You should not take dronedarone if you have severe heart failure. Dronedarone may increase the risk of death in people who have severe heart failure. Tell your doctor if you have heart failure that is severe enough to cause shortness of breath while you are at rest, after a small amount of exercise, or after any physical activity. Also tell your doctor if you have been hospitalized for heart failure during the past month even if you are feeling better. Your doctor will not prescribe dronedarone for you.
You should not take dronedarone if you have atrial fibrillation (a heart rhythm disorder that may cause the heartbeat to be fast and irregular) that will not or cannot be converted back to a normal heart rhythm. Dronedarone may increase the risk of death, stroke, and the need to be hospitalized in people with permanent atrial fibrillation. Your doctor will check your heart rhythm at least every 3 months while you are taking dronedarone. Call your doctor immediately if your heartbeat becomes fast or irregular while you are taking dronedarone.
Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with dronedarone and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.
Dronedarone is used to treat people who currently have normal heart rhythm, but have had atrial fibrillation in the past. Dronedarone decreases the risk that people who have this condition will need to be hospitalized to treat atrial fibrillation. Dronedarone is in a class of medications called antiarrhythmics. It works by helping the heart to beat normally.
Dronedarone comes as a tablet to take by mouth. It is usually taken twice a day, with the morning meal and the evening meal. Take dronedarone at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take dronedarone exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Your doctor may prescribe certain medications to decrease the risk of stroke while you are taking dronedarone. Take this medication exactly as directed during your treatment.
Dronedarone will help control your heartbeat only as long as you continue to take it. Continue to take dronedarone even if you feel well and have felt well for a long time. Do not stop taking dronedarone without talking to your doctor.
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
Do not eat grapefruit or drink grapefruit juice while taking this medication.
Unless your doctor tells you otherwise, continue your normal diet.
Skip the missed dose and continue your regular dosing schedule. Do not try to make up for a missed dose or take a double dose to make up for a missed one.
shortness of breath
difficulty swallowing or breathing
coughing up frothy mucus
difficulty sleeping due to breathing problems
need to prop yourself up with extra pillows in order to breathe at night
weight gain (of 5 or more pounds) in a short period of time
swelling of the eyes, face, lips, throat, hands, feet or legs
yellowing of the skin or eyes
unusual bruising or bleeding
loss of appetite
pain in the upper right part of the stomach
tiredness or lack of energy
unusual darkening of the urine
light colored stools
sudden severe headache
sudden complete or partial loss of vision
weakness or numbness of an arm or leg
difficulty thinking clearly, remembering, or learning new things
Dronedarone may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/Safety/MedWatch] or by phone [1-800-332-1088].
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to dronedarone.
Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
Last Revised - 11/15/2012
AHFS® Consumer Medication Information. © Copyright, 2014. The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.