Objective  To explore the risk signals for adverse events of thalidomide based on the Food and Drug Administration (FDA) Adverse Event Reporting System ( FAERS) database, and provide reference for clinical safe medication.

Methods  Through the Open Vigil 2.1 data platform, the adverse drug event reports of thalidomide in the FAERS database from the first quarter of 2019 to the third quarter of 2024 were collected. The report odds ratio (ROR) and proportional report odds ratio (PRR) in the proportional imbalance method were used for signal mining.

Results  A total of 1  469 reports of thalidomide-related adverse events were retrieved,  and the data were reported equally for male and female.The age distribution was mainly concentrated in 18-64 years old and ≥ 65 years old. The main reporting area was the United States (82.64%). There were 19 types of effective adverse events with 1 360 signals, and the number of signals of various types of injury, poisoning and operation complications was the highest (39.85%). According to the frequency of reports and signal intensity, peripheral neuropathy was listed in the top 20 preferred terms (PT). Eight new signals were found that were not recorded in the drug report.

Conclusion  Data mining analysis of thalidomide based on FAERS database shows that most of them are consistent with the drug instructions. Thalidomide adverse events involve a wide range, with particular attention to peripheral neuropathy-related monitoring. At the same time, clinical attention should be paid to the use of off-label drugs, which is prone to adverse reactions. Corona virus disease 2019 (COVID-19) and peripheral swelling are new and potential adverse events of thalidomide, but need to be further verified in clinical practice.

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