Exploring Definity‐related adverse reaction: A real‐world pharmacovigilance study via FAERS database analysis

Aims Definity, an ultrasound contrast agent (UCA), is widely utilized in echocardiography. Real‐world studies on the safety of Definity in large populations are still lacking. This study aims to explore Definity‐related adverse events via real‐world data from the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS). Methods We adopted disproportionality analysis to identify significant adverse drug reactions (ADRs) related to Definity by utilizing algorithms like reporting odds ratio (ROR), roportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN), and the empirical Bayes geometric mean (EBGM). Results In our analysis, there were 1522 cases specifically attributed to Definity. Thirty‐five Definity‐related preferred terms (PTs) across 10 system organ classes (SOCs) were identified through disproportionality analysis. The top five SOCs with the highest reported cases included “Musculoskeletal and connective tissue disorders”, “Cardiac disorders”, “Immune system disorders”, “Respiratory, thoracic and mediastinal disorders” and “General disorders and administration site conditions.” Conclusions This real‐world pharmacovigilance study has identified vital ADRs linked to Definity, particularly hypersensitivity‐mediated and cardiopulmonary reactions, underscoring the need for vigilant monitoring and further studies to clarify their clinical relevance.