Upper GI complications (perforations, ulcers or bleedings), some fatal, occurred in patients treated with etoricoxib (caution with risk of developing GI complication with NSAIDs, the elderly, patients using any other NSAID or acetylsalicylic acid concomitantly or with history of GI disease, such as ulceration and GI bleeding). Further increase in risk of GI adverse effects (GI ulceration or other GI complications) when etoricoxib is taken concomitantly with acetylsalicylic acid (even at low doses). Clinical trials suggest that the selective COX-2 inhibitor class of drugs may be associated with risk of thrombotic events (especially MI and stroke), relative to placebo and some NSAIDs. As cardiovascular risks of etoricoxib may increase with dose and duration of exposure, shortest duration possible and lowest effective daily dose should be used. Patients with significant risk factors for cardiovascular events (e.g. hypertension, hyperlipidemia, diabetes mellitus, smoking) should only be treated with etoricoxib after careful consideration. Renal prostaglandins may play a compensatory role in the maintenance of renal perfusion. Therefore, under conditions of compromised renal perfusion, administration of etoricoxib may cause reduction in prostaglandin formation and, secondarily, in renal blood flow, thereby impairing renal function. Patients at greatest risk of this response are those with pre-existing significantly impaired renal function, uncompensated heart failure, or cirrhosis. Fluid retention, edema and hypertension observed in patients taking etoricoxib. All NSAIDs, including etoricoxib, can be associated with new onset or recurrent CHF (caution should be exercised in history of cardiac failure, left ventricular dysfunction, or hypertension and in patients with pre-existing edema from any other reason). Etoricoxib may be associated with more frequent and severe hypertension than some other NSAIDs and selective COX-2 inhibitors, particularly at high doses. Elevations of ALT and/or AST (approximately three or more times the ULN) reported in approximately 1% of patients in clinical trials treated for up to one year with etoricoxib 30, 60 and 90 mg daily. If signs of hepatic insufficiency occur, or if persistently abnormal liver function tests (three times ULN) are detected, etoricoxib should be discontinued. Medically appropriate supervision should be maintained when using etoricoxib in the elderly and in renal, hepatic, or cardiac dysfunction. Use caution when initiating treatment with etoricoxib in dehydration. Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, reported very rarely in association with use of NSAIDs and some selective COX-2 inhibitors during post-marketing surveillance. Serious hypersensitivity reactions (such as anaphylaxis and angioedema) reported in patients receiving etoricoxib. Some selective COX-2 inhibitors associated with increased risk of skin reactions in history of any drug allergy. Etoricoxib should be discontinued at first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity. Etoricoxib may mask fever and other signs of inflammation. Use caution when co-administering etoricoxib with warfarin or other oral anticoagulants. Use of etoricoxib not recommended in women attempting to conceive. Etoricoxib tablets contain lactose. Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.