Background: Tremelimumab was recently approved by the US Food and Drug Administration (FDA) for non-small cell lung cancer treatment. This study aimed to review the characteristics and profiles of adverse events (AEs) of tremelimumab to offer a reference for its safe use.

Methods: All data were acquired from the (FDA) Adverse Event Reporting System (FAERS) database from the first quarter of 2004 to the third quarter of 2022. Disproportionality analysis, Benjamini-Hochberg adjustment method, and volcano plot were used to identify and evaluate the AE signals of tremelimumab.

Results: Two hundred thirty-three tremelimumab-related AE cases were found. Pyrexia [reporting odds ratios (ROR): 15.31, 95% confidence interval (CI): 10.85-21.60], biliary tract infection (ROR: 6158.81; 95%CI, 3909.51-9702.23), and sepsis (ROR: 23.28; 95%CI, 14.87-36.46) were the top three AEs. Gastrointestinal disorders (17.9%), infections and infestations (16.6%), and general disorders and administration site conditions (11.2%) were the top three system organ classes associated with tremelimumab. Infections, dyspnoea, hypotension, dehydration, presyncope, thrombophlebitis superficial, thrombotic microangiopathy, and pleural effusion were AEs not listed on the drug label.

Conclusion: This pharmacovigilance study detected several safety signals not listed on the drug label of tremelimumab. The results help clinicians manage patients on tremelimumab therapy.