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Nitrofurantoin Pregnancy and Breastfeeding Warnings

Nitrofurantoin is also known as: Furadantin, Macrobid, Macrodantin, Nitro Macro

Medically reviewed on Mar 12, 2018

Nitrofurantoin Pregnancy Warnings

-This drug is contraindicated in pregnant patients at term (38 to 42 weeks' gestation), during labor and delivery, or when the onset of labor is imminent because of the possibility of hemolytic anemia due to immature erythrocyte enzyme systems (glutathione instability).
-This drug should be used during pregnancy up to 38 weeks' gestation only if the benefit outweighs the risk.

AU TGA pregnancy category: A (short-term therapy)
US FDA pregnancy category: B

Comment:
-This drug has been associated with reduced sperm counts and abnormal testicular histology in humans. Caution is recommended if use is considered in young males.

Animal studies have failed to reveal evidence of fetotoxicity or teratogenicity. 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 A: Drugs which have been taken by a large number of pregnant women and women of childbearing age without any proven increase in the frequency of malformations or other direct or indirect harmful effects on the fetus having been observed.

US FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

See references

Nitrofurantoin 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: Yes

Comment:
-Although the amount of this drug excreted in breast milk after normal therapeutic doses is considered negligible, there is a theoretical risk of hemolytic anemia in neonates less than 3 months old and glucose-6-phosphate dehydrogenase (G-6-PD) deficient infants.

Because of the low levels of this drug in breastmilk, amounts ingested by the infant are small and would not be expected to cause any adverse effects in breastfed infants.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. "Product Information. Nitrofurantoin (nitrofurantoin)." AA Pharma Inc, Vaughan , ON.
  3. Cerner Multum, Inc. "Australian Product Information." O 0

References for breastfeeding information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. "Product Information. Nitrofurantoin (nitrofurantoin)." AA Pharma Inc, Vaughan , ON.
  4. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):

Further information

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

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