Xarelto Warnings and Precautions

Extreme caution must be used if you are taking Xarelto and have certain medical problems, such as kidney disease, diabetic retinopathy, or any obvious bleeding. Other safety precautions and warnings include potential drug interactions and an increased risk for dangerous internal bleeding. Also, people who have certain allergies and women who are pregnant or breastfeeding may not be able to take this drug.

What Should I Tell My Healthcare Provider?

Talk with your healthcare provider prior to taking Xarelto® (rivaroxaban) if you have:
 
  • A bleeding disorder (not a clotting disorder)
  • Intestinal or stomach ulcers or bleeding
  • Bleeding in the brain
  • An aneurysm
  • A prosthetic heart valve
  • Plans to receive spinal or epidural anesthesia or spinal puncture
  • Kidney disease, such as kidney failure (renal failure)
  • Liver disease, such as hepatitis, liver failure, or cirrhosis
  • Any allergies, including to foods, dyes, or preservatives.
 
Also, let your healthcare provider know if you are:
 
  • Breastfeeding
  • Pregnant or thinking of becoming pregnant.
 
You should also tell your healthcare provider about all other medications you are taking, including prescription and nonprescription medicines, vitamins, and herbal supplements.
 

Specific Precautions and Warnings With Xarelto

Some warnings and precautions to be aware of prior to using this medication include the following:
 
  • As with all "blood thinners," most of the serious Xarelto side effects are related to bleeding, especially internal bleeding, which can be fatal. Let your healthcare provider know if you develop any signs of bleeding, such as:
 
    • Easy bruising
    • Cuts or scrapes that are slow to stop bleeding
    • Black, tarry stools; bright red blood in the stool; or vomiting of blood (signs of gastrointestinal bleeding)
    • Signs of a bleeding in the brain, such as vision or speech changes, weakness or numbness in an arm or leg, or a severe headache.
 
  • There have been reports of spinal or epidural hematoma in people who had spinal or epidural anesthesia or spinal punctures while taking anticoagulants, including Xarelto. This is a serious problem that can sometimes cause long-term or permanent paralysis. Each case must be evaluated on an individual basis, but you may not be a candidate for these types of anesthesia or procedures if you are taking Xarelto. If you have an epidural catheter that needs to be removed, this must be timed carefully with when you take your dose of Xarelto.
 
  • Before taking Xarelto, make sure your healthcare provider knows if you have any of the following medical conditions:
 
    • Kidney disease
    • Diabetic retinopathy
    • Uncontrolled high blood pressure
    • Current or recent ulcers of the digestive tract
    • Any obvious bleeding
    • Bleeding disorders that increase the risk for bleeding
    • Bleeding in the brain
    • Recent brain, spinal, or eye surgery.
Extreme caution must be taken in these situations.

 

  • If you are taking Xarelto to prevent blood clots and strokes due to atrial fibrillation, stopping this drug will increase your risk of stroke. Unless there is a very good reason not to do so, you should be switched to a different anticoagulant if you need to stop taking Xarelto.
  • Xarelto has not been studied in people with prosthetic heart valves. As a result, it is not recommended for such use.

 

  • This drug may not be a good choice for people with kidney or liver disease, as these organs help break down Xarelto and remove it from the body. If your liver or kidneys are not functioning properly, high levels of the drug could accumulate, increasing the risk for dangerous bleeding. In addition, people with liver disease are naturally at a higher risk for bleeding, even without anticoagulant medications.
 
  • It is not known if Xarelto passes through breast milk. Therefore, if you are breastfeeding or plan to start, discuss this with your healthcare provider prior to taking the drug (see Xarelto and Breastfeeding).
 
  • This product is a pregnancy Category C medication. This means that it might not be safe for use during pregnancy, although the full risks are currently unknown (see Xarelto and Pregnancy).
 
 
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