<p>US FDA pregnancy category C. Animal studies have revealed evidence of embryotoxicity in rats at doses 125 times the human dose (in mg/kg); this dose given orally to rats led to prolonged gestation and dystocia, and several females died during the perinatal period (likely due to labor complications). Animal studies have failed to reveal evidence of teratogenicity in rats or rabbits at oral doses of 50 mg/kg/day. There are no controlled data in human pregnancy.<br />
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Excreted into human milk: Unknown. Excreted into animal milk: Data not available</p>