Descriptive analysis of anaphylactic events reported in the FDA Adverse Event Reporting System (FAERS)

Background: Anaphylaxis is a severe, life-threatening reaction with a growing global prevalence. Drugs are a leading trigger in adults, but real-world data on the severity and specific agents involved are limited. This study aimed to utilize the FDA Adverse Event Reporting System database to systematically identify cases of drug-induced anaphylaxis, quantify the distribution of outcomes, and identify the medications most frequently associated with these severe reactions. Design and methods: A retrospective pharmacovigilance study was conducted using FAERS data from its inception to September 2025. Cases were identified by searching for anaphylaxis-related preferred terms. Data on patient demographics, reporter type, outcomes, and suspect drugs were extracted and analyzed descriptively. Results: Among 98,081 cases analyzed, the vast majority (91.10%) were serious but non-fatal, with a 5.53% fatality rate. Reports were most common in adults aged 18–64 (49.79%) and females (55.44%). A dramatic increase in annual reports was observed from 1969 to 2025. Antibiotics (25.00%), analgesics (20.00%), and radiocontrast media (15.00%) were the most frequently reported drug categories. The top individual drugs associated with anaphylaxis included omalizumab, propofol, and infliximab. Conclusion: This analysis underscores the significant and growing public health burden of drug-induced anaphylaxis. The findings emphasize the need for continued clinician vigilance and enhanced pharmacovigilance to improve patient safety.