Signal detection and analysis of adverse events related to nirmatrelvir/ritonavir based on JADER database

doi:10.19803/j.1672-8629.20230091

Abstract

Abstract: Objective To detect and analyze the potential adverse event signals related to nirmatrelvir/ritonavir based on Japanese Adverse Drug Event Report (JADER) database in order to provide reference for safe clinical use of nirmatrelvir/ritonavir. Methods The reporting odds ratio (ROR) method and the MHRA method were used to search the JADER database (version 202212) for ADE reports related to nirmatrevir/ritonavir from pharmaceutical companies or healthcare institutions between April 2004 and August 2022. Results A total of 92 reports of ADE related to nirmatrelvir/ritonavir were retrieved. Thirty-four disproportional signals related to 11 system organs classes (SOC) were detected. ADE signals were mostly distributed in various examinations, gastrointestinal disorders, general disorders, manifestations of administration sites and renal and urinary disorders. Among them, there were 27 new ADE signals, such as renal impairment, increases of blood urea, off-label use and c-reactive protein elevation. Conclusion The new ADE signals detected in this study can add to the information about safety specified in the instructions. In the process of medication, related ADE should be monitored to ensure the safety of patients.

Key words: nirmatrelvir, ritonavir, adverse drug event, JADER, renal impairment, increases of blood urea, off-label, C-reactive protein elevation

CLC Number:

R978
R994.11

QIAN Peipei, CAO Kai, XU Bingxin, YING Yabin, ZHAO Ningke, ZHAO Liang. Signal detection and analysis of adverse events related to nirmatrelvir/ritonavir based on JADER database[J]. Chinese Journal of Pharmacovigilance, 2023, 20(10): 1154-1158.

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