Abstract: Objective To mine the risk signals related to lamivudine-caused adverse events (AE) of the kidney and urinary system based on the Food and Drug Administration Adverse Event Reporting System (FAERS), and provide references for clinical safe drug use. Methods AE in the FAERS database collected between the first quarter of 2004 and the second quarter of 2023 were retrieved. According to the primary suspected drugs, the method of the reporting odds ratio (ROR) and compression estimation algorithm were used to identify the risk signals of AE associated with lamivudine in the kidney and urinary system by taking tenofovirdisoproxil, nevirapine, zidovudine and adefovirdipivoxil as control. Subgroup signal mining was performed on HIV and HBV patients respectively. Results There were 1 165 AE related to the kidney and the urinary system with lamivudine as the primary suspected drug and 2 713 cases in the control group. The risk of renal impairment by lamivudine was higher than in the control group, so was the risk of renal failure in the HIV group and toxic nephropathy in the HBV group. HIV complicated with HBV infection was a risk factor for renal impairment by lamivudine. Conclusion The AE signals of the kidney and urinary system based on FAERS point to the risk of lamivudine-caused damage to the kidney and urinary system, which could provide references for long-term use of lamivudine.

Key words: lamivudine, nucleoside/nucleotide analogues, kidney, urinary system, renal impairment, HIV, HBV, adverse drag event, FAERS