Skip to Content
Is it Exocrine Pancreatic Insufficiency? Get more info

Pantoprazole Pregnancy and Breastfeeding Warnings

Pantoprazole is also known as: Protonix, Protonix IV

Pantoprazole Pregnancy Warnings

Animal models have failed to revealed evidence of impaired fertility or fetal harm. 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 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.

This drug is only recommended for use during pregnancy when there are no alternatives and the benefit outweighs the risk. AU TGA pregnancy category: B3 US FDA pregnancy category: B

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

References for breastfeeding information

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

See Also...

Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Wolters Kluwer Health and Drugs.com is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective, or appropriate for any given patient. Multum Information Services, Inc. does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. Copyright 2000-2008 Multum Information Services, Inc. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.

Hide