Risks & Side Effects

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.

Do not use ADVAIR HFA:

• to treat sudden, severe symptoms of asthma
• if you are allergic to any of the ingredients in ADVAIR HFA. 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
• 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 may harm your unborn baby.
• are breastfeeding. It is not known if ADVAIR passes into your milk and if it can harm your baby.
• are allergic to any of the ingredients in ADVAIR, any other medicines, or food products. See Medication Guides for ADVAIR DISKUS and ADVAIR HFA for a complete list of the ingredients in ADVAIR.
• 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 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.

NORVIR and KALETRA are registered trademarks of Abbott Laboratories.

ADVAIR 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.
• slowed growth in children. A child's growth should be checked often.
• 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 the mouth and 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 HFA for asthma 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.

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.

Do not use ADVAIR more often than prescribed.

While you are using ADVAIR, do not use other medicines that contain a LABA for any reason.

Do not stop using ADVAIR 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.

Call your healthcare provider or get medical care right away if:

• your breathing problems worsen with ADVAIR
• 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
• you have asthma and your symptoms do not improve after using ADVAIR regularly for 1 week

Call your doctor for medical advice about side effects.