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:

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

• 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:

• Diarrhea
• lack or loss of strength

• 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

• 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]

Some side effects of dronedarone may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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