Pregnancy: There are no adequate and well-controlled studies of topically administered azelaic acid in pregnant women.
Animal studies do indicate the potential for effects with respect to pregnancy, embryo-fetal development, parturition or postnatal development. However, the dose levels without observed adverse effects in animals ranged across studies from 3-32 times the maximum recommended human dose based on body surface area. It is advisable to avoid Skinoren cream during pregnancy unless the benefit outweighs the risk.
Lactation: It is not known if azelaic acid is secreted in human milk in vivo. However an in vitro equilibrium dialysis experiment demonstrated that passage of drug into maternal milk may occur. But the distribution of azelaic acid into maternal milk is not expected to cause a significant change from baseline azelaic acid levels in the milk since azelaic acid is not concentrated in milk and less than 4% of topically applied azelaic acid is systemically absorbed not increasing endogenous azelaic acid exposure above physiological levels. However, Skinoren cream should not be used by lactating woman unless the benefit outweighs the risk.