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Pregnancy: Pregnancy Category D.
Tibolone is contraindicated in pregnant women including those in the perimenopausal period. Tibolone has been shown to cross the placenta in rabbits and was found to be teratogenic in rats and rabbits, and therefore, tibolone should be withdrawn immediately if patient becomes pregnant during the course of therapy.
Lactation: Tibolone is contraindicated in breastfeeding mothers.
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