Pregnancy: Animal studies do not indicate harmful effects with respect to effects on pregnancy or embryonal/fetal development. Limited data from available pregnancy databases do not suggest a causal relationship between Montelukast and malformations (i.e. limb defects) that have been rarely reported in worldwide post-marketing experience.
Montelukast may be used during pregnancy only if it is considered to be clearly essential.
Lactation: Studies in rats have shown that Montelukast is excreted in milk. It is not known if Montelukast is excreted in human milk.
Montelukast may be used in nursing mothers only if it is considered to be clearly essential.