<p><strong>Pregnancy</strong>: Ospemifene is contraindicated in women who are or may become pregnant. If this drug is used during pregnancy, or if a woman becomes pregnant while taking this drug, she should be apprised of the potential hazard to a fetus. Based on animal data, Ospemifene is likely to increase the risk of adverse outcomes during pregnancy and labor. Adverse findings at maternally toxic doses included embryofetal lethality in rats and rabbits, and neonatal mortality and difficult labor in rats. The reproductive effects observed are consistent with and are considered to be related to the estrogen receptor activity of Ospemifene.<br />
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<strong>Lactation</strong>: It is not known whether Ospemifene is excreted in human breast milk. There are no data on the effects of Ospemifene on the breastfed child or the effects on milk production. Do not breastfeed while taking Ospemifene. Ospemifene was excreted in rat milk</p>