Safety profile differences between salbutamol and levosalbutamol: Results from the FDA Adverse Event Reporting System

Purpose: To examine the safety profiles of salbutamol and levosalbutamol reported in the Food and Drug Administration Adverse Event Reporting System (FAERS) database. Methods: Retrospective pharmacovigilance disproportionality analysis for drug-related ADRs reported in the FAERS database was performed from October 1, 2003 to March 31, 2020. The proportion of report ratio (PRR), proportional reporting ratio (PRR), and reporting odds ratio (ROR) were calculated and used for the determination of safety signals. The definition was based on system organ class (SOCs) and Standardized Medical Dictionary for Regulatory Activities Queries (SMQ) by the Medical Dictionary for Regulatory Activities (MedDRA). Results: A total of 83,166 and 3,133 adverse event reports were identified for albuterol and levalbuterol, respectively, and were linked mainly with 12 SOCs, i.e., cardiac, vascular disorders, respiratory, thoracic, mediastinal disorders, and immune system disorders. The largest ROR among the 20 most frequent SMQs was asthma/bronchospasm for reports both in salbutamol group (ROR: 13.585, 95% CI: 13.254, 13.923) and levosalbutamol group (ROR: 16.225, 95% CI: 14.575, 18.063). Conclusion: Data mining of the FAERS may be considered a useful approach for identifying salbutamol and levosalbutamol-related adverse events, which might provide additional information to guide their use in clinical practice.