Xarelto (rivaroxaban) is one of the newest anticoagulants, more commonly known as blood thinners, on the market today. The drug is an oral medication developed by Bayer and Johnson & Johnson’s New Jersey-based unit, Janssen Pharmaceuticals. Blood thinners prevent dangerous blood clots that can obstruct the blood flow to the vital organs. Unlike older anticoagulants that require doctors to prescribe specific doses for each individual, Xarelto belongs to a new type of oral anticoagulant that is prescribed in one uniform dose.


The FDA approved Xarelto in 2011 for use in patients who have had knee or hip replacement surgery to reduce the risk of blood clots, reducing the risk of stroke in people with atrial fibrillation (AF). Following a fast-track regulatory review, the FDA approved the drug for general treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE).


In a Phase III study intended to examine the drugs safety, 73 percent of the 16,041 participants who took at least one dose of Xarelto experienced side effects. Some of the most prominent serious side effects were anemia and bleeding events. People who took a higher dose were more likely to suffer from bleeding.

The FDA has issued several warnings regarding the usage of Xarelto including two black box warnings, the strictest warnings that the FDA can attach to a drug short of recalling it, meaning there is a reasonable risk of harm associated with the drug in question. The FDA also indicated that patients taking Xarelto were at an increased risk for developing blood clots. Xarelto also has an extensive list of drug interactions that can cause serious problems.


One of the most severe side effects of Xarelto is uncontrolled bleeding, and when it occurs near a major organ, such as the brain, lungs or kidneys, blood flow to that organ is interrupted, causing it to lose some or all of its functionality. Also, pools of blood may form within the body and can cause other severe health risks. Because Xarelto prevents clotting, the hemorrhaging will continue until the drug is flushed out of the system.

As there is currently no known antidote to stop incontrollable bleeds and the drugs manufacturers have not released information for doctors on how to treat this problem, this has lead to a number of fatalities.Bleeding is one of the most dangerous side effects associated with Xarelto. As there is currently no known antidote to stop uncontrollable bleeds and the drugs manufacturers have not released information for doctors on how to treat this problem, this has lead to a number of fatalities. Blood clots are also a serious side effect of the drug, with patients who have had hip or knee replacement surgery at the highest risk, and possibly triggering strokes or heart attacks if they travel to the brain. Patients who have spinal injections or other procedures are also at increased risk for developing blood clots in the spine that can cause permanent paralysis.

In addition, Xarelto’s side effects include abdominal bleeding, brain hemorrhage, abnormal liver function and reduced platelet levels.


Since the onset of litigation, the manufacturer has paid more than $650 million to patients and families of those who took Xarelto and experienced irreversible bleeding or died as a consequence of having taken the drug.

We strongly encourage anyone who may have taken Xarelto and experienced any adverse side effects to contact us immediately. The mounting data and lawsuits emerging on Xarelto is that the manufacturer was aware of the dangers and released the drug to market anyway, and the number of lawsuits filed will only continue to increase.

Dalimonte Rueb has extensive experience handling multiple district litigation for a number of drugs and devices, and can help people navigate the process and understand how their voice can be heard as well.