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Amiodarone Side Effects

The most commonly reported side effects of amiodarone include dyspnoea, drug interaction, and atrial fibrillation, based on 79,864 FDA adverse event reports from 2004 to 2025. 4.3% of reports found the drug to be ineffective.

Amiodarone side effects

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

1
Dyspnoea5.2%4,174
2
Drug Interaction4.5%3,631
3
Drug Ineffective4.3%3,459
4
Atrial Fibrillation4.1%3,269
5
Off Label Use4.0%3,210
6
Asthenia3.6%2,908
7
Acute Kidney Injury3.6%2,905
8
Fatigue3.5%2,823
9
Hypotension3.2%2,567
10
Death3.1%2,472
11
Fall2.9%2,308
12
Dizziness2.8%2,258
13
Nausea2.6%2,108
14
Anaemia2.6%2,088
15
Pneumonia2.6%2,082

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

Report severity

89.8%Serious71,733 reports
56.0%Hospitalizations44,760 reports
17.4%Fatal13,903 reports

Seriousness is determined by the reporter, not by OpenClaim.

Amiodarone drug interactions

Other drugs that appear in adverse event reports alongside amiodarone. 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
Apixaban5.8%4,596
2
Rivaroxaban5.0%3,984
3
Furosemide4.9%3,887
4
Dabigatran-etexilate-mesylate3.6%2,911
5
Warfarin3.3%2,622
6
Aspirin3.2%2,571
7
Valsartan3.0%2,391
8
Bisoprolol-fumarate3.0%2,381
9
Lenalidomide2.8%2,205
10
Metoprolol2.6%2,075
11
Sacubitril2.3%1,876
12
Digoxin2.3%1,838
13
Atorvastatin-calcium1.9%1,497
14
Spironolactone1.8%1,458
15
Ramipril1.8%1,421

Taken alongside

1
Furosemide22.7%18,092
2
Aspirin14.4%11,503
3
Metoprolol13.4%10,683
4
Atorvastatin-calcium12.2%9,756
5
Levothyroxine-sodium11.8%9,422
6
Acetaminophen9.4%7,493
7
Warfarin9.1%7,289
8
Apixaban8.4%6,732
9
Pantoprazole-sodium8.4%6,680
10
Omeprazole7.4%5,911
11
Spironolactone7.3%5,791
12
Bisoprolol-fumarate7.2%5,753
13
Carvedilol7.2%5,731
14
Amlodipine6.8%5,405
15
Insulin6.1%4,855

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 amiodarone side effects

38.2% of amiodarone adverse event reports involve female patients and 55.1% involve male patients. The largest age group is elderly at 74%. These figures reflect who reports side effects, not underlying risk.

Sex

Female38.2%
Male55.1%
Unknown6.7%

Age group

< 20.9%
2–110.3%
12–170.4%
18–6424.5%
65+73.9%

What is amiodarone used for

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

Abdominal PainAbnormal Sleep-related EventAccelerated Idioventricular RhythmAccidental Exposure To ProductAcute Coronary SyndromeAcute Lymphocytic LeukaemiaAcute Myocardial InfarctionAcute Pulmonary OedemaAcute Respiratory FailureAdjuvant TherapyAdverse EventAdverse ReactionAgonal RhythmAlopeciaAmerican Trypanosomiasis

Showing 15 of 748 indications

Amiodarone brand names and reporting trend

Amiodarone is sold under the brand name Pacerone.

Brand names

Pacerone825

Quarterly reports (20042025)

20052010201520202025

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

Taking amiodarone with another medication?

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