No overall effect on rat fertility was observed with desloratadine at an exposure that was 34 times higher than the exposure in humans at the recommended clinical dose.
No teratogenic or mutagenic effects were observed in animal trials with desloratadine (see Pharmacology: Toxicology: PRECLINICAL TOXICOLOGY under Actions). Since no clinical data on exposed pregnancies are available with desloratadine, the safe use of AERIUS during pregnancy has not been established. AERIUS is not to be used during pregnancy unless the potential benefits outweigh the risks.
Desloratadine is excreted into breast milk; therefore the use of AERIUS is not recommended in breast-feeding women.