Multaq Side Effects
Generic name: dronedarone
Medically reviewed by Drugs.com. Last updated on May 23, 2024.
Note: This document provides detailed information about Multaq Side Effects associated with dronedarone. Some dosage forms listed on this page may not apply specifically to the brand name Multaq.
Applies to dronedarone: oral tablet.
Important warnings
This medicine can cause some serious health issues
Oral route (tablet)
In patients with symptomatic heart failure and recent decompensation requiring hospitalization or NYHA Class IV heart failure, dronedarone hydrochloride doubles the risk of death.
Dronedarone hydrochloride is contraindicated in patients with symptomatic heart failure with recent decompensation requiring hospitalization or NYHA Class IV heart failure.
In patients with permanent atrial fibrillation, dronedarone hydrochloride doubles the risk of death, stroke, and hospitalization for heart failure.
Dronedarone hydrochloride is contraindicated in patients in atrial fibrillation (AF) who will not or cannot be cardioverted into normal sinus rhythm .
Precautions
It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.
Using this medicine while you are pregnant can harm your unborn baby. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting this medicine. Use an effective form of birth control during treatment and for 5 days after the last dose. If you think you have become pregnant while using the medicine, tell your doctor right away.
Do not use this medicine if you are also using cyclosporine (Gengraf®, Neoral®, Sandimmune®), ritonavir (Norvir®), medicine for depression (eg, nefazodone, Serzone®), medicine for heart rhythm problems (eg, amiodarone, disopyramide, dofetilide, flecainide, propafenone, quinidine, sotalol, Cardioquin®, Cordarone®, Norpace®, Tikosyn®), medicine for infections (eg, clarithromycin, erythromycin, itraconazole, ketoconazole, telithromycin, voriconazole, Ery-tab®, Ketek®, Klaricid®, Nizoral®, Sporanox®, Vfend®), or a phenothiazine medicine (eg, chlorpromazine, prochlorperazine, promethazine, thioridazine, Compazine®, Mellaril®, Phenergan®, Thorazine®, Trilafon®). Using these medicines together may cause serious side effects.
Check with your doctor right away if you have chest pain, swelling of your hands, ankles, or feet, trouble breathing, or weight gain. These may be symptoms of heart failure.
This medicine can cause changes in your heart rhythm, including QT prolongation. It may cause fainting or serious side effects in some patients. Contact your doctor right away if you have fast, pounding, or irregular heartbeats.
Check with your doctor right away if you have upper stomach pain, pale stools, dark urine, loss of appetite, nausea, unusual tiredness, or yellow eyes or skin. These could be symptoms of a serious liver problem.
This medicine may cause lung problems (eg, interstitial lung disease, pneumonitis, and pulmonary fibrosis). Check with your doctor right away if you have chest pain, chills, cough, fever, general feeling of discomfort or illness, thickening of bronchial secretions, or trouble breathing.
Hypokalemia (low potassium in the blood) or hypomagnesemia (low magnesium in the blood) can occur with this medicine. Check with your doctor right away if you have decreased urine, drowsiness, dry mouth, irregular heartbeat, increased thirst, loss of appetite, mood changes, muscle pain, cramps, spasms or twitching, nausea or vomiting, numbness or tingling in the hands, feet, or lips, seizures, trembling, trouble breathing, or unusual tiredness or weakness.
This medicine may increase the risk for heart attack, stroke, or other serious side effects. Talk to your doctor about whether you should continue to take this medicine.
Do not Stop taking dronedarone (the active ingredient contained in Multaq) without first checking with your doctor.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.
Common side effects of Multaq
Some side effects of dronedarone may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.
Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common side effects
- diarrhea
- lack or loss of strength
Less common side effects
- acid or sour stomach
- belching
- blistering, crusting, irritation, itching, or reddening of the skin
- cracked, dry, or scaly skin
- heartburn
- indigestion
- itching skin
- rash
- redness or discoloration of the skin
- skin rash, encrusted, scaly, and oozing
- skin rash, hives, itching, or redness
- stomach discomfort, upset, or pain
- swelling
Rare side effects
- change in taste
- increased sensitivity of the skin to sunlight
- loss of taste
- severe sunburn
Serious side effects of Multaq
Along with its needed effects, dronedarone may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking dronedarone:
Less common side effects
- chest pain or discomfort
- lightheadedness, dizziness, or fainting
- slow or irregular heartbeat
- trouble breathing
- unusual tiredness
Incidence not known
- chills
- cough
- dark urine
- fever
- general feeling of discomfort or illness
- loss of appetite
- nausea or vomiting
- stomach pain
- thickening of bronchial secretions
- unusual tiredness or weakness
- yellow eyes or skin
For healthcare professionals
Applies to dronedarone: oral tablet.
General adverse events
- Common (1% to 10%): Asthenia, fatigue[Ref]
Renal
- Frequency not reported: Hypokalemia and hypomagnesemia with potassium-depleting diuretics, serum creatinine increased 10% or more within 5 days after treatment initiation[Ref]
Gastrointestinal
- Common (1% to 10%): Diarrhea, nausea, abdominal pain, vomiting, dyspeptic symptoms
- Frequency not reported: Dysgeusia, ageusia[Ref]
Dermatologic
- Common (1% to 10%): Rashes (generalized, macular, maculopapular, erythematous), pruritus, eczema, dermatitis, allergic dermatitis
- Uncommon (0.1% to 1%): Photosensitivity[Ref]
Cardiovascular
- Very common (10% or more): QT prolongation (28%)
- Common (1% to 10%): Bradycardia
- Very rare (less than 0.01%): New or worsening heart failure, atrial flutter with 1:1 atrioventricular conduction[Ref]
Hepatic
- Frequency not reported: Liver injury, including acute liver failure requiring transplant, serum hepatic enzymes, serum bilirubin increase
Respiratory
- Frequency not reported: Dyspnea, nonproductive cough
- Postmarketing reports: Interstitial lung disease including pneumonitis and pulmonary fibrosis
Genitourinary
- Common (1% to 10%): Urinary tract infection
Hematologic
- Postmarketing reports: Vasculitis, including leukocytoclastic vasculitis
Immunologic
- Postmarketing reports: Anaphylactic reactions including angioedema
Metabolic
- Frequency not reported: Increased serum creatinine[Ref]
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References
1. Cerner Multum, Inc. "UK Summary of Product Characteristics."
2. (2009) "Product Information. Multaq (dronedarone)." sanofi-aventis
3. Cerner Multum, Inc. "Australian Product Information."
More about Multaq (dronedarone)
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Further information
Multaq side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.