The most serious side effect associated with Xarelto, and the focus of the growing litigation against the medication and its parent companies, is internal uncontrolled bleeding.

Uncontrolled bleeding is a common risk among blood thinners and in 2012, many serious bleeding events and several deaths were attributed to Xarelto.

The serious side effects associated with Xarelto, even after as little as one dose, include:

  • Hemorrhagic Stroke
  • Gastrointestinal Bleeding
  • Cerebral Hemorrhages
  • Severe Anemia Requiring Transfusion
  • Internal Bleeding
  • Serious or Life-Threatening Bleeds Requiring Hospitalization
  • Bleeds Resulting in Death

The main focus of lawsuits related to the current generation of anticoagulants, including Xarelto, is on internal and gastrointestinal bleeding, primarily in the stomach and intestines. Internal bleeds have occurred from as little as one dose including in the brain and gastrointestinal tracts, and have been associated with hematuria (blood in urine) and pericardial effusion or hemopericardium (blood in sac surrounding the heart).

In instances of internal bleeding, bodily cavities and spaces fill with blood from the vascular system, and when this occurs near a major organ, blood flow may be interrupted which can have dire consequences in terms of the organ’s proper functioning.

Because Xarelto is a blood thinner and prevents clotting, hemorrhaging can continue until the drug is no longer in the system, causing severe, life-threatening blood loss.

In the first quarter of 2012, more than 356 reports of serious, disabling, or fatal injury were received on Xarelto, which more than doubled from the previous quarter which reported approximately 128 cases. The primary reported events were pulmonary embolism, the very events Xarelto is intended to prevent.

Since 2013, Xarelto has been increasingly connected to cases involving serious internal bleeds, with some resulting in death. Unlike Coumadin, which bleeding events can be treated with vitamin K to reverse, patients on Xarelto have no such antidote.

According to Bloomberg (12/4/14), as many as 65 deaths have allegedly been linked to the use of Xarelto, and 21 lawsuits have been filed in 10 federal courts, alleging among other things, that Xarelto was not properly tested before it was approved for market in 2011, that the company failed to warn about its risks, and that the drug was marketed as being superior to Coumadin when in fact, unlike Coumadin, bleeds occurring as a result of Xarelto have no antidote.


If you have been affected by any of these side effects, or if someone you know has died in association with treatment by Xarelto, please contact us right away. You can fill out a free case evaluation form, or call us for a free consultation.