Breztri Aerosphere (budesonide, glycopyrrolate, and formoterol fumarate) was first approved in July 2020 as maintenance therapy for adults with chronic obstructive pulmonary disease (COPD). In April of 2026, Breztri received its second indication: maintenance treatment for asthma in adults and pediatric patients 12 years and older. Notably, this marks Breztri as the first FDA-approved triple therapy for patients 12 and older who are living with asthma.

Today, we are taking a closer look at Breztri, including its sixteen warnings and precautions, dosage and administration information, and more. 

Medication Overview:
  • Brand Name: Breztri Aerosphere
  • Generic Name: budesonide, glycopyrrolate, formoterol fumarate
  • Treatment for: COPD, asthma
  • Company: AstraZeneca
  • Initial FDA Approval: July 2020
Indicated ConditionIndicationAgeDate Approved
Chronic Obstructive Pulmonary Disease (COPD)Indicated for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients.AdultsJuly 2020
AsthmaIndicated for the maintenance treatment of asthma in adult and pediatric patients 12 years of age and older.Adults and Pediatric Patients 12 and OlderApril 2026
Warnings and Precautions:
  • LABA as monotherapy (without an inhaled-corticosteroid) is associated with an increased risk of serious asthma-related events.
  • Do not initiate in acutely deteriorating COPD or asthma. Do not use to relieve acute symptoms. 
  • Do not use in combination with an additional therapy containing a LABA because of the risk of overdose. 
  • Candida albicans infection of the mouth and pharynx may occur. Monitor patients periodically. Advise the patient to rinse his/her mouth with water without swallowing after inhalation to help reduce the risk.
  • Increased risk of pneumonia in patients with COPD. Monitor patients for signs and symptoms of pneumonia.
  • Potential worsening of infections (e.g., existing tuberculosis; fungal, bacterial, viral, or parasitic infections; ocular herpes simplex). Use with caution in patients with these infections. More serious or even fatal course of chickenpox or measles can occur in susceptible patients.
  • Risk of impaired adrenal function when transferring from systemic corticosteroids. Taper patients slowly from systemic corticosteroids if transferring to Breztri Aerosphere.
  • Hypercorticism and adrenal suppression may occur with very high dosages or at the regular dosage in susceptible individuals. If such changes occur, consider appropriate therapy. 
  • If paradoxical bronchospasm occurs, discontinue Breztri Aerosphere and institute alternative therapy.
  • Use with caution in patients with cardiovascular disorders because of beta-adrenergic stimulation.
  • Assess for decrease in bone mineral density initially and periodically thereafter.
  • Monitor growth in pediatric patients.
  • Glaucoma and cataracts may occur with long-term use of ICS. Worsening of narrow-angle glaucoma may occur. Use with caution in patients with narrow-angle glaucoma and instruct patients to contact a healthcare provider immediately if symptoms occur. Consider referral to an ophthalmologist in patients who develop ocular symptoms or use Breztri Aerosphere long term.
  • Worsening of urinary retention may occur. Use with caution in patients with prostatic hyperplasia or bladder-neck obstruction and instruct patients to contact a healthcare provider immediately if symptoms occur.
  • Use with caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus, and ketoacidosis.
  • Be alert to hypokalemia and hyperglycemia.
Dosage and Administration:
  • For oral inhalation only.
  • Prime Breztri Aerosphere before first time use and re-prime if not used for more than 7 days.
  • Maintenance treatment of COPD: 2 inhalations of Breztri Aerosphere 160 mcg/9 mcg/4.8 mcg twice daily administered by oral inhalation.
  • Maintenance treatment of asthma: 2 inhalations of Breztri Aerosphere 160 mcg/18 mcg/4.8 mcg twice daily administered by oral inhalation.
Contraindications:

Breztri Aerosphere is contraindicated in the following conditions:

  • Primary treatment of status asthmaticus or other acute episodes of COPD or asthma where intensive measures are required [see Warnings and Precautions].
  • Hypersensitivity to budesonide, glycopyrrolate, formoterol, or any of the excipients [see Warnings and Precautions and Description].
  • Primary treatment of status asthmaticus or other acute episodes of asthma or COPD requiring intensive measures.
  • Hypersensitivity to budesonide, glycopyrrolate, formoterol fumarate, or to any of the excipients.
Drug Interactions:
  • Strong cytochrome P450 3A4 inhibitors (e.g. ritonavir): Use with caution. May cause systemic corticosteroid effects.
  • Other adrenergic drugs may potentiate effect: Use with caution.
  • Diuretics, xanthine derivatives or steroids may potentiate hypokalemia or ECG changes. Use with caution.
  • Monoamine oxidase inhibitors and tricyclic antidepressants: Use with extreme caution. May potentiate effect of formoterol fumarate on cardiovascular system.
  • Beta-blockers: Use with caution. May block bronchodilatory effects of beta-agonists and produce severe bronchospasm. 
  • Anticholinergics: May interact additively with concomitantly used anticholinergic medications. Avoid administration of Breztri Aerosphere with other anticholinergic-containing drugs.
Adverse Reactions:
  • COPD: Most common adverse reactions (incidence ≥ 2%) are upper respiratory tract infection, pneumonia, back pain, oral candidiasis, influenza, muscle spasm, urinary tract infection, cough, sinusitis and diarrhea. 
  • Asthma: Most common adverse reactions (incidence ≥ 2%) are nasopharyngitis, pneumonia, and headache.
Related Guidelines:

Please note: This article is current as of July 8, 2026. Consult our clinical guidelines library or drug information tool to ensure you always have the most up-to-date information.

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