Aerius Special Precautions

No teratogenic effects were observed in animal studies with desloratadine (See Pharmacology: Toxicology: Preclinical Studies under Actions). Since no clinical data on exposure during pregnancy are available with desloratadine, the safe use of desloratadine during pregnancy has not been established. Desloratadine should not be used during pregnancy unless the potential benefit outweighs the risks. Desloratadine passes into breast milk; therefore, breastfeeding is not recommended in lactating women taking desloratadine.
Desloratadine showed no mutagenic effects in in vitro and in vivo mutagenicity studies.
Desloratadine should be administered with caution in patients with a medical or family history of seizures. In particular, young children may be more susceptible to developing new seizures under desloratadine treatment. Healthcare providers may consider discontinuing desloratadine in patients who experience a seizure while on treatment.
Drug Abuse and Dependence: There is no information to indicate that abuse or dependency occurs with desloratadine tablets.
Interference with Laboratory Tests: None identified.
Other Relevant Safety Information: None.