Dronedarone Side Effects
Medically reviewed by Drugs.com. Last updated on May 23, 2022.
More frequently reported side effects include: abdominal pain, allergic dermatitis, diarrhea, eczema, nausea, pruritus, and skin rash. See below for a comprehensive list of adverse effects.
For the Consumer
Applies to dronedarone: oral tablets
- Contraindicated in patients with NYHA class IV heart failure or symptomatic heart failure with recent decompensation requiring hospitalization.1 (See New-Onset or Worsening Heart Failure under Cautions.)
- In the ANDROMEDA study in patients with severe heart failure requiring recent hospitalization or referral to a specialized heart failure clinic for worsening symptoms, dronedarone therapy was associated with a greater than twofold increase in mortality rate relative to placebo;1 4 do not use dronedarone in such patients.1
- Contraindicated in patients with permanent atrial fibrillation; doubles the risk of cardiovascular death and heart failure in such patients.1 9 35 (See Warnings under Cautions.)
FDA approved a REMS for dronedarone to ensure that the benefits outweigh the risks. However, FDA later rescinded REMS requirements. See the FDA REMS page ([Web]).
Side effects include:
Early increases in Scr (increase of ≥10%), prolonged QTc interval, diarrhea, asthenic conditions, nausea, skin reactions (e.g., rash [generalized, macular, maculopapular, erythematous], pruritus, eczema, dermatitis, allergic dermatitis), abdominal pain, bradycardia, vomiting, dyspeptic manifestations. (See Prolongation of QT Interval and Increased Scr under Cautions.)
For Healthcare Professionals
Applies to dronedarone: oral tablet
Very common (10% or more): QT prolongation (28%)
Common (1% to 10%): Bradycardia
Common (1% to 10%): Diarrhea, nausea, abdominal pain, vomiting, dyspeptic symptoms
Frequency not reported: Dysgeusia, ageusia[Ref]
Common (1% to 10%): Rashes (generalized, macular, maculopapular, erythematous), pruritus, eczema, dermatitis, allergic dermatitis
Uncommon (0.1% to 1%): Photosensitivity[Ref]
Common (1% to 10%): Asthenia, fatigue[Ref]
Frequency not reported: Liver injury, including acute liver failure requiring transplant, serum hepatic enzymes, serum bilirubin increase
Frequency not reported: Dyspnea, nonproductive cough
Postmarketing reports: Interstitial lung disease including pneumonitis and pulmonary fibrosis
Common (1% to 10%): Urinary tract infection
Postmarketing reports: Vasculitis, including leukocytoclastic vasculitis
Postmarketing reports: Anaphylactic reactions including angioedema
Frequency not reported: Increased serum creatinine[Ref]
More about dronedarone
- Drug interactions
- Dosage information
- During pregnancy
- Reviews (50)
- En español
- Drug class: group III antiarrhythmics
Related treatment guides
1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
2. "Product Information. Multaq (dronedarone)." sanofi-aventis (2009):
3. Cerner Multum, Inc. "Australian Product Information." O 0
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Some side effects may not be reported. You may report them to the FDA.