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Xarelto

"June 22, 2012 -- The FDA has decided -- for now -- against allowing the new blood thinner Xarelto to be used to treat patients with blocked coronary arteries.

Federal officials issued a complete response letter late Thursday, which me"...

Xarelto

Xarelto Patient Information Including Side Effects

Brand Names: Xarelto

Generic Name: rivaroxaban (Pronunciation: RIV a ROX a ban)

What is rivaroxaban (Xarelto)?

Rivaroxaban is an anticoagulant (blood thinner) that prevents the formation of blood clots.

Rivaroxaban is used to prevent a type of blood clot called deep vein thrombosis (DVT), which can lead to blood clots in the lungs (pulmonary embolism). A DVT can occur after certain types of surgery.

Rivaroxaban is also used in people with atrial fibrillation (a heart rhythm disorder) to lower the risk of stroke caused by a blood clot.

Rivaroxaban may also be used for purposes not listed in this medication guide.

What are the possible side effects of rivaroxaban (Xarelto)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using rivaroxaban and call your doctor at once if you have a serious side effect such as:

  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), bleeding from wounds or needle injections, any bleeding that will not stop;
  • heavy menstrual periods;
  • headache, dizziness, weakness, feeling like you might pass out;
  • red or pink urine;
  • black or bloody stools, coughing up blood or vomit that looks like coffee grounds;
  • numbness, tingling, or muscle weakness (especially in your legs and feet); or
  • loss of movement in any part of your body.

Less serious side effects may include:

  • muscle pain;
  • itching; or
  • pain in your arms or legs.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the Xarelto (rivaroxaban film-coated oral tablets) Side Effects Center for a complete guide to possible side effects

What is the most important information I should know about rivaroxaban (Xarelto)?

You should not use this medication if you are allergic to rivaroxaban, or if you have active or uncontrolled bleeding.

Tell any doctor who treats you that you are using rivaroxaban. If you need anesthesia for a medical procedure or surgery, you may need to stop using the medicine for a short time.

Rivaroxaban can cause a very serious blood clot around your brain or spinal cord if you undergo a spinal tap or receive spinal anesthesia (epidural), especially if you have a genetic spinal defect, a history of spinal surgery or repeated spinal taps, or if you are using other medications to treat or prevent blood clots. Symptoms of this type of blood clot include numbness, tingling, muscle weakness, or loss of movement.

Blood clots around the brain or spinal cord may occur during a spinal tap or epidural if you are using rivaroxaban with other drugs that can affect blood clotting, including aspirin, non-steroidal anti-inflammatory drugs (NSAIDs) such as Advil or Motrin, and any other medications to treat or prevent blood clots.

Many other drugs (including some over-the-counter medicines) can increase your risk of bleeding or life-threatening blood clots, and it is very important to tell your doctor about all medicines you have recently used.

Tell your caregivers at once if you have signs of bleeding such as black or bloody stools, coughing up blood, confusion, feeling like you might pass out, or any bleeding that will not stop.

Do not stop taking this medication without first talking to your doctor. Stopping suddenly can increase your risk of blood clot or stroke.

Side Effects Centers
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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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