The safety of Ebastine during human pregnancy has not been established. Studies in rats and rabbits do not indicate any direct or indirect harmful effects with respect to the development of the embryo or fetus, or the course of gestation and peri- and post-natal development. No teratogenic effects have been identified in animals. However, there are no well-controlled studies in pregnant women and reproductive studies are not always predictive of human response. Therefore, Ebastine should be used during pregnancy only if clearly needed. It is not known whether Ebastine is excreted in human milk, therefore, Ebastine should not be used during lactation.