Dronedarone Side Effects

Medically reviewed by Drugs.com. Last updated on May 23, 2024.

Applies to dronedarone: oral tablet.

Important warnings This medicine can cause some serious health issues

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 .

Common 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 side effects

• diarrhea
• lack or loss of strength

Less common side effects

• acid or sour stomach
• belching
• blistering, crusting, irritation, itching, or reddening of the skin
• cracked, dry, or scaly skin
• heartburn
• indigestion
• itching skin
• rash
• redness or discoloration of the skin
• skin rash, encrusted, scaly, and oozing
• skin rash, hives, itching, or redness
• stomach discomfort, upset, or pain
• swelling

Rare side effects

• change in taste
• increased sensitivity of the skin to sunlight
• loss of taste
• severe sunburn

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 side effects

• chest pain or discomfort
• lightheadedness, dizziness, or fainting
• slow or irregular heartbeat
• trouble breathing
• unusual tiredness

Incidence not known

• chills
• cough
• dark urine
• fever
• general feeling of discomfort or illness
• loss of appetite
• nausea or vomiting
• stomach pain
• thickening of bronchial secretions
• unusual tiredness or weakness
• yellow eyes or skin

For healthcare professionals

Applies to dronedarone: oral tablet.

General adverse events

• Common (1% to 10%): Asthenia, fatigue^[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]

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]

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]

Further information

Dronedarone side effects can vary depending on the individual. 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