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Pregnancy: The safety and efficacy of montelukast have not been determined in pregnant women. Rarely, congenital limb defects have been reported during postmarketing surveillance; however, causality has not been established. Due to the lack of human safety information, montelukast should be used in pregnant women only if the potential benefit outweighs the potential risk to the fetus.
Lactation: Lactation studies with montelukast in humans have not been conducted. Montelukast is excreted into the milk of lactating rats. Until further data are available, caution is advised if montelukast is used in nursing women.
Available evidence and/or expert consensus is inconclusive or is inadequate for determining infant risk when used during breastfeeding. Weigh the potential benefits of drug treatment against potential risks before prescribing this drug during breastfeeding.
