IMPORTANT SAFETY INFORMATION

People with asthma who take long-acting beta2-adrenergic agonist (LABA) medicines, such as salmeterol (one of the medicines in ADVAIR), have an increased risk of death from asthma problems.
See full Important Safety Information below

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Risks and Side Effects for ADVAIR DISKUS

Please review this safety information.

Below you can learn about the risks and side effects of ADVAIR. This, however, is not all the safety information, and does not replace your talking to your healthcare professional about your medical condition or treatment. Please see the complete Prescribing Information, including Boxed Warning and Medication Guide, for
ADVAIR DISKUS and ADVAIR HFA for more information or ask your healthcare provider or pharmacist.

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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 LABA medicines.
  • It is not known if LABA medicines such as salmeterol increase the risk of death in people with COPD.
  • Call your healthcare provider if breathing problems worsen over time while using
    ADVAIR DISKUS.
    You may need different treatment.
  • Get emergency medical care if:
    • your breathing problems worsen quickly.
    • you use your rescue inhaler, but it does not relieve your breathing problems.
  • ADVAIR DISKUS 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 ADVAIR DISKUS. Your healthcare provider will decide if you can stop ADVAIR DISKUS without loss of asthma control. Your healthcare provider may prescribe a different 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.

Do not use ADVAIR DISKUS if you:

  • have a severe allergy to milk proteins. Ask your healthcare provider if you are not sure.
  • are allergic to fluticasone propionate, salmeterol, or any of the ingredients in ADVAIR DISKUS. See "What are the ingredients in ADVAIR HFA?" below for a list of ingredients in ADVAIR HFA.

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 weak bones (osteoporosis).
  • have an immune system problem.
  • have eye problems such as glaucoma or cataracts.
  • are allergic to any of the ingredients in ADVAIR DISKUS, any other medicines, or food products. See “What are the ingredients in ADVAIR DISKUS?” below for a complete list of ingredients.
  • have any type of viral, bacterial, or fungal infection.
  • are exposed to chickenpox or measles.
  • have any other medical conditions.
  • 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 the medicines in ADVAIR DISKUS pass into your milk and if they can harm your baby.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter 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 antifungal or anti-HIV medicines.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

Read the step-by-step instructions for using ADVAIR DISKUS at the end of the Medication Guide for ADVAIR DISKUS.

  • Do not use ADVAIR DISKUS unless your healthcare provider has taught you how to use the inhaler and you understand how to use it correctly.
  • Children should use ADVAIR DISKUS with an adult’s help, as instructed by the child’s healthcare provider.
  • ADVAIR DISKUS comes in 3 different strengths. Your healthcare provider prescribed the strength that is best for you.
  • Use ADVAIR DISKUS exactly as your healthcare provider tells you to use it. Do not use ADVAIR DISKUS more often than prescribed.
  • Use 1 inhalation of ADVAIR DISKUS 2 times each day. Use ADVAIR DISKUS at the same time each day, about 12 hours apart.
  • If you miss a dose of ADVAIR DISKUS, just skip that dose. Take your next dose at your usual time. Do not take 2 doses at 1 time.
  • If you take too much ADVAIR DISKUS, call your healthcare provider or go to the nearest hospital emergency room right away if you have any unusual symptoms, such as worsening shortness of breath, chest pain, increased heart rate, or shakiness.
  • Do not use other medicines that contain a LABA for any reason. Ask your healthcare provider or pharmacist if any of your other medicines are LABA medicines.
  • Do not stop using ADVAIR DISKUS unless told to do so by your healthcare provider because your symptoms might get worse. Your healthcare provider will change your medicines as needed.
  • ADVAIR DISKUS does not relieve sudden symptoms. Always have a rescue inhaler with you to treat sudden symptoms. If you do not have a rescue inhaler, call your healthcare provider to have one prescribed for you.
  • Call your healthcare provider or get medical care right away if:
    • your breathing problems get worse.
    • you need to use your rescue inhaler more often than usual.
    • your rescue inhaler does not work as well to relieve your symptoms.
    • you need to use 4 or more inhalations of your rescue inhaler in 24 hours for 2 or more days in a row.
    • you use 1 whole canister of your rescue inhaler in 8 weeks.
    • your peak flow meter results decrease. Your healthcare provider will tell you the numbers that are right for you.
    • you have asthma and your symptoms do not improve after using ADVAIR DISKUS regularly for 1 week.

ADVAIR DISKUS can cause serious side effects, including:

  • See “What is the most important information I should know about ADVAIR DISKUS?”
  • fungal infection in your mouth or throat (thrush). Rinse your mouth with water without swallowing after using ADVAIR DISKUS to help reduce your chance of getting thrush.
  • 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
  • weakened immune system and increased chance of getting infections (immunosuppression)
  • reduced adrenal function (adrenal insufficiency). Adrenal insufficiency is a condition where the adrenal glands do not make enough steroid hormones. This can happen when you stop taking oral corticosteroid medicines (such as prednisone) and start taking a medicine containing an inhaled steroid (such as ADVAIR DISKUS). When your body is under stress such as from fever, trauma (such as a car accident), infection, surgery, or worse COPD symptoms, adrenal insufficiency can get worse and may cause death.
    Symptoms of adrenal insufficiency include:
    • feeling tired
    • lack of energy
    • weakness
    • nausea and vomiting
    • low blood pressure
  • sudden breathing problems immediately after inhaling your medicine
  • 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 your face, mouth, and tongue
    • breathing problems
  • effects on heart
    • increased blood pressure
    • a fast or irregular heartbeat
    • chest pain
  • effects on nervous system
    • tremor
    • nervousness
  • bone thinning or weakness (osteoporosis)
  • slowed growth in children. A child’s growth should be checked often.
  • eye problems including glaucoma and cataracts. You should have regular eye exams while using ADVAIR DISKUS.
  • changes in laboratory blood values (sugar, potassium, certain types of white blood cells)
  • Common side effects of ADVAIR DISKUS include:
  • In people with asthma:
  • upper respiratory tract infection
  • throat irritation
  • hoarseness and voice changes
  • thrush in your mouth or throat. Rinse your mouth with water without swallowing after use to
    help prevent this.
  • bronchitis
  • cough
  • headache
  • nausea and vomiting
  • In children with asthma, infections in the ear, nose, and throat are common.
  • In people with COPD:
  • thrush in your mouth or throat. Rinse your mouth with water without swallowing after use to
    help prevent this.
  • throat irritation
  • hoarseness and voice changes
  • viral respiratory infections
  • headache
  • muscle and bone pain
  • 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.
  • Store ADVAIR DISKUS at room temperature between 68°F and 77°F (20°C and 25°C). Keep in a dry place away from heat and sunlight.
  • Store ADVAIR DISKUS in the unopened foil pouch and only open when ready for use.
  • Safely throw away ADVAIR DISKUS in the trash 1 month after you open the foil pouch or when the counter reads 0, whichever comes first.
  • Keep ADVAIR DISKUS and all medicines out of the reach of children.

    Active ingredients: fluticasone propionate, salmeterol xinafoate

    Inactive ingredient: lactose monohydrate (contains milk proteins)

Risks and Side Effects for ADVAIR HFA

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ADVAIR HFA 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 HFA), have an increased risk of death from asthma problems. It is not known whether fluticasone propionate, the other medicine in ADVAIR HFA, reduces the risk of death from asthma problems seen with salmeterol.
  • Call your healthcare provider if breathing problems worsen over time while using ADVAIR HFA. 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.
  • ADVAIR HFA 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 inhaled corticosteroids.
  • When your asthma is well controlled, your healthcare provider may tell you to stop taking ADVAIR HFA. Your healthcare provider will decide if you can stop ADVAIR HFA 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.

Do not use ADVAIR HFA:

  • to treat sudden, severe symptoms of asthma and
  • if you are allergic to any of the ingredients in ADVAIR HFA. See "What are the ingredients in
    ADVAIR HFA?" below for a list of ingredients in ADVAIR HFA.

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.
  • have eye problems such as increased pressure in the eye (glaucoma) or cataracts.
  • are pregnant or planning to become pregnant. It is not known if ADVAIR HFA may harm your
    unborn baby.
  • are breastfeeding. It is not known if ADVAIR HFA passes into your milk and if it can harm your baby.
  • are allergic to ADVAIR HFA or any other medicines.
  • 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 HFA 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.

See the step-by-step instructions for using ADVAIR HFA at the end of the Medication Guide for ADVAIR HFA. Do not use ADVAIR HFA unless your healthcare provider has taught you and you understand everything. Ask your healthcare provider or pharmacist if you have any questions.

  • Use ADVAIR HFA exactly as prescribed. Do not use ADVAIR HFA more often than prescribed. ADVAIR HFA comes in 3 strengths. Your healthcare provider has prescribed the one that is best for your condition.
  • The usual dosage of ADVAIR HFA is 2 inhalations 2 times each day (morning and evening). The 2 doses should be about 12 hours apart. Rinse your mouth with water after using ADVAIR HFA.
  • If you take more ADVAIR HFA than your doctor has prescribed, get medical help right away if you have any unusual symptom, such as worsening shortness of breath, chest pain, increased heart rate, or shakiness.
  • If you miss a dose of ADVAIR HFA, just skip that dose. Take your next dose at your usual time. Do not take 2 doses at one time.
  • While you are using ADVAIR HFA 2 times each day, do not use other medicines that contain a LABA for any reason. Ask your healthcare provider or pharmacist if any of your other medicines are LABA medicines.
  • Do not stop using ADVAIR HFA or other asthma medicines unless told to do so by your healthcare provider because your symptoms might get worse. Your healthcare provider will change your medicines as needed.
  • ADVAIR HFA does not relieve sudden symptoms. Always have a rescue inhaler medicine with you to treat sudden symptoms. If you do not have a short-acting bronchodilator rescue inhaler, call your healthcare provider to have one prescribed for you.
  • Call your healthcare provider or get medical care right away if:
    • your breathing problems worsen with ADVAIR HFA.
    • you need to use your rescue inhaler medicine more often than usual.
    • your rescue inhaler medicine does not work as well for you at relieving symptoms.
    • you need to use 4 or more inhalations of your rescue inhaler medicine for 2 or more days in a row.
    • you use 1 whole canister of your rescue inhaler medicine in 8 weeks’ time.
    • your peak flow meter results decrease. Your healthcare provider will tell you the numbers that are right for you.
    • your asthma symptoms do not improve after using ADVAIR HFA regularly for 1 week.

ADVAIR HFA can cause serious side effects, including:

  • See "What is the most important information I should know about ADVAIR HFA?"
  • 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 HFA.
  • slowed growth in children. A child’s growth should be checked often.
  • throat tightness
  • pneumonia. ADVAIR HFA contains the same medicine found in ADVAIR DISKUS. ADVAIR DISKUS is used to treat people with asthma and people with chronic obstructive pulmonary disease (COPD). People with COPD have a higher chance of getting pneumonia. ADVAIR DISKUS may increase the chance of getting pneumonia. ADVAIR HFA has not been studied in people with COPD. 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 HFA include:
  • upper respiratory tract infection
  • throat irritation
  • hoarseness and voice changes
  • headache
  • dizziness
  • nausea and vomiting
  • 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 HFA. 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.
  • Store ADVAIR HFA at room temperature between 59°F to 86°F (15°C to 30°C), with the mouthpiece down.
  • Contents Under Pressure: Do not puncture. Do not use or store near heat or open flame. Exposure to temperatures above 120°F may cause bursting.
  • Do not throw into fire or an incinerator.
  • Keep ADVAIR HFA and all medicines out of the reach of children.

Active ingredients: fluticasone propionate, salmeterol xinafoate

Inactive ingredient: propellant HFA-134a

Approved Uses for ADVAIR

ADVAIR DISKUS is a prescription medicine for the treatment of asthma in patients 4 years and older.
ADVAIR HFA is a prescription medicine for the treatment of asthma in patients 12 years and older.

ADVAIR 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.

ADVAIR DISKUS 250/50 is a prescription medicine approved for adults with chronic obstructive pulmonary disease (COPD), including chronic bronchitis, emphysema, or both. You should only take 1 inhalation of ADVAIR DISKUS twice a day. Higher doses will not provide additional benefits.

ADVAIR is not for, and should not be used to treat, sudden symptoms of asthma or COPD. ADVAIR won't replace a rescue inhaler.

ADVAIR HFA is not approved for the treatment of COPD.

Important Safety Information for ADVAIR

  • People with asthma who take long-acting beta2-adrenergic agonist (LABA) medicines, such as salmeterol (one of the medicines in ADVAIR), have an increased risk of death from asthma problems. It is not known whether fluticasone propionate, the other medicine in ADVAIR, reduces the risk of death from asthma problems seen with LABA medicines, such as salmeterol.
  • It is not known if LABA medicines, such as salmeterol, increase the risk of death in people with COPD.
  • Call your healthcare provider if breathing problems worsen over time while using ADVAIR. You may need different treatment.
  • Get emergency medical care if:
    • your breathing problems worsen quickly
    • you use your rescue inhaler, but it does not relieve your breathing problems
  • ADVAIR 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 ADVAIR. Your healthcare provider will decide if you can stop ADVAIR without loss of asthma control. Your healthcare provider may prescribe a different asthma control medicine for you, such as an inhaled corticosteroid.
  • Children and adolescents with asthma who take LABA medicines may have an increased risk of hospitalization for asthma problems.
  • Do not use ADVAIR to treat sudden symptoms of asthma or COPD. Always have a rescue inhaler with you to treat sudden symptoms.
  • Do not use ADVAIR DISKUS if you have a severe allergy to milk proteins. Do not use ADVAIR DISKUS or ADVAIR HFA if you are allergic to any of the ingredients in the products. Ask your healthcare provider if you are not sure.
  • Do not use ADVAIR more often than prescribed.
  • Do not take ADVAIR with other medicines that contain a LABA for any reason.
  • Tell your healthcare provider about all the medicines you take and about all of your health conditions.
  • ADVAIR can cause serious side effects, including:
    • fungal infection in your mouth or throat (thrush). Rinse your mouth with water without swallowing after using ADVAIR to help reduce your chance of getting thrush.
    • 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
    • weakened immune system and increased chance of getting infections (immunosuppression). You should avoid exposure to chickenpox and measles, and, if exposed, tell your healthcare provider right away. Worsening of existing tuberculosis, fungal, bacterial, viral, or parasitic infections, or herpes infection of the eye (ocular herpes simplex) may occur.
    • reduced adrenal function. This can happen when you stop taking an oral corticosteroid (such as prednisone) and start taking a medicine containing an inhaled corticosteroid (such as ADVAIR). When your body is under stress such as from fever, trauma (such as a car accident), infection, surgery, or worse COPD symptoms, adrenal insufficiency can get worse and may cause death. Symptoms of adrenal insufficiency include:
      • feeling tired
      • lack of energy
      • weakness
      • nausea and vomiting
      • low blood pressure
    • sudden breathing problems immediately after inhaling your medicine
    • 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 your face, mouth, and tongue
      • breathing problems
    • effects on heart
      • increased blood pressure
      • a fast or irregular heartbeat
      • chest pain
    • effects on nervous system
      • tremor
      • nervousness
    • bone thinning or weakness (osteoporosis)
    • slowed growth in children. A child’s growth should be checked often.
    • eye problems including glaucoma and cataracts. You should have regular eye exams
      while using ADVAIR.
    • changes in laboratory blood values (sugar, potassium, certain types of white blood cells)
    • ADVAIR HFA can cause throat tightness.
  • Common side effects of ADVAIR DISKUS for asthma include:
    • upper respiratory tract infection
    • throat irritation
    • hoarseness and voice changes
    • thrush in your mouth or throat
    • bronchitis
    • cough
    • headache
    • nausea and vomiting
  • In children with asthma, infections in the ear, nose, and throat are common.
  • Common side effects of ADVAIR DISKUS 250/50 for COPD include:
    • thrush in your mouth or throat
    • throat irritation
    • hoarseness and voice changes
    • viral respiratory infections
    • headache
    • muscle and bone pain
  • Common side effects of ADVAIR HFA for asthma include:
    • upper respiratory tract infection
    • throat irritation
    • hoarseness and voice changes
    • headache
    • dizziness
    • nausea and vomiting
  • Rinse your mouth with water without swallowing after using ADVAIR to help reduce your chance of
    getting thrush.