Oxymetholone Side Effects
For the Consumer
Applies to oxymetholone: oral tablet
What are some side effects that I need to call my doctor about right away?
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
- Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
- Signs of electrolyte problems like mood changes, confusion, muscle pain or weakness, a heartbeat that does not feel normal, seizures, not hungry, or very bad upset stomach or throwing up.
- Pimples (acne).
- Shortness of breath, a big weight gain, or swelling in the arms or legs.
- Change in color of skin.
- Enlarged breasts.
- Hair loss.
- For males, erections (hard penis) that happen often or that last a long time.
- Change in sex interest.
- Not able to get or keep an erection.
- For females, a deep voice, facial hair, pimples, or period changes.
What are some other side effects of this drug?
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
- Upset stomach or throwing up.
- Feeling nervous and excitable.
- Not able to sleep.
These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.
For Healthcare Professionals
Applies to oxymetholone: oral tablet
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).[Ref]
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.[Ref]
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.[Ref]
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.[Ref]
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.[Ref]
Oncologic side effects have included hepatic neoplasms and hepatocellular carcinomas following prolonged therapy with large doses of anabolic steroids[Ref]
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.[Ref]
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.[Ref]
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.[Ref]
Renal side effects have included retention of nitrogen, sodium, potassium, chloride, water and phosphorus, and decreased urinary excretion of calcium.[Ref]
Dermatologic side effects have frequently included acne. The greatest incidence of occurrence has been in women and prepubertal males.[Ref]
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3. Sheffer AL, Fearon DT, Austen KF "Clinical and biochemical effects of impeded androgen (oxymetholone) therapy of hereditary angioedema." J Allergy Clin Immunol 64 (1979): 275-80
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5. Arnold GL, Kaplan MM "Peliosis hepatis due to oxymetholone--a clinically benign disorder." Am J Gastroenterol 71 (1979): 213-6
6. Obeid DA, Hill FG, Harnden D, Mann JR, Wood BS "Fanconi anemia. Oxymetholone hepatic tumors, and chromosome aberrations associated with leukemic transition." Cancer 46 (1980): 1401-4
7. Hirose H, Ohishi A, Nakamura H, Sugiura H, Umezawa A, Hosoda Y "Fatal splenic rupture in anabolic steroid-induced peliosis in a patient with myelodysplastic syndrome." Br J Haematol 78 (1991): 128-9
8. McDonald EC, Speicher CE "Peliosis hepatis associated with administration of oxymetholone." JAMA 240 (1978): 243-4
9. Young GP, Bhathal PS, Sullivan JR, Wall AJ, Fone DJ, Hurley TH "Fatal hepatic coma complicating oxymetholone therapy in multiple myeloma." Aust N Z J Med 7 (1977): 47-51
10. McCredie KB "Oxymetholone in refractory anaemia." Br J Haematol 17 (1969): 265-73
11. Shapiro P, Ikeda RM, Ruebner BH, Connors MH, Halsted CC, Abildgaard CF "Multiple hepatic tumors and peliosis hepatis in Fanconi's anemia treated with androgens." Am J Dis Child 131 (1977): 1104-6
12. Sheffer AL, Fearon DT, Austen KF "Clinical and biochemical effects of stanozolol therapy for hereditary angioedema." J Allergy Clin Immunol 68 (1981): 181-7
13. Ekert H, Muntz RH, Colebatch JH "Decreased anticoagulant tolerance with oxymetholone." Lancet 2 (1971): 609-10
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Some side effects may not be reported. You may report them to the FDA.