Hepatic effects may occur with prolonged use and/or high doses (i.e. peliosis hepatis, liver cell tumors, cholestatic hepatitis with jaundice or abnormal liver function tests). Use with caution in breast cancer (may cause hypercalcemia by stimulating osteolysis), diabetes mellitus, in edematous conditions (may cause fluid retention), hepatic impairment, or in elderly patients (might be at greater risk for prostatic hyperplasia, fluid retention, and transaminase elevations). May accelerate bone maturation without producing compensatory gain in linear growth in children. May cause mild virilization in women. Product may contain tartrazine.