Dronedarone Side Effects

Medically reviewed by Drugs.com. Last updated on May 23, 2025.

Applies to dronedarone: oral tablet.

Precautions

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting this medicine. Use an effective form of birth control during treatment and for 5 days after the last dose. If you think you have become pregnant while using the medicine, tell your doctor right away.

Do not use this medicine if you are also using cyclosporine (Gengraf®, Neoral®, Sandimmune®), ritonavir (Norvir®), medicine for depression (eg, nefazodone, Serzone®), medicine for heart rhythm problems (eg, amiodarone, disopyramide, dofetilide, flecainide, propafenone, quinidine, sotalol, Cardioquin®, Cordarone®, Norpace®, Tikosyn®), medicine for infections (eg, clarithromycin, erythromycin, itraconazole, ketoconazole, telithromycin, voriconazole, Ery-tab®, Ketek®, Klaricid®, Nizoral®, Sporanox®, Vfend®), or a phenothiazine medicine (eg, chlorpromazine, prochlorperazine, promethazine, thioridazine, Compazine®, Mellaril®, Phenergan®, Thorazine®, Trilafon®). Using these medicines together may cause serious side effects.

Check with your doctor right away if you have chest pain, swelling of your hands, ankles, or feet, trouble breathing, or weight gain. These may be symptoms of heart failure.

This medicine can cause changes in your heart rhythm, including QT prolongation. It may cause fainting or serious side effects in some patients. Contact your doctor right away if you have fast, pounding, or irregular heartbeats.

Check with your doctor right away if you have upper stomach pain, pale stools, dark urine, loss of appetite, nausea, unusual tiredness, or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine may cause lung problems (eg, interstitial lung disease, pneumonitis, and pulmonary fibrosis). Check with your doctor right away if you have chest pain, chills, cough, fever, general feeling of discomfort or illness, thickening of bronchial secretions, or trouble breathing.

Hypokalemia (low potassium in the blood) or hypomagnesemia (low magnesium in the blood) can occur with this medicine. Check with your doctor right away if you have decreased urine, drowsiness, dry mouth, irregular heartbeat, increased thirst, loss of appetite, mood changes, muscle pain, cramps, spasms or twitching, nausea or vomiting, numbness or tingling in the hands, feet, or lips, seizures, trembling, trouble breathing, or unusual tiredness or weakness.

This medicine may increase the risk for heart attack, stroke, or other serious side effects. Talk to your doctor about whether you should continue to take this medicine.

Do not Stop taking dronedarone without first checking with your doctor.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.

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:

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:

See also:

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.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer