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Dexlansoprazole Pregnancy and Breastfeeding Warnings

Dexlansoprazole is also known as: Dexilant, Dexilant SoluTab, Kapidex

Medically reviewed on November 23, 2016

Dexlansoprazole Pregnancy Warnings

Animal models have failed to reveal evidence of impaired fertility or harm to the fetus when given during organogenesis. There are no controlled data in human pregnancy.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

This drug should be used during pregnancy only if clearly needed.

US FDA pregnancy category: Not assigned.

Risk Summary: No data available on use of this drug in pregnant women to inform a drug-related risk.

See references

Dexlansoprazole Breastfeeding Warnings

The manufacturer makes no recommendation regarding use during lactation.

Excreted into human milk: Unknown
Excreted into animal milk: Yes (lansoprazole)

Comment: The effects in the nursing infant are unknown.

No information is available regarding use during breastfeeding or the effects on milk production.

See references

References for pregnancy information

  1. "Product Information. Kapidex (dexlansoprazole)." Takeda Pharmaceuticals America, Lincolnshire, IL.

References for breastfeeding information

  1. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL:" ([cited 2013 -]):
  2. "Product Information. Kapidex (dexlansoprazole)." Takeda Pharmaceuticals America, Lincolnshire, IL.

Further information

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