Increased risk of serious CV thrombotic events, MI, & stroke; serious GI adverse events including bleeding, ulceration, & perforation of the stomach or intestines. Long-term administration has resulted in renal papillary necrosis & other renal injury. Renal toxicity in patients in whom renal prostaglandins have a compensatory role in the maintenance of renal perfusion; in these patients, NSAID administration may cause a dose-dependent reduction in prostaglandin formation &, secondarily, in renal blood flow, which may precipitate overt renal decompensation. Not recommended in patients w/ advanced renal disease. Associated w/ serious liver injury in rare cases. Risk of premature closure of ductus arteriosus & potential to prolong parturition if used during the 3rd trimester of pregnancy. Should not be used during the 1st & 2nd trimesters of pregnancy unless expected benefits to mother outweigh risks to fetus. If treatment is considered necessary to be administered anywhere from the middle (onset at approx 20 wk) to the end of the 2nd trimester of pregnancy, limit use to the lowest effective dose & shortest duration possible, & consider ultrasound monitoring of amniotic fluid if treatment extends >48 hr, & discontinue treatment if oligohydramnios occurs.