"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"...
- Clinician Information:
Xarelto Patient Information Including Side Effects
Brand Names: Xarelto
Generic Name: rivaroxaban (Pronunciation: RIV a ROX a ban)
- What is rivaroxaban (Xarelto)?
- What are the possible side effects of rivaroxaban (Xarelto)?
- What is the most important information I should know about rivaroxaban (Xarelto)?
- What should I discuss with my healthcare provider before taking rivaroxaban (Xarelto)?
- How should I take rivaroxaban (Xarelto)?
- What happens if I miss a dose (Xarelto)?
- What happens if I overdose (Xarelto)?
- What should I avoid while taking rivaroxaban (Xarelto)?
- What other drugs will affect rivaroxaban (Xarelto)?
- Where can I get more information?
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 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;
- feeling like you might pass out;
- 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)?
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.
Blood clots around the brain or spinal cord may occur if you use 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.
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.
Additional Xarelto Information
- Xarelto Drug Interactions Center: rivaroxaban oral
- Xarelto Side Effects Center
- Xarelto FDA Approved Prescribing Information including Dosage
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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