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

A A A

Talk to your doctor to learn more about ADVAIR.

PRESCRIBING INFORMATION

Click to see full safety and Prescribing Information, including Boxed Warning, for
ADVAIR DISKUS and ADVAIR HFA.

MORE INFO FOR ADVAIR DISKUS
MORE INFO FOR ADVAIR HFA

MEDICATION GUIDE

Read the Medication Guide for ADVAIR DISKUS and Medication Guide for ADVAIR HFA.


MEDICATION GUIDE FOR ADVAIR DISKUS
MEDICATION GUIDE FOR ADVAIR HFA

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.