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Nystatin Pregnancy and Breastfeeding Warnings

Brand names: Bio-Statin, Mycostatin, Mycostatin Pastilles, Nilstat, Nystat-Rx, Nystex

Medically reviewed by Drugs.com. Last updated on Jan 15, 2024.

Nystatin Pregnancy Warnings

Caution is recommended.

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

Animal reproduction studies have not been conducted with this drug. There are no controlled data in human pregnancy and/or reproductive capacity.

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 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

Nystatin Breastfeeding Warnings

Caution is recommended.

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

See references

See also

References for pregnancy information

  1. (2001) "Product Information. Mycostatin Pastilles (nystatin)." Ernest Jackson & Co. Ltd
  2. (2022) "Product Information. Nystatin (nystatin)." Paddock Laboratories Inc
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics."
  4. Cerner Multum, Inc. "Australian Product Information."

References for breastfeeding information

  1. (2001) "Product Information. Mycostatin Pastilles (nystatin)." Ernest Jackson & Co. Ltd
  2. (2022) "Product Information. Nystatin (nystatin)." Paddock Laboratories Inc
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics."
  4. Cerner Multum, Inc. "Australian Product Information."
  5. United States National Library of Medicine (2013) Toxnet. Toxicology Data Network. http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT

Further information

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

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