Multaq

• Overview
• Consumer Information
• Professional Information

 

Multaq Side Effects Center

What Is Multaq?

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.

What Are Side Effects of Multaq?

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 Multaq with your doctor for your specific situation.

Dosage for Multaq

The recommended dosage of Multaq is 400 mg twice daily in adults. Multaq should be taken as one tablet with the morning meal and one tablet with the evening meal.

What Drugs, Substances, or Supplements Interact with Multaq?

Multaq may interact with cyclosporine, dexamethasone, medications for treating tuberculosis, cyclosporine, sirolimus, tacrolimus, St. John's wort, theophylline, antibiotics, antifungals, antidepressants, anti-malaria medications, barbiturates, beta-blockers, cholesterol-lowering medicines, heart or blood pressure medications, heart rhythm medicines, medicines to prevent blood clots, medicines to prevent or treat nausea and vomiting, medicines to treat HIV/AIDS or hepatitis C, medicines to treat psychiatric disorders, migraine headache medicines, narcotics, seizure medications, and other drugs. Tell your doctor all medications and supplements you use.

Multaq During Pregnancy and Breastfeeding

Do not use Multaq if you are pregnant. Tell your doctor right away if you become pregnant during treatment with Multaq. Multaq can harm a fetus or cause birth defects. Use effective birth control while you are using Multaq. It is unknown if Multaq passes into breast milk or if it could harm a nursing baby. Breastfeeding while taking Multaq is not recommended.

Additional Information

Our Multaq Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

 

Multaq Consumer Information

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

Call your doctor at once if you have:

• dry cough, shortness of breath;
• little or no urination;
• fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness (like you might pass out);
• heart problems--swelling, rapid weight gain, feeling short of breath;
• liver problems--loss of appetite, stomach pain (upper right side), tiredness, itching, dark urine, jaundice (yellowing of the skin or eyes); or
• low magnesium or potassium levels--dizziness, numbness or tingling, irregular heartbeats, fluttering in your chest, increased thirst or urination, muscle cramps or limp feeling.

Common side effects may include:

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

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.

Read the entire detailed patient monograph for Multaq (Dronedarone Tablets)

 

Multaq Professional 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

	Placebo (N=2875)	Dronedarone 400 mg twice daily (N=3282)
Gastrointestinal
Diarrhea	6%	9%
Nausea	3%	5%
Abdominal pain	3%	4%
Vomiting	1%	2%
Dyspeptic signs and symptoms	1%	2%
General
Asthenic conditions	5%	7%
Cardiac
Bradycardia	1%	3%
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
	(N=2875)	(N=3282)
Early increases in creatinine ≥10%	21%	51%
	(N=2237)	(N=2701)
QTc prolonged	19%	28%

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 subgroup.

Postmarketing Experience

The following adverse reactions have been identified during postapproval 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.

Cardiac: New or worsening heart failure [see WARNINGS AND PRECAUTIONS]

Atrial flutter with 1:1 atrioventricular conduction has been reported very rarely.

Hepatic: Liver injury [see WARNINGS AND PRECAUTIONS]

Respiratory: Interstitial lung disease including pneumonitis and pulmonary fibrosis [see WARNINGS AND PRECAUTIONS]

Immune: Anaphylactic reactions including angioedema

Vascular: Vasculitis, including leukocytoclastic vasculitis

Read the entire FDA prescribing information for Multaq (Dronedarone Tablets)