Objective  To explore the adverse drug event (ADE) signals of anifrolumab, and to provide references for clinical safe medication.

Methods  The ADE reports related to anifrolumab from the third quarter of 2021 to the third quarter of 2024 in the U. S. Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) were collected. The report odds ratio (ROR) method, the comprehensive standard method of the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA), and the Bayesian Confidence Interval Progressive Neural Network (BCPNN) method were employed to identify ADE signals related to anifrolumab. System-organ class (SOC) and preferred term in the Medical Dictionary for Regulatory Activities were used for data classification and statistics.

Results  A total of 1,186 ADE reports with anifrolumab as the primary suspected drug were collected, and 49 signals were identified, involving 14 SOCs. The top 3 SOCs in terms of report frequency ranking were general disorders and administration site reactions, infections and infestations, and nervous system disorders. The top 3 ADEs in terms of report frequency ranking were headache, joint pain, and herpes zoster. Vasculitis, pericarditis, proteinuria, and blood pressure abnormalities were suspected ADEs not documented in the specification and were also ADE signals with a high signal strength ranking.

Conclusion  The common ADE signals of anifrolumab are consistent with its drug instructions. However, when using anifrolumab in clinical practice, it is also necessary to be vigilant against the increase of various infectious diseases such as herpes zoster and new ADEs not included in the instructions such as pericarditis, to ensure the safety of patients' medication.

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