Dronedarone is an antiarrhythmic medication that affects the rhythm of heartbeats.

Dronedarone helps keep the heart beating normally in people with life-threatening heart rhythm disorders of the atrium (the upper chambers of the heart that allow blood to flow into the heart) and risk factors such as diabetes, high blood pressure, a history of stroke, or being over 70 years old.

Dronedarone is used to treat certain heart rhythm disorders called atrial fibrillation or atrial flutter. Dronedarone is given to reduce the need for hospitalization due to these heart conditions.

Dronedarone may also be used for purposes not listed in this medication guide.

Dronedarone is used to treat intermittent or "temporary" heart rhythm disorders. In some people with "permanent" atrial fibrillation, dronedarone increased the risk of stroke, hospitalization due to heart failure, and death. Talk with your doctor about your individual risk. Do not stop taking this medication without first talking to your doctor. Stopping suddenly may make your condition worse.

You should not use dronedarone if you are allergic to dronedarone, if you are pregnant or breast-feeding, or if you have severe liver disease, certain serious heart conditions, especially severe heart failure, "AV block" or sick sinus syndrome (unless you have a pacemaker), a history of slow heart beats that have caused you to faint, or if you were recently hospitalized for heart failure.

There are many other medicines that can cause serious medical problems if you take them together with dronedarone. You may need to stop taking certain drugs while you are taking dronedarone. Tell your doctor about all other medications you use.

Also tell your doctor if you have kidney disease, liver disease, a history of heart failure, an electrolyte imbalance (such as low levels of potassium or magnesium in your blood), or if you have a pacemaker or defibrillator implanted in your chest.

Dronedarone can harm an unborn baby or cause birth defects. Do not use dronedarone if you are pregnant.

You may need regular medical tests to be sure this medication is not causing harmful effects. Visit your doctor regularly.

Dronedarone is used to treat intermittent or "temporary" heart rhythm disorders. In some people with "permanent" atrial fibrillation, dronedarone increased the risk of stroke, hospitalization due to heart failure, and death. Talk with your doctor about your individual risk. Do not stop taking this medication without first talking to your doctor. Stopping suddenly may make your condition worse.

You should not use this medication if you are allergic to dronedarone, or if you have:

• severe liver disease;

• certain serious heart conditions, especially severe heart failure, "AV block" or sick sinus syndrome (unless you have a pacemaker);

• a history of slow heart beats that have caused you to faint;

• if you were hospitalized with severe heart failure within the past 30 days; or

• if you are pregnant or breast-feeding.

There are many other medicines that can cause serious medical problems if you take them together with dronedarone. You may need to stop taking certain drugs while you are taking dronedarone. Tell your doctor about all other medications you use, especially:

• heart rhythm medication;

• an antibiotic or antifungal medication;

• an antidepressant;

• medicine to treat HIV or AIDS;

• medicine to treat or prevent malaria;

• medicine to treat a psychiatric disorder;

• migraine headache medication;

• narcotic pain medicine;

• medicine to prevent or treat nausea and vomiting; or

• medicine used to prevent organ transplant rejection.

To make sure you can safely take dronedarone, tell your doctor if you have any of these other conditions:

• kidney disease;

• liver disease;

• a history of heart failure;

• an electrolyte imbalance (such as low levels of potassium or magnesium in your blood); or

• if you have a pacemaker or defibrillator implanted in your chest.

FDA pregnancy category X. This medication can harm an unborn baby or cause birth defects. Do not use dronedarone if you are pregnant. Tell your doctor right away if you become pregnant during treatment. Use effective birth control while you are using this medication.

It is not known whether dronedarone passes into breast milk or if it could harm a nursing baby. You should not breast-feed while taking dronedarone.