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Formoterol / mometasone Pregnancy and Breastfeeding Warnings

Medically reviewed by Last updated on Feb 6, 2023.

Formoterol / mometasone is also known as: Dulera

Formoterol / mometasone Pregnancy Warnings

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.

US FDA pregnancy category: C

Animal studies have shown teratogenicity at higher than clinically used doses. In these studies, mometasone and formoterol were administered separately. There are no controlled data in human pregnancy.

US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

See references

Formoterol / mometasone Breastfeeding Warnings

Studies of formoterol in rats have shown excretion in breast milk.

Caution is recommended.

Excreted into human milk: Unknown (formoterol, mometasone)
Excreted into animal milk: Data not available (mometasone); Yes (formoterol)

Comments: The effects in the nursing infant are unknown.

See references

References for pregnancy information

  1. "Product Information. Dulera (formoterol-mometasone)." Schering-Plough Corporation (2010):

References for breastfeeding information

  1. "Product Information. Dulera (formoterol-mometasone)." Schering-Plough Corporation (2010):

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.