Multaq (dronedarone) is a brand-name oral tablet prescribed to lower the risk of hospitalization for atrial fibrillation in certain adults. As with other drugs, Multaq can cause side effects that range from mild to serious.

Multaq can cause certain side effects, some of which are more common than others. These side effects may be temporary, lasting a few days to weeks. However, if the side effects last longer than that, bother you, or become severe, be sure to talk with your doctor or pharmacist.

These are just a few of the more common side effects reported by people who took Multaq in clinical trials:

* For more information about this side effect, see “Side effect specifics” below.

Mild side effects can occur with Multaq use. This list doesn’t include all possible mild side effects of the drug. For more information, you can refer to Multaq’s prescribing information.

Mild side effects that have been reported with Multaq include:

These side effects may be temporary, lasting a few days to weeks. However, if the side effects last longer than that, bother you, or become severe, be sure to talk with your doctor or pharmacist.

Note: After the Food and Drug Administration (FDA) approves a drug, it tracks and reviews side effects of the medication. If you develop a side effect while taking Multaq and want to tell the FDA about it, visit MedWatch.

* For more information about this side effect, see “Side effect specifics” below.
† An allergic reaction is possible after taking Multaq. To learn more, see the “Side effect specifics” section below.

Multaq may cause serious side effects. The list below may not include all possible serious side effects of the drug. For more information, you can refer to Multaq’s prescribing information.

If you develop serious side effects while taking Multaq, call your doctor right away. If the side effects seem life threatening or you think you’re having a medical emergency, immediately call 911 or your local emergency number.

Serious side effects that have been reported and their symptoms include:

* This side effect of Multaq has been reported since the drug was approved. For more information, talk with your doctor.
† Multaq has a boxed warning for this side effect. This is the most serious warning from the Food and Drug Administration (FDA). To learn more, see the “Side effect specifics” section below.
‡ An allergic reaction is possible after taking Multaq. To learn more, see the “Side effect specifics” section below.

Multaq may cause several side effects. Here are some frequently asked questions about the drug’s side effects and their answers.

Is Multaq safe for older adults?

In general, yes. In clinical trials, the safety of Multaq was similar for older adults (those ages 65 years and older) as for other adults taking the drug. However, Multaq use may not be the right treatment option for some people. This includes people with certain medical conditions, such as sick sinus syndrome. This is a type of irregular heart rhythm that’s more common in older adults. (To learn more about this and other conditions, see the “Multaq precautions” section below.)

If you have questions about the safety of Multaq for you, talk with your doctor. They’ll evaluate your overall health and determine whether Multaq is safe for you.

Does Multaq cause long-term side effects?

It’s possible for Multaq to cause long-term side effects. In clinical trials, the drug was found to increase the risk of stroke or heart failure in certain people.* Also, cases of new or worsening heart failure have been reported in some people since the drug was approved. Both stroke and heart failure can cause long lasting health problems.

To help prevent long-term side effects, be sure to talk with your doctor about your health history before you take Multaq. This drug may not be the right treatment option for you if you have certain medical conditions or other factors that affect your health. Also, while you’re taking Multaq, your doctor will monitor you regularly to determine whether the drug continues to be a safe treatment for you.

For more information about possible long-term side effects, talk with your doctor. They can help determine whether Multaq is the right treatment option for your condition.

* Multaq has a boxed warning for this side effect. This is the most serious warning from the Food and Drug Administration (FDA). To learn more, see the “Side effect specifics” section below.

Can Multaq cause hair loss or eye-related side effects?

No, Multaq isn’t likely to cause hair loss or eye problems. There were no reports of hair- or eye-related side effects in the drug’s clinical trials.

If you have questions about hair loss or eye problems during Multaq treatment, talk with your doctor for more information.

Learn more about some of the side effects that Multaq may cause. To find out how often side effects occurred in clinical trials, see the prescribing information for Multaq.

Increased risk of death, stroke, and heart failure in certain people

Multaq has a boxed warning about the increased risk of death, stroke, and heart failure in certain people. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). It lets doctors and patients know about drug effects that may be dangerous. This side effect was rare in Multaq’s clinical trials.

In these trials, Multaq use doubled the risk of death, stroke, or hospitalization for heart failure in people with permanent atrial fibrillation (AFib). (With AFib, the heart beats erratically due to a problem with its electrical activity.) This is compared with Multaq treatment in people with a normal heart rhythm who have had short AFib episodes (paroxysmal AFib). Note that Multaq is FDA-approved to reduce the risk of hospitalization for AFib in adults who have a normal heart rhythm and a history of paroxysmal AFib.

In addition, Multaq use doubled the risk of death in people with decompensated heart failure (a sudden worsening of heart failure). This is compared with people with that condition who didn’t take the drug.

Stroke was more common in certain people during the first 2 weeks of starting Multaq. Stroke symptoms may include dizziness, confusion, and paralysis on one side of the body or face.

Symptoms of heart failure may include shortness of breath, a sudden increase in weight, and fluid accumulation causing swelling of the legs and feet.

What you can do

If you develop any symptoms of heart failure or stroke, call 911 or your local emergency number.

To help reduce Multaq’s risks, your doctor will evaluate your cardiovascular health before prescribing the drug. They’ll determine whether Multaq is a safe treatment option for your condition. They’ll likely not prescribe the drug if you have any of these conditions:

  • permanent AFib
  • severe (class IV) heart failure
  • decompensated heart failure that required recent hospitalization

During Multaq treatment, your doctor will check your heart rhythm regularly. They may have you stop taking the drug if they detect AFib. They may also use cardioversion to treat your AFib. (Cardioversion is a procedure used to help correct an irregular heartbeat.)

If you have questions about the safety of Multaq, talk with your pharmacist or doctor.

Diarrhea

In Multaq’s clinical trials, the most common side effect was diarrhea (loose, watery stools). Other digestive side effects that were commonly seen in trials were:

These side effects are usually mild and temporary. Less commonly, diarrhea and other digestive side effects of Multaq may become severe.

What you can do

Be sure to take each dose of Multaq with a meal. Doing so can help prevent or lessen digestive side effects with Multaq.

If you experience diarrhea during Multaq treatment, the following tips may ease diarrhea and help prevent dehydration:

  • following the BRAT diet (bananas, rice, applesauce, and dry toast)
  • sipping clear liquids,* including water and sugar-free juice or electrolyte drinks
  • limiting foods that worsen diarrhea, such as dairy products and foods and drinks high in sugar, fat, and caffeine

If your diarrhea persists or your symptoms feel severe, talk with your doctor. They’ll determine whether you should keep taking Multaq. They may prescribe a different medication for your condition.

* Try to drink at least 1 cup of liquid after each loose stool to replace lost fluids.

Allergic reaction

As with most drugs, Multaq can cause an allergic reaction in some people. However, it’s not clear how often allergic reactions occurred in clinical trials of Multaq. Also, severe allergic reactions have been reported since the drug was approved.

Symptoms can be mild or serious and can include:

  • skin rash
  • itching
  • flushing
  • swelling under your skin, typically in your eyelids, lips, hands, or feet
  • swelling of your mouth, tongue, or throat, which can make it hard to breathe

What you can do

For mild symptoms of an allergic reaction, call your doctor right away. They may recommend ways to ease your symptoms and determine whether you should keep taking Multaq. However, if your symptoms are serious and you think you’re having a medical emergency, immediately call 911 or your local emergency number.

Below is important information you should consider before taking Multaq.

Boxed warning: Increased risk of death, stroke, and heart failure in certain people

This drug has a boxed warning about the increased risk of death, stroke, and heart failure in certain people. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). For details, see the “Side effect specifics” section above.

Other precautions

Be sure to talk with your doctor about your health history before you take Multaq. This drug may not be the right treatment for you if you have certain medical conditions or other factors that affect your health. These are considered drug-condition or drug-factor interactions. The conditions and factors to consider include:

Allergic reaction: If you’ve had an allergic reaction to Multaq or any of its ingredients, your doctor will likely not prescribe Multaq. Ask your doctor what other medications may be better options for you.

Slow heart rate (bradycardia): Taking Multaq can cause a slow heart rate as a side effect. If you already have a slow heart rate, taking Multaq could make your heart rate even slower. Your doctor will probably not prescribe Multaq if you have a slow heart rate. They can advise you about medications that may be more appropriate for your condition.

Certain heart rhythm problems: If you have heart block (also called AV block) or sinus sick syndrome without a working pacemaker, your doctor may not prescribe Multaq. This is because taking Multaq increases the risk of serious heart rhythm problems. Your doctor can recommend a different treatment option.

Certain problems with amiodarone: Amiodarone (Pacerone) is a prescription drug that’s similar to Multaq. Your doctor will likely not prescribe Multaq if you’ve taken amiodarone in the past and developed certain problems during treatment. These problems include liver damage or lung problems. You may have a higher risk of these same problems with Multaq. Ask your doctor what other medications may be right for you.

Severe liver damage: Tell your doctor if you have a serious liver condition such as hepatitis. Taking Multaq may damage the liver. If you already have a liver condition and take Multaq, you have an increased risk of liver injury. Due to this risk, your doctor will monitor your liver function during Multaq treatment. If there are signs of liver damage, your doctor will likely stop Multaq. They’ll advise you on treatment options that may be a better fit for you.

Interaction risks: Several types of medications can interact with Multaq and may lead to harmful effects. This may include serious heart rhythm problems. Due to this risk, doctors typically will not prescribe Multaq with certain medications. For more details about this, talk with your doctor or pharmacist. Be sure to tell them about all prescription, over-the-counter, and other medications you take. (You can also view the interactions listed in Multaq’s prescribing information.)

Pregnancy or breastfeeding: If you’re pregnant or breastfeeding your child, Multaq is not considered safe for your pregnancy or your child. Be sure to tell your doctor if you’re pregnant or breastfeeding. They can let you know about other treatment options for your condition.

Alcohol consumption: Multaq isn’t known to interact with alcohol. However, heavy alcohol consumption can damage the liver. And there have been reports of liver damage with Multaq treatment since the drug was approved. So heavy drinking during Multaq treatment may further increase the risk of liver problems.

If you drink alcohol, talk with your pharmacist or doctor about how much alcohol is safe to consume while taking Multaq.

If you’d like to learn more about Multaq, talk with your doctor or pharmacist. They can help answer any questions you have about side effects from taking the drug.

Besides talking with your doctor, you can do some research on your own. These articles might help:

  • More information about Multaq: For details about other aspects of Multaq, refer to this article.
  • Cost: If you’d like to learn about Multaq and cost, see this article.
  • Dosage: For information about the dosage of Multaq, view this article.
  • A look at atrial fibrillation: For details about atrial fibrillation (AFib), see our list of AFib articles.

Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.