Dronedarone Side Effects

In Summary

More frequently reported side effects include: pruritus, diarrhea, skin rash, nausea, eczema, abdominal pain, and allergic dermatitis. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to dronedarone: oral tablet

In addition to its needed effects, some unwanted effects may be caused by dronedarone. In the event that any of these side effects do occur, they may require medical attention.

Major Side Effects

You should check with your doctor immediately if any of these side effects occur when 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

Minor Side Effects

Some of the side effects that can occur with dronedarone may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

• 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]

Not all side effects for dronedarone may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

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