What the label lists and what reports show
Budesonide and formoterol and glycopyrrolate side effects
Budesonide and formoterol and glycopyrrolate's FDA label: “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.” FAERS holds 10,386 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is dyspnoea (2,012 reports).
- No generic listed
Check it at the source: the budesonide and formoterol and glycopyrrolate FDA label on DailyMed (effective April 27, 2026, AstraZeneca Pharmaceuticals LP); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of BREZTRI AEROSPHERE?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. […]
Source: FDA drug label, AstraZeneca Pharmaceuticals LP, effective April 27, 2026 (SPL set 715433dc-cb2b-43ea-b6df-c5b4177adc6c), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost 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.
Table 2: Adverse Reactions Occurring at an Incidence of ≥ 2% of Subjects with COPD and More Common in BREZTRI AEROSPHERE Compared to GFF MDI and/or BFF MDI (ETHOS)
| Adverse Reaction | BREZTRI AEROSPHERE BREZTRI AEROSPHERE = budesonide/glycopyrrolate/formoterol fumarate 320… 320 mcg/18 mcg/9.6 mcg N=2144 (%) | GFF MDI 18 mcg/9.6 mcg N=2125 (%) | BFF MDI 320 mcg/9.6 mcg N=2136 (%) |
|---|---|---|---|
| Upper Respiratory Tract Infection | 123 (5.7) | 102 (4.8) | 115 (5.4) |
| Pneumonia | 98 (4.6) | 61 (2.9) | 107 (5.0) |
| Back pain | 67 (3.1) | 55 (2.6) | 64 (3.0) |
| Oral candidiasis | 65 (3.0) | 24 (1.1) | 57 (2.7) |
| Influenza | 63 (2.9) | 42 (2.0) | 61 (2.9) |
| Muscle spasms | 60 (2.8) | 19 (0.9) | 53 (2.5) |
| Urinary tract infection | 58 (2.7) | 60 (2.8) | 41 (1.9) |
| Cough | 58 (2.7) | 50 (2.4) | 51 (2.4) |
| Sinusitis | 56 (2.6) | 47 (2.2) | 55 (2.6) |
| Diarrhea | 44 (2.1) | 37 (1.7) | 38 (1.8) |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following adverse reactions are discussed in greater detail in other sections of the labeling. • Serious asthma-related events – hospitalizations, intubations, death [see Warnings and Precautions (5.1) ] • Oropharyngeal candidiasis infection [see Warnings and Precautions (5.4) ] • Increased risk of pneumonia in COPD [see Warnings and Precautions (5.5) ] • Immunosuppression and risk of infections [see Warnings and Precautions (5.6) ] • Hypercorticism and adrenal suppression [see Warnings and Precautions (5.8) ] • Paradoxical bronchospasm [see Warnings and Precautions (5.10) ] • Hypersensitivity reactions including anaphylaxis [see Contraindications (4) and Warnings and Precautions (5.11) ] • Cardiovascular effects [see Warnings and Precautions (5.12) ] • Reduction in bone mineral density [see Warnings and Precautions (5.13) ] • Growth effects in pediatric patients [see Warnings and Precautions (5.14) ] • Worsening of narrow-angle glaucoma and cataracts [see Warnings and Precautions (5.15) ] • Worsening of urinary retention [see Warnings and Precautions (5.16) ] Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. …
Source: FDA drug label, AstraZeneca Pharmaceuticals LP, effective April 27, 2026 (SPL set 715433dc-cb2b-43ea-b6df-c5b4177adc6c), via openFDA; the full label on DailyMed
What do FAERS reports show?
10,386 reports list budesonide and formoterol and glycopyrrolate among the medicines taken, each a report of something that happened, not proof the medicine caused it; 1,280 are coded as a death and 1,379 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2025 (3,164, against a median of 80 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens. Of the 13 reactions below, 5 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Budesonide and formoterol and glycopyrrolate: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions