What are the safety considerations and most common adverse reactions observed with dronedarone?

Dronedarone is subject to a boxed warning regarding increased risk of death, stroke, and heart failure in patients with decompensated heart failure or permanent atrial fibrillation. Please see the label insert for the complete boxed warning. The most common adverse reactions observed with dronedarone were diarrhea, nausea, abdominal pain, vomiting, and weakness or lack of energy. Rare but serious side effects may occur. A detailed list can be found on the label insert.