| Side Effects |
Side Effects
Dronedarone has the potential to induce side effects, and it's important to inform your doctor if you encounter any of the following symptoms, especially if they persist or worsen:
• Diarrhea
• Heartburn
• Weakness
• Rash
• Redness
Certain side effects could be more serious in nature. Should you experience any of the following symptoms, or those highlighted in the IMPORTANT WARNING section, discontinue dronedarone and promptly contact your doctor or seek immediate medical attention:
• Shortness of breath
• Difficulty swallowing or breathing
• Wheezing
• Chest tightness
• Dry cough
• Coughing up frothy mucus
• Difficulty sleeping due to breathing problems
• Needing extra pillows to sleep comfortably due to breathing difficulties
• Sudden weight gain (5 pounds or more) in a brief timeframe
• Swelling of the eyes, face, lips, throat, hands, feet, or legs can occur as a side effect.
• Slowed heartbeat
• Fainting
• Fever
• Flu-like symptoms
• Itching
• Unusual bruising or bleeding
• Nausea
• Vomiting
• Loss of appetite
• Discomfort or pain in the upper right part of the stomach
• Fatigue or lack of energy
• Unusual darkening of urine
• Light-colored stools
• Sudden severe headache
• Sudden complete or partial loss of vision
• Weakness or numbness in an arm or leg
• Difficulty in clear thinking, memory, or learning new information
It is possible that dronedarone may lead to other side effects not mentioned here. Should you encounter any unusual issues while using this medication, contact your doctor for further guidance and evaluation.
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| Storage |
Storage
Ensure that you store this medication properly by following these guidelines:
• Keep it in the original container, tightly sealed, and out of the reach of children.
• Store it at room temperature, away from excessive heat and moisture, avoiding bathroom storage.
• Dispose of any unused medication in a manner that prevents access by pets, children, or others. Do not flush it down the toilet. Consider participating in a medicine take-back program, which can be coordinated through your pharmacist or local garbage/recycling department.
• Keep all medication containers, including those for weekly pill organizers, eye drops, creams, patches, and inhalers, out of reach and sight of young children, as these containers may not be child-resistant and can be easily opened. To safeguard against accidental poisoning, always secure safety caps and promptly store medication in a safe location, ensuring it is out of the reach and sight of children.
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| Special Precaution |
Special Precaution
Before starting dronedarone, it is essential to provide comprehensive information to your doctor and pharmacist, as follows:
• Notify them if you have any allergies to dronedarone, other medications, or any components present in dronedarone tablets. You can consult the Medication Guide or inquire with your pharmacist for a list of ingredients.
• Inform your healthcare provider if you are currently taking any of the following medications: specific antidepressants like amitriptyline (found in Limbitrol), amoxapine, clomipramine (Anafranil), desipramine (Norpramin), doxepin (Sinequan), imipramine (Tofranil), nortriptyline (Aventyl, Pamelor), protriptyline (Vivactil), and trimipramine (Surmontil); certain antifungal drugs including itraconazole (Sporanox), ketoconazole (Nizoral), or voriconazole (Vfend); clarithromycin (Biaxin); cyclosporine (Gengraf, Neoral, Sandimmune); erythromycin (E.E.S., E-Mycin, Erythrocin); medications for irregular heartbeats such as amiodarone (Cordarone, Pacerone), disopyramide (Norpace), dofetilide (Tikosyn), flecainide (Tambocor), propafenone (Rythmol), quinidine, and sotalol (Betapace); nefazodone; phenothiazine medications for mental health issues or nausea; ritonavir (Norvir); or telithromycin (Ketek). Your doctor may advise against taking dronedarone if you are using any of these drugs.
• Ensure your doctor and pharmacist are aware of all prescription and nonprescription medications, vitamins, and nutritional supplements you are currently taking or plan to take. Highlight the use of anticoagulants (blood thinners) such as dabigatran (Pradaxa) and warfarin (Coumadin); beta blockers such as atenolol (Tenormin), labetalol (Normodyne), metoprolol (Lopressor, Toprol XL), nadolol (Corgard), and propranolol (Inderal); calcium channel blockers like diltiazem (Cardizem, Dilacor, Tiazac), nifedipine (Adalat, Procardia), and verapamil (Calan, Covera, Isoptin, Verelan); carbamazepine (Epitol, Equetro, Tegretol); cholesterol-lowering medications (statins) such as atorvastatin (Lipitor), fluvastatin (Lescol), lovastatin (Mevacor), pravastatin (Pravachol), and simvastatin (Zocor); digoxin (Lanoxicaps, Lanoxin); diuretics (water pills); phenobarbital; phenytoin (Dilantin); rifampin (Rifadin, Rimactane); selective serotonin reuptake inhibitors (SSRIs) like citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), paroxetine (Paxil), and sertraline (Zoloft); sirolimus (Rapamune); and tacrolimus (Prograf). Your doctor may need to adjust your medication doses or closely monitor you for potential side effects.
• Mention any herbal products you are using, particularly St. John's wort.
• If you have other heart problems such as a fast or slow heartbeat, a prolonged QT interval (a heart condition associated with irregular heartbeat, fainting, or sudden death), liver disease, or if you have experienced liver or lung issues after taking amiodarone (Cordarone, Pacerone), please share this information with your doctor. They may advise against dronedarone use.
• If you are pregnant or planning to become pregnant, it is crucial to communicate this to your doctor. During dronedarone treatment, effective birth control must be used, so consult with your doctor about suitable birth control methods for you. In case you become pregnant while taking dronedarone, contact your doctor immediately, as dronedarone may pose risks to the fetus.
• Breastfeeding is not recommended during dronedarone treatment.
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| Important Warning |
Important Warning
Dronedarone is contraindicated in individuals with severe heart failure, as it may elevate the risk of death in people suffering from this condition. To determine your eligibility for dronedarone, it is crucial to inform your doctor if you have heart failure of such severity that it causes breathlessness at rest, after minimal physical exertion, or following any physical activity. Additionally, even if you are currently feeling better, it is essential to notify your doctor if you have been hospitalized for heart failure within the past month. In such cases, dronedarone may not be prescribed.
Moreover, dronedarone should not be taken by individuals with atrial fibrillation, a heart rhythm disorder characterized by a fast and irregular heartbeat, which cannot be reverted to a normal heart rhythm. This is because dronedarone may heighten the risk of death, stroke, and the necessity for hospitalization in individuals with permanent atrial fibrillation.
Your doctor will regularly monitor your heart rhythm, with assessments scheduled at least every three months during your dronedarone treatment. If you experience a sudden increase in heart rate or an irregular heartbeat while taking dronedarone, promptly contact your doctor.
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