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Prescribing Information TRIXEO®
(formoterol fumarate dihydrate/ glycopyrronium/budesonide)
Prescribing Information SYMBICORT®
(budesonide/formoterol) COPD 200/6 and 400/12
Prescribing Information BEVESPI®
(glycopyrronium/formoterol fumarate dihydrate)
Adverse Event
Reporting

This website is intended for UK Healthcare Professionals only. Other UK residents please visit astrazeneca.co.uk

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TRIXEO safety and side effects

TRIXEO Safety and side effects

Possible side effects of TRIXEO

TRIXEO (formoterol fumarate dihydrate/glycopyrronium/budesonide) can cause side effects in some patients. The following common and uncommon side effects may occur with this medicine.

The safety profile was consistent with the well-established profiles of its components1–3*

Most common TRIXEO inhaler side effects

In trials of more than 10,000 patients,1,2 the three most commonly reported side effects in patients receiving TRIXEO were:3

Pneumonia (4.6%)

Headache (2.7%)

Urinary tract infection (2.7%)

Other common side effects noted in the clinical trials included:3

  • Oral candidiasis
  • Insomnia
  • Cough
  • Hyperglycaemia
  • Palpitations
  • Nausea
  • Anxiety
  • Dysphonia
  • Muscle spasms

 

This is not an exhaustive list. Please consult the Summary of Product Characteristics for a full list of adverse reactions before prescribing.

*Budesonide (ICS), glycopyrronium (LAMA) and formoterol fumarate (LABA).
†Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10), and uncommon (≥1/1,000 to <1/100). Only the common and very common side effects are presented. Please refer to the Summary of Product Characteristics for the full list of adverse events.3

Important TRIXEO AEROSPHERE side effects

Immediate breathing difficulties

If a patient experiences breathing difficulties straight after using TRIXEO AEROSPHERE, they should immediately discontinue inhaler use and seek urgent medical attention. Breathing difficulties include tightness in the chest, coughing, wheezing, or feeling breathless.4

If a patient experiences breathlessness, tightness in the chest, wheezing, or coughing getting worse whilst using TRIXEO, the patient should continue to use TRIXEO, but they should contact a doctor as soon as possible, as additional treatment may be needed.4

Allergic reactions

If any allergic reactions occur, the patient should immediately discontinue the medicine and seek urgent medical attention.4

These reactions include:4

  • Swelling of the face, particularly around the mouth
  • Rash or hives together with difficulty breathing
  • Suddenly feeling faint

Pneumonia risk

Healthcare professionals should always look for signs of possible development of pneumonia in patients with COPD. Additional risk factors for pneumonia in patients with COPD include current smoking, older age, low BMI and severe COPD.3

The risk of pneumonia associated with TRIXEO is low relative to its benefits for exacerbations.5

ICS are associated with an increased risk of pneumonia in patients with COPD;6 however, results from the ETHOS and KRONOS clinical trials showed that, in patients with moderate or very severe COPD, the risk of pneumonia associated with TRIXEO is low relative to its benefits for exacerbations.2,5

A post hoc analysis (n=8509) quantified the exacerbation benefits relative to pneumonia risk (expressed as NNT and NNH, respectively) in ETHOS5

**NNT is the number needed to treat for 1 year to prevent 1 moderate/severe COPD exacerbation. NNH is the number needed to harm for 1 year for there to be 1 extra case of confirmed pneumonia NNT and NNH calculated using 1/(rate BGF pMDI – rate comparator).5
†NNH for TRIXEO vs ICS/LABA not shown as the rate was lower for TRIXEO than ICS/LABA.5
‡The strength of TRIXEO referred to here is 320/14.4/10 μg BID.

Efficacy

TRIXEO safety precautions

The safety profile of TRIXEO AEROSPHERE is considered similar to that of medicines containing combinations of a corticosteroid, beta-2 agonist and antimuscarinic.3

Patients should take no more than 2 inhalations twice a day; more than this may lead to blurred vision, dry mouth, nausea, muscle spasm, tremor, headache, palpitations and systolic hypertension.3
If overused chronically, systemic glucocorticoid effects may appear. If an overdose occurs, the patient should be treated and monitored as necessary.3

Patients should not take a double dose to make up for a missed dose. Instead, patients should take a dose as soon as they remember, unless it is nearly time for their next dose. If this is the case, patients should skip the missed dose.3 Click here for dosing information.

Patients should not discontinue TRIXEO AEROSPHERE without first consulting their doctor as symptoms could abruptly worsen.3

This is not an exhaustive list. Please consult the Summary of Product Characteristics for a full list of precautions and contraindications before prescribing.

Download the full prescribing information for TRIXEO AEROSPHERE

How to use the TRIXEO inhaler

Information to educate your patients on how to administer their TRIXEO inhaler.

Discover how to use inhaler
patient patient

BGF, budesonide/ glycopyrronium/ formoterol; BID, twice daily; BMI, body mass index; CI, confidence interval; COPD, chronic obstructive pulmonary disease; ICS, inhaled corticosteroids; LABA, long-acting beta2-agonist; LAMA, long-acting muscarinic antagonist; NNH, numbers needed to harm; NNT, numbers needed to treat; pMDI, pressurised metered-dose inhaler.

  1. Rabe KF, et al. N Engl J Med 2020;383:35-48.
  2. Ferguson GT, et al. Lancet Respir Med 2018;6:747-758.
  3. TRIXEO AEROSPHERE 5 micrograms/7.2 micrograms/160 micrograms pressurised inhalation, suspension. Summary of Product Characteristics. SmPC available at: https://www.medicines.org.uk/emc/product/12028/smpc#gref. Accessed: November 2025.
  4. TRIXEO AEROSPHERE 5 micrograms/7.2 micrograms/160 micrograms pressurised inhalation, suspension - Patient Information Leaflet (PIL) - (emc) (2025). Available at: https://www.medicines.org.uk/emc/product/12028/pil Accessed: November 2025
  5. Rabe KF, et al. Eur Respir J 2020;56:5230.
  6. Janson C, et al. Respir Res 2018;19:172.

GB-70609 | November 2025

TRIXEO and AEROSPHERE are registered trademarks of the AstraZeneca group of companies.

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to AstraZeneca by visiting https://contactazmedical.astrazeneca.com/ or by calling ‌‌‌0‌‌‌8‌‌‌‌‌0‌‌‌‌0‌‌‌ ‌‌7‌‌‌‌‌‌8‌‌‌3‌‌‌ ‌‌0‌‌‌‌‌0‌‌‌‌3‌‌‌‌3‌‌‌.

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