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Dronedarone Side Effects

Medically reviewed by Drugs.com. Last updated on May 23, 2022.

Summary

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

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 However, FDA later rescinded REMS requirements.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]

References

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

Further information

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.

Medical Disclaimer