What it ishERG-blocking class III antiarrhythmic and noniodinated amiodarone analog; paroxysmal atrial fibrillation.
Why this oneIts noniodinated design greatly reduces thyroid toxicity but sacrifices rhythm-control efficacy versus amiodarone.
What limits itContraindicated in decompensated heart failure and permanent atrial fibrillation; it also raises digoxin exposure.
FDA-approved for
- atrial fibrillation (2009)
FDA label
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BOXED WARNING Doubles risk of death in NYHA Class IV/recently decompensated HF and in permanent AF; contraindicated in both.
| FDA dosing | Population | Start | Target | Max |
| Paroxysmal/persistent atrial fibrillation (in sinus rhythm) | Adults | 400 mg BID | 400 mg BID | 400 mg BID |
Renal No adjustment needed
Hepatic No adjustment for moderate impairment; contraindicated in severe impairment
Instructions
- Take one tablet with the morning meal and one with the evening meal
- Stop Class I/III antiarrhythmics and strong CYP3A inhibitors before starting
Contraindications
- Permanent AF (sinus rhythm cannot be restored)
- Symptomatic HF with recent decompensation requiring hospitalization or NYHA Class IV
- Second/third-degree AV block or sick sinus syndrome (without functioning pacemaker)
- Bradycardia <50 bpm
- Concomitant strong CYP3A inhibitors
- Concomitant erythromycin
- Concomitant QT-prolonging drugs/herbals that may induce torsade de pointes
- Liver or lung toxicity related to prior amiodarone use
- QTc >500 ms or PR >280 ms
- Severe hepatic impairment
Cautions
- New/worsening heart failure
- Increased stroke risk in permanent AF
- Hepatocellular liver injury
- Pulmonary toxicity (interstitial lung disease)
- Hypokalemia/hypomagnesemia with potassium-depleting diuretics
- QT interval prolongation
- Renal impairment/acute renal failure
- Embryofetal toxicity
Adverse reactions
- Diarrhea
- Nausea
- Abdominal pain
- Vomiting
- Dyspepsia
- Asthenia
- Bradycardia
- Skin reactions (rash, pruritus, eczema, dermatitis)
Pregnancy May cause fetal harm (animal malformations); verify not pregnant and use effective contraception.
Lactation Do not breastfeed during treatment and for 5 days after last dose.
⚠ BOXED WARNING
- Increased mortality in decompensated heart failure and in permanent atrial fibrillation
Cost, est. cash$300–$2,500/month
Generic entry2024
Classes and tags
Clinical profile
Therapeutic safety burden3 / 4
Overdose danger4 / 4
Weight-gain liability0 / 4
Sedation liability0 / 4
QT / Torsades3 / 4
Direct muscarinic antagonism0 / 4
Embryofetal risk2 / 4
Legacy pregnancy categoryC
Defining liabilityProarrhythmia, conduction slowing and agent-specific organ toxicity; overdose may cause malignant dysrhythmia.
Mechanism of action: Dronedarone ballicule
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