Table 1_Distinct renal adverse event profiles among CDK4/6 inhibitors: a comparative pharmacovigilance analysis.docx

Renal adverse events were reported in 898, 2,636, and 1,826 reports, respectively. Acute kidney injury was more frequently reported with abemaciclib (35.7%) and ribociclib (19.7%) than with palbociclib (12.4%) (p < 0.001). Renal impairment/failure was the most commonly reported grouped renal adverse event category.

Abemaciclib demonstrated the highest reporting odds for acute kidney injury (ROR 4.06, 95% CI 3.53–4.67), followed by ribociclib (ROR 1.94, 95% CI 1.69–2.22), whereas ribociclib showed the strongest disproportionality signals for decreased glomerular filtration rate, hypocalcemia, creatinine increased, hyponatremia, and hypokalemia. Overall, 65.6% of reports were serious and hospitalization occurred in 32.5% of cases.</p>Conclusion<p>This large-scale pharmacovigilance analysis identified substantial differences in renal adverse event reporting patterns among CDK4/6 inhibitors.

Abemaciclib was more frequently associated with acute kidney injury and adverse events suggestive of intrinsic renal injury, whereas ribociclib demonstrated stronger signals for laboratory indicators of renal dysfunction and electrolyte abnormalities. Although spontaneous reporting data cannot establish causality or estimate incidence, these findings suggest heterogeneous renal adverse event profiles among CDK4/6 inhibitors and support careful renal monitoring during treatment.</p>