Increased incidence of bone fractures in females observed during analysis of long-term trial. Not recommended for use in symptomatic heart failure. Use with caution in edema (may increase plasma volume and/or cause fluid retention). Use may be associated with an increased risk of angina and MI (use with caution in risk for cardiovascular events; discontinue if deterioration in cardiac status occurs). May decrease hemoglobin, hematocrit, and/or WBC count (slight). Dose-related weight gain observed with use (probably associated with fluid retention and fat accumulation). Use with caution in anemia (may reduce hemoglobin and hematocrit). Use in type 1 diabetes (insulin-dependent) or diabetic ketoacidosis not recommended. Use with caution in elevated transaminases (AST or ALT). Do not initiate in active liver disease or ALT >2.5 times upper limit of normal at baseline (discontinue if elevation persists or if jaundice occurs at any time during use). Idiosyncratic hepatotoxicity reported with another thiazolidinedione agent (troglitazone). Avoid use in patients who previously experienced jaundice during troglitazone therapy. Use with caution in pre-existing macular edema or diabetic retinopathy (postmarketing events of new-onset or worsening diabetic macular edema with decreased visual acuity reported). Combination therapy with other hypoglycemic agents may increase risk for hypoglycemic events. Avoid use of rosiglitazone with insulin due to increased risk of edema, congestive heart failure, and myocardial ischemic events. Concomitant use of rosiglitazone with nitrates not recommended. Increased risk of myocardial ischemia observed in nitrate users vs non-nitrate users in clinical studies. Rosiglitazone may be added to metformin or a sulfonylurea if glycemic control is inadequate. Use of triple therapy (rosiglitazone in combination with metformin and a sulfonylurea) not indicated due to increased risks of congestive heart failure and fluid retention.