Objective  To explore the adverse events and renal safety of tenofovir disoproxil (TD) and tenofovir alafenamide (TA) by data mining from the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) database, so as to provide reference for clinical drug safety.

Methods  The adverse events of TD and TA reported in FAERS database between the first quarter of 2004 and the first quarter of 2023 were analyzed with the methods of the reporting odds ratio (ROR) method, proportional reporting ratio (PRR) method, the Medicines and Healthcare products Regulatory Agency (MHRA) method, and Bayesian Confidence Propagation Neural Network (BCPNN) method. The distribution and intensity of risk signals of the data were analyzed, and the SMQ search tool was employed to conduct in-depth analysis of "acute renal failure" and "chronic kidney disease".

Results  A total of 19 530 and 1 587 reports were extracted as primary suspect drugs for TD and TA. There were more males than females were found in reports,and the age was concentrated in 45-65 years old, and the number of signals satisfying the four excavation methods was 185 and 68, respectively. The high-frequency adverse event distribution showed significant differences between TD and TA. The main risk signals of TD were bone and renal diseases, manifested as decreased bone density, bone injury, osteoporosis, chronic kidney disease, and renal failure. The main risk signals of TA was systemic disease with few reports of bone and renal damage, most of which were negative signals. Further analysis of renal safety showed similar results.

Conclusion  There are certain differences in terms of high-frequency adverse events, systemic organ distribution, and overall safety between TD and TA, especially the safety of renal and bone. Patients with pre-existing renal and bone diseases prefer TA to TD, however, the short time to market and the deviation caused by the small number of reports for TA, the safety of the two drugs should be continuously paid attention to.

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