Breo fluticasone vilanterol side effects
Pro Research Analysisby 
Searched over 200M research papers
Common Side Effects of Breo (Fluticasone Furoate/Vilanterol) in Asthma and COPD
Breo, a combination of fluticasone furoate (an inhaled corticosteroid) and vilanterol (a long-acting beta2-agonist), is used for asthma and COPD. Clinical studies show that it is generally well tolerated, but some side effects are reported. The most common side effects include oral or oropharyngeal candidiasis (a fungal infection in the mouth or throat), dysphonia (voice changes or hoarseness), extrasystoles (irregular heartbeats), and cough. Fewer than 15% of patients in trials experienced treatment-related adverse events, and the side effect profile is similar to other inhaled corticosteroid/long-acting beta2-agonist combinations like fluticasone propionate/salmeterol 14.
Serious and Systemic Adverse Events
Long-term use of Breo can increase the risk of pneumonia, especially in patients with COPD. This risk is consistent with other inhaled corticosteroid treatments. However, studies did not find an excess of other serious adverse events, such as cardiovascular problems or severe exacerbations, compared to usual care or other treatments 34. In asthma studies, no serious side effects were reported with single doses, and the medication was generally well tolerated .
Cardiovascular and Pediatric Safety Concerns
In pediatric patients, vilanterol (the LABA component) was associated with a slightly higher rate of abnormal ECGs compared to placebo, but these were not considered adverse events and did not require stopping the medication. Other cardiovascular parameters were unremarkable, but the studies were small and short-term, so rare or long-term side effects could not be fully assessed. More research is needed to confirm the safety profile in children .
Systemic Effects and Cortisol Suppression
There are concerns about systemic effects, such as suppression of cortisol (a hormone produced by the adrenal glands), but studies have taken steps to minimize confounding factors in their assessments. No significant systemic safety issues have been highlighted in the available data .
Conclusion
Breo (fluticasone furoate/vilanterol) is generally well tolerated for asthma and COPD, with the most common side effects being oral candidiasis, hoarseness, irregular heartbeat, and cough. There is an increased risk of pneumonia with long-term use, especially in COPD patients. Serious adverse events are rare, and the overall safety profile is similar to other inhaled corticosteroid/LABA combinations. Pediatric safety data are limited, and more research is needed for this group.
Sources and full results
Most relevant research papers on this topic