ADVAIR DISKUS 250/50 (fluticasone propionate 250 mcg and salmeterol 50 mcg inhalation powder) - COPD Treatment, Continued Below, ADVAIR, Risks & Side Effects, Print, Get your first 30-day prescription of ADVAIR for free, Learn More, See how to use ADVAIR DISKUS, Learn More, Learn about ADVAIR DISKUS, Learn More, Live Assistance

Risks & Side Effects

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This is not all the safety information about ADVAIR DISKUS. This information does not replace talking with your healthcare provider about your medical condition or treatment. Please see the complete Prescribing Information, including Boxed Warning and Medication Guide, for ADVAIR DISKUS for more information or ask your healthcare provider or pharmacist.

ADVAIR DISKUS can cause serious side effects, including:

  • People with asthma who take long-acting beta2-adrenergic agonist (LABA) medicines, such as salmeterol (one of the medicines in ADVAIR DISKUS), have an increased risk of death from asthma problems. It is not known whether fluticasone propionate, the other medicine in ADVAIR DISKUS, reduces the risk of death from asthma problems seen with salmeterol.
    • Call your healthcare provider if breathing problems worsen over time while using ADVAIR DISKUS. 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.

Do not use ADVAIR DISKUS:

  • to treat sudden, severe symptoms of asthma or COPD and
  • if you have a severe allergy to milk proteins. Ask your doctor if you are not sure.

Tell your healthcare provider about all of your health conditions, including if you:

  • have heart problems
  • have high blood pressure
  • have seizures
  • have thyroid problems
  • have diabetes
  • have liver problems
  • have osteoporosis
  • have an immune system problem
  • are pregnant or planning to become pregnant. It is not known if ADVAIR DISKUS may harm your unborn baby.
  • are breastfeeding. It is not known if ADVAIR DISKUS passes into your milk and if it can harm your baby.
  • are allergic to any of the ingredients in ADVAIR DISKUS, any other medicines, or food products. See the end of this Medication Guide for a complete list of the ingredients in ADVAIR DISKUS.
  • are exposed to chickenpox or measles

Tell your healthcare provider about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. ADVAIR DISKUS and certain other medicines may interact with each other. This may cause serious side effects. Especially, tell your healthcare provider if you take ritonavir. The anti-HIV medicines NORVIR® (ritonavir capsules) Soft Gelatin, NORVIR (ritonavir oral solution), and KALETRA® (lopinavir/ritonavir) Tablets contain ritonavir.

Know the medicines you take. Keep a list and show it to your healthcare provider and pharmacist each time you get a new medicine.

ADVAIR DISKUS can cause serious side effects, including:

  • See "What is the most important information I should know about ADVAIR DISKUS?"
  • serious allergic reactions. Call your healthcare provider or get emergency medical care if you get any of the following symptoms of a serious allergic reaction:
    • rash
    • hives
    • swelling of the face, mouth, and tongue
    • breathing problems
  • sudden breathing problems immediately after inhaling your medicine
  • effects on heart
    • increased blood pressure
    • a fast and irregular heartbeat
    • chest pain
  • effects on nervous system
    • tremor
    • nervousness
  • reduced adrenal function (may result in loss of energy)
  • changes in blood (sugar, potassium, certain types of white blood cells)
  • weakened immune system and a higher chance of infections
  • lower bone mineral density. This may be a problem for people who already have a higher chance of low bone density (osteoporosis).
  • eye problems including glaucoma and cataracts. You should have regular eye exams while using ADVAIR DISKUS.
  • slowed growth in children. A child's growth should be checked often.
  • pneumonia. People with COPD have a higher chance of getting pneumonia. ADVAIR DISKUS may increase the chance of getting pneumonia. Call your healthcare provider if you notice any of the following symptoms:
    • increase in mucus (sputum) production
    • change in mucus color
    • fever
    • chills
    • increased cough
    • increased breathing problems
  • Common side effects of ADVAIR include:
  • COPD:
    • thrush in the mouth and throat
    • throat irritation
    • hoarseness and voice changes
    • viral respiratory infections
    • headache
    • muscle and bone pain
  • After each dose, rinse your mouth with water and spit the water out. Do not swallow.

Tell your healthcare provider about any side effect that bothers you or that does not go away.

These are not all the side effects with ADVAIR DISKUS. Ask your healthcare provider or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Active ingredients: fluticasone propionate, salmeterol xinafoate
Inactive ingredient: lactose (contains milk proteins)

Approved Uses for ADVAIR DISKUS 250/50 for COPD

ADVAIR DISKUS 250/50 is approved for adults with with chronic obstructive pulmonary disease (COPD), including chronic bronchitis, emphysema, or both. ADVAIR DISKUS is not for, and should not be used to treat, sudden, severe symptoms of COPD. ADVAIR DISKUS won't replace a rescue inhaler. You should only take 1 inhalation of ADVAIR DISKUS twice a day. Higher doses will not provide additional benefits.

Important Safety Information for ADVAIR DISKUS® 250/50 (fluticasone propionate 250 mcg and salmeterol 50 mcg inhalation powder)

  • People with asthma who take long-acting beta2-adrenergic agonist (LABA) medicines, such as salmeterol (one of the medicines in ADVAIR DISKUS), have an increased risk of death from asthma problems. It is not known whether fluticasone propionate, the other medicine in ADVAIR DISKUS, reduces the risk of death from asthma problems seen with salmeterol.
    • Call your healthcare provider if breathing problems worsen over time while using ADVAIR DISKUS. 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.
  • Do not use ADVAIR DISKUS to treat sudden, severe symptoms of asthma or COPD. Always have a rescue inhaler medicine with you to treat sudden symptoms.
  • Do not use ADVAIR DISKUS if you have a severe allergy to milk proteins. Ask your doctor if you are not sure.
  • Do not use ADVAIR DISKUS more often than prescribed. Do not take ADVAIR DISKUS with other medicines that contain long-acting beta2-agonists for any reason. Tell your doctor about medicines you take and about all of your medical conditions.
  • ADVAIR DISKUS can cause serious side effects, including:
    • serious allergic reactions. Call your healthcare provider or get emergency medical care if you get any of the following symptoms of a serious allergic reaction:
      • rash
      • hives
      • swelling of the face, mouth, and tongue
      • breathing problems
    • sudden breathing problems immediately after inhaling your medicine
    • effects on heart
      • increased blood pressure
      • a fast and irregular heartbeat
      • chest pain
    • effects on nervous system
      • tremor
      • nervousness
    • reduced adrenal function (may result in loss of energy)
    • changes in blood (sugar, potassium, certain types of white blood cells)
    • weakened immune system and a higher chance of infections. You should avoid exposure to chickenpox and measles, and, if exposed, consult your healthcare provider without delay. Worsening of existing tuberculosis, fungal, bacterial, viral, or parasitic infections, or ocular herpes simplex may occur.
    • lower bone mineral density. This may be a problem for people who already have a higher chance of low bone density (osteoporosis).
    • eye problems including glaucoma and cataracts. You should have regular eye exams while using ADVAIR DISKUS.
    • pneumonia. People with COPD have a higher chance of getting pneumonia. ADVAIR DISKUS may increase the chance of getting pneumonia. Call your doctor if you notice any of the following symptoms:
      • increase in mucus (sputum) production
      • change in mucus color
      • fever
      • chills
      • increased cough
      • increased breathing problems
    • Common side effects of ADVAIR DISKUS 250/50 for COPD include:
      • thrush in the mouth and throat
      • throat irritation
      • hoarseness and voice changes
      • viral respiratory infections
      • headache
      • muscle and bone pain
    • After each dose, rinse your mouth with water and spit the water out. Do not swallow.

    Complete Prescribing Information, including Boxed Warning and Medication Guide, for ADVAIR DISKUS


    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.

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