<p><strong>Gout Flare</strong>: An increase in gout flares is frequently observed during initiation of anti-hyperuricemic agents, including Febuxostat. If a gout flare occurs during treatment, Febuxostat need not be discontinued. Prophylactic therapy (i.e., non-steroidal anti-inflammatory drug (NSAID) or colchicine upon initiation of treatment) may be beneficial for up to six months.<br />
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<strong>Cardiovascular Events</strong>: A higher rate of cardiovascular thromboembolic events was observed in patients treated with febuxostat than allopurinol in clinical trials. Monitor for signs and symptoms of MI and stroke.<br />
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<strong>Liver Enzyme Elevation</strong>: Transaminase elevations have been observed in febuxostat -treated patients. Monitor liver function tests periodically.</p>