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Dronedarone Side Effects

Brand Names: Multaq

Please note - some side effects for Dronedarone may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Dronedarone - for the Consumer

Dronedarone

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Dronedarone:

Diarrhea; indigestion; mild stomach pain; nausea; tiredness; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur when using Dronedarone:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; slow heartbeat; symptoms of heart failure (eg, shortness of breath; swelling of the hands or feet; sudden, unexplained weight gain; wheezing; coughing up frothy mucus at rest, at night, or after minor exercise; trouble sleeping because of breathing problems); symptoms of liver problems (eg, yellowing of the skin or eyes; dark urine; pale stools, nausea, vomiting, or loss of appetite; right-sided stomach pain; fever; fatigue; unexplained itching; general feeling of being unwell); worsening of irregular heartbeat.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Side Effects by Body System - for Healthcare Professionals

Cardiovascular

Cardiovascular side effects have included new or worsening heart failure, QT prolongation, and bradycardia.

Renal

Renal side effects have included hypokalemia and hypomagnesemia with potassium-depleting diuretics, and serum creatinine increased 10% or more within five days after treatment initiation.

Gastrointestinal

Gastrointestinal side effects have included diarrhea, nausea, abdominal pain, vomiting, and dyspeptic signs and symptoms.

Dermatologic

Dermatologic side effects have included rashes (generalized, macular, maculopapular, erythematous), pruritus, eczema, dermatitis, and allergic dermatitis.

General

General side effects have included asthenia.

Hepatic

Hepatic side effects have included hepatocellular liver injury, including acute liver failure requiring transplant, serum hepatic enzymes and serum bilirubin increase.

Respiratory

Respiratory side effects have included postmarketing cases of interstitial lung disease including pneumonitis and pulmonary fibrosis.

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