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TRELEGY Ellipta safety profile

TRELEGY Ellipta is generally well tolerated and has a comparable safety profile to that of its components.1

The safety profile of TRELEGY Ellipta is based primarily on two phase III clinical studies.
The first study (The FULFIL Study) included safety data from 911 patients with COPD who received TRELEGY Ellipta, once daily, for up to 24 weeks, of whom 210 patients received TRELEGY Ellipta once daily for up to 52 weeks.1,2

The second study (The IMPACT Trial) included safety data from 4,151 patients with COPD who received TRELEGY Ellipta once daily for up to 52 weeks.1,3

In these studies, the incidence of adverse events was generally comparable for TRELEGY Ellipta once daily vs. ICS/LABA therapies (budesonide/formoterol, 400/12 mcg twice daily and fluticasone furoate/vilanterol, 92/22 mcg, once daily) and a LAMA/LABA therapy (umeclidinium/vilanterol, 55/22 mcg, once daily).2,3

Common adverse reactions (≥1/100 to <1/10):

Headache Back pain
Bronchitis Sinusitis
Nasopharyngitis Rhinitis
Influenza Cough
Upper respiratory tract infection Pharyngitis
Pneumonia Arthralgia
Candidiasis of mouth and throat Urinary tract infection
Oropharyngeal pain

Find the full list of adverse reactions in the TRELEGY Ellipta Summary of Product Characteristics.1

  • Pneumonia

    • In common with other corticosteroid-containing medicines, there is an increased risk of pneumonia in patients with COPD treated with TRELEGY Ellipta, including pneumonia requiring hospitalisation1
    • There is no conclusive clinical evidence for intra-class differences in the magnitude of the pneumonia risk among inhaled corticosteroid products1
    • Physicians should remain vigilant for the possible development of pneumonia in patients with COPD as the clinical features of such infections overlap with the symptoms of COPD exacerbations1
    • Risk factors for pneumonia in patients with COPD include current smoking, older age, low body mass index and severe COPD1
  • Cardiovascular

    Cardiovascular effects, such as cardiac arrhythmias (e.g. atrial fibrillation and tachycardia), may be seen after the administration of muscarinic receptor antagonists and sympathomimetics, including umeclidinium and vilanterol, respectively. Therefore, TRELEGY Ellipta should be used with caution in patients with unstable or life-threatening cardiovascular disease.1


ICS, inhaled corticosteroid; LABA, long-acting β2 agonist; LAMA, long-acting muscarinic antagonist; OD, once daily

TRELEGY Ellipta OD is indicated for maintenance treatment in adult patients with moderate-to-severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an ICS and a LABA, or a combination of a LAMA and a LABA1


  1. TRELEGY Ellipta SmPC, 2022. Available at Accessed October 2022.
  2. Lipson DA et al. Am J Crit Care Med 2017; 196:438–446.
  3. Lipson DA et al. N Engl J Med 2018; 378:1671–1680

Adverse events should be reported directly to the Health Products Regulatory Authority (HPRA) on their website: Adverse events should also be reported to GlaxoSmithKline on 1800 244 255.

Trelegy is a registered trademark of the GlaxoSmithKline group of companies.

TRELEGY Ellipta was developed in collaboration with

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Last Updated: October 2022 PM-IE-FVU-WCNT-220017