There are no adequate well-controlled clinical studies in pregnant or breastfeeding women.
Pregnancy: It is not known if budesonide can cross the placenta but due to its relatively low molecular weight, placental transfer may be possible. When given at therapeutic doses, systemic exposure after intranasal administration is low.
Lactation: Budesonide is excreted in breast milk. However, due to negligible systemic exposure, minimal exposure to nasal budesonide in breast-fed infants is expected. The infant daily dose of inhaled budesonide is around 0.3% of the maternal daily dose. There is a linear relationship between budesonide concentration in plasma and breast milk, where concentration of budesonide in breast milk is less than plasma concentration.
Fertility: There is no evidence that intranasally administered budesonide has an effect on fertility.
This product should not be used during pregnancy or lactation unless the potential benefit of treatment to the mother outweighs the possible risks to the developing fetus or nursing infant. Ask a physician before use if you are pregnant or breastfeeding.