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What is DULERA?
Using Your DULERA Inhaler
Possible Side Effects
Talking to Your Doctor
Asthma Control Checklist
Special Offers and More Information
Helpful Info and Support

Important Safety Information About DULERA

  • People with asthma who take long-acting beta2-adrenergic agonist (LABA) medicines such as formoterol (one of the medicines in DULERA), have an increased risk of death from asthma problems. It is not known whether mometasone furoate, the other medicine in DULERA, reduces the risk of death from asthma problems seen with formoterol.
    • Call your healthcare provider if breathing problems worsen over time while using DULERA. You may need different treatment.
    • Get emergency medical care if breathing problems worsen quickly, and you use your rescue inhaler medicine, but it does not relieve your breathing problems.
  • DULERA should be used only if your healthcare provider decides that your asthma is not well controlled with a long-term asthma-control medicine, such as an inhaled corticosteroid.
  • When your asthma is well controlled, your healthcare provider may tell you to stop taking DULERA. Your healthcare provider will decide if you can stop DULERA without loss of asthma control. Your healthcare provider may prescribe a different long-term asthma-control medicine for you, such as an inhaled corticosteroid.
  • Children and adolescents who take LABA medicines may have an increased risk of being hospitalized for asthma problems.
  • DULERA does not replace rescue inhalers for sudden asthma symptoms. Always have a rescue inhaler medicine with you to treat sudden symptoms.
  • Do not use DULERA more often than prescribed. Do not take DULERA with other medicines that contain a LABA for any reason, as using too much LABA may cause chest pain, increase or decrease in blood pressure, fast and irregular heartbeat, headache, tremor, nervousness, dizziness, weakness, seizures and electrocardiogram (ECG) changes. Tell your doctor about medicines you take and about all of your medical conditions.
  • People taking DULERA may experience
    • Serious allergic reactions. Call your healthcare provider or get emergency medical care if you get any of these symptoms of a serious allergic reaction: rash, hives, swelling, including swelling of the face, mouth and tongue, or breathing problems.
    • Thrush (yeast infection) in the mouth and throat.
    • A higher chance of infection. Avoid exposure to chickenpox or measles. If exposed, or if you have any signs of infection, tell your healthcare provider immediately. Worsening of existing tuberculosis, fungal, bacterial, viral or parasitic infections, or ocular herpes simplex may occur.
    • Reduced adrenal function (may result in loss of energy). This can happen when you stop taking oral corticosteroid medicines and start inhaled corticosteroid medicines.
    • Increase in wheezing right after taking DULERA.
    • Lower bone mineral density. This may be a problem for people who already have a higher chance for low bone density (osteoporosis).
    • Slowed growth in children.
    • Eye problems including glaucoma and cataracts. You should have regular eye exams while using DULERA.
    • Decrease in blood potassium and increase in blood sugar levels.
  • If you are switching to DULERA from an oral corticosteroid, follow your healthcare provider's instructions to avoid serious health risks when you stop using oral corticosteroids.
  • The most common side effects of DULERA include inflammation of the nose and throat, inflammation of the sinuses, and headache.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1.800.FDA.1088.

Please read the Medication Guide for DULERA, including the information about asthma-related death, and discuss it with your doctor. The physician Prescribing Information also is available.