Patients w/ ischemic heart disease & those w/ risk factors for heart disease; HTN; hyperlipidemia, diabetes, smoking & patients w/ peripheral arterial disease; patients w/ compromised cardiac function, pre-existing edema or other conditions predisposing to, or worsened by, fluid retention including those taking diuretic treatment or otherwise at risk of hypovolemia; patients w/ dehydration; moderate hepatic impairment (Child-Pugh class B); patients who are known or suspected to be poor CYP2C9 metabolizers. Increased risk of serious CV thrombotic events, MI, & stroke. Not a substitute for ASA for prophylaxis of CV thromboembolic diseases. Can lead to onset of new HTN or worsening of pre-existing HTN. Closely monitor BP during initiation of therapy & throughout the course of therapy. Risk of fluid retention & edema. Risk of developing GI complications (upper & lower GI perforations, ulcers or bleeds). Risk of anaphylactoid reactions. Discontinue treatment at the 1st appearance of skin rash, mucosal lesions, or any other signs of hypersensitivity. Concomitant use w/ oral anticoagulants including warfarin/coumarin-type & novel oral anticoagulant (eg, apixaban, dabigatran & rivaroxaban); drugs that are metabolized by CYP2D6. Avoid concomitant use w/ non-aspirin NSAID. May diminish utility of diagnostic signs in detecting infections eg, fever. May cause renal toxicity; carefully monitor patients at greatest risk for renal toxicity eg, those w/ impaired renal function, heart failure, liver dysfunction, & elderly. Closely monitor renal function in patients w/ advanced renal disease. Not recommended w/ severe hepatic impairment (Child-Pugh class C). Carefully monitor patients w/ symptoms &/or signs of liver dysfunction, or in whom abnormal LFT has occurred, for evidence of development of a more severe hepatic reaction while on therapy. Avoid use during 3rd trimester of pregnancy. May cause fetal renal dysfunction if used during 2nd or 3rd trimester of pregnancy. Use during pregnancy only if potential benefit to the mother justifies potential risk to the fetus. Decision should be made whether to discontinue nursing during treatment or discontinue the drug. Consider w/drawal of treatment in women who have difficulties conceiving or who are undergoing investigation of infertility.