Assessing the Risk of Drug-Induced Influenza-Like Illness: A Disproportionality Analysis of Two Decades of FAERS Data (2004-2025)

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This study aims to identify drugs associated with influenza-like illness (ILI) using disproportionality analysis of FAERS data from 2004 to 2025.
Disproportionality analysis of 77,060 ILI reports from FAERS spanning Q1 2004 to Q1 2025.
Data processed using SAS 9.4 and analyzed through four statistical methods: ROR, PRR, BCPNN, and EBGM.
Drugs were classified based on the ATC system, and time to onset was evaluated using Weibull distribution modeling.
60 drugs exhibited positive signals for ILI, with interferon β-1a showing the highest reporting rate (n=12,470, ROR 22.12).
Antineoplastic and immunomodulating agents represented the majority of reported cases (n=43,436), followed by nervous and cardiovascular system agents.
Analysis revealed early failure characteristics for most drugs (β<1), indicating drug-induced ILI often manifests quickly.

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Shows associations between specific drugs and influenza-like illness, indicating potential safety concerns.

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Gao et al. (2026) studied this question.

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