Known hypersensitivity to metformin hydrochloride.
Diabetic coma and ketoacidosis.
Renal dysfunction (e.g., as suggested by serum creatinine levels ≥1.5 mg/dL [males], ≥1.4 mg/dL [females] or abnormal creatinine clearance).
Chronic hepatic disease, cardiac failure, ischemic heart disease (e.g., acute myocardial infarction), alcoholism, history of lactic acidosis or states associated with lactic acidosis such as shock or pulmonary insufficiency, and conditions associated with hypoxia.
Metformin hydrochloride is not recommended for use in pregnancy and nursing mothers.