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Pantoprazole Pregnancy and Breastfeeding Warnings

Pantoprazole is also known as: Protonix, Protonix IV

Medically reviewed on Jun 26, 2018

Pantoprazole Pregnancy Warnings

Animal models have revealed evidence of changes to femur bone length and weight when given during gestation day 6 through lactation day 21. There are no controlled data in human pregnancy.

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.

This drug is only recommended for use during pregnancy when there are no alternatives and the benefit outweighs the risk.
-Some experts state that this drug should not be used in pregnancy.

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

See references

Pantoprazole Breastfeeding Warnings

Use is not recommended and 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

Comment: The effects in the nursing infant are unknown.

Animal models have evidence of decreased pup weight at doses of at least 10 mg/kg/day. There have been reports of excretion into human breast milk.

See references

References for pregnancy information

  1. "Product Information. Protonix (pantoprazole)" Wyeth-Ayerst Laboratories, Philadelphia, PA.
  2. "Product Information. Protonix I.V. (pantoprazole)" Wyeth-Ayerst Laboratories, Philadelphia, PA.
  3. Cerner Multum, Inc. "Australian Product Information." O 0
  4. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

References for breastfeeding information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. 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 -]):
  4. "Product Information. Protonix I.V. (pantoprazole)" Wyeth-Ayerst Laboratories, Philadelphia, PA.
  5. "Product Information. Protonix (pantoprazole)" Wyeth-Ayerst Laboratories, Philadelphia, PA.

Further information

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

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