Breztri Aerosphere can cause serious side effects, including:
fungal infection in your mouth or throat (thrush). Rinse your mouth with water without swallowing after using Breztri Aerosphere to help reduce your chance of getting thrush.
pneumonia. People with COPD have a higher chance of getting pneumonia. Breztri Aerosphere may increase your 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 ICS (such as Breztri Aerosphere). During this transition period, when your body is under stress 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 (hypotension)
sudden breathing problems immediately after inhaling your medicine. If you have sudden breathing problems immediately after inhaling your medicine, stop taking Breztri Aerosphere and call your healthcare provider right away.
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 your heart.
increased blood pressure
a fast or irregular heartbeat
chest pain
effects on your nervous system.
tremor
nervousness
bone thinning or weakness (osteoporosis).
new or worsened eye problems including acute narrow-angle glaucoma and cataracts.
Acute narrow-angle glaucoma can cause permanent loss of vision if not treated. Symptoms of acute narrow-angle glaucoma may include:
eye pain or discomfort
nausea or vomiting
blurred vision
seeing halos or bright colors around lights
red eyes
If you have these symptoms, call your healthcare provider right away before taking another dose.
urinary retention. People who take Breztri Aerosphere may develop new or worsening urinary retention. Symptoms of urinary retention may include:
difficulty urinating
urinating frequently
painful urination
urination in a weak stream or drips
If you have these symptoms of urinary retention, stop taking Breztri Aerosphere and call your healthcare provider right away before taking another dose.
changes in laboratory blood values, including high levels of blood sugar (hyperglycemia) and low levels of potassium (hypokalemia). Low levels of potassium may cause symptoms of muscle spasm, muscle weakness, or abnormal heart rhythm.
Common side effects include:
upper respiratory tract infection
pneumonia
back pain
thrush in your mouth and throat. Rinse your mouth with water without swallowing after use to help prevent this.
joint pain
flu
headache
high blood sugar levels
muscle spasms
cough
inflammation of the sinuses
diarrhea
hoarseness
painful and frequent urination (signs of a urinary tract infection)
nausea
difficulty sleeping
feeling anxious
awareness of your heart beating (palpitations)
Tell your healthcare provider about any side effect that bothers you or that does not go away.
These are not all the possible side effects. 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. You may also report side effects to AstraZeneca at 1-800-236-9933.
 Breztri Aerosphere side effects (more detail)
How should I store Breztri Aerosphere?
Store Breztri Aerosphere at room temperature between 68ºF to 77ºF (20ºC to 25ºC). Keep in a dry place away from heat and sunlight.
Store Breztri Aerosphere in the unopened foil pouch and only open when ready for use.
Do not put a hole in the canister.
Do not use or store Breztri Aerosphere near heat or a flame. Temperatures above 120ºF (49ºC) may cause the canister to burst.
Do not throw the canister into a fire or an incinerator.
Throw away Breztri Aerosphere 3 months after you open the foil pouch (for the 120-inhalation canister), or 3 weeks after you open the foil pouch (for the 28-inhalation canister), or when the dose indicator reaches zero “0”, whichever comes first.
Keep Breztri Aerosphere and all medicines out of the reach of children.
General information about the safe and effective use of Breztri Aerosphere.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use this medicine for a condition for which it was not prescribed. Do not give it to other people, even if they have the same condition that you have. It may harm them.
You can ask your healthcare provider or pharmacist for information that is written for healthcare professionals.
What are the ingredients in Breztri Aerosphere?
Active ingredients: micronized budesonide, micronized glycopyrrolate, and micronized formoterol fumarate
Inactive ingredients: hydrofluoroalkane (HFA 134a) and porous particles (comprised of DSPC [1,2-Distearoyl-sn-glycero-3-phosphocholine] and calcium chloride)
