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Edoxaban Pregnancy and Breastfeeding Warnings

Brand names: Savaysa

Medically reviewed by Drugs.com. Last updated on Jul 31, 2023.

Edoxaban Pregnancy Warnings

Use is contraindicated per some authorities.

US FDA pregnancy category: Not assigned.

Risk Summary: Insufficient data exist to determine whether there are drug-associated risks for adverse developmental outcomes.

Animal studies revealed embryofetal toxicity at maternotoxic doses. 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.

See references

Edoxaban Breastfeeding Warnings

Use is not recommended, and per some authorities is contraindicated.

Excreted into human milk: Unknown
Excreted into animal milk: Yes

Comments: The effects in the nursing infant are unknown.

See references

References for pregnancy information

  1. Cerner Multum, Inc. UK Summary of Product Characteristics.
  2. Product Information. Savaysa (edoxaban). Daiichi Sankyo, Inc. 2015.

References for breastfeeding information

  1. Cerner Multum, Inc. UK Summary of Product Characteristics.
  2. Product Information. Savaysa (edoxaban). Daiichi Sankyo, Inc. 2015.

Further information

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