Skip to Content

Pirfenidone Pregnancy and Breastfeeding Warnings

Pirfenidone is also known as: Esbriet

Medically reviewed by Last updated on Jul 24, 2019.

Pirfenidone Pregnancy Warnings

Use should be avoided unless the benefit outweighs the risk.

US FDA pregnancy category: C

Fertility and embryo-fetal development studies revealed no evidence of impaired fertility or fetal harm in rats and rabbits that received oral doses up to 3 and 2 times, respectively, the maximum recommended daily dose (MRDD) in adults. However, a pre- and post-natal development study showed gestation prolongation, decreased number of live newborns, reduction in fetal viability and lower body weights in rats receiving an oral dosage approximately 3 times the MRDD in adults. Additionally, acyclic/irregular cycles were seen in rats at doses approximately equal to and higher that the MRDD in adults in the presence of maternal toxicity. 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

Pirfenidone Breastfeeding Warnings

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

Excreted into human milk: Unknown
Excreted into animal milk: Yes

Comments: The effects in the nursing infant are unknown.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. "Product Information. Esbriet (pirfenidone)." Intermune Inc, Brisbane, CA.

References for breastfeeding information

  1. "Product Information. Esbriet (pirfenidone)." Intermune Inc, Brisbane, CA.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

Further information

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