Summary
More frequently reported side effects include: abdominal pain, allergic dermatitis, diarrhea, eczema, nausea, pruritus, and skin rash. Continue reading for a comprehensive list of adverse effects.
Applies to dronedarone: oral tablets.
Warning
- 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.)
REMS:
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 However, FDA later rescinded REMS requirements.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.
Cardiovascular
Very common (10% or more): QT prolongation (28%)
Common (1% to 10%): Bradycardia
Very rare (less than 0.01%): New or worsening heart failure, atrial flutter with 1:1 atrioventricular conduction[Ref]
Renal
Frequency not reported: Hypokalemia and hypomagnesemia with potassium-depleting diuretics, serum creatinine increased 10% or more within 5 days after treatment initiation[Ref]
Gastrointestinal
Common (1% to 10%): Diarrhea, nausea, abdominal pain, vomiting, dyspeptic symptoms
Frequency not reported: Dysgeusia, ageusia[Ref]
Dermatologic
Common (1% to 10%): Rashes (generalized, macular, maculopapular, erythematous), pruritus, eczema, dermatitis, allergic dermatitis
Uncommon (0.1% to 1%): Photosensitivity[Ref]
General
Common (1% to 10%): Asthenia, fatigue[Ref]
Hepatic
Frequency not reported: Liver injury, including acute liver failure requiring transplant, serum hepatic enzymes, serum bilirubin increase
Respiratory
Frequency not reported: Dyspnea, nonproductive cough
Postmarketing reports: Interstitial lung disease including pneumonitis and pulmonary fibrosis
Genitourinary
Common (1% to 10%): Urinary tract infection
Hematologic
Postmarketing reports: Vasculitis, including leukocytoclastic vasculitis
Immunologic
Postmarketing reports: Anaphylactic reactions including angioedema
Metabolic
Frequency not reported: Increased serum creatinine[Ref]
