Skip to main content

Dronedarone Side Effects

Medically reviewed by Drugs.com. Last updated on May 23, 2023.

Applies to dronedarone: oral tablet.

Warning

Oral route (Tablet)

In patients with symptomatic heart failure and recent decompensation requiring hospitalization or NYHA Class IV heart failure, dronedarone hydrochloride doubles the risk of death. Dronedarone hydrochloride is contraindicated in patients with symptomatic heart failure with recent decompensation requiring hospitalization or NYHA Class IV heart failure. In patients with permanent atrial fibrillation, dronedarone hydrochloride doubles the risk of death, stroke, and hospitalization for heart failure. Dronedarone hydrochloride is contraindicated in patients in atrial fibrillation (AF) who will not or cannot be cardioverted into normal sinus rhythm .

Serious side effects of Dronedarone

Along with its needed effects, dronedarone may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking dronedarone:

Less common

Incidence not known

Other side effects of Dronedarone

Some side effects of dronedarone may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Less common

Rare

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.

2. Product Information. Multaq (dronedarone). sanofi-aventis. 2009.

3. Cerner Multum, Inc. Australian Product Information.

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.