Signal Mining for Non-Bleeding Adverse Events in Novel Oral Anticoagulants: A Pharmacovigilance Study Based on the FAERS Database
July 2025
Studysummary This study found that non-bleeding adverse events associated with NOACs affect multiple organ systems, emphasizing the importance of clinical vigilance. Specific NOACs like dabigatran, apixaban, edoxaban, and rivaroxaban were linked to distinct adverse reactions, including metabolic imbalances, thyroid disorders, and menstrual irregularities. Our plain-language summary of this paper — not a Tressless recommendation.
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.
