Signal Mining for Non-Bleeding Adverse Events in Novel Oral Anticoagulants: A Pharmacovigilance Study Based on the FAERS Database

July 2025

Guimu Guo, Ying Song, Yunda Chen, Jinhua Zhang

rivaroxaban alopecia menstrual irregularities

TLDR Different oral anticoagulants cause various non-bleeding side effects, so careful monitoring is needed.

This pharmacovigilance study analyzed non-bleeding adverse events (AEs) associated with novel oral anticoagulants (NOACs) using the FAERS database from 2014 to 2024. Significant AEs were identified in three organ systems, with each NOAC exhibiting distinct safety profiles. Dabigatran was linked to potassium imbalance and mental status changes, apixaban to thyroid disorders and sleep disturbances, edoxaban to lymphatic disorders and delirium, and rivaroxaban to alopecia and menstrual irregularities. The study emphasizes the need for vigilance in clinical practice due to the diverse AEs associated with NOACs.

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