Objective: Inhaled corticosteroids (ICs), administered as metered dose inhalers (MDIs) or dry powder inhalers (DPIs), are widely used pulmonary treatments. However, they have been consistently associated with adverse events (AEs), such as dysphonia and oral candidiasis. We set out to investigate the reported adverse events of different ICs in use today.
Method: Data for 20 ICs from the FDA Adverse Event Reporting System (FAERS) database were analyzed. AEs were categorized into clinical, non-clinical, and other.
Results: 326,646 AE reports were identified. The frequency of non-clinical AEs differed significantly by inhaler type (25.0% DPI, 21.5% MDI; p<0.001) while the frequency of clinical AEs did not (25.9% vs 26.2%; p=0.115). The frequency of non-clinical events related to misuse (64.4% vs 49.8%; p<0.001), clinical events related to dysphonia (6.6% vs 6.1%; p=0.013), and clinical events related to oral candidiasis (3.1% vs 3.8%; p<0.001) differed significantly by inhaler type. There was a significant difference in the frequency of clinical events related to dysphonia among IC active ingredients (fluticasone 8.4%, budesonide 4.1%, beclomethasone 4.2%; p<0.001) and to oral candidiasis (4.9% vs 2.4% vs 2.9%; p<0.001).
Conclusion: Overall, DPIs had a higher frequency of non-clinical AEs, such as device misuse, as well as clinical events, such as dysphonia. However, MDIs had an increased risk of candidiasis. Fluticasone was more likely to result in both dysphonia and oral candidiasis. Further research is necessary to determine whether device use optimization influences the frequency of AEs.