Objective  To identify drugs associated with thrombocytopenia based on the U.S. FDA Adverse Event Reporting System (FAERS) database, and to provide reference for safe clinical drug use.

Methods  Adverse drug event (ADE) reports related to thrombocytopenia were extracted from the FAERS database (Q1 2004 to Q3 2024). Signal detection and data analysis were performed using the reporting odds ratio (ROR) method, proportional reporting ratio (PRR) method, Bayesian confidence propagation neural network (BCPNN) method, and multi-item gamma Poisson shrinker (MGPS) method. The time-to-onset of ADEs were evaluated using median, interquartile range, and Weibull Distribution.

Results  A total of 199,497 thrombocytopenia-related ADE reports were collected, identifying 1,701 primary suspected drugs, with 261 drugs showing positive signals. Excluding cases with missing gender data, female patients accounted for a slightly higher proportion (44.02%). Life-threatening or fatal outcomes were reported in 48,238 cases (24.61%). The most frequently reported first-level Anatomical Therapeutic Chemical (ATC) groups were the drugs for the antineoplastic and immunomodulating agents system(48.96%), followed by drugs for blood and hematopoietic organs (7.70%). The top three drugs by report frequency were lenalidomide (12,165 cases), niraparib (4,996 cases), and ruxolitinib (4,978 cases). The three drugs with the highest ROR values were romiplostim [ROR=28.22, 95%CI (27.20, 29.28)), eltrombopag [ROR=25.24, 95%CI (24.50, 26.00)), and linezolid[ROR=16.37, 95%CI (15.65, 17.13)). Lenalidomide was associated with the highest number of fatal outcomes (1,391 cases). Weibull shape parameter analysis indicated that most thrombocytopenia-inducing drugs exhibited an early failure pattern.

Conclusion A total of 261 drugs associated with positive signals of thrombocytopenia were monitored, with varying risk levels. Clinicians should closely monitor hematologic parameters during treatment, particularly for drugs that do not mention the risk of thrombocytopenia in their inserts, in order to prevent thrombocytopenia.

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