Dabigatran Pregnancy and Breastfeeding Warnings

Brand names: Pradaxa

Medically reviewed by Drugs.com. Last updated on Jun 12, 2023.

Dabigatran Pregnancy Warnings

AU: Use should be avoided.
UK: Use is not recommended unless clearly needed.
US: Safety has not been established during pregnancy.

AU TGA pregnancy category: C
US FDA pregnancy category: Not assigned

Risk Summary: Insufficient data exist to determine a drug-associated risk of adverse developmental outcomes.

Comments: Women of childbearing potential should avoid pregnancy during treatment with this drug.

Animal studies have revealed evidence of embryofetal lethality at maternally toxic doses. There are no controlled data in human pregnancy.

AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details.

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

Dabigatran Breastfeeding Warnings

Use is not recommended.

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

The effects in the nursing infant are unknown.

See references

Further information

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

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