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

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.

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.

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.

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.