What is the most important information I should know about dronedarone?
You should not use dronedarone if you have severe liver disease, if you are pregnant or breast-feeding, or if you have ever used amiodarone and then had liver or lung problems. You should not use dronedarone if you have a serious heart condition such as very slow heartbeats, "sick sinus syndrome," or "AV block" (unless you have a pacemaker).
Dronedarone can double your risk of death if you have certain heart conditions. You should not use this medicine if you have severe heart failure, if you were recently hospitalized for worsening heart failure symptoms, or if you have a "permanent" type of atrial fibrillation (this will be determined by your doctor).
Check your pulse often, and tell your doctor right away if you notice an irregular rhythm.
Tell your doctor about all your current medicines and any you start or stop using. Many drugs can interact with dronedarone, and some drugs should not be used together.
Dronedarone can cause liver problems. Call your doctor at once if you have symptoms such as nausea, loss of appetite, unusual tiredness, dark urine, or yellowing of your skin or eyes.
What is dronedarone?
Dronedarone is a heart rhythm medicine that helps maintain normal heartbeats in certain people with life-threatening rhythm disorders of the atrium (the upper chambers of the heart that allow blood to flow into the heart).
Dronedarone helps lower your risk of needing to be hospitalized for a heart rhythm disorder called atrial fibrillation. Dronedarone is for people who have had this disorder in the past, but now have normal heart rhythm.
Dronedarone may also be used for purposes not listed in this medication guide.
What should I discuss with my healthcare provider before taking dronedarone?
You should not use dronedarone if you are allergic to it, or if:
- you have severe liver disease;
- you have a serious heart condition such as "sick sinus syndrome," "AV block" (unless you have a pacemaker), or very slow heartbeats that have caused you to faint;
- you are pregnant or breast-feeding; or
- you used a medicine called amiodarone and then had lung problems or liver problems.
Dronedarone is used to treat intermittent or "temporary" heart rhythm disorders. In some people with "permanent" atrial fibrillation, dronedarone increased the risk of stroke, hospitalization, and death. Dronedarone can double your risk of death if you have certain heart conditions. You should not use this medicine if:
- you have severe heart failure;
- you were recently hospitalized for worsening heart failure symptoms (shortness of breath, chest tightness, night-time breathing problems, swelling, rapid weight gain); or
- you have a "permanent" atrial fibrillation that cannot be changed back to a normal rhythm (this will be determined by your doctor).
Some medicines can cause unwanted or dangerous effects when used with dronedarone. Your doctor may need to change your treatment plan if you use any of the following drugs:
- cyclosporine;
- ritonavir;
- other heart rhythm medicines;
-
an antibiotic --azithromycin, clarithromycin, erythromycin, levofloxacin, moxifloxacin, pentamidine, telithromycin;
-
antifungal medicine --ketoconazole, itraconazole, voriconazole;
-
an antidepressant --amitriptyline, amoxapine, clomipramine, desipramine, doxepin, imipramine, maprotiline, mirtazapine, nefazodone, nortriptyline, protriptyline, trimipramine; or
-
antipsychotic medicine --chlorpromazine, fluphenazine, perphenazine, prochlorperazine, promethazine, thioridazine, trifluoperazine.
To make sure dronedarone is safe for you, tell your doctor if you have ever had:
- other heart problems;
- an electrolyte imbalance (such as low levels of potassium or magnesium in your blood); or
- liver or kidney disease.
Do not use dronedarone if you are pregnant. It could harm the unborn baby or cause birth defects. Use effective birth control to prevent pregnancy while you are using this medicine and tell your doctor if you become pregnant.
It is not known whether dronedarone passes into breast milk or if it could harm a nursing baby. You should not breast-feed while taking dronedarone.
How should I take dronedarone?
Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.
Dronedarone works best if you take it with your morning and evening meals.
Your heart function may need to be checked using an electrocardiograph or ECG (sometimes called an EKG) every 3 months. This will help your doctor determine how long to treat you with dronedarone. Your liver and kidney function may also need to be checked.
Check your own pulse often, and call your doctor right away if you notice an irregular rhythm.
Use dronedarone regularly even if you feel fine or have no symptoms. Get your prescription refilled before you run out of medicine completely.
You should not stop using dronedarone suddenly. Stopping suddenly may make your condition worse.
Store at room temperature away from heat and moisture.
What happens if I miss a dose?
Skip the missed dose and take the next regularly scheduled dose. Do not use extra medicine to make up the missed dose.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while taking dronedarone?
Grapefruit and grapefruit juice may interact with dronedarone and lead to unwanted side effects. Avoid the use of grapefruit products while taking dronedarone.
What are the possible side effects of dronedarone?
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
- shortness of breath (even with mild exertion), swelling, rapid weight gain;
- chest pain, wheezing, trouble breathing, dry cough, or coughing up mucus;
- breathing problems while lying down trying to sleep;
- severe dizziness, fainting, fast or pounding heartbeats;
- slow heart rate, feeling like you might pass out;
- a new or a worsening irregular heartbeat pattern;
-
kidney problems --little or no urination, swelling in your feet or ankles, feeling tired or short of breath; or
-
liver problems --nausea, upper stomach pain, itching, unusual tiredness, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
Common side effects may include:
- stomach pain, indigestion, nausea, vomiting, diarrhea;
- feeling weak or tired; or
- skin rash, itching, or redness.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect dronedarone?
Many drugs can interact with dronedarone. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any you start or stop using, especially:
- digoxin;
- St. John's wort;
- a blood thinner (warfarin, Coumadin, Jantoven);
- heart or blood pressure medication;
- medicines to treat tuberculosis;
- medicine to prevent organ transplant rejection;
- seizure medicine; or
- "statin" cholesterol medication (Lipitor, Zocor, Vytorin, and others).
This list is not complete and many other drugs can interact with dronedarone. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.
Where can I get more information?
Your pharmacist can provide more information about dronedarone.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
Copyright 1996-2018 Cerner Multum, Inc. Version: 12.01. Revision date: 11/15/2017.
