Skip to Content

Amiodarone Pregnancy and Breastfeeding Warnings

Amiodarone is also known as: Cordarone, Cordarone IV, Nexterone, Pacerone

Amiodarone Pregnancy Warnings

Use is considered contraindicated and should be used during pregnancy only if the benefit outweighs the risk.

AU TGA pregnancy category: C
US FDA pregnancy category: D

Comments:
-If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus.
-Patients planning pregnancy should be advised of the long half-life associated with this drug and its metabolite.

Animal studies have revealed evidence of fetotoxicity. In humans, congenital goiter/hypothyroidism, hyperthyroidism, and neonatal bradycardia have been reported. 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 D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

See references

Amiodarone Breastfeeding Warnings

Some authorities believe this drug can be used during breastfeeding with periodic monitoring of infant cardiac and thyroid function, especially if only one dose is administered.

Use is considered contraindicated and should not be used during breastfeeding.

Excreted into human milk: Yes

See references

References for pregnancy information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. "Product Information. Cordarone Intravenous (amiodarone)." Wyeth-Ayerst Laboratories, Philadelphia, PA.
  4. "Product Information. Cordarone (amiodarone)." Wyeth-Ayerst Laboratories, Philadelphia, PA.

References for breastfeeding information

  1. "Product Information. Cordarone Intravenous (amiodarone)." Wyeth-Ayerst Laboratories, Philadelphia, PA.
  2. 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 -]):
  3. "Product Information. Cordarone (amiodarone)." Wyeth-Ayerst Laboratories, Philadelphia, PA.
  4. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  5. Cerner Multum, Inc. "Australian Product Information." O 0

Further information

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

Hide