Oxymetholone Side Effects

Some side effects of oxymetholone 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 oxymetholone: oral tablet

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

Call your doctor at once if you have a serious side effect such as:

• swelling, rapid weight gain;

• increased or ongoing erection of the penis;

• changes in skin color;

• urination problems; or

• nausea, vomiting, stomach pain, loss of appetite, and jaundice (yellowing of the skin or eyes).

Women receiving oxymetholone may develop male characteristics, which could be irreversible if treatment is continued. Call your doctor as soon as possible if you notice any of these side effects:

• acne;

• changes in your menstrual periods;

• hoarse or deepened voice;

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

• male pattern baldness;

• enlarged clitoris; or

• increase or decrease in sex drive.

Less serious side effects of oxymetholone may include:

• breast swelling in men;

• feeling restless or excited;

• sleep problems (insomnia); or

• diarrhea.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

For Healthcare Professionals

Applies to oxymetholone: oral tablet

Cardiovascular

Cardiovascular side effects have included fluid retention. Edema, with and without congestive heart failure, has occurred during anabolic steroid therapy.

Genitourinary

Genitourinary effects have included oligospermia and decreased ejaculatory volume. Elderly male patients may experience prostatic enlargement resulting in urinary obstruction. Priapism and excessive stimulation may develop. Female patients may experience virilization, including deepening voice, hirsutism, acne, clitomegaly (not reversible), and menstrual abnormalities. Discontinuation of anabolic steroids at signs of mild virilization may prevent irreversible virilization. Alterations in libido may occur (increased/decreased).

Hepatic

Hepatic tumors associated with anabolic steroid use are more vascular than other hepatic tumors and may remain silent until the development of life-threatening abdominal hemorrhage. Peliosis hepatitis may present as mild liver dysfunction, but has resulted in liver failure.

Hepatic side effects have included life-threatening peliosis hepatitis and hepatic abnormalities such as hepatic neoplasms and hepatocellular carcinomas following prolonged therapy with high doses of anabolic steroids. Tumor regression did not occur in all cases following medication withdrawal. Cholestatic hepatitis, jaundice, and abnormal liver function tests can occur at relatively low dosages.

Other

Other side effects have included female patients experiencing virilization including deepening voice, hirsutism, acne, clitomegaly (not reversible), and menstrual abnormalities. Discontinuation of anabolic steroids at signs of mild virilization may prevent irreversible virilization.

Musculoskeletal

Musculoskeletal side effects have included closure of the epiphyseal growth centers by termination of linear bone growth. Appropriate monitoring of bone age is recommended during use in prepubertal patients.

Oncologic

Oncologic side effects have included hepatic neoplasms and hepatocellular carcinomas following prolonged therapy with large doses of anabolic steroids

Hematologic

Hematologic side effects have included alterations in clotting factors II, V, VII and X , prolonged prothrombin time (PT), and increased red cell production. Leukemia has been reported rarely during oxymetholone therapy in patients with aplastic anemia. A causal relationship has not been established and leukemia has been observed in patients with aplastic anemia who were not treated with oxymetholone.

Endocrine

Endocrine side effects have included inhibition of endogenous testosterone release by means of feedback inhibition of pituitary luteinizing hormone (LH). Large doses of exogenous anabolic steroids may suppress spermatogenesis through inhibition of pituitary follicle stimulating hormone (FSH). The androgenic activity of anabolic steroids may decrease levels of thyroxin-binding globulin and result 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.

Metabolic

Metabolic side effects have included osteolytic-induced hypercalcemia in immobilized patients or those with metastatic breast disease. Anabolic steroids affect electrolyte balance, nitrogen retention, and urinary calcium excretion. Edema, with and without congestive heart failure, has occurred. Decreased glucose tolerance requiring adjustments in hyperglycemic control has been noted in diabetic patients. Significant increases in low density lipoproteins (LDL) and decreases in high density lipoproteins (HDL) have occurred.

Renal

Renal side effects have included retention of nitrogen, sodium, potassium, chloride, water and phosphorus, and decreased urinary excretion of calcium.

Gastrointestinal

Gastrointestinal side effects have included nausea, vomiting, and diarrhea.

Psychiatric

Psychiatric side effects have included habituation, excitation, insomnia, depression, and libido changes.

Dermatologic

Dermatologic side effects have frequently included acne. The greatest incidence of occurrence has been in women and prepubertal males.

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