The use of Xarelto has been linked to serious side effects, including life-threatening bleeding in the gastrointestinal tract and in the brain. 

What is Xarelto? 

Xarelto is a new-generation anticoagulant, used to reduce the risk of stroke and blood clots in people with atrial fibrillation (irregular heartbeat), not caused by a heart valve problem. Xarelto is also prescribed to patients undergoing hip or knee replacement surgery to reduce their risk of blood clots in the legs and lungs. 

Manufactured by Bayer and Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, Xarelto was first approved by the FDA in 2011, and quickly rose in popularity because of its convenience: Xarelto is taken as a single daily pill, and it does not require the routine blood-test monitoring necessary with older-generation anticoagulants. It is now prescribed to millions of people in the U.S. annually. 

Soon after its approval, however, the FDA began receiving an unusually high number of reports about serious, disabling, or fatal injuries associated with Xarelto. In 2016, the FDA received over 15,000 such reports about Xarelto, a number far outpacing any other drug. 

Xarelto can cause serious and fatal bleeding, for which there is no antidote. Patients on Xarelto are at risk for gastrointestinal bleeding and strokes (brain bleeds). 

Due to the severe nature of Xarelto’s side effects, a high percentage of patients experiencing these adverse health consequences require hospitalization, sometimes recurrently. 

Symptoms of Xarelto’s Side Effects 

Because Xarelto can cause life-threatening bleeding, including in the gastrointestinal tract and in the brain, the FDA urges patients on Xarelto to seek immediate medical attention if they experience any of the following symptoms: 

  • bloody, black, or tarry stools
  • pink, or brown urine
  • coughing up or vomiting blood or material that looks like coffee grounds
  • frequent nosebleeds
  • bleeding from your gums
  • heavy menstrual bleeding
  • weakness
  • tiredness
  • headache
  • dizziness or fainting
  • blurred vision
  • pain in arm or leg
  • rash
  • itching
  • difficulty breathing or swallowing
  • hives
  • pain or swelling at wound sites
  • muscle spasms
  • unusual bruising 

Although Xarelto has not been recalled and does remain on the market, the high incidence of injuries associated with Xarelto prompted the FDA to issue Safety Communications and to require additional warnings and information to be included on Xarelto’s label. 


More than 20,000 Xarelto lawsuits are pending against Bayer, Janssen Pharmaceuticals and Johnson and Johnson. These lawsuits seek compensation for injuries suffered by patients taking Xarelto, claiming that the defendants knew about the risks associated with Xarelto, but continued to promote and sell this medication without additional warnings. Plaintiffs argue, for example, that the manufacturers of Xarelto failed to disclose the elevated risk of gastric ulcers associated with the ingestion of this medication. Once a gastric ulcer begins to bleed, the bleeding cannot be stopped due to Xarelto’s anticoagulant activity. If health care practitioners and patients had been warned about the increased risks, many would not have used Xarelto. 

In December 2017, a Pennsylvania jury found for a plaintiff who suffered gastrotintestinal bleeding after taking Xarelto. 

How We Can Help 

If you have suffered serious health problems after taking Xarelto, you may be entitled to reimbursement for medical expenses, lost wages, and other costs.  Attorneys at Wilentz, Goldman & Spitzer P.A. may be able to help you recover compensation if you suffered serious injuries due to taking Xarelto. As a nationally recognized personal injury law firm and one of New Jersey’s largest law firms, Wilentz is committed to helping clients with their cases. 

For a free consultation or more information about your legal options, please call the number below. Or, if you prefer to complete our free case evaluation form, our client relations representative will contact you shortly.