Multaq Side Effects
Generic Name: dronedarone
Please note - some side effects for Multaq may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
Side Effects of Multaq - for the Consumer
Multaq
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Multaq:
Seek medical attention right away if any of these SEVERE side effects occur when using Multaq:Diarrhea; indigestion; mild stomach pain; nausea; tiredness; vomiting; weakness.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; slow heartbeat; symptoms of heart failure (eg, shortness of breath; swelling of the hands or feet; sudden, unexplained weight gain; wheezing; coughing up frothy mucus at rest, at night, or after minor exercise; trouble sleeping because of breathing problems); symptoms of liver problems (eg, yellowing of the skin or eyes; dark urine; pale stools, nausea, vomiting, or loss of appetite; right-sided stomach pain; fever; fatigue; unexplained itching; general feeling of being unwell); worsening of irregular heartbeat.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
TopMultaq Side Effects - for the Professional
Multaq
The following safety concerns are described elsewhere in the label:
- New or worsening heart failure [see Warnings and Precautions (5.1)]
- Liver Injury [see Warnings and Precautions (5.2)]
- Hypokalemia and hypomagnesemia with potassium-depleting diuretics [see Warnings and Precautions (5.3)]
- QT prolongation [see Warnings and Precautions (5.4)]
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.
| Placebo | Dronedarone 400 mg twice daily | |
|---|---|---|
| (N=2875) | (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.
| Placebo | Multaq 400 mg twice daily |
|
|---|---|---|
| (N=2875) | (N=3282) | |
| Serum creatinine increased ≥10% five days after treatment initiation | 21% | 51% |
| (N=2237) | (N=2701) | |
| QTc Bazett prolonged (>450 ms in males >470 ms in females) | 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 sub-group.
Postmarketing Experience
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.
Cardiac: Heart failure [see Warnings and Precautions (5.1)].
Postmarketing cases of new onset and worsening heart failure have been reported during treatment with Multaq.
Hepatic: Serum hepatic enzymes and serum bilirubin increase: Hepatocellular liver injury, including acute liver failure requiring transplant, has been reported [see Warnings and Precautions (5.2)].
Respiratory: Postmarketing cases of interstitial lung disease including pneumonitis and pulmonary fibrosis have been reported.
TopSide Effects by Body System - for Healthcare Professionals
Cardiovascular
Cardiovascular side effects have included new or worsening heart failure, QT prolongation, and bradycardia.
Renal
Renal side effects have included hypokalemia and hypomagnesemia with potassium-depleting diuretics, and serum creatinine increased 10% or more within five days after treatment initiation.
Gastrointestinal
Gastrointestinal side effects have included diarrhea, nausea, abdominal pain, vomiting, and dyspeptic signs and symptoms.
Dermatologic
Dermatologic side effects have included rashes (generalized, macular, maculopapular, erythematous), pruritus, eczema, dermatitis, and allergic dermatitis.
General
General side effects have included asthenia.
Hepatic
Hepatic side effects have included hepatocellular liver injury, including acute liver failure requiring transplant, serum hepatic enzymes and serum bilirubin increase.
Respiratory
Respiratory side effects have included postmarketing cases of interstitial lung disease including pneumonitis and pulmonary fibrosis.
TopMore Multaq resources
- Multaq Prescribing Information (FDA)
- Multaq Monograph (AHFS DI)
- Multaq Advanced Consumer (Micromedex) - Includes Dosage Information
- Multaq Consumer Overview
- Multaq MedFacts Consumer Leaflet (Wolters Kluwer)
- Dronedarone Professional Patient Advice (Wolters Kluwer)
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