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. Since no clinical data on exposed pregnancies are available with desloratadine, the safe use of Avenez Syrup during pregnancy has not been established. Avenez Syrup is not to be used during pregnancy unless the potential benefits outweigh the risks.
Desloratadine is excreted into breast milk, therefore the use of Avenez Syrup is not recommended in breast-feeding women.