US BOXED WARNINGS :
-PELIOSIS HEPATITIS: Peliosis hepatitis is a condition in which liver and sometimes splenic tissue is replaced with blood-filled cysts, has been reported in patients receiving androgenic anabolic steroid therapy. These cysts are sometimes present with minimal hepatic dysfunction, but at other times have been associated with liver failure. They are often not recognized until life-threatening liver failure or intraabdominal hemorrhage develops. Withdrawal of this drug usually results in complete disappearance of lesions.
-LIVER CELL TUMORS: Liver cell tumors have been reported. Most often, these tumors are benign and androgen-dependent, but fatal malignant tumors have been reported. Withdrawal of this drug often results in regression or cessation of progression of the tumor. However, hepatic tumors associated with androgens or anabolic steroids are much more vascular than other hepatic tumors and may be silent until life-threatening intraabdominal hemorrhage develops.
-BLOOD LIPID CHANGES: Blood lipid changes that are known to be associated with an increased risk of atherosclerosis are seen in patients treated with androgens or anabolic steroids. These changes include decreased high-density lipoproteins and sometimes increased low-density lipoproteins. The changes may be very marked and could have a serious impact on the risk of atherosclerosis and coronary artery disease.
Consult WARNINGS section for additional precautions.