From the Guidelines
Dronedarone is associated with a significant reduction in cardiovascular outcome events, but its use is contraindicated in patients with unstable haemodynamic conditions, with a history of (or current) heart failure or left ventricular dysfunction, and in patients with permanent atrial fibrillation, particularly those with a significant cardiovascular disease burden 1. The most common side effects of dronedarone include gastrointestinal issues, fatigue, weakness, and bradycardia, which typically occur in about 10-15% of patients. More serious but less common side effects include liver injury, worsening heart failure, and QT interval prolongation, potentially leading to dangerous heart rhythm disturbances.
- The safety profile of dronedarone is advantageous in patients without structural heart disease and in stable patients with heart disease, with a low potential for proarrhythmia 1.
- Dronedarone can cause skin reactions like rashes and interacts with many other drugs, particularly those metabolized by the CYP3A4 enzyme system, which can increase the risk of side effects.
- The medication affects multiple ion channels in the heart and has systemic effects throughout the body, and patients should report any unusual symptoms to their healthcare provider immediately, especially signs of liver problems or worsening heart symptoms.
- Regular monitoring of liver function and heart rhythm is essential during treatment, and the use of dronedarone should be supervised by a specialist, with subsequent monitoring including input from an appropriate specialist 1.
- The results of the PALLAS trial, which showed an increase in cardiovascular events, including cardiovascular mortality, in patients with permanent atrial fibrillation, highlight the importance of careful patient selection and monitoring when using dronedarone 1.
From the FDA Drug Label
The most common side effects of MULTAQ include: Stomach problems such as
- diarrhea
- nausea
- vomiting
- stomach area (abdominal) pain
- indigestion
- feeling tired and weak
- skin problems such as redness, rash, and itching
The possible side effects of dronedarone include:
- Slowed heartbeat (bradycardia)
- Stomach problems
- Skin problems The most frequent adverse reactions observed with dronedarone were diarrhea, nausea, abdominal pain, vomiting, and asthenia 2. Key side effects to consider are those related to the gastrointestinal, cardiac, and dermatological systems. Important to note that dronedarone may cause serious side effects, including liver injury and QT interval prolongation 2.
From the Research
Dronedarone Side Effects
- Dronedarone, an antiarrhythmic agent, has been shown to have a different side effect profile compared to amiodarone, with a lower risk of thyroid and pulmonary toxicity due to the lack of an iodine moiety 3, 4.
- Common side effects of dronedarone include gastrointestinal disorders such as diarrhea, nausea, and vomiting, as well as cutaneous disorders 5.
- Dronedarone has also been associated with an increased risk of renal failure, with transient elevation of creatinine levels and cases of renal failure reported 5.
- The risk of arrhythmogenic effects, including bradycardia and QT prolongation, is also present with dronedarone, similar to other antiarrhythmic drugs 5.
- Long-term adverse effects of dronedarone are not well understood, particularly with regards to pulmonary fibrosis, which is a concern due to the drug's structural similarity to amiodarone 5.
- Post-marketing data have demonstrated rare hepatic toxicity associated with dronedarone use 4.
- The European trial and non-European trial showed that dronedarone was significantly more effective than placebo in maintaining sinus rhythm and reducing the ventricular rate during recurrence of arrhythmia, with no significant increase in rates of pulmonary toxic effects, thyroid and liver dysfunction 6.
Comparison to Amiodarone
- Dronedarone has been shown to be less effective than amiodarone in maintaining sinus rhythm, but with a more favorable side effect profile 3, 5.
- Amiodarone is associated with a higher risk of thyroid and pulmonary toxicity, which is reduced in dronedarone due to its structural differences 3, 4.
- The choice between dronedarone and amiodarone should be based on individual patient factors, including the presence of heart failure and the risk of adverse effects 3, 7.
Patient Selection
- Dronedarone is recommended for use in patients with non-permanent atrial fibrillation who have at least one cardiovascular risk factor and are not controlled by first-line therapy 7.
- Patients with unstable New York Heart Association (NYHA) class III or IV heart failure should not be treated with dronedarone 7.
- The use of dronedarone in patients with advanced heart failure is contraindicated due to an increased risk of mortality and cardiovascular hospitalizations 3, 4.