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The safety profile of Relvar

Relvar: well tolerated in asthma and COPD, with over 5 million patient-years of exposure1,2

Relvar has a generally well-tolerated safety profile2 with adverse events consistent with the ICS/LABA class of medications.2

See below for a brief summary of adverse events associated with Relvar. Full details can be found in the Relvar Summary of Product Characteristics.

Very common adverse events (≥1/10)⁴

Common adverse events (≥1/100 to <1/10)⁴

  • Headache
  • Nasopharyngitis
  • Pneumonia
  • Upper respiratory tract infections
  • Bronchitis
  • Influenza
  • Candidiasis of mouth and throat
  • Oropharyngeal pain
  • Pharyngitis
  • Rhinitis
  • Sinusitis
  • Cough
  • Dysphonia
  • Abdominal pain
  • Arthralgia
  • Back pain
  • Fractures
  • Pyrexia
  • Muscle spasm

Pneumonia risk in asthma4

Pneumonia risk in COPD4

In an integrated analysis of 11 studies asthma (n=7034), the incidence of pneumonia per 1000 patient-years was 18.4 for Relvar 184/22 mcg vs. 9.6 for Relvar 92/22 mcg and 8.0 for placebo2 In common with other ICS-containing medicines, there is an increased risk of pneumonia in COPD patients treated with these types of medicines. The incidence of pneumonia with Relvar is similar to that seen with other ICS/LABA combinations3

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*If using on average two doses per day.


COPD, chronic obstructive pulmonary disorder; ICS, inhaled corticosteroid; LABA, long-acting β2-agonist. 

  1. GSK Data on File 16221; 2019.
  2. Global Datasheet Fluticasone furoate/vilanterol: v11, Accessed June 2023.
  3. Kew KM, et al. Cochrane Syst Rev 2014;3:CD010115.
  4. Relvar Ellipta SmPC, available at

RELVAR Ellipta was created in collaboration with

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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.

Relvar is a registered trademark of the GlaxoSmithKline group of companies

PM-IE-FFV-WCNT-230010 June 2023