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Nystatin Pregnancy and Breastfeeding Warnings

Nystatin is also known as: Bio-Statin, Mycostatin, Mycostatin Pastilles, Nilstat, Nystat-Rx, Nystex

Medically reviewed on Mar 12, 2018

Nystatin Pregnancy Warnings

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.

Caution is recommended.

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

See references

Nystatin Breastfeeding Warnings

Caution is recommended.

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

See references

References for pregnancy information

  1. "Product Information. Nystatin, USP from Extemporaneous Preparation of Oral Suspension (nystatin)." Paddock Laboratories Inc, Minneapolis, MN.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. Cerner Multum, Inc. "Australian Product Information." O 0
  4. "Product Information. Mycostatin Pastilles (nystatin)." Ernest Jackson & Co., Ltd., Crediton, Devon, England, .

References for breastfeeding information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. "Product Information. Nystatin, USP from Extemporaneous Preparation of Oral Suspension (nystatin)." Paddock Laboratories Inc, Minneapolis, MN.
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  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 -]):
  5. "Product Information. Mycostatin Pastilles (nystatin)." Ernest Jackson & Co., Ltd., Crediton, Devon, England, .

Further information

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

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