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Omeprazole / sodium bicarbonate Pregnancy and Breastfeeding Warnings

Omeprazole / sodium bicarbonate is also known as: Zegerid, Zegerid OTC

Medically reviewed on Jun 26, 2018

Omeprazole / sodium bicarbonate Pregnancy Warnings

Epidemiological data have failed to reveal evidence of an increased risk of congenital malformations or other outcomes when patients took this drug during the first trimester. Animal models have revealed evidence of bone morphology changes in offspring exposed to high doses throughout pregnancy and lactation.

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 should be used during pregnancy only if the benefit outweighs the risk to the fetus.

US FDA pregnancy category: C

See references

Omeprazole / sodium bicarbonate Breastfeeding Warnings

Following an oral dose of 20 mg, the peak concentration of omeprazole in breast milk was less than 7% of the mother's peak serum concentration, or a dose of approximately 0.004 mg of omeprazole in 200 mL of milk.

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: Yes (omeprazole); Data not available (sodium bicarbonate)
Excreted into animal milk: Data not available (sodium bicarbonate)

Comments:
-This drug may cause serious adverse events and/or tumorigenicity in breastfed neonates and infants.
-The American Academy of Pediatrics (AAP) state that omeprazole should be avoided until additional studies can confirm the safe use of this drug during breastfeeding.
-The AAP state that chronic or indiscriminate use of sodium bicarbonate is not recommended during breastfeeding.

See references

References for pregnancy information

  1. "Product Information. Zegerid (omeprazole-sodium bicarbonate)." Santarus Inc, San Diego, CA.
  2. "Product Information. Zegerid (omeprazole)." Santarus Inc, San Diego, CA.

References for breastfeeding information

  1. 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 -]):
  2. Briggs GG, Freeman RK. "Drugs in Pregnancy and Lactation. 10th ed." Philadelphia, PA: Wolters Kluwer Health (2015):
  3. "Product Information. Zegerid (omeprazole-sodium bicarbonate)." Santarus Inc, San Diego, CA.
  4. "Product Information. Zegerid (omeprazole)." Santarus Inc, San Diego, CA.

Further information

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

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