Rupatadine and Breastfeeding

Summary of use during lactation

Information from two mother taking rupatadine found no adverse effects in their breastfed infants. Because little information is available on the use of rupatadine during breastfeeding, an alternate drug may be preferred, especially while nursing a newborn or preterm infant. If it is used in a nursing mother, monitor the infant for sedation, poor feeding and poor weight gain.

Drug levels in milk and infant serum

Maternal Levels. Relevant published information was not found as of the revision date. Infant Levels. Relevant published information was not found as of the revision date.

Effects in breastfed infants

Two infants were breastfed during maternal rupatadine use. One mother was taking rupatadine 10 mg daily as well as bupropion, mirtazapine and sertraline. She exclusively breastfed her infant for 3 months. At 16 months of age, the infant had age-appropriate weight gain, normal sleeping and appetite, normal development. The second mother was taking 20 mg daily (twice the recommended dose). Her milk production decreased and the dose was decreased to 10 mg daily, but the infant was only about 50% breastfed until 2 months of age when breastfeeding was stopped. No adverse effects occurred in the infant, and the infant had age-appropriate weight gain, normal sleeping and appetite, normal development were noted at 4 months of age.[1]

Effects on lactation and breastmilk

One mother was taking 20 mg of rupatadine daily (twice the recommended dose). Her milk production decreased so that the infant was only about 50% breastfed. The dose was decreased to 10 mg daily, but the milk continued to decline until 2 months of age when breastfeeding was stopped.[1] It is not clear if the decline in milk production was caused by rupatadine.

Alternative drugs to consider

Cetirizine, Desloratadine, Fexofenadine, Levocetirizine, Loratadine

References

1. Shalit S, Yehuda S, De-Haan T, et al. Rupatadine during breastfeeding: Two case reports. Neurotoxicol Teratol 2025;109 (Suppl 2):26.doi:10.1016/j.ntt.2025.107515