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Precautions and Warnings With Dronedarone

There are many precautions and warnings to be aware of before starting dronedarone. For example, it is important to know that the medication may actually increase the risk of life-threatening arrhythmias. Although most people respond well to dronedarone, the drug is not for everyone. You should not take this arrhythmia medication if you have severe heart failure, long QT syndrome, or severe liver disease.

What Should I Tell My Healthcare Provider Before Taking Dronedarone?

You should talk with your healthcare provider prior to taking dronedarone (Multaq®) if you have:
 
  • Severe or prolonged diarrhea or vomiting
  • Low electrolytes (such as low potassium levels)
  • Long QT syndrome
  • Peripheral artery disease (PAD)
  • Liver disease, such as hepatitis, cirrhosis, or liver failure
  • Heart failure
  • Sick sinus syndrome
  • A slow heart rate (bradycardia)
  • Any allergies, including allergies to food, dyes, or preservatives.
     
Also, let your healthcare provider know if you are:
 
  • Pregnant or thinking of becoming pregnant
  • Breastfeeding.
     
Make sure to tell your healthcare provider about all other medicines you are taking, including prescription and non-prescription medicines, vitamins, and herbal supplements.
 

Specific Dronedarone Warnings and Precautions

Some warnings and precautions to be aware of prior to taking this drug include the following:
 
  • Like other arrhythmia medications, dronedarone may actually increase the risk of life-threatening arrhythmias. For this reason, it should be used only if absolutely necessary.

 

  • Dronedarone must not be used in people whose heart rhythm cannot be converted to normal ("permanent atrial fibrillation"). Studies have shown that dronedarone doubles the risk of heart failure and heart-related death and increases the risk of stroke in people with permanent atrial fibrillation. Your healthcare provider should check your heart rhythm every three months to make sure your atrial fibrillation has not returned. 

 

  • Dronedarone may interact with many other medications. Some of these interactions are quite dangerous (see Drug Interactions With Dronedarone). For this reason, make sure your healthcare provider has a complete, accurate, and current list of your medications. Check with your healthcare provider before starting any new medications while taking dronedarone.
     
  • One study suggested that dronedarone may increase the risk of death in people with severe heart failure. For this reason, people who have severe heart failure should not take dronedarone. You probably have severe heart failure if you have been hospitalized within the past month for the condition (even if you are better now) or if you experience shortness of breath with any physical activity (or at rest).
     
  • Let your healthcare provider know if you develop any heart failure symptoms (or worsening of heart failure) while on dronedarone. Such symptoms may include:

 

    • Shortness of breath
    • Wheezing
    • Difficulty sleeping because of breathing problems
    • Needing multiple pillows to prop up your head in order to sleep
    • Rapid weight gain
    • Water retention or swelling of the arms, legs, feet, or hands.

 

  • Low electrolytes may increase the risk of dangerous arrhythmias due to dronedarone. Tell your healthcare provider if you have severe or prolonged diarrhea while taking dronedarone, since such problems may cause low electrolytes. 

 

  • There have been a few rare cases of liver damage possibly due to dronedarone. Let your healthcare provider know if you develop any liver failure symptoms while on dronedarone. Such symptoms may include:
     
    • Loss of appetite, nausea, and vomiting
    • Upper-right abdominal (stomach) pain
    • Yellow skin (jaundice) or yellow eyes
    • Very dark urine
    • Itching.
  
  • Be sure to take dronedarone with food (usually with the morning and evening meals). Taking it on an empty stomach may decrease its effectiveness. Also, do not drink grapefruit juice while taking dronedarone.

 

  • There have been reports of serious lung problems possibly due to this medication. If you experience shortness of breath or a dry cough, let your healthcare provider know right away. 

 

  • Dronedarone is considered a pregnancy Category X medication. This means that pregnant women should never take this medication, as there is a clear risk of harm to the fetus (see Multaq and Pregnancy).
     
  • It is unknown if dronedarone passes through breast milk in humans. Therefore, if you are breastfeeding or plan to start breastfeeding, discuss this with your healthcare provider prior to taking the drug (see Multaq and Breastfeeding).
     
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Dronedarone Drug Information

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