Dronedarone Side Effects

In 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 tablet

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

• Chest pain or discomfort
• lightheadedness, dizziness, or fainting
• shortness of breath
• slow or irregular heartbeat
• unusual tiredness

Incidence Not Known

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

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

• Diarrhea
• lack or loss of strength

Less Common

• 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

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

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]

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