What are the side effects of Multaq (dronedarone)?

From the Guidelines

Multaq (dronedarone) can cause severe side effects, including liver problems, heart rhythm issues, and increased risk of cardiovascular events, particularly in patients with permanent atrial fibrillation or significant cardiovascular disease burden, as evident from the PALLAS trial 1.

Side Effects of Multaq

The side effects of Multaq can range from mild to severe and include:

• Common side effects: nausea, diarrhea, abdominal pain, vomiting, and weakness
• More concerning side effects: liver problems, which may present as yellowing of the skin or eyes, dark urine, or upper right abdominal pain
• Serious heart rhythm problems: bradycardia (slow heart rate) or QT prolongation, which may lead to dangerous arrhythmias
• Lung problems: pulmonary toxicity can occur, causing symptoms like shortness of breath or cough
• Skin reactions: rash or sensitivity to sunlight
• Interactions with many medications, potentially increasing the risk of side effects
• Increased blood creatinine levels, though this doesn't necessarily indicate kidney damage

Important Considerations

• Patients with permanent atrial fibrillation should not be treated with dronedarone, particularly those with a significant cardiovascular disease burden, as shown in the PALLAS trial 1
• The drug can still be used in patients with paroxysmal or persistent atrial fibrillation after cardioversion, under the supervision of a specialist 1
• Regular medical check-ups, including liver function tests, are essential for patients taking Multaq, especially during the first six months of treatment
• Any unusual symptoms should be reported to a healthcare provider immediately, as some side effects can be life-threatening if not addressed promptly

Recent Guidelines

The 2014 AHA/ACC/HRS guideline for the management of patients with atrial fibrillation provides dosage and safety considerations for dronedarone, including the need for caution with inhibitors and inducers of CYP3A, and the potential for increased concentrations of certain statins, sirolimus, tacrolimus, beta blockers, and digoxin 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 Multaq include stomach problems and skin problems. Common side effects are diarrhea, nausea, vomiting, abdominal pain, indigestion, feeling tired and weak, and skin problems such as redness, rash, and itching. 2 2

From the Research

Side Effects of Multaq (Dronedarone)

• The most common side effects of dronedarone are gastrointestinal in nature, including:
  • Nausea 3, 4, 5
  • Vomiting 3, 4, 5
  • Diarrhea 3, 4, 5
• Other reported side effects include:
  • Cutaneous disorders 4
  • Transient elevation of creatinin levels 4
  • Renal failure (in some cases) 4
  • Bradycardia and QT prolongation (arrhythmogenic effects) 4
• Dronedarone has been associated with an increased risk of mortality in patients with severe heart failure and left ventricular dysfunction 4, 5
• It is worth noting that dronedarone has a more favorable adverse effect profile compared to amiodarone, with less frequent thyroid disorders, neurological disorders, hypersensitivity reactions, hypertension, and QT prolongation 4
• However, there is limited information available on the long-term adverse effects of dronedarone, particularly with regards to pulmonary fibrosis 4