Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The following safety concerns are described elsewhere in the label: • New or worsening heart failure [see Warnings and Precautions (5.4) ] • Liver Injury [see Warnings and Precautions (5.5) ] • Pulmonary toxicity [see Warnings and Precautions (5.6) ] • Hypokalemia and hypomagnesemia with potassium-depleting diuretics [see Warnings and Precautions (5.7) ] • QT prolongation [see Warnings and Precautions (5.8) ] Most common adverse reactions (≥2%) are diarrhea, nausea, abdominal pain, vomiting, dyspepsia, bradycardia, skin issues (rashes, pruritus, eczema, dermatitis, dermatitis allergic), and asthenia ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact sanofi-aventis U.S.
LLC at 1-800-633-1610 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 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% vs 1.8% in the placebo group) and QT prolongation (1.5% vs 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.
5 WARNINGS AND PRECAUTIONS • Determine cardiac rhythm at least once every 3 months.
If AF is detected discontinue MULTAQ or cardiovert.
( 5.2 ) • Ensure appropriate antithrombotic therapy prior to and throughout MULTAQ use.
( 5.3 ) • Liver injury: If hepatic injury is suspected, discontinue MULTAQ.
( 5.5 ) • If pulmonary toxicity is confirmed, discontinue treatment.
Like all medications, Multaq can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: