OBJECTIVE  To explore the toxicity burden of atezolizumab combined with bevacizumab by mining and analyzing the FAERS database.

METHODS  Based on the FAERS database from the 1st quarter of 2004 to the 4th quarter of 2022, disproportionality analysis and combination risk ratio model were used to mine the adverse event signals and analyze the demographic characteristics, toxicity burden, important medical event signals and new signals of adverse events associated with atezolizumab combined with bevacizumab.

RESULTS  A total of 74 192 adverse events reports were extracted, including 13 414 for atezolizumab, 56 054 for bevacizumab, and 4 724 for atezolizumab combined with bevacizumab. The incidence of adverse events reported for atezolizumab combined with bevacizumab was higher in males at 57.79%, with the highest number of cases reported in the age group >65 years(n=1912, 40.47%). Outcomes were most common for hospitalization and least common for required intervention in three groups. The median time to onset was 40, 58 and 41 days in the three groups, respectively. A total of 353 positive signals were detected for atezolizumab plus bevacizumab, including 83 toxicity burden signals, 63 important medical event signals and 23 new signals, mainly involving gastrointestinal disorders, hepatobiliary disorders and infections and infestations.

CONCLUSION  When clinically administering atezolizumab combined with bevacizumab, healthcare providers should be vigilant about the occurrence of related adverse reactions and ensure adequate medication monitoring.