Xarelto Side Effects

(Updated Nov. 28, 2018)

Xarelto (rivaroxaban) is an anticoagulant, or blood thinner, that may cause uncontrollable bleeding. Since there was no antidote for rivaroxaban until 2018, this side effect proved to be life-threatening for some patients.

The FDA has received thousands of adverse event reports from Xarelto patients, which include incidents of uncontrollable bleeding and strokes.

The drug’s once-daily dosing creates periods of high and low-drug concentrations, putting patients at a higher risk of bleeding and developing blood clots—the very thing Xarelto is supposed to prevent. Since 2011, there have been more than 83,000 Xarelto-related serious adverse events reported to the FDA.

Patients who suffered from adverse events after taking Xarelto are now filing lawsuits against manufacturer Bayer and marketer Janssen (part of Johnson & Johnson).

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FDA-Approved Uses

Xarelto is approved for the following treatments:

  •    Stroke prevention for patients with non-valvular atrial fibrillation (abnormal heart rhythm)
  •    Reduction of the risk of major cardiovascular events (including stroke) in people with chronic coronary or peripheral artery disease
  •    Prevention and treatment of deep vein thrombosis (DVT) or pulmonary embolism, particularly for patients undergoing hip or knee replacement surgery

FDA Warnings

Despite its alleged dangers, Xarelto has not been recalled. However, in 2017, the FDA issued warnings for the following complications:

  • Xarelto lacks an antidote to reverse bleeding.
  • Premature discontinuation of Xarelto increases the risk of life-threatening blood clots.
  • The optimal timing between taking Xarelto and receiving an epidural or other spinal-area injection is unknown. This puts patients at risk of developing blood clots near the spine.

Xarelto Bleeding Side Effects

Patients taking Xarelto as directed may experience excessive or unusual bleeding or bruising, including the following side effects:

  • Bleeding gums
  • Bloody stools
  • Red or dark brown urine
  • Nosebleeds
  • Coughing or vomiting blood
  • Heavier menstrual flow
  • Intracranial hemorrhages
  • Abdominal hemorrhages
  • Retinal hemorrhages
  • Epidural hematoma
  • Adrenal bleeding
  • Spinal hematoma
  • Stroke
  • Death

Other Side Effects

Patients may also suffer from the following:

  • Back pain
  • Dizziness
  • Headache
  • Numbness
  • Paralysis
  • Bowel or bladder dysfunction

Xarelto May Have Caused Uncontrollable Bleeding

Xarelto patients may bleed and bruise more easily. This risk is higher for seniors, patients with kidney problems, or if Xarelto is used with another drug that increases the risk for bleeding, like aspirin or anti-inflammatory drugs.

These side effects are not unique—uncontrollable bleeding is a potential consequence of taking any blood thinner. 

Blood thinners are designed to prevent the formation of blood clots, which can slow or stop blood flow to vital organs. These blockages in the bloodstream can result in complications like deep vein thrombosis and strokes. Xarelto fights this by targeting the Xa factor that is necessary for blood clot formation.

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However, not all blood clots are bad. Blood clotting helps to naturally stop blood flow in the event of an injury. Without this form of natural protection, the body can no longer prevent a brain hemorrhage after a fall, or stop the flow of blood from a small cut. 

What makes Xarelto even more dangerous, is that unlike generic drug warfarin, it did not have an antidote to stop the bleeding until seven years after it was first prescribed. Nor does Xarelto require regular blood monitoring. This means that doctors not only lacked an easy way of fighting this dangerous side effect, they also had a harder time spotting patients with a higher risk of bleeding.

When to Seek Medical Attention for Blood Loss

When does bleeding become a matter of concern? Look out for these signs:

  • Frequent nosebleeds
  • Bleeding from the gums
  • Coughing or vomiting blood
  • Wound infection and complication
  • Headaches, dizziness, weakness, or confusion
  • Slurred speech or vision problems (could indicate a brain hemorrhage)
  • Heavier than normal menstrual bleeding
  • Red, pink, or brown urine
  • Red or black stool
  • Uncontrollable bleeding

Dangers of Once-Daily Dosing

The once-daily dosing causes periods of high and low-drug concentration, which may increase the risk for uncontrollable bleeding, blood clots, and strokes.

Once on Xarelto, it’s important that patients continue to take it as prescribed until otherwise instructed by a medical professional. Missing a dose can increase the risk of developing blood clots and having a stroke.

But, as it turns out, even taking the medication as prescribed may put patients in danger because of Xarelto’s once-daily dosing, which is marketed as a convenience over other blood thinners.

The once-daily dosing causes periods of high-drug concentration, when the risk for uncontrollable bleeding is high, and low-drug concentration, when the risk of blood clots and strokes is high.

This is a dangerous rollercoaster, as the FDA’s adverse event reports show. In 2014, the FDA received 1,129 reports of treatment failure (including blood clots and strokes) and 1,657 hemorrhage events caused by Xarelto.

The American Heart and Stroke Association recommends that patients seek emergency medical help if they exhibit the following stroke warning signs: face drooping, arm weakness, and speech difficulty.

Safety Tips for Xarelto Patients

If you are currently taking Xarelto, it’s important to take the following precautions:

  • Take your medication consistently: Contact your doctor for guidance if you miss a dose.
  • Prevent falls and injuries: Avoid contact sports, and always wear helmets and protective gear.
  • Handle sharp objects with care: Wear protective gloves and use electric razors.
  • Be gentle with your gums: Use soft-bristled toothbrushes and waxed floss.
  • Be wary of drug interactions: Make sure your doctor knows that you are on Xarelto.

What to Do If You Were Harmed

If you or a loved one suffered severe side effects after taking Xarelto as instructed, contact our attorneys to learn about the potential benefits of filing a lawsuit. More than 20,000 claims against Xarelto’s manufacturers await trial in a multidistrict litigation (MDL) in Louisiana Federal Court and a Philadelphia mass tort program.

A lawsuit may result in compensation for medical costs, loss of wages, and more.