No animal reproduction studies have been performed with fexofenadine hydrochloride. Supportive pharmacokinetic studies with terfenadine have been performed and show exposure to fexofenadine at the high dose level in animal reproduction studies performed with terfenadine to be higher than is achieved at the recommended clinical fexofenadine dose. In these studies no evidence of teratogenicity or effects on male fertility were observed. Effects on female fertility and on peri and post natal development were seen only at maternally toxic doses.
There is no experience with fexofenadine hydrochloride in pregnant women. As with other medications fexofenadine hydrochloride should not be used during pregnancy unless the expected benefit to the patient outweighs any possible risk to the foetus. There are no data on the content of human milk after administering fexofenadine hydrochloride. However, when terfenadine was administered to nursing mothers fexofenadine was found to cross into human breast milk. Therefore, fexofenadine hydrochloride is not recommended for mothers breast feeding their babies.
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