Importantly, given that renal insufficiency produced clinically significant increases in rivaroxaban exposure with amiodarone co-administration, the FDA label warns that renally impaired patients taking rivaroxaban with P-glycoprotein inhibitors and weak to moderate CYP3A4 inhibitors (such as amiodarone) may have a higher risk of bleeding. This evidence concerns the gene ABCB1 and Renal insufficiency.