Objective To mine adverse drug reaction (ADR) signals of the novel oral anticoagulants rivaroxaban and dabigatran etexilate used in children based on the FDA Adverse Event Reporting System (FAERS) database, with a focus on mental and neurological-related reactions, in order to provide a basis for safe pediatric medication use.

Methods The adverse event report data of children aged 18 and under using novel oral anticoagulants from the first quarter of 2004 to the third quarter of 2025 in the FAERS database were extracted by the OpenVigil 2.1 platform. The reporting odds ratio (ROR) and proportional reporting ratio (PRR) methods were used for ADR signal detection. To assess the robustness of the signals, a sensitivity analysis was conducted by raising the case count threshold from a ≥ 3 to a ≥ 5.

Results A total of 481 440 reports were included, including 395 cases of rivaroxaban related reports and 45 cases of dabigatran etexilate related reports. ROR and PRR methods detected 79 ADR signals for rivaroxaban (including 5 mental and neurological-related signals) and 7 ADR signals for dabigatran etexilate. At the threshold of a ≥ 5, 5 mental and neurological ADR signals were detected for rivaroxaban, including suicidal attempt, confusion state, suicide death, suspected suicide and sensory abnormality. The ROR values and 95% confidence intervals of these signals were all greater than 1, and none of them were recorded in the current drug instructions; no positive signals were detected for dabigatran etexilate.

Conclusion When children use rivaroxaban and dabigatran etexilate, potential ADR related to the mental and neurological systems should be vigilant. Given that the data are derived from a spontaneous reporting system, the above results should be interpreted with caution.

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