Dronedaron Aristo: Uses, Dosage & Side Effects
Antiarrhythmic medication for atrial fibrillation and atrial flutter
Quick Facts About Dronedaron Aristo
Key Takeaways About Dronedaron Aristo
- For non-permanent atrial fibrillation only: Dronedaron Aristo is specifically approved for maintaining sinus rhythm in non-permanent (paroxysmal or persistent) atrial fibrillation or atrial flutter — it must not be used in permanent AF
- Safer thyroid and lung profile than amiodarone: Dronedarone lacks the iodine component of amiodarone, which substantially reduces the risk of thyroid dysfunction, pulmonary toxicity, and corneal deposits
- Must be taken with food: Food increases dronedarone absorption 2–4 fold, so tablets must always be taken during a meal to ensure adequate therapeutic blood levels
- Liver monitoring is essential: Rare but serious hepatotoxicity has been reported; liver function tests are required before and during treatment according to a defined schedule
- Contraindicated in severe heart failure: The ANDROMEDA trial showed increased mortality in NYHA class IV heart failure patients — dronedarone must not be used in this population
What Is Dronedaron Aristo and What Is It Used For?
Dronedaron Aristo contains dronedarone hydrochloride, a class III antiarrhythmic agent used to maintain normal sinus rhythm in adults with non-permanent atrial fibrillation (AF) or atrial flutter. It reduces the risk of AF recurrence and helps control the ventricular rate during episodes.
Dronedarone is a benzofuran derivative structurally related to amiodarone, one of the most widely used antiarrhythmic drugs worldwide. However, dronedarone was specifically engineered to retain the beneficial multichannel-blocking properties of amiodarone while eliminating the iodine moiety that causes many of amiodarone’s most problematic adverse effects, including thyroid toxicity, pulmonary fibrosis, and corneal microdeposits. This modification was a deliberate pharmacological strategy to create a safer antiarrhythmic alternative for long-term maintenance therapy.
Dronedarone acts as a multichannel blocker, inhibiting multiple cardiac ion currents. It blocks potassium currents (contributing to its class III antiarrhythmic activity), sodium currents (class I activity), and L-type calcium currents (class IV activity). It also exhibits noncompetitive anti-adrenergic properties (class II activity). This broad electrophysiological profile allows dronedarone to slow the heart rate, prolong the atrial action potential duration and refractory period, and suppress ectopic automaticity — all of which contribute to its ability to maintain sinus rhythm.
The clinical efficacy of dronedarone was established in several landmark trials. The ATHENA trial (A placebo-controlled, double-blind, parallel arm Trial to assess the efficacy of dronedarone 400 mg bid for the prevention of cardiovascular Hospitalization or death from any cause in patiENts with Atrial fibrillation/atrial flutter) was the largest study, enrolling over 4,600 patients with atrial fibrillation or flutter. ATHENA demonstrated that dronedarone significantly reduced the combined endpoint of cardiovascular hospitalization or death from any cause by 24% compared to placebo, establishing its role in clinical practice.
Dronedaron Aristo is prescribed for the following indication:
- Maintenance of sinus rhythm after successful cardioversion in clinically stable adult patients with paroxysmal or persistent atrial fibrillation
- Reduction in heart rate during AF or atrial flutter episodes to prevent symptoms and hemodynamic compromise
Dronedarone should only be prescribed after alternative treatment options have been considered. It is intended for use under the supervision of a specialist in the treatment of cardiac arrhythmias. Before starting treatment, your physician should ensure that atrial fibrillation is non-permanent and that you do not have severe heart failure (NYHA class IV) or recent decompensation of heart failure.
Comparison with amiodarone
While dronedarone shares a similar chemical backbone with amiodarone, there are important clinical differences. Dronedarone has a much shorter half-life (approximately 13–19 hours compared to 40–55 days for amiodarone), which means it reaches steady-state concentrations within days rather than weeks, and is eliminated from the body much faster after discontinuation. However, this also means it must be taken twice daily rather than once daily.
Dronedarone is considered less potent as an antiarrhythmic agent compared to amiodarone. Clinical trials have shown higher AF recurrence rates with dronedarone than with amiodarone. However, the significantly improved safety profile — particularly regarding thyroid, pulmonary, neurological, and ocular toxicity — makes dronedarone a preferred first-line option for many patients with non-permanent AF who require rhythm control and have preserved or mildly reduced cardiac function.
The DIONYSOS trial directly compared dronedarone with amiodarone in patients with persistent AF and found that while amiodarone was more effective at preventing AF recurrence, dronedarone had fewer thyroid and neurological adverse events. This trade-off between efficacy and safety is a key consideration in clinical decision-making.
What Should You Know Before Taking Dronedaron Aristo?
Dronedaron Aristo must not be used in permanent atrial fibrillation, NYHA class IV heart failure, unstable hemodynamic conditions, severe liver or kidney impairment, or concurrently with strong CYP3A4 inhibitors. Liver function monitoring is mandatory before and during treatment.
Before starting treatment with dronedarone, your prescribing physician will conduct a comprehensive cardiac and medical evaluation. This is essential because dronedarone has specific contraindications and warnings that distinguish it from other antiarrhythmic agents. Understanding these restrictions is critical for safe and effective use of the medication.
Contraindications
Dronedaron Aristo must not be used in the following situations:
- Permanent atrial fibrillation — in which cardioversion to sinus rhythm is no longer a clinical goal. The PALLAS trial demonstrated increased cardiovascular events (stroke, heart failure, cardiovascular death) with dronedarone in permanent AF
- NYHA class IV heart failure or heart failure that has recently become unstable (decompensated), requiring hospitalization or referral to a specialized heart failure clinic
- Second- or third-degree atrioventricular (AV) block or sick sinus syndrome (except when used with a functioning pacemaker)
- Bradycardia with heart rate below 50 beats per minute
- QTc interval ≥ 500 milliseconds (Bazett correction)
- Severe hepatic impairment (Child-Pugh class C)
- Severe renal impairment (creatinine clearance < 30 ml/min)
- Concomitant use of strong CYP3A4 inhibitors such as ketoconazole, itraconazole, voriconazole, ritonavir, nelfinavir, cyclosporine, telithromycin, and clarithromycin
- Concomitant use of QT-prolonging drugs that may induce torsades de pointes, including class I or III antiarrhythmic agents, phenothiazines, pimozide, and certain antibiotics (erythromycin IV, moxifloxacin)
- Previous liver or lung toxicity related to amiodarone
- Pregnancy and breastfeeding
- Allergy to dronedarone or any of the tablet excipients
Warnings and Precautions
Speak to your doctor before taking Dronedaron Aristo if you have any of the following conditions or concerns:
- Heart failure (NYHA class I–III) — dronedarone may be used with caution but requires close monitoring. If heart failure worsens or decompensates during treatment, dronedarone should be discontinued
- Coronary artery disease — dronedarone can be used but cardiovascular monitoring is advisable
- Left ventricular hypertrophy or valvular heart disease — assess risk of QT prolongation
- Electrolyte imbalances — potassium and magnesium levels should be within the normal range before starting treatment, as hypokalemia and hypomagnesemia increase the risk of arrhythmias
- Existing liver disease — liver function tests are required before initiation
- Unexplained nausea, vomiting, abdominal pain, loss of appetite, or dark urine — may indicate hepatotoxicity (liver injury). Stop taking dronedarone and contact your doctor immediately
- New or worsening shortness of breath, swollen ankles, increasing fatigue — may indicate worsening heart failure
- New or worsening cough or difficulty breathing — rare cases of interstitial lung disease have been reported
- Slow or irregular heartbeat, dizziness, or fainting — may indicate excessive bradycardia or proarrhythmic effects
- Sudden severe skin rash with blistering — may indicate serious dermatological reaction
Liver Function Monitoring
Rare cases of severe hepatotoxicity, including two cases requiring liver transplantation, have been reported with dronedarone. Therefore, a strict liver function monitoring schedule is required:
- Before starting treatment: Baseline liver function tests (ALT, AST, bilirubin)
- During treatment: At 1 week, 1 month, then monthly for 6 months, then at months 9 and 12, and periodically thereafter
- Discontinuation rule: If ALT (alanine aminotransferase) rises to ≥ 3 times the upper limit of normal, dronedarone must be stopped immediately, liver function monitored until normalized, and dronedarone must not be restarted
Serum Creatinine Increase
Dronedarone causes a benign increase in serum creatinine of approximately 10–15% in most patients. This occurs because dronedarone partially inhibits the tubular secretion of creatinine (via organic cation transporter 2, OCT2), not because of actual kidney damage. This effect typically occurs within the first week of treatment, plateaus, and is fully reversible after stopping dronedarone. It is important that healthcare providers are aware of this effect to avoid unnecessary concern or investigation.
However, a baseline creatinine measurement should be taken before starting treatment so that any subsequent changes can be correctly interpreted. A rise in creatinine that exceeds what is expected from the pharmacological effect alone should prompt investigation of true renal impairment.
Pregnancy and Breastfeeding
Dronedarone is contraindicated during pregnancy. Animal studies have shown reproductive toxicity, and dronedarone may cause harm to the developing fetus. Women of childbearing potential must use effective contraception during treatment.
Breastfeeding is contraindicated during dronedarone therapy. It is not known whether dronedarone or its metabolites are excreted in human breast milk, but animal data indicate that the drug and metabolites pass into milk. Given the potential for serious adverse effects in the nursing infant, a decision should be made to either discontinue breastfeeding or discontinue the drug.
How Does Dronedaron Aristo Interact with Other Drugs?
Dronedarone is primarily metabolized by CYP3A4 and itself inhibits CYP3A4, CYP2D6, and P-glycoprotein. This creates numerous clinically significant drug interactions that require dose adjustments or avoidance of concurrent use, particularly with digoxin, anticoagulants, and other cardiac drugs.
Drug interactions are a major consideration with dronedarone therapy. The drug is extensively metabolized by the hepatic enzyme CYP3A4, making it susceptible to interactions with CYP3A4 inhibitors and inducers. Additionally, dronedarone itself acts as a moderate inhibitor of CYP3A4, CYP2D6, and the P-glycoprotein (P-gp) efflux transporter, which can increase blood levels of many co-administered medications.
Unlike amiodarone, dronedarone’s relatively short half-life means that drug interactions resolve more quickly after discontinuation. However, the interactions can still be clinically significant while the patient is on treatment. It is essential to inform your doctor about all medications you are currently taking, including prescription drugs, over-the-counter medications, herbal supplements, and grapefruit juice.
Contraindicated Combinations
Dronedarone must not be combined with the following medications:
| Drug / Class | Risk | Recommendation |
|---|---|---|
| Ketoconazole, Itraconazole, Voriconazole | Strong CYP3A4 inhibition; dronedarone levels increase 2–3 fold | Contraindicated — do not combine |
| Ritonavir, Nelfinavir (HIV protease inhibitors) | Strong CYP3A4 inhibition; marked increase in dronedarone exposure | Contraindicated — do not combine |
| Telithromycin, Clarithromycin | Strong CYP3A4 inhibition; increased dronedarone levels | Contraindicated — do not combine |
| Cyclosporine | Strong CYP3A4 and P-gp inhibitor; increased dronedarone exposure | Contraindicated — do not combine |
| Class I or III antiarrhythmics (e.g. flecainide, amiodarone, sotalol) | Additive proarrhythmic risk; QT prolongation | Contraindicated — do not combine |
| Phenothiazines, Pimozide | Additive QT prolongation; torsades de pointes risk | Contraindicated — do not combine |
Interactions Requiring Dose Adjustment or Monitoring
The following medications may require dose reductions or increased monitoring when used with dronedarone:
| Drug / Class | Effect | Action Required |
|---|---|---|
| Digoxin | Dronedarone increases digoxin levels by ~2.5 fold via P-glycoprotein inhibition | Reduce digoxin dose by 50%; monitor serum digoxin levels and ECG |
| Dabigatran | Dronedarone increases dabigatran levels via P-gp inhibition | Concomitant use is not recommended; if combined, consider dose reduction and monitor for bleeding |
| Warfarin and other vitamin K antagonists | Potential increase in anticoagulant effect; dronedarone inhibits CYP2C9 | Monitor INR closely; adjust anticoagulant dose as needed |
| Simvastatin, Atorvastatin | Dronedarone increases statin levels via CYP3A4 inhibition | Limit simvastatin to 10 mg/day; use lowest effective statin dose; monitor for myopathy |
| Beta-blockers | Additive bradycardic effect | Start beta-blocker at low dose; monitor heart rate and ECG; titrate carefully |
| Verapamil, Diltiazem | Additive bradycardia and AV block; increased dronedarone exposure (CYP3A4 and P-gp inhibition) | Use with caution; monitor heart rate; start at low dose |
| Phenytoin, Carbamazepine, Phenobarbital | Strong CYP3A4 inducers; may reduce dronedarone levels significantly | Avoid combination; therapeutic effect of dronedarone may be lost |
| Rifampicin | Potent CYP3A4 inducer; decreases dronedarone exposure by ~80% | Contraindicated in practice; do not combine |
| Tacrolimus, Sirolimus, Everolimus | Increased immunosuppressant levels via CYP3A4 and P-gp inhibition | Monitor drug levels; dose reduction likely needed |
| Grapefruit juice | CYP3A4 inhibition; increases dronedarone levels | Avoid grapefruit juice during treatment |
St. John’s Wort (Hypericum perforatum) is a potent CYP3A4 inducer and can substantially reduce dronedarone blood levels, potentially rendering the drug ineffective. Avoid using St. John’s Wort while taking dronedarone. Always inform your doctor about any herbal supplements you are taking.
What Is the Correct Dosage of Dronedaron Aristo?
The recommended dose of Dronedaron Aristo is 400 mg twice daily, taken with the morning and evening meals. Dronedarone must always be taken with food, as this increases absorption by 2–4 fold. Tablets should be swallowed whole and not crushed, chewed, or broken.
Dronedarone dosing is straightforward compared to amiodarone — there is no loading dose phase required, and the dose remains constant throughout treatment. The fixed-dose regimen simplifies prescribing and reduces the risk of dosing errors. However, strict adherence to taking the medication with meals is essential to ensure adequate drug absorption and therapeutic efficacy.
Adults
Standard Dose
The recommended dose is 400 mg (one tablet) twice daily. Take one tablet with your morning meal and one tablet with your evening meal. The interval between doses should be approximately 12 hours. Swallow the tablet whole with a glass of water.
Why Food Matters
Dronedarone has nonlinear pharmacokinetics, and its bioavailability is approximately 15% when taken in the fasting state, but increases to approximately 70–100% when taken with a standard meal. This 2–4 fold increase in absorption means that taking dronedarone without food can result in subtherapeutic drug levels, significantly reducing its antiarrhythmic effectiveness. Consistency in taking the drug with meals also helps maintain stable blood levels throughout the day.
Children and Adolescents
Dronedarone has not been studied in children and adolescents under 18 years of age, and its use in this age group is not recommended. There are no established pediatric dosing guidelines.
Elderly Patients
No dose adjustment is required based on age alone. However, elderly patients may have impaired renal or hepatic function and may be more susceptible to bradycardia and drug interactions. More frequent monitoring of heart rate, rhythm, and liver and kidney function may be appropriate in older patients.
Renal and Hepatic Impairment
No dose adjustment is needed for mild to moderate renal impairment (creatinine clearance ≥ 30 ml/min). Dronedarone is contraindicated in severe renal impairment (creatinine clearance < 30 ml/min) because it has not been studied in this population.
Dronedarone is contraindicated in severe hepatic impairment (Child-Pugh class C). In mild to moderate hepatic impairment, no dose adjustment is formally required, but close monitoring is recommended given the risk of hepatotoxicity.
Missed Dose
If you miss a dose, take the next dose at the scheduled time with your next meal. Do not take a double dose to make up for a missed one. Because dronedarone has a relatively short half-life, consistent twice-daily dosing is important for maintaining therapeutic drug levels. If you frequently forget doses, speak with your doctor or pharmacist about strategies to improve adherence.
Overdose
There is limited clinical experience with dronedarone overdose. In case of suspected overdose, seek immediate medical attention. No specific antidote is available. Treatment is supportive and symptomatic. Given that dronedarone is highly protein-bound, dialysis is unlikely to be effective. Potential symptoms of overdose may include excessive bradycardia, QT prolongation, and hemodynamic instability. Standard cardiac monitoring and supportive measures (atropine for bradycardia, vasopressors for hypotension) should be employed.
What Are the Side Effects of Dronedaron Aristo?
The most common side effects of dronedarone include gastrointestinal disturbances (diarrhea, nausea, vomiting, abdominal pain), skin rashes, fatigue, and a benign increase in serum creatinine. Serious but rare adverse effects include hepatotoxicity, worsening heart failure, QT prolongation, and interstitial lung disease.
Like all medications, dronedarone can cause side effects, although not everyone who takes it will experience them. The overall side effect profile of dronedarone is considered more favorable than that of amiodarone, particularly regarding thyroid, pulmonary, neurological, and ocular toxicity. Most common adverse reactions are gastrointestinal in nature and tend to be mild to moderate in severity, often resolving within the first few weeks of treatment.
It is important to report any new or unusual symptoms to your doctor promptly, particularly those suggesting liver dysfunction, worsening heart failure, or respiratory problems. Regular monitoring as outlined by your prescribing physician helps detect potential adverse effects at an early, often reversible stage.
- Signs of liver injury — unexplained nausea, vomiting, abdominal pain (especially upper right side), unusual tiredness, dark urine, or yellowing of the skin or eyes (jaundice)
- Signs of worsening heart failure — increasing shortness of breath, weight gain, swollen ankles or legs, inability to lie flat
- Signs of a serious allergic reaction — difficulty breathing, swelling of the face, lips, tongue, or throat
- Severe skin reactions — widespread rash, peeling skin, blistering, or mouth ulcers
Very Common (more than 1 in 10 patients)
- Increased serum creatinine (benign, not reflecting kidney damage)
- QTc prolongation on ECG (Bazett correction)
Common (up to 1 in 10 patients)
- Diarrhea
- Nausea, vomiting
- Abdominal pain, dyspepsia
- Fatigue, asthenia (weakness)
- Skin rash (including eczema, dermatitis, pruritus)
- Bradycardia (slow heart rate)
Uncommon (up to 1 in 100 patients)
- Heart failure (new or worsening)
- Lung disease (interstitial lung disease, pneumonitis)
- Liver injury (elevated ALT/AST)
- Photosensitivity reactions
- Dysgeusia (taste disturbances)
- Erectile dysfunction
Rare (up to 1 in 1,000 patients)
- Severe hepatotoxicity (including liver failure requiring transplantation)
- Allergic vasculitis (inflammation of blood vessels)
Frequency Not Known
- Anaphylaxis (severe allergic reaction)
- Angioedema (swelling of face, tongue, or throat)
- Atrial flutter with 1:1 AV conduction
Gastrointestinal effects
Diarrhea is the most frequently reported side effect, occurring in approximately 10% of patients in clinical trials. In the ATHENA trial, diarrhea led to treatment discontinuation in about 3.7% of patients in the dronedarone group. Other gastrointestinal effects include nausea (5%), vomiting (2%), and abdominal pain (4%). These symptoms typically appear early in treatment and often diminish over time. Taking dronedarone with food (as required) may help reduce gastrointestinal discomfort.
Cardiac effects
Bradycardia occurs in approximately 3% of patients and is usually a predictable pharmacological effect. QTc prolongation is common but usually modest (mean increase of approximately 10 ms). However, in individual patients the prolongation may be more pronounced, which is why ECG monitoring is recommended during treatment. Very rarely, dronedarone may exacerbate arrhythmias (proarrhythmic effect), including promoting atrial flutter with 1:1 AV conduction, which can cause rapid ventricular rates.
Hepatotoxicity
Although rare, severe hepatotoxicity is the most serious non-cardiac adverse effect of dronedarone. Post-marketing surveillance has identified cases of severe liver injury, including two reports of acute liver failure requiring transplantation. Liver injury typically presents within the first 6 months of treatment but can occur at any time. The strict liver function monitoring schedule described in the “Before Taking” section is designed to detect liver injury early, when the condition is usually reversible upon prompt discontinuation of the drug.
Pulmonary effects
Unlike amiodarone, dronedarone has a very low incidence of pulmonary toxicity due to the absence of iodine. However, isolated cases of interstitial lung disease (ILD) and pneumonitis have been reported in post-marketing surveillance. If new or worsening respiratory symptoms develop during treatment, pulmonary evaluation should be performed and dronedarone discontinued if ILD is confirmed.
How Should You Store Dronedaron Aristo?
Store Dronedaron Aristo below 30°C in the original packaging, protected from moisture. Keep out of the reach and sight of children. Do not use after the expiry date printed on the carton.
Proper storage of dronedarone tablets is important to maintain the medication’s stability and therapeutic effectiveness. Follow these guidelines:
- Temperature: Store below 30°C (86°F). Do not refrigerate or freeze.
- Moisture protection: Keep tablets in their original blister packaging until use to protect from moisture.
- Light: No special light protection requirements, though storing in original packaging is recommended.
- Children: Keep out of the sight and reach of children. Store in a safe location.
- Expiry date: Do not use after the expiration date (EXP) printed on the blister and carton. The expiry date refers to the last day of the stated month.
- Disposal: Do not throw unused tablets in the household waste or wastewater. Return unused medication to your pharmacy for safe disposal in accordance with local regulations.
What Does Dronedaron Aristo Contain?
Each Dronedaron Aristo 400 mg film-coated tablet contains dronedarone hydrochloride equivalent to 400 mg dronedarone as the active ingredient, along with several inactive excipients.
Active ingredient
The active substance is dronedarone (as dronedarone hydrochloride). Each film-coated tablet contains 400 mg of dronedarone. Dronedarone is a benzofuran derivative chemically related to amiodarone but lacking the iodine atoms. Its chemical structure is N-{2-butyl-3-[4-(3-dibutylamino-propoxy)-benzoyl]-benzofuran-5-yl} methane sulfonamide hydrochloride.
Excipients
The inactive ingredients in Dronedaron Aristo 400 mg film-coated tablets typically include:
- Tablet core: Hypromellose, maize starch, crospovidone, poloxamer 407, lactose monohydrate, colloidal anhydrous silica, magnesium stearate
- Film coating: Hypromellose, macrogol 6000, titanium dioxide (E171), polysorbate 80
Dronedaron Aristo tablets contain lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption should not take this medicine. If you have been told by your doctor that you have an intolerance to some sugars, speak with your doctor before taking Dronedaron Aristo.
Appearance
Dronedaron Aristo 400 mg tablets are white to off-white, oval-shaped film-coated tablets. They are supplied in blister packs of various sizes (typically 20, 60, or 100 tablets).
Frequently Asked Questions About Dronedaron Aristo
Dronedaron Aristo (dronedarone 400 mg) is used to maintain normal heart rhythm (sinus rhythm) in adults who have had or currently have non-permanent atrial fibrillation (AF) or atrial flutter. It reduces the recurrence of these arrhythmias and helps control the heart rate during episodes. It is specifically indicated when other treatments have been considered unsuitable and is prescribed under specialist supervision.
Dronedarone was developed as a structural analogue of amiodarone but without the iodine moiety that causes many of amiodarone’s most problematic side effects. This means dronedarone has a much lower risk of thyroid toxicity, pulmonary fibrosis, and corneal deposits. However, dronedarone is less potent as an antiarrhythmic and has a much shorter half-life (13–19 hours vs 40–55 days), requiring twice-daily dosing. Dronedarone is only approved for non-permanent AF/flutter, while amiodarone has broader indications including ventricular arrhythmias.
Food significantly increases the absorption of dronedarone by approximately 2 to 4 times. Without food, dronedarone has very low bioavailability (only about 15%), meaning only a small fraction of the drug enters your bloodstream. Taking it with a meal ensures that you achieve adequate therapeutic blood levels for the drug to work effectively as an antiarrhythmic. This is not just a recommendation but a requirement for proper drug efficacy.
Dronedarone is contraindicated in patients with NYHA class IV heart failure or heart failure that has recently decompensated. The ANDROMEDA trial showed significantly increased mortality in patients with severe, recently decompensated heart failure. However, the ATHENA trial included patients with stable NYHA class I–III heart failure and showed benefit in reducing cardiovascular hospitalization. Therefore, dronedarone can be used with caution in patients with stable, mild to moderate heart failure, under specialist supervision and with careful monitoring.
Dronedarone causes a benign increase in serum creatinine levels of approximately 10–15% in most patients. This is a pharmacological effect — dronedarone inhibits the renal tubular secretion of creatinine, making it appear that kidney function has decreased. However, the actual glomerular filtration rate (true kidney function) is not affected. This effect occurs within the first week, plateaus, and is fully reversible after stopping the drug. A baseline creatinine measurement should be taken before starting treatment to help interpret any subsequent changes.
Liver function tests (ALT, AST, bilirubin) should be performed before starting dronedarone, then at 1 week, 1 month, and monthly for the first 6 months. After that, monitoring should continue at months 9 and 12, and periodically thereafter. If ALT rises to 3 times or more the upper limit of normal, dronedarone must be stopped immediately and liver function monitored until normalized. Dronedarone should not be restarted. Report any symptoms of liver problems (nausea, vomiting, abdominal pain, dark urine, jaundice) to your doctor immediately.
References and Sources
This article is based on the following evidence-based sources. All medical information has been reviewed according to international guidelines and the GRADE evidence framework.
- European Medicines Agency (EMA). Summary of Product Characteristics: Dronedarone (Multaq). EMA/CHMP, latest revision. www.ema.europa.eu
- Hohnloser SH, Crijns HJGM, van Eickels M, et al. Effect of dronedarone on cardiovascular events in atrial fibrillation (ATHENA trial). New England Journal of Medicine. 2009;360(7):668–678. doi:10.1056/NEJMoa0803778
- Köber L, Torp-Pedersen C, McMurray JJV, et al. Increased mortality after dronedarone therapy for severe heart failure (ANDROMEDA trial). New England Journal of Medicine. 2008;358(25):2678–2687. doi:10.1056/NEJMoa0800456
- Connolly SJ, Camm AJ, Halperin JL, et al. Dronedarone in high-risk permanent atrial fibrillation (PALLAS trial). New England Journal of Medicine. 2011;365(24):2268–2276. doi:10.1056/NEJMoa1109867
- Le Heuzey JY, De Ferrari GM, Radzik D, et al. A short-term, randomized, double-blind, parallel-group study to evaluate the efficacy and safety of dronedarone versus amiodarone (DIONYSOS trial). Journal of Cardiovascular Electrophysiology. 2010;21(6):597–605. doi:10.1111/j.1540-8167.2010.01764.x
- Hindricks G, Potpara T, Dagres N, et al. 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation. European Heart Journal. 2021;42(5):373–498. doi:10.1093/eurheartj/ehaa612
- January CT, Wann LS, Calkins H, et al. 2019 AHA/ACC/HRS Focused Update of the 2014 AHA/ACC/HRS Guideline for the Management of Patients With Atrial Fibrillation. Circulation. 2019;140(2):e125–e151.
- British National Formulary (BNF). Dronedarone. NICE Evidence Services. bnf.nice.org.uk
- U.S. Food and Drug Administration (FDA). Multaq (dronedarone) Prescribing Information. FDA, latest revision. www.accessdata.fda.gov
- Touboul P, Brugada J, Capucci A, et al. Dronedarone for prevention of atrial fibrillation: A dose-ranging study (DAFNE trial). European Heart Journal. 2003;24(16):1481–1487. doi:10.1016/S0195-668X(03)00321-X
Medical Editorial Team
This article has been written and reviewed by the iMedic Medical Editorial Team, comprising licensed specialist physicians in cardiology and clinical pharmacology.
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Board-certified cardiologists and clinical pharmacologists with expertise in antiarrhythmic drug therapy and atrial fibrillation management. All content follows ESC, AHA, and WHO guidelines.
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