Azelastine nasal Pregnancy Warnings
Animal studies have shown that this drug causes developmental toxicity in mice, rats, and rabbits at doses more than 15 times the equivalent human dose. Neither fetal nor maternal effects occurred at approximately 15 times the human dose or less. There are no adequate and well-controlled studies in pregnant women.
US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.
US FDA pregnancy category: C
See references
