What the label lists and what reports show
Formoterol and glycopyrrolate side effects
Formoterol and glycopyrrolate's FDA label: “Most common adverse reactions (incidence ≥2% and more common than with placebo) include: urinary tract infection and cough.” FAERS holds 1,941 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 (371 reports).
- No generic listed
Check it at the source: the formoterol and glycopyrrolate FDA label on DailyMed (effective March 24, 2023, 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 with BEVESPI AEROSPHERE?BEVESPI AEROSPHERE can cause serious side effects, including: • people with asthma who take LABA medicines, such as formoterol fumarate (one of the medicines in BEVESPI AEROSPHERE), without also using a medicine called an inhaled corticosteroid, have an increased risk of serious problems from asthma, including being hospitalized, needing a tube placed in their airway to help them breathe, or death. • Call your healthcare provider if breathing problems worsen over time while using BEVESPI AEROSPHERE. You may need a different treatment. • Get emergency medical care if: ∘ your breathing problems worsen quickly ∘ you use your rescue inhaler medicine, but it does not relieve your breathing problems • using too much of a LABA medicine may cause: ∘ chest pain ∘ fast and irregular heartbeat ∘ tremor ∘ increased blood pressure ∘ headache ∘ nervousness • COPD symptoms can get worse over time. […]
Source: FDA drug label, AstraZeneca Pharmaceuticals LP, effective March 24, 2023 (SPL set ae02436e-9528-490e-a844-0c0f6f2843f9), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (incidence ≥2% and more common than with placebo) include: urinary tract infection and cough.
From the label: adverse reactions, continuedThe following adverse reactions are described in greater detail elsewhere in the labeling: • Paradoxical bronchospasm [see Warnings and Precautions (5.4) ] • Hypersensitivity reactions including Anaphylaxis [see Contraindications (4), Warnings and Precautions (5.5) ] • Cardiovascular effects [see Warnings and Precautions (5.6) ] • Worsening of narrow-angle glaucoma [see Warnings and Precautions (5.7) ] • Worsening of urinary retention [see Warnings and Precautions (5.8) ] Most common adverse reactions (incidence ≥2% and more common than with placebo) include: urinary tract infection and cough. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact AstraZeneca at 1-800-236-9933 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience 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. The clinical program for BEVESPI AEROSPHERE included 4,911 subjects with COPD in two 24-week lung function trials, one long-term safety extension study of 28 weeks, and 10 other trials of shorter duration. A total of 1,302 subjects have received at least 1 dose of BEVESPI AEROSPHERE. …
Source: FDA drug label, AstraZeneca Pharmaceuticals LP, effective March 24, 2023 (SPL set ae02436e-9528-490e-a844-0c0f6f2843f9), via openFDA; the full label on DailyMed
What do FAERS reports show?
1,941 reports list formoterol and glycopyrrolate among the medicines taken, each a report of something that happened, not proof the medicine caused it; 232 are coded as a death and 279 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. Of the 13 reactions below, 3 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?
- 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