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Brand Names: Multaq

Generic Name: dronedarone (Pronunciation: droe NE da rone)

• What is dronedarone (Multaq)?
• What are the possible side effects of dronedarone (Multaq)?
• What is the most important information I should know about dronedarone (Multaq)?
• What should I discuss with my healthcare provider before taking dronedarone (Multaq)?
• How should I take dronedarone (Multaq)?
• What happens if I miss a dose (Multaq)?
• What happens if I overdose (Multaq)?
• What should I avoid while taking dronedarone (Multaq)?
• What other drugs will affect dronedarone (Multaq)?
• Where can I get more information?

What is dronedarone (Multaq)?

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 other purposes not listed in this medication guide.

What are the possible side effects of dronedarone (Multaq)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

• slow heart rate, fast or pounding heartbeats, feeling like you might pass out;
• a new or a worsening irregular heartbeat pattern;
• feeling short of breath, even with mild exertion, swelling in your ankles or feet, rapid weight gain;
• wheezing, cough, chest pain, trouble breathing, coughing up mucus;
• breathing problems while lying down trying to sleep; or
• low electrolytes (confusion, jerky muscle movements, uneven heartbeats, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling).

Less serious side effects may include:

• nausea, vomiting, stomach pain, diarrhea, upset stomach;
• feeling weak or tired; or
• mild skin rash, redness, or itching

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about dronedarone (Multaq)?

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 recently hospitalized for heart failure, 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.

Also tell your doctor if you have 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.

This medication can harm an unborn baby or cause birth defects. Do not use dronedarone if you are pregnant. Use effective birth control, and tell your doctor right away if you become pregnant during treatment.

To be sure this medication is not causing harmful effects, your blood and heart rhythm may need to be tested on a regular basis. Do not miss any scheduled appointments.