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Safety profile

Relvar is a well tolerated treatment for asthma and COPD, with over 10 million patient-years of exposure.1,2 Adverse events associated with Relvar are 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.

A table describing the very common adverse events, common adverse events, and pneumonia risk associated with Relvar/Breo in both asthma and COPD

Discover Relvar

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Asthma control

See how Relvar can help achieve asthma control

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Proactive asthma management

See how dosing with Relvar differs to other commonly-prescribed asthma treatment regimens.

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Ease of use

Discover the features and benefits of the Ellipta device

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Safety profile

Read about the safety profile associated with Relvar

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21st-century molecules[2,4–6]

Relvar’s unique combination of fluticasone furoate, a potent inhaled corticosteroid, and vilanterol, an ultra-long-β2-agonist, delivers the everyday stability asthma patients need.2,4,7–15

Abbreviations

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

Relvar Safety Information16

Contraindications
Hypersensitivity to the active substances or to any of the excipients.

Undesirable effects
Very Common: Headache, Nasopharyngitis.

Common: Infections and infestations, Oropharyngeal pain, Sinusitis, Pharyngitis, Rhinitis, Cough, Dysphonia, Abdominal pain, Arthralgia, Back pain, Fractures, Muscle spasms and Pyrexia.

References
  1. GSK Data on File 133009;2021.
  2. Global Datasheet Fluticasone furoate/vilanterol: v13, September 2022.
  3. Kew KM, et al. Cochrane Syst Rev 2014;3:CD010115.
  4. Bernstein DI, et al. J Asthma 2015;52:1073–1083.
  5. Braithwaite I, et al. Respir Med 2016;119:115–121.
  6. Center for Drug Evaluation and Research. Approval package for Breo Ellipta. Application number: 204275Orig1s000. Accessed April 2024.
  7. Woodcock A, et al. Lancet 2017;390:2247–2255.
  8. Svedsater H, et al. Respir Med 2018;141:198–206.
  9. Averell CM, et al. J Asthma 2022;59:1805–1818.
  10. Daley-Yates P, et al. Adv Ther 2023;40:4042–4059.
  11. Parimi M, et al. Adv Ther 2020;37:2916–2931.
  12. van der Palen J, et al. NPJ Prim Care Respir Med 2016;26:16079.
  13. van der Palen J, et al. Respir Med 2022;205:107031.
  14. Janson C, et al. Thorax 2020;75:82–84.
  15. Woodcock A, et al. Thorax 2022;77:1187–1192.
  16. Relvar Prescribing Information.

GSK does not recommend, endorse, or accept liability for the 3rd party sites.

For more information, please refer to the prescribing information or contact GlaxoSmithKline via gcc.medinfo@gsk.com
To report Adverse Event/s associated with the use of GSK product/s, please contact us via
gulf.safety@gsk.com
To report quality complaint/s associated with the use of GSK product/s, please contact us via
 Gulf.ProductQualityComplaints@gsk.com

Department of Pharmacovigilance & Drug Information
Drug Safety Center
Ministry of Health, Sultanate of Oman
Phone Nos. 0096822357687 / 0096822357690
Fax: 0096822358489
Email: pharma-vigil@moh.gov.om
Website: https://moh.gov.om/en/

 دائرة التيقظ و المعلومات الدوائية
مركز سلامة الدواء
وزارة الصحة, سلطنة عمان
هاتف: 0096822357687 / 0096822357690
0096822358489 :فاكس
pharma-vigil@moh.gov.om :البريد االكتروني
https://moh.gov.om/en/ : الموقع االكتروني

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PM-RCH-FFV-WCNT-250001 Date of preparation: July 2025