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Dronedarone Side Effects

The most commonly reported side effects of dronedarone include atrial fibrillation, atrial fibrillation, and dyspnoea, based on 10,559 FDA adverse event reports from 2009 to 2025. 2.5% of reports found the drug to be ineffective.

Dronedarone side effects

Percentages show how often each reaction appears relative to total reports for dronedarone.

1
Atrial Fibrillation7.2%763
2
Atrial Fibrillation6.7%704
3
Dyspnoea4.8%502
4
Fatigue4.2%441
5
Gastrointestinal Haemorrhage3.8%397
6
Dyspnoea3.7%390
7
Drug Interaction3.5%365
8
Off Label Use3.3%349
9
Diarrhoea3.0%316
10
Dizziness2.9%305
11
Nausea2.8%300
12
Cardiac Failure2.7%283
13
Drug Ineffective2.5%266
14
Asthenia2.4%249
15
Blood Creatinine Increased2.0%206

These are voluntary reports and do not establish that dronedarone caused these reactions.

Report severity

72.8%Serious7,690 reports
34.8%Hospitalizations3,678 reports
6.9%Fatal724 reports

Seriousness is determined by the reporter, not by OpenClaim.

Dronedarone drug interactions

Other drugs that appear in adverse event reports alongside dronedarone. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Dabigatran-etexilate-mesylate9.4%989
2
Rivaroxaban5.7%607
3
Apixaban3.2%335
4
Aspirin2.8%291
5
Warfarin2.4%249
6
Amiodarone-hydrochloride2.3%244
7
Lenalidomide2.0%209
8
Metoprolol1.5%161
9
Atorvastatin-calcium1.1%112
10
Adalimumab0.8%87
11
Clopidogrel-bisulfate0.8%87
12
Diltiazem0.7%77
13
Omeprazole0.7%72
14
Simvastatin0.6%68
15
Pomalidomide0.6%64

Taken alongside

1
Metoprolol16.1%1,700
2
Aspirin13.6%1,439
3
Furosemide12.3%1,304
4
Warfarin12.0%1,263
5
Levothyroxine-sodium9.7%1,021
6
Atorvastatin-calcium9.6%1,018
7
Simvastatin7.3%766
8
Omeprazole6.8%714
9
Apixaban6.7%706
10
Ergocalciferol6.2%657
11
Amlodipine6.2%654
12
Lisinopril6.1%642
13
Diltiazem6.0%638
14
Acetaminophen5.9%622
15
Metformin5.2%554

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports dronedarone side effects

48.1% of dronedarone adverse event reports involve female patients and 43.6% involve male patients. The largest age group is elderly at 77%. These figures reflect who reports side effects, not underlying risk.

Sex

Female48.1%
Male43.6%
Unknown8.3%

Age group

< 2<0.1%
2–11<0.1%
12–17<0.1%
18–6423.2%
65+76.6%

What is dronedarone used for

Conditions and purposes for which patients were taking dronedarone when the adverse event was reported.

Abdominal DiscomfortAccidental Exposure To ProductAcute Coronary SyndromeAnticoagulant TherapyAntifungal TreatmentAortic StenosisAortic Valve ReplacementArrhythmiaArrhythmia AbsolutaArrhythmia ProphylaxisArrhythmia SupraventricularArterial FibrosisArthritisAtrial FibrillationAtrial Fibrillation Paroxysmal

Showing 15 of 169 indications

Dronedarone brand names and reporting trend

Dronedarone is sold under brand names including Dronedarone, Multaq.

Brand names

Dronedarone1,744
Multaq10

Quarterly reports (20092025)

200920122016202020242025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking dronedarone with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.