Cardiovascular Thrombotic Events • Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use (See and ). WARNINGS PRECAUTIONS • Indomethacin Extended-release Capsules are contraindicated in the setting of coronary artery bypass graft (CABG) surgery (See and ). CONTRAINDICATIONS WARNINGS Gastrointestinal Risk • NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events. (See ). WARNINGS
<table width="595"> <tbody> <tr styleCode="First Last"> <td align="left" valign="top">tinnitus </td> <td align="left" valign="top">ocular-corneal deposits and retinal disturbances, including those of macula, have been reported in some patients on prolonged therapy with indomethacin </td> <td align="left" valign="top"> <paragraph>blurred vision</paragraph> <paragraph>diplopia</paragraph> <paragraph>hearing disturbances, deafness </paragraph> </td> </tr> </tbody> </table>