Dronedarone Side Effects

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.

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

Renal

Frequency not reported: Hypokalemia and hypomagnesemia with potassium-depleting diuretics, serum creatinine increased 10% or more within 5 days after treatment initiation

Gastrointestinal

Common (1% to 10%): Diarrhea, nausea, abdominal pain, vomiting, dyspeptic symptoms
Frequency not reported: Dysgeusia, ageusia

Dermatologic

Common (1% to 10%): Rashes (generalized, macular, maculopapular, erythematous), pruritus, eczema, dermatitis, allergic dermatitis
Uncommon (0.1% to 1%): Photosensitivity

General

Common (1% to 10%): Asthenia, fatigue

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

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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