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Xarelto, generic name rivaroxaban, is an anticoagulant medication that prevents blood clots by blocking specific blood proteins. Taken orally one to two times per day, this medication is used by patients with atrial fibrillation, an irregular heartbeat, and patients who have recently had hip replacement surgery to prevent both blood clots and strokes. It is also used by patients suffering from pulmonary embolus-PE or deep vein thrombosis-DVT to prevent future blood clots.

Xarelto acts as a blood thinner, also known as a direct factor Xa inhibitor, by inhibiting the function of Factor X in the naturally occurring blood coagulation process of the body. Xarelto is often compared with a similar drug known as warfarin, generic name coumadin, which is also a blood thinner—and is said to be as equally effective in preventing non-hemorrhagic strokes in non-valvular atrial fibrillation, or an irregular heartbeat.

Xarelto was approved in 2012 by the Federal Drug Administration (FDA) to be used as a blood thinner to prevent strokes. However, in the same year, the FDA ruled against approving Xarelto for blocked coronary arteries.


The most dangerous side effect associated with Xarelto is bleeding, including internal bleeding. In some cases, Xarelto is safer than other blood thinners, such as warfarin, because its side effects cause less serious or fatal bleeding. However, Xarelto does cause higher rates of gastrointestinal tract bleeding than warfarin. In an FDA approved study, Xarelto was found to result in a higher risk of bleeding in the brain than another blood thinner medication known as Pradaxa.

There is a reversal medication that can be used in cases of bleeding caused by Xarelto, but the efficacy and safety of the medication, known as Andexant alfa, has not been established or verified in trials. In this case, warfarin is more reliable because its reversal medication has been proven to be safe and effective. Other side effects of Xarelto include:

  • Unusual swelling, pain, or discomfort
  • Prolonged bleeding of any kind
  • Unusual bruising
  • Prolonged or unusually heavy menstrual flow
  • Persistent or unusually frequent nosebleeds
  • Coughing up blood
  • Dark urine
  • Severe headaches
  • Bloody or especially dark vomit
  • Fatigue or unusual weakness
  • Unusual dizziness or fainting
  • Bloody or black stools

If you are on Xarelto and are experiencing any of the above side effects, please contact your doctor immediately for a consultation on your health.


The main complication with Xarelto is uncontrolled bleeding or internal bleeding that cannot be contained due to the lack of an effective reversal medication. Uncontrolled bleeding due to use of Xarelto has led to the severe injury and death of many Xarelto patients. This is a significant risk in using Xarelto.

Experiencing a trauma such as a car accident, a fall, or a deep gash may cause internal or external bleeding. A normal person will need to take proper medical precautions to address the bleeding, including application of bandages, and can usually prevent extreme blood loss. But with patients taking Xarelto, a blood thinner, the blood will not coagulate properly and, even with proper and professional medical treatment, these patients can suffer from excessive blood loss—which can lead to further medical complications and even death.


In 2015, the FDA claimed that Xarelto (rivaroxaban) had the most reported cases of serious injury out of all drug medications that are regularly monitored by the FDA’s Adverse Events Reporting System. This is a highly significant statistic that patient consumers of Xarelto should be fully aware of. The Centers for Disease Control have also reported that blood thinners are one of the most dangerous drugs, accounting for a greater number of visits to the emergency department than any other medication.

Xarelto is taken to reduce the risk of blood clotting, which can lead to strokes and other medical problems. However, since Xarelto has been listed as the top medication causing adverse events, patients may need to decide if it is worth the risk.


There are now over 20,000 pending lawsuits against Xarelto, the main complaint being that Johnson & Johnson and Bayer, the manufacturers of the medication, failed to adequately warn patients about the very severe risks of uncontrollable bleeding associated with the drug, as well as the lack of an established drug that can reverse the dangerous side effects. With the FDA reporting 22,000 severe injuries and over 3,000 deaths resulting from blood thinner / anticoagulant medications in 2016, it’s no surprise that such a high volume of litigation has been filed against the makers of Xarelto.


  • Lack or inadequacy of warning labels on packaging regarding the potential side effect of severe bleeding
  • Lack of information regarding the absence of a reversal medication
  • Omission of clinical trial results on the warning label
  • Lack of continuous monitoring to ensure safety while taking the medication
  • Lack of information on prescription indications, including warnings and side effects, given to healthcare professionals