Applies to oxandrolone: oral tablets.
Warning
-
Peliosis Hepatis
- Peliosis hepatis, a condition in which the liver contains blood-filled cysts, reported with androgen therapy.1 4 30 31 34 May present with minimal hepatic dysfunction,1 4 34 or effects may not be apparent until complicated by life-threatening liver failure or rupture of the cysts resulting in intra-abdominal hemorrhage.1 4 5 7 31 34 (See Hepatic Effects under Cautions.)
- Discontinuance of androgen therapy usually results in resolution of liver lesions.1 4 32 34
-
Hepatic Adenoma and Carcinoma
- Liver cell tumors reported with androgen therapy.1 4 5 7 30 31 34 Tumors are usually benign and androgen dependent; hepatocellular carcinoma, sometimes fatal, also reported.1 4 5 7 34
- Liver cell tumors associated with androgens are more vascular than other hepatic tumors; hepatic effects may not be apparent until complicated by life-threatening intra-abdominal hemorrhage.1 4 5 34
- Discontinuance of androgen therapy often but not always results in regression or cessation of progression of the tumor.1 4 5 34
-
Lipid Abnormalities
- May markedly alter serum lipoprotein concentrations; decreased HDL- and increased LDL-cholesterol reported with androgen therapy.1 4 30 31 34 Consider increased risk of cardiovascular disease (e.g., atherosclerosis and CAD).1 4 31 34 (See Lipid Abnormalities under Cautions.)
Side effects include:
Elevated aminotransferases (ALT, AST), lipid abnormalities (e.g., decreased HDL cholesterol concentrations).
For Healthcare Professionals
Applies to oxandrolone: oral tablet.
Dermatologic
Frequency not reported: Hirsutism and male pattern baldness in females, acne (especially in females and prepubertal males), changes in skin color[Ref]
Gastrointestinal
Frequency not reported: Nausea, vomiting[Ref]
Genitourinary
Frequency not reported:
-Prepubertal Males: Phallic enlargement and increased frequency or persistence of erections
-Postpubertal Males: Inhibition of testicular function, testicular atrophy and oligospermia, impotence, chronic priapism, epididymitis, and bladder irritability
-Females: Clitoral enlargement, menstrual irregularities[Ref]
Hematologic
Frequency not reported: Bleeding in patients on concomitant anticoagulant therapy[Ref]
Hepatic
Frequency not reported: Cholestatic jaundice with, rarely, hepatic necrosis and death; hepatocellular neoplasms and peliosis hepatis with long-term therapy; reversible changes in liver function tests also occur including increased bromsulfophthalein (BSP) retention, changes in alkaline phosphatase and increases in serum bilirubin, aspartate aminotransferase (AST, SGOT) and alanine aminotransferase (ALT, SGPT).[Ref]
Musculoskeletal
Frequency not reported: Premature closure of epiphyses in children, ankle swelling[Ref]
Metabolic
Frequency not reported: Edema, retention of serum electrolytes (sodium chloride, potassium, phosphate, calcium); decreased glucose tolerance; increased creatinine excretion; increased serum levels of creatinine phosphokinase[Ref]
Oncologic
Frequency not reported: Gynecomastia, hepatic neoplasms and hepatocellular carcinomas following prolonged therapy with large doses of anabolic steroids[Ref]
Other
Frequency not reported: Virilization of female patients including deepening voice, hirsutism, acne, clitoromegaly (not reversible), and menstrual abnormalities.[Ref]
Psychiatric
Frequency not reported: Habituation, excitation, insomnia, depression, libido changes[Ref]
