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Multaq Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Multaq (dronedarone) is an antiarrythmic drug used to treat atrial fibrillation or atrial flutter, types of abnormal heart rhythms. The only recommended dosage of MULTAQ (dronedarone tablets) is 400 mg twice daily in adults. The most common side effects of Multaq are diarrhea, nausea, abdominal pain, vomiting, and weakness. A clinical trial of Multaq was halted when the drug doubled the risk of death, stroke, and hospitalization for heart failure in heart patients with permanent atrial fibrillation, so it is important to discuss the risks and benefits of this drug with your doctor for your specific situation.
Multaq can harm an unborn baby or cause birth defects. Do not use dronedarone if you are pregnant. To be sure this medication is not causing harmful effects, your blood and heart rhythm may need to be tested on a regular basis.
Our Multaq Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
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 Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Multaq in Detail - Patient Information: Side Effects
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 a serious side effect such as:
- severe dizziness, fainting, fast or pounding heartbeats;
- slow heart rate, 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;
- nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
- 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:
- mild stomach pain, diarrhea, upset stomach;
- feeling weak or tired; or
- mild skin rash or redness.
Read the entire detailed patient monograph for Multaq (Dronedarone Tablets)
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Multaq Overview - Patient Information: Side Effects
Nausea or diarrhea may occur. If either of these effects persists or worsens, tell your doctor promptly.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if you have any serious side effects, including: symptoms of liver disease (such as persistent nausea/vomiting, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine), symptoms of lung problems (such as persistent dry cough, shortness of breath), change in the amount of urine.
Get medical help right away if you have any very serious side effects, including: slow/fast/irregular heartbeat, severe dizziness, fainting.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Multaq (Dronedarone Tablets)
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Multaq FDA Prescribing Information: Side Effects
The following safety concerns are described elsewhere in the label:
- New or worsening heart failure [see WARNINGS AND PRECAUTIONS]
- Liver Injury [see WARNINGS AND PRECAUTIONS]
- Pulmonary toxicity [see WARNINGS AND PRECAUTIONS]
- Hypokalemia and hypomagnesemia with potassium-depleting diuretics [see WARNINGS AND PRECAUTIONS]
- QT prolongation [see WARNINGS AND PRECAUTIONS]
Clinical Trials Experience
The safety evaluation of dronedarone 400 mg twice daily in patients with AF or AFL is based on 5 placebo controlled studies, ATHENA, EURIDIS, ADONIS, ERATO and DAFNE. In these studies, a total of 6285 patients were randomized and treated, 3282 patients with MULTAQ 400 mg twice daily, and 2875 with placebo. The mean exposure across studies was 12 months. In ATHENA, the maximum follow-up was 30 months.
In clinical trials, premature discontinuation because of adverse reactions occurred in 11.8% of the dronedarone-treated patients and in 7.7% of the placebo-treated group. The most common reasons for discontinuation of therapy with MULTAQ were gastrointestinal disorders (3.2 % versus 1.8% in the placebo group) and QT prolongation (1.5% versus 0.5% in the placebo group).
The most frequent adverse reactions observed with MULTAQ 400 mg twice daily in the 5 studies were diarrhea, nausea, abdominal pain, vomiting, and asthenia.
Table 1 displays adverse reactions more common with dronedarone 400 mg twice daily than with placebo in AF or AFL patients, presented by system organ class and by decreasing order of frequency. Adverse laboratory and ECG effects are presented separately in Table 2.
Table 1: Adverse Drug Reactions that Occurred in at Least
1% of Patients and Were More Frequent than Placebo
|Dronedarone 400 mg twice daily
|Dyspeptic signs and symptoms||1%||2%|
|Skin and subcutaneous tissue|
|Including rashes (generalized, macular, maculo-papular, erythematous), pruritus, eczema, dermatitis, dermatitis allergic||3%||5%|
Photosensitivity reaction and dysgeusia have also been reported at an incidence less than 1% in patients treated with MULTAQ.
The following laboratory data/ECG parameters were reported with MULTAQ 400 mg twice daily.
Table 2: Laboratory data/ECG
parameters not necessarily reported as adverse events
|Placebo||MULTAQ 400 mg twice daily|
|Early increases in creatinine ≥ 10%||21%||51%|
Assessment of demographic factors such as gender or age on the incidence of treatment-emergent adverse events did not suggest an excess of adverse events in any particular sub-group.
The following adverse reactions have been identified during post-approval use of MULTAQ. Because these reactions are reported voluntarily from a population of an unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Hepatic: Liver Injury [see WARNINGS AND PRECAUTIONS]
Immune: Anaphylactic reactions including angioedema
Vascular: Vasculitis, including leukocytoclastic vasculitis
Read the entire FDA prescribing information for Multaq (Dronedarone Tablets)
Additional Multaq Information
Multaq - User Reviews
Multaq User Reviews
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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