Skip to main content

Pimecrolimus topical Pregnancy and Breastfeeding Warnings

Brand names: Elidel

Medically reviewed by Drugs.com. Last updated on Oct 23, 2023.

Pimecrolimus topical Pregnancy Warnings

Use should be avoided.

AU TGA pregnancy category: B3
US FDA pregnancy category: C

Animal studies using dermal application do not indicate direct or indirect harmful effects with respect to embryofetal development. There are no controlled data in human pregnancy. It is not known whether this drug can cause fetal harm or adversely affect reproductive capacity in humans.

AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.

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

Pimecrolimus topical Breastfeeding Warnings

AU, US: A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.
UK: Use is considered acceptable.

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

Based on the minimal extent of absorption of this drug after topical application, the potential risk for humans is considered limited. Breastfeeding mothers should not apply this drug to the breast because ointments may expose the infant to high levels of mineral paraffin via licking.

See references

See also

References for pregnancy information

  1. Product Information. Elidel (pimecrolimus topical). Novartis Pharmaceuticals. 2002.
  2. Cerner Multum, Inc. UK Summary of Product Characteristics.
  3. Cerner Multum, Inc. Australian Product Information.

References for breastfeeding information

  1. Product Information. Elidel (pimecrolimus topical). Novartis Pharmaceuticals. 2002.
  2. Cerner Multum, Inc. UK Summary of Product Characteristics.
  3. Cerner Multum, Inc. Australian Product Information.

Further information

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

Medical Disclaimer