Heart Home > Amiodarone and Pregnancy

As a pregnancy Category D medicine, amiodarone is usually only given to a pregnant woman if the benefits to the mother outweigh the potential risks to the fetus. During animal studies, amiodarone appeared to increase the risk of miscarriage and certain birth defects. Due to these potential risks, women who are pregnant or wish to become pregnant should talk to their healthcare provider before starting this medicine.

Can Pregnant Women Use Amiodarone?

Amiodarone (Cordarone®, Pacerone®, Nexterone®) is a prescription medication used to treat people with ventricular arrhythmias (a type of irregular heartbeat) when the arrhythmia is considered life-threatening. This drug may cause harm to an unborn child if taken during pregnancy.

What Is Pregnancy Category D?

The U.S. Food and Drug Administration (FDA) uses a category system to classify the possible risks to a fetus when a specific medicine is taken during pregnancy. Amiodarone is classified as a pregnancy Category D medication.
Pregnancy Category D is a classification given to medicines that have been shown to present a risk to the fetus in studies of pregnant women but may still offer benefits that outweigh the risks the drug presents. A pregnancy Category D medicine may still be given to a pregnant woman if her healthcare provider believes that the benefits to the woman outweigh the possible risks to her unborn child.
In animal studies, amiodarone increased the risk for miscarriage when given to pregnant rats and rabbits. It also caused defects of the fetal skull, sternum, and toe bones in the rats.
When used by pregnant women, amiodarone may reduce fetal heart rate and cause heart rhythm changes in newborn infants. However, these effects are usually short-term, and normally do not lead to significant problems.
Perhaps more importantly, amiodarone has been reported to cause thyroid problems in the developing infant when used by the mother during pregnancy. Problems have included:
Amiodarone may still be used during pregnancy if a healthcare provider believes the potential benefits outweigh the potential risks. This may be the case in instances where a life-threatening arrhythmia is not adequately controlled with other medications in a pregnant woman.
It is important to note that amiodarone remains in the body for months after you stop taking it. Therefore, if you plan to get pregnant, let your healthcare provider know if you have recently taken amiodarone, even if you no longer take the medication. You will need to stop taking it several months before becoming pregnant to avoid any potential risks to your unborn child.
Written by/reviewed by:
Last reviewed by: Kristi Monson, PharmD;
Last updated/reviewed:
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