Apixaban- and Rivaroxaban-Associated Bleeding: A Retrospective Analysis Using the FDA Adverse Event Reporting System

TL;DR

This study compares bleeding risks of apixaban and rivaroxaban, finding that rivaroxaban is associated with higher bleeding rates in several organs.

Contribution

The study provides new comparative insights into the bleeding risk profiles of apixaban and rivaroxaban using real-world adverse event data.

Findings

Rivaroxaban showed significantly higher bleeding risk in cerebral, GI, rectal, and renal systems compared to apixaban.

Apixaban may be safer for patients with a history of bleeding complications.

Ocular hemorrhage risk was not significantly different between the two drugs.

Abstract

Apixaban and rivaroxaban are two agents commonly used for anticoagulation to treat and prevent blood clots and strokes in individuals with atrial fibrillation (AF). We extracted data from the FDA Adverse Event Reporting System (FAERS) database to evaluate the reporting frequency of ocular, cerebral, gastrointestinal (GI), rectal, and renal hemorrhage, epistaxis, and hemoptysis related to apixaban and rivaroxaban from January 2012 to March 2024. We calculated relative odds ratios (RORs) with 95% confidence intervals (CIs) to compare the hemorrhagic risk profiles of the two agents. There was no statistical significance in reported cases of ocular hemorrhage in apixaban versus rivaroxaban. Based on RORs, rivaroxaban overall has a significantly higher risk of bleeding in multiple organ systems - especially cerebral, GI, rectal, and renal hemorrhage, as well as epistaxis and hemoptysis. Apixaban may be a safer option for individuals at risk for, or with a history of, these complications.