Discontinue use if serious skin & hypersensitivity reactions including SJS, DRESS, & TEN are suspected. Permanently discontinue use if no other explanation for abnormalities is elucidated & in patients who develop ALT >3x ULN & serum total bilirubin >2x ULN. Not recommended in patients w/ ischemic or congestive heart disease; conditions which greatly increase urate formation rate (eg, malignant disease & treatment, Lesch-Nyhan syndrome). CV thromboembolic events (CV deaths, non-fatal MI & strokes). Monitor patients for signs & symptoms of CV events. Fatal & non-fatal hepatic failure. Increased gout flares may occur after initiating treatment. Gout patients w/ established CV disease. Patients w/ previous similar skin reactions to allopurinol. Evaluate LFTs at baseline & periodically thereafter & in patients experiencing signs & symptoms of hepatic injury (eg, fatigue, LFTs (eg, ALT >3x ULN). Consider prophylactic low-dose aspirin in patients w/ history of CV disease. Administer NSAID or colchicine (up to 6 mth) to prevent gout flare. Moderate to severe (Child-Pugh class C) hepatic impairment. Severe renal impairment (CrCl <30 mL/min). Not to be used during pregnancy & lactation. Childn <18 yr.