MULTAQ- dronedarone tablet, film coated 
sanofi-aventis U.S. LLC


Medication Guide
(dronedarone) Tablets

Read this Medication Guide before you start taking MULTAQ and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment.

What is the most important information I should know about MULTAQ?

MULTAQ can cause serious side effects.

Do not take MULTAQ if you:

have symptoms of heart failure that recently worsened and you were hospitalized, or if you have severe heart failure.

MULTAQ doubles your risk of dying if you have these conditions. Heart failure means your heart does not pump blood through your body as well as it should.

Call your doctor right away if you have any signs or symptoms of heart failure during treatment with MULTAQ:

have a type of atrial fibrillation (irregular heart rhythm) called permanent atrial fibrillation (AF).

You and your doctor may decide not to try to change your heart rhythm back to a normal heart rhythm or your heart rhythm cannot be changed back to a normal rhythm. If you have permanent AF and take MULTAQ, you have a higher risk of death, stroke, and needing to be treated in a hospital for your heart failure.

Your doctor will monitor your heart rhythm regularly to make sure your heartbeat keeps a normal rhythm.

Call your doctor right away if you notice that your pulse is irregular during treatment with MULTAQ. This is a sign that you are in atrial fibrillation.

MULTAQ may cause liver problems, including life-threatening liver failure. Your doctor may order blood tests to check your liver before you start taking MULTAQ and during treatment. In some cases, MULTAQ treatment may need to be stopped.

Call your doctor right away if you develop any of these signs and symptoms of liver problems during treatment with MULTAQ:

What is MULTAQ?

MULTAQ is a prescription medicine used to lower the chance that you will need to go into the hospital for atrial fibrillation. It is meant for people who have had certain types of atrial fibrillation (paroxysmal or persistent AF) in the past, but are now in normal rhythm.

It is not known if MULTAQ is safe and effective in children younger than age 18 years old.

Who should not take MULTAQ?

See "What is the most important information I should know about taking MULTAQ?"

Do not take MULTAQ if:

What should I tell my doctor before taking MULTAQ?

Before taking MULTAQ, tell your doctor if you:

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements. MULTAQ and certain other medicines can react with each other, causing serious side effects.

Especially tell your doctor and pharmacist if you take:

Know the medicines you take. Keep a list of them and show it to your doctor and pharmacist when you get a new medicine.

How should I take MULTAQ?

What should I avoid while taking MULTAQ?

Do not drink grapefruit juice while you are being treated with MULTAQ. Grapefruit juice can increase the amount of MULTAQ in your blood and increase the likelihood that you will have a side effect of MULTAQ.

What are the possible side effects of MULTAQ?

MULTAQ may cause serious side effects, including:

The most common side effects of MULTAQ include:

Tell your doctor about any side effect that bothers you or that does not go away. These are not all the possible side effects of MULTAQ. For more information ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store MULTAQ?

Store MULTAQ at room temperature (59°F–86°F or 15°C–30°C).

Keep MULTAQ and all medicines out of the reach of children.

General information about MULTAQ

Medicines are sometimes used for purposes other than those listed in a Medication Guide. Do not use MULTAQ for a condition for which it was not prescribed. Do not give MULTAQ to other people, even if they have the same symptoms or condition. It may harm them.

This Medication Guide summarizes the most important information about MULTAQ. If you would like more information:

What are the ingredients in MULTAQ?

Active ingredient: dronedarone

Inactive ingredients: hypromellose, starch, crospovidone, poloxamer 407, lactose monohydrate, colloidal silicon dioxide, magnesium stearate, polyethylene glycol 6000, titanium dioxide, carnauba wax

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Revised: November 2020

Manufactured by:

sanofi-aventis U.S. LLC
Bridgewater, NJ 08807

©sanofi-aventis 2020
All rights reserved.

MULTAQ is a trademark of sanofi-aventis.
The brands listed are the registered trademarks of their respective owners and are not trademarks of sanofi-aventis U.S. LLC.

Revised: 11/2020
sanofi-aventis U.S. LLC