[8] Specifically it is used to treat deep vein thrombosis and pulmonary emboli and prevent blood clots in atrial fibrillation and following hip or knee surgery.

[14][15] In those with non-valvular atrial fibrillation, rivaroxaban appears to be as effective as warfarin in preventing strokes and embolic events in patients who are classified as moderate-to-high risk, as defined by a score of a number of specific medical conditions.

[16][17] In July 2012, the UK's National Institute for Health and Clinical Excellence recommended rivaroxaban to prevent and treat venous thromboembolism.

[5][21] A small retrospective cohort study reported that the use of moderate CYP3A4 and P-glycoprotein inhibitors such as amiodarone or verapamil, increased the risk of bleeding when administered with rivaroxaban.

[citation needed] As for mitochondrial toxicity, in vitro studies published before 2008 found the risk to be low.

[42] Using rivaroxaban rather than warfarin costs 70 times more, according to Express Scripts Holding Co, the largest U.S. pharmacy benefits manager.

[44] In the same month, the European Commission also granted marketing authorization of rivaroxaban to prevent venous thromboembolism in adults undergoing elective hip and knee replacement.

[45][6] In July 2011, the US Food and Drug Administration (FDA) approved rivaroxaban for prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in adults undergoing hip and knee replacement surgery.

Plaintiffs accused the drugmakers of not warning about the bleeding risks, claiming their injuries could have been prevented had doctors and patients been provided adequate information.

[50] The clinical trial, published 2011 in the New England Journal of Medicine[51] and headed by Robert Califf, later Commissioner of the FDA,[52] found rivaroxaban to be more effective than warfarin in reducing the likelihood of ischemic strokes in patients with atrial fibrillation.

[51] The validity of the study was called into question in 2014, when pharmaceutical sponsors Bayer and Johnson & Johnson revealed that the INRatio blood monitoring devices used were not functioning properly,[49][50] A subsequent analysis by the Duke team published in February 2016 found that this had no significant effect on efficacy and safety in the trial.