Dronedarone
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Warning
Do not take this medication if you have severe heart failure that makes you short of breath during light activity or even while resting, or if you recently had to stay in a hospital because your heart failure got worse. Also, do not take this medication if you have a certain kind of irregular heartbeat (permanent atrial fibrillation) that will not or cannot be changed back to a normal heart rhythm. Dronedarone may increase your risk of death, stroke, or the need to be treated in the hospital for heart failure if you have any of these conditions. Consult your doctor for more details and to discuss the risks and benefits of dronedarone. Tell your doctor right away if you have new or worsening symptoms of heart failure such as shortness of breath, swelling ankles/feet, unusual tiredness, unusual/sudden weight gain.
Precautions
See also Warning section.
Before taking dronedarone, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, certain types of irregular heartbeat (second- or third-degree atrioventricular block or sick sinus syndrome, unless you have a heart pacemaker), serious side effects (such as liver/lung disease) from taking the medication amiodarone.
Dronedarone may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.
The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using dronedarone, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).
Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using dronedarone safely.
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
Older adults may be more sensitive to the side effects of this drug, especially QT prolongation (see above).
Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using dronedarone. Dronedarone may harm an unborn baby. Your doctor should order a pregnancy test before you start this medication. Ask about reliable forms of birth control while using this medication and for 5 days after the last dose. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.
It is unknown if this medication passes into breast milk. Because of the possible risk to the infant, breastfeeding is not recommended while using this medication and for 5 days after the last dose. Consult your doctor before breastfeeding.
Side Effects
See also Warning section.
Nausea or diarrhea may occur. If either of these effects lasts or gets worse, tell your doctor promptly.
Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if you have any serious side effects, including: symptoms of liver disease (such as nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine), symptoms of lung problems (such as dry cough that doesn't go away, shortness of breath), signs of kidney problems (such as change in the amount of urine).
Get medical help right away if you have any very serious side effects, including: slow/fast/irregular heartbeat, severe dizziness, fainting.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
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