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Clinical trial data may not reflect the full AE profile of <jats:italic>BCR\u2010ABL<\/jats:italic> inhibitors because of stringent study entry criteria, relatively small sample size, and limited duration of follow\u2010up. To determine the utility of the FDA AE Reporting System (FAERS) surveillance database for identifying AEs possibly associated with the <jats:italic>BCR\u2010ABL<\/jats:italic> inhibitors imatinib, dasatinib, and nilotinib in the postmarketing patient population, we conducted Multi\u2010Item Gamma Poisson Shrinker disproportionality analyses of FAERS reports on AEs in relevant system organ classes. Signals consistent with the known safety profiles of these agents as well as signals for less well\u2010described AEs were detected. Bone marrow necrosis, conjunctival hemorrhage, and peritoneal fluid retention events were uniquely associated with imatinib. AEs that most commonly reached the threshold for dasatinib consisted of terms relating to hemorrhage and fluid retention, including pleural effusion and pericardial effusion. Most terms that reached the threshold solely with nilotinib were related to peripheral and cardiac vascular events. Although this type of analysis cannot determine AE incidence or establish causality, these findings elucidate the AEs reported in patients treated with <jats:italic>BCR\u2010ABL<\/jats:italic> inhibitors across multiple clinical trials and in the community setting for all approved and nonapproved indications, suggesting drug\u2010AE associations warrant further investigation. These findings emphasize the need to consider patient comorbidities when selecting amongst <jats:italic>BCR\u2010ABL<\/jats:italic> inhibitors. Am. J. 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