What question did this study set out to answer?

To identify drugs significantly associated with drug-induced anaphylactic shock (DIAS) using large data analysis.

April 1, 2026Open Access

Comprehensive Study of Drug-Associated Severe Allergic Reactions: An Analysis of High-Risk Medications and Epidemiological Trends Based on the FAERS Database

Key Points

To identify drugs significantly associated with drug-induced anaphylactic shock (DIAS) using large data analysis.
Retrospective cohort study of 20,748,017 adverse event reports from the FAERS database (2004-2023)
Descriptive statistical analysis for basic characteristics
Disproportionality analysis using reporting odds ratio (ROR) and proportional reporting ratio (PRR)
Analysis of yearly trends and demographics of DIAS events
21,073 DIAS events recorded, representing 0.10% of all reports
Higher DIAS incidence observed in females (56.57%) compared to males (35.24%)
Key drugs associated with DIAS include amoxicillin, propofol, and carboplatin
Top drugs with strongest signals include remifentanil and meloxicam
Antibiotics, anesthetics, monoclonal antibodies, and antitumor drugs identified as high-risk categories

Abstract

Purpose: Drug-induced anaphylactic shock (DIAS) is a severe adverse drug reaction.This study aimed to identify drugs significantly associated with DIAS through the real-time updated analysis of large-sample data.Methods: This retrospective cohort study analyzed 20,748,017 adverse event reports from the Food and Drug Administration Adverse Event Reporting System database spanning from the first quarter of 2004 to the fourth quarter of 2023 to identify the main drugs causing anaphylactic shock.Descriptive statistical analysis was used to report the basic characteristics, while disproportionality analysis was employed to assess the correlation between specific drugs and DIAS events using metrics such as the reporting odds ratio (ROR), proportional reporting ratio (PRR), and 2 test values.Additionally, detailed descriptive analyses were performed to examine yearly trends, sex and age distributions, and the sources and countries of reported DIAS events.Results: There were a total of 21,073 DIAS events, accounting for 0.10% of all reports.The median weight of the DIAS patients was 70 kg, the median age was 55 years, and the incidence of DIAS was significantly higher among females (56.57%) than among males (35.24%).DIAS was primarily associated with indications such as anesthesia, sclerosis, and arthritis.The top 10 drugs most strongly associated with anaphylactic shock were amoxicillin, propofol, moxifloxacin, infliximab, omalizumab, carboplatin, paclitaxel, cefuroxime, ceftriaxone, natalizumab, and rocuronium bromide.Asymmetric analysis revealed that the top 10 drugs with the strongest signals were remifentanil, carboplatin, propofol, ceftriaxone, iopromide, atracurium, meloxicam, cefuroxime, desflurane, and ringer lactate.(all ROR > 3, PRR > 2, 2 > 4, P < 0.001).Conclusions: Antibiotics, anesthetics, monoclonal antibodies (mAbs), and antitumor drugs are the main categories of drugs associated with anaphylactic shock.Specifically, high clinical vigilance should be given to -lactam antibiotics, intravenous anesthetics, antitumor drugs, and mAbs.Future research on DIAS should further explore its mechanisms, evaluate risk factors, and develop effective prevention strategies to enhance the safety and efficacy of drug therapy.

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