Dronedarone Pregnancy and Breastfeeding Warnings

Brand names: Multaq

Medically reviewed by Drugs.com. Last updated on Apr 16, 2026.

Dronedarone Pregnancy Warnings

According to some authorities: Use is not recommended.

US FDA pregnancy category: Not assigned

Risk summary: No data are available on the use of this drug in pregnant women to inform a drug-related risk; however, based on animal data, this drug may cause fetal harm when administered to a pregnant woman.

Comments:
-Verify pregnancy status prior to treatment.
-Advise females of reproductive potential of the possible risk to a fetus and to use effective contraception during treatment with this drug and for 5 days after the final dose (some authorities recommend 7 days after the final dose).

Animal studies have revealed evidence of fetotoxicity. 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

Dronedarone Breastfeeding Warnings

AU and US: Use is contraindicated.
UK: 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

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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