Not recommended for treatment of asymptomatic hyperuricemia. May increase gout flares; concurrent prophylactic treatment w/ NSAID or colchicine is recommended. Monitor for signs & symptoms of MI & stroke. Risk for severe drug-induced liver injury & do not restart treatment in patients who have serum ALT >3 times the reference range w/ serum total bilirubin >2 times the reference range w/o alternative etiologies. Not recommended for use in patients w/ increased rate of urate formation (eg, malignant disease & its treatment, Lesch-Nyhan syndrome). Severe renal & hepatic impairment. Moderate hepatic impairment. Pregnancy & lactation. Childn <18 yr.