| Sumario: | Chimeric antigen receptor T‐cell therapy (CAR‐T) is an emerging therapy for malignancies, including refractory B‐cell lymphoma, follicular lymphoma, multiple myeloma, and chronic lymphocytic leukemia. Postmarketing monitoring is essential to ensure the rational administration of CAR‐T because of its high occurrence rate of adverse events. Thus, we collected the adverse event reports from the FAERS database between the first quarter of 2017 and the second quarter of 2025. Disproportion analysis methods, including the reporting odds ratio and information component, were used to identify potential hematological AEs associated with CAR‐T therapy. A total of 47,118,226 reports were analyzed, and 99,497 adverse events associated with CAR‐T‐cell therapy were identified. We found 11,689 hematological adverse events accounted for 11.75% of the total adverse events, of which cytopenia (ROR025 = 33.87, IC025 = 4.95), hemophagocytic lymphohistiocytosis (HLH, ROR025 = 28.20, IC025 = 4.71), and myelodysplastic syndrome (MS, ROR025 = 34.41, IC025 = 4.98) were highly underrated in the real world. All six CAR‐T products were associated with hematological adverse events, and the typical hematological adverse events varied among different products. A high proportion and frequency of death outcomes were identified after CAR‐T‐related hematological adverse events, such as thrombocytopenia, HLH, and cytopenia. Cytokine release syndrome frequently overlapped with hematological adverse events, including cytopenia, HLH, and thrombocytopenia. Our results may help clinicians identify rare but potentially fatal hematological AEs at an early stage, effectively reducing the risk of lethal hematological toxicity of CAR‐T therapy.
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