Budesonide, glycopyrrolate, and formoterol inhaler

A budesonide, glycopyrrolate, and formoterol inhaler (Breztri Aerosphere) combines 3 medicines into 1 inhaler and is used as a long-term treatment for COPD (chronic obstructive pulmonary disease) in adults or asthma in adults and children 12 years and older. The 3 medicines are:

• an inhaled corticosteroid (ICS) medicine (budesonide)
• an anticholinergic medicine (glycopyrrolate)
• a long-acting beta2-adrenergic agonist (LABA) medicine (formoterol).

Budesonide, glycopyrrolate, and formoterol should not be used for asthma in children younger than 12 years of age. It is not known if it is safe and effective in children this young.

Budesonide, glycopyrrolate, and formoterol first gained FDA approval for COPD under the brand name Breztri Aerosphere on July 23, 2020. There is no generic. On April 26, 2026, approval was extended to include asthma.

The 3 ingredients in a budesonide, glycopyrrolate, and formoterol inhaler have different mechanisms of action and work together to help control COPD or asthma symptoms.

• Budesonide decreases lung inflammation, which can lead to breathing problems.
• Glycopyrrolate blocks the neurotransmitter acetylcholine in the lungs, allowing the airways to relax and widen, making breathing easier.
• Formoterol activates beta2-adrenergic receptors on the smooth muscle cells in the airways, allowing the airways to widen, making breathing easier. Formoterol has a long-lasting effect, typically lasting 12 hours or more, which provides sustained symptom relief throughout the day for COPD or asthma patients. LABA medicines, such as formoterol fumarate, when used alone, increase the risk of hospitalizations and death from asthma problems. Breztri contains an ICS, an anticholinergic, and a LABA. When an ICS and LABA are used together, there is no significant risk in hospitalizations and deaths from asthma problems.

This inhaler should not be used to relieve sudden breathing problems and will not replace a rescue inhaler, such as albuterol. If you do not have a rescue inhaler, talk to your healthcare provider.

A budesonide, glycopyrrolate, and formoterol inhaler is used as 2 puffs in the morning and 2 puffs in the evening.

• When used for COPD, budesonide, glycopyrrolate, and formoterol improve symptoms of COPD for better breathing and to reduce the number of flare-ups (the worsening of your COPD symptoms for several days).
• When used for asthma, budesonide, glycopyrrolate, and formoterol prevent and control symptoms of asthma for better breathing and to prevent symptoms such as wheezing in adults and children 12 years of age and older.

Read the step-by-step instructions that come with your prescription or refer to the Breztri website.

• Before using budesonide, glycopyrrolate, and formoterol inhaler, make sure your healthcare provider has taught you how to use the inhaler and that you understand how to use it correctly.
• Use this medicine exactly as your healthcare provider tells you to use it. Do not use it more often than prescribed.
• Use 2 inhalations of budesonide, glycopyrrolate, and formoterol inhaler, 2 times each day (2 puffs in the morning and 2 puffs in the evening).
• Do not take more than 2 inhalations of this inhaler 2 times each day.
• If a dose (2 puffs) is missed, it should be taken as soon as possible and the next dose should be taken at the usual time. Do not take more than one dose to make up for a forgotten dose.
• Rinse your mouth with water and spit the water out after each dose (2 puffs). Do not swallow the water. This will help to reduce the chance of getting a fungal infection (thrush) in the mouth and throat.
• If you take too much budesonide, glycopyrrolate, and formoterol inhaler, 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 spray the budesonide, glycopyrrolate, and formoterol inhaler into your eyes. If it gets in your eyes, rinse them well with water. If redness continues, call your healthcare provider.
• Do not use other medicines that contain a LABA or an anticholinergic for any reason. Ask your healthcare provider or pharmacist if any of your other medicines are LABA or anticholinergic-containing medicines.
• Do not change or stop any medicines used to control or treat your breathing problems. Your healthcare provider will change your medicines as needed.
• A budesonide, glycopyrrolate, and formoterol inhaler will not relieve sudden breathing problems, and you should not take extra doses to 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 emergency 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.

Do not use a budesonide, glycopyrrolate, and formoterol inhaler if you are allergic to budesonide, glycopyrrolate, formoterol, or any of the other ingredients in your inhaler. See "What are the ingredients in Breztri Aerosphere?" at the end of this page for a complete list of ingredients.

Before using budesonide, glycopyrrolate, and formoterol aerosphere, tell your healthcare provider about all of your medical conditions, including if you:

• have heart problems
• have high blood pressure
• have seizures
• have thyroid problems
• have diabetes
• have liver problems
• have kidney problems
• have weak bones (osteoporosis)
• have an immune system problem
• have eye problems such as glaucoma or cataracts. Using a budesonide, glycopyrrolate, and formoterol inhaler may make your glaucoma worse
• have prostate or bladder problems, or problems passing urine. Using a budesonide, glycopyrrolate, and formoterol inhaler may make these problems worse
• have a viral, bacterial, parasitic, or fungal infection
• are exposed to chickenpox or measles
• are pregnant, or plan to become pregnant. It is not known if budesonide, glycopyrrolate, and formoterol inhaler may harm your unborn baby
• are breastfeeding. It is not known if the medicines in budesonide, glycopyrrolate, and formoterol inhaler pass into your breast milk and if they can harm your baby. You and your healthcare provider should decide if you will take budesonide, glycopyrrolate, and formoterol inhaler while breastfeeding.

The most common side effects of a budesonide, glycopyrrolate, and formoterol inhaler are:

• upper respiratory tract infections (such as sinusitis) or the flu
• lung infections (such as pneumonia)
• back pain
• oral thrush in your mouth and throat. Wash your mouth out with water and spit out after using the inhaler to help prevent this
• joint pain or muscle spasms
• headache
• high blood sugar levels
• a cough or hoarseness
• gastrointestinal effects such as diarrhea or nausea
• signs of a urinary tract infection, including painful and frequent urination
• difficulty sleeping
• feeling anxious
• heart palpitations.

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

Serious side effects and warnings

A budesonide, glycopyrrolate, and formoterol inhaler can cause the following serious side effects:

• Fungal infections in your mouth or throat (thrush). Rinse your mouth with water without swallowing after using your budesonide, glycopyrrolate, and formoterol inhaler to help reduce your chance of getting thrush.
• Pneumonia. People with COPD or asthma have a higher chance of getting pneumonia. Budesonide, glycopyrrolate, and formoterol arosphere may increase your chance of getting pneumonia. Call your healthcare provider if you notice any of the following symptoms: an increase in sputum production change in the color of your mucus fever chills increased cough increased breathing problems.
• A weakened immune system and an increased chance of getting infections (immunosuppression). Budesonide, glycopyrrolate, and formoterol may make it harder for your immune system to fight infections.
• 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 budesonide, glycopyrrolate, and formoterol inhaler). During this transition period, when your body is under stress from fever, trauma (such as a car accident), infection, surgery, or worse COPD or asthma 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 using your budesonide, glycopyrrolate, and formoterol inhaler, stop using it 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 after using your budesonide, glycopyrrolate, and formoterol inhaler: rash hives swelling of your face, mouth, and tongue breathing problems.
• Effects on Your Heart. A budesonide, glycopyrrolate, and formoterol inhaler may affect your heart. Tell your healthcare provider immediately if your blood pressure increases or you develop a fast or irregular heartbeat or chest pain after using budesonide, glycopyrrolate, and formoterol.
• Effects on Your Nervous System. A budesonide, glycopyrrolate, and formoterol inhaler may affect your nervous system. Tell your healthcare provider immediately if you develop a tremor or if you find yourself more anxious or nervous after using this inhaler.
• Bone Thinning or Weakness (Osteoporosis). A budesonide, glycopyrrolate, and formoterol inhaler may reduce your bone density and cause bone thinning or weakness (osteoporosis). Talk to your healthcare provider about monitoring with bone density scans.
• Slowed Growth in Children. A child's growth should be checked regularly while using a budesonide, glycopyrrolate, and formoterol inhaler.
• New or Worsened Eye Problems Including Acute Narrow-Angle Glaucoma and Cataracts. A budesonide, glycopyrrolate, and formoterol inhaler may cause 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 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 use a budesonide, glycopyrrolate, and formoterol inhaler 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 budesonide, glycopyrrolate, and formoterol 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), have been reported after using a budesonide, glycopyrrolate, and formoterol inhaler. Low levels of potassium may cause symptoms of muscle spasm, muscle weakness, or abnormal heart rhythm.

These are not all the possible side effects of budesonide, glycopyrrolate, and formoterol. Ask your healthcare provider or pharmacist for more information. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800- FDA-1088. You may also report side effects to AstraZeneca at 1-800-236-9933.

Note: The asthma dose of a budesonide, glycopyrrolate, and formoterol inhaler (160 mcg/18 mcg/4.8 mcg) contains 18 mcg of glycopyrrolate per inhalation, which is twice the 9 mcg found in the COPD formulation (160 mcg/9 mcg/4.8 mcg). The doses of the other ingredients remain the same.

Dose of Budesonide, Glycopyrrolate, and Formoterol for COPD Maintenance Treatment

• 2 inhalations of a budesonide, glycopyrrolate, and formoterol inhaler (160 mcg/9 mcg/4.8 mcg) twice daily (morning and evening).

Dose of Budesonide, Glycopyrrolate, and Formoterol for Asthma Maintenance Treatment

• 2 inhalations of Breztri Aerosphere (160 mcg/18 mcg/4.8 mcg) twice daily (morning and evening).

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Budesonide, glycopyrrolate, and formoterol inhaler, and certain other medicines may interact with each other. This may cause serious side effects.

Especially tell your healthcare provider if you take:

• anticholinergics (including tiotropium, ipratropium, aclidinium, and umeclidinium)
• other LABAs (including salmeterol, formoterol, arformoterol tartrate, vilanterol, olodaterol, and indacaterol)
• atropine
• antifungal or anti-HIV medicines.

Budesonide, glycopyrrolate, and formoterol should not be used with other combination inhalers, such as Trelegy (see What is the difference between Breztri vs Trelegy?). Budesonide, glycopyrrolate, and formoterol may be used with rescue inhalers, such as albuterol.

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

Store your budesonide, glycopyrrolate, and formoterol inhaler at room temperature between 68ºF and 77ºF (20ºC and 25ºC). Keep in a dry place away from heat and sunlight. Keep the inhaler in its unopened foil pouch and only open it when ready to use.

Do not use or store your budesonide, glycopyrrolate, and formoterol inhaler 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. Do not put a hole in the canister.

Throw away the budesonide, glycopyrrolate, and formoterol inhaler 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 your inhaler and all medicines out of the reach of children.

Active ingredients: budesonide (160 mcg), glycopyrrolate (9 mcg/18 mcg), and formoterol (4.8 mcg)Inactive ingredients: hydrofluoroalkane (HFA 134a) and porous particles (comprised of DSPC [1,2-Distearoyl-sn-glycero-3-phosphocholine] and calcium chloride)

The budesonide, glycopyrrolate, and formoterol inhaler is made by AstraZeneca, under the brand name Breztri Aerosphere. Their headquarters are in Cambridge, UK.