Xarelto Side Effects

Reported FDA Adverse Events related to Xarelto.

Approval of Xarelto

Xarelto was first approved for consumer use by Health Canada in September 2008 for the prevention of blood clots in those who had undergone hip or knee replacement operations. The European Medicines Agency approved it the same month for identical use.

In July 2011, the U.S. FDA approved Xarelto to prevent deep vein thrombosis (DVT) and pulmonary embolism in those who had undergone hip or knee surgery. That November, the agency approved it for stroke prevention in adults with atrial fibrillation.

In December 2011, Xarelto was approved by the European Medicines Agency to also prevent stroke and blood clots in adults with atrial fibrillation, to manage deep vein thrombosis (DVT), and to prevent recurring DVT and pulmonary embolism in those who had suffered a serious blood clot.

In November of 2012, the FDA granted approval to use Xarelto for the general treatment and prevention of DVT and pulmonary embolism. Finally, in May 2013, the EMA approved the drug to prevent blood clots in adults with verified acute coronary syndrome (ACS).

Xarelto Side Effects

The makers of Xarelto have advised of certain common Xarelto side effects listed below.

Manufacturer Side Effects

Some of the common side effects of Xarelto include:

  • Pain in extremities
  • Itchiness
  • Wound drainage
  • Dizziness
  • Red blood cell deficiency
  • Swelling of the feet or ankles
  • Loss of strength or energy.

Unfortunately, reports have identified more serious side effects of Xarelto that can cause severe and uncontrollable internal bleeding. Unlike warfarin and Coumadin, which use vitamin K as a bleeding antidote, there is no FDA-approved drug or compound doctors can give to stop emergency bleeding from Xarelto.

So far, the FDA and European health officials have received nearly 2,000 reports of patients suffering injury or death from serious internal bleeding Xarelto side effects. In fact, studies have shown it may be 48% more likely to cause bleeding than traditional treatments.

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