Important Safety Information for MULTAQ (dronedarone)
What is the most important safety information I should know about MULTAQ?
Do not take MULTAQ if you have symptoms of
heart failure that recently worsened and you were hospitalized, or if you
have severe heart failure. MULTAQ doubles your risk of dying if you have these conditions.
Do not take MULTAQ if you have a type of
atrial fibrillation (AFib) called
permanent AFib. You should not
take MULTAQ if you are in AFib and your doctor is not planning to change you back
into normal rhythm. People with
permanent AFib who take MULTAQ have a higher risk
of death, stroke, and needing to be treated in a hospital for heart failure.
MULTAQ may cause liver problems, including life-threatening liver failure. Call
your doctor right away if you are taking MULTAQ and develop any of these signs and
symptoms of liver problems: loss of appetite; nausea; vomiting; fever; feeling unwell;
unusual tiredness; itching; yellowing of the skin or the whites of the eyes; unusual
darkening of the urine; right upper stomach area pain or discomfort.
When should I call the doctor?
Call your doctor right away if you're taking MULTAQ and have any signs and symptoms
of heart failure. These may include shortness of breath or wheezing at rest; wheezing,
chest tightness, or coughing up frothy sputum at rest, nighttime, or after minor
exercise; trouble sleeping or waking up at night or using more pillows to prop yourself
at night because of breathing problems; weight gain; or foot or leg swelling.
Call your doctor right away if you notice that your heartbeat or pulse is irregular.
This is a sign that you are in AFib.
Call your doctor if you develop shortness of breath or a dry cough during treatment
Call your doctor if you experience an allergic reaction, such as itchy rash, low
blood pressure, or rapid swelling of the throat or skin, especially around the lips
Who else shouldn't take MULTAQ?
You should not take MULTAQ if you are allergic to dronedarone or any of the other
ingredients in MULTAQ.
You should not take MULTAQ if you have severe liver problems or if you had liver
or lung problems after using amiodarone.
You should not take MULTAQ if you have a certain type of heart problem called heart
block, and you do not have an implanted pacemaker.
You should not take MULTAQ if you are breastfeeding, pregnant, or plan to become
pregnant as it is not known if it may pass to or harm your baby. Women who may become
pregnant should use effective birth control while taking MULTAQ. Talk to your doctor
about the best birth control methods for you.
Are there any medications I should avoid while taking MULTAQ?
MULTAQ can interact with certain medications. Do not use the following medications
Are there other medicines that would be harmful when taken with MULTAQ?
The following medicines can lead to a dangerous abnormal heart
rhythm if taken with
- Tricyclic antidepressants
- Certain medicines used to treat an abnormal heart
rhythm or fast heartbeat
What are possible serious side effects from taking MULTAQ?
MULTAQ may cause serious side effects including slowed heartbeat, inflammation of
the lungs (including scarring and thickening), low potassium and magnesium levels
in your blood, and changes in kidney function blood tests.
What are the most common side effects?
The most common side effects when taking MULTAQ include stomach problems such as
diarrhea, nausea, vomiting, stomach area pain, and indigestion; feeling tired and
weak; skin problems such as redness, rash, and itching. Tell your doctor about any
side effect that bothers you or that does not go away.
Are there other things I should avoid while taking MULTAQ?
Do not drink grapefruit juice while taking MULTAQ, as this can increase the likelihood
that you will have a side effect of MULTAQ.
What else should I tell my doctor?
Tell your doctor about all medications, vitamins, and herbal remedies (including
St. John's Wort) you take to help avoid serious drug interactions.
Is it OK to take a diuretic ("water pill") while on MULTAQ?
Your potassium levels should be within the normal range prior to and while taking
MULTAQ. Tell your doctor about any diuretic medications ("water pills") you are
taking as some can lower the level of potassium or magnesium in your blood.
Will I need any tests while I'm on MULTAQ?
Your doctor will monitor your heart rhythm regularly to make sure your heartbeat
keeps a normal rhythm. Your doctor may perform certain tests, such as heart exams
and blood tests, while you're taking MULTAQ.
Full Prescribing Information Including boxed WARNING
Medication Guide (English)
Remember, your doctor is the single best source of
information regarding your health. Please consult your doctor if you have any questions
about your health or your medicine.
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