Rivaroxaban (riv-a-ROX-a-ban)

Treats and prevents blood clots, which lowers the risk of stroke, deep vein thrombosis (DVT), pulmonary embolism (PE), heart attack, major amputation, sudden decrease in blood flow to the legs, and similar conditions. Also prevents blood clots in people who are hospitalized for an acute illness or with congenital heart disease. This medicine is a blood thinner.

Brand Name(s):

Xarelto, Xarelto Starter Pack

When This Medicine Should Not Be Used:

How to Use This Medicine:

Liquid, Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed. Take this medicine at the same time each day.
• 2.5 milligram (mg) or 10 mg tablet: Take with or without food.
• 15 mg or 20 mg tablet: Take with food.
• If you cannot swallow the tablets whole, you may crush the tablet and mix it with a small amount of applesauce. Eat some food right after you swallow the mixture.
• Tube feeding: You may crush the tablet and mix the medicine in 50 milliliters (mL) of water before giving it via the tube. This must be followed by a feeding.
• Oral liquid:
  • Shake the bottle slowly for 10 seconds before each use.
  • Measure the medicine with the provided oral dosing syringe.
  • Ask your doctor if you should take it with or without food.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose:
  • Ask your doctor or pharmacist if you are not sure what to do if you miss a dose.
  • Once-daily dose: If you miss a dose or forget to use your medicine, use it as soon as you can on the same day. Do not use extra medicine to make up for a missed dose.
  • Twice-daily dose to prevent serious heart or blood vessel problems (2.5 mg tablet): If you miss a dose, skip the missed dose and take your next dose at your usual time.
  • Twice-daily dose to treat a blood clot (oral liquid or 15 mg tablet): If you miss a dose or forget to use your medicine, use it as soon as you can on the same day. You may take 2 doses at the same time to make up for the missed dose. This is only for people who take a total of 30 mg per day.
  • Thrice-daily dose: If you miss a dose, skip the missed dose, then take your regularly scheduled doses the next day.
  • Oral liquid: If your child vomits or spits up right after or within 30 minutes after receiving the dose, give another dose. If it is more than 30 minutes after the dose is taken, give the next dose at the regular time. Call your doctor right away if your child vomits or spits out the medicine repeatedly.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
  • You may store the crushed tablet with applesauce or water mixture for up to 4 hours.
  • Throw away the oral liquid 60 days after opening.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how rivaroxaban works. Tell your doctor if you are using any of the following:
  • Carbamazepine, conivaptan, erythromycin, indinavir, itraconazole, ketoconazole, lopinavir, phenytoin, rifampin, ritonavir, St John's wort
  • Another blood thinner (including clopidogrel, enoxaparin, heparin, warfarin)
  • NSAID pain or arthritis medicine (including aspirin, celecoxib, diclofenac, ibuprofen, naproxen)

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, bleeding problems, cancer, lung problems, an artificial heart valve, or antiphospholipid syndrome.
• This medicine may increase your risk of bleeding. Be careful to avoid injuries that could cause bleeding. Stay away from rough sports or other situations where you could be bruised, cut, or hurt. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers. Avoid picking your nose. If you need to blow your nose, blow it gently.
• This medicine may cause nerve damage if you have a medical procedure done to your back, including anesthesia or a spinal puncture. This is more likely to happen if you have a history of back injury, back surgery, problems with your spine, or procedures or punctures to your back. Tell your doctor if you are also taking another blood thinner, because this also increases the risk.
• Do not stop using this medicine suddenly without asking your doctor. You might have an increased risk for stroke for a short time after you stop using this medicine.
• Tell any doctor or dentist who treats you that you are using this medicine.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, red skin rash
• Decrease in how much or how often you urinate
• Heavy menstrual bleeding or vaginal bleeding
• Red or brown urine, bloody or black, tarry stools
• Unusual bleeding or bruising, including frequent nosebleeds
• Vomiting of blood or material that looks like coffee grounds

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088