplasms and hepatocellular carcinomas following prolonged therapy with large doses of androgens.[Ref]
Respiratory side effects have included potentiation of sleep apnea, particularly in obese patients or those with chronic lung disease. Androgen therapy for hypogonadal conditions has been reported to[Ref]
Other side effects have included virilization including deepening voice, hirsutism, acne, clitomegaly (not reversible), and menstrual abnormalities in female patients. Discontinuation of methyltestosterone (the active ingredient contained in Oreton Methyl) at signs of mild virilization may prevent irreversible virilization.[Ref]
1. "Product Information. Android Capsules (methyltestosterone)." ICN Pharmaceuticals Inc, Costa Mesa, CA.
2. Fisher DA, Oddie TH "Effect of methyl testosterone on thyroxine metabolism and on triiodothyronine kinetics." J Clin Endocrinol Metab 28 (1968): 1690-8
3. Pope HG Jr, Katz DL "Psychiatric and medical effects of anabolic-androgenic steroid use. A controlled study of 160 athletes." Arch Gen Psychiatry 51 (1994): 375-82
4. Borhan-Manesh F, Farnum JB "Methyltestosterone-induced cholestasis. The importance of disproportionately low serum alkaline phosphatase level." Arch Intern Med 149 (1989): 2127-9
5. Hartleb M, Nowak A "Severe jaundice with destructive cholangitis after administration of methyltestosterone." Am J Gastroenterol 85 (1990): 766-7
6. Boyd PR, Mark GJ "Multiple hepatic adenomas and a hepatocellular carcinoma in a man on oral methyl testosterone for eleven years." Cancer 40 (1977): 1765-70
7. Bird D, Vowles K, Anthony PP "Spontaneous rupture of a liver cell adenoma after long term methyltestosterone: report of a case successfully treated b emergency right hepatic lobectomy." Br J Surg 66 (1979): 212-3
8. Lucey MR, Moseley RH "Severe cholestasis associated with methyltestosterone: a case report." Am J Gastroenterol 82 (1987): 461-2
9. Robinson RW, Lebeau RJ, Cohen WD "Effects of methyl testosterone upon serum lipids." J Clin Endocrinol Metab 24 (1964): 708-13
Some side effects may not be reported. You may report them to the FDA.