Rivaroxaban is used to treat or prevent blood clots (venous thromboembolism, or VTE). Blood clots can occur in the legs (deep vein thrombosis, DVT) or the lungs (pulmonary embolism, PE).

Rivaroxaban is sometimes used to lower your risk of a blood clot coming back after you have received treatment for blood clots for at least 6 months in adults, and at least 5 days in children from birth to less than 18 years of age.

Rivaroxaban is also given together with aspirin to lower the risk of stroke, heart attack, or other serious heart and blood circulation problems in adults with coronary artery disease (clogged arteries) or peripheral artery disease (reduced blood flow to the legs), including adults who recently had a procedure to improve blood flow to the legs.

Rivaroxaban can also be used to prevent blood clots in adults that are not able to move as normal during and after a hospital stay or after a hip or knee replacement surgery.

Rivaroxaban can be used to prevent blood clots in children 2 years and older that have undergone surgery for a heart disease present at birth.

Rivaroxaban is also used to lower the risk of stroke and blood clots in adults with atrial fibrillation (a heart rhythm disorder).

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

Do not stop taking rivaroxaban without your doctor's advice. Stopping it suddenly can increase your risk of blood clots or stroke.

Some drugs can increase your risk of bleeding when used with rivaroxaban. Tell your doctor about all other medicines you use.

Call your doctor at once if you or your child have signs of bleeding such as: headaches, feeling very weak or dizzy, bleeding gums, nosebleeds, heavy menstrual periods or abnormal vaginal bleeding, blood in your urine, bloody or tarry stools, coughing up blood, vomit that looks like coffee grounds or any bleeding that will not stop.

Rivaroxaban can cause a very serious blood clot around your spinal cord if you undergo a spinal tap or receive spinal anesthesia (epidural). Tell any doctor who treats you that you are taking rivaroxaban.

Rivaroxaban comes as a tablet and a suspension (liquid) to take by mouth. When rivaroxaban is used to treat DVT or PE in adults, it is usually taken with food twice daily for 21 days, then once daily with food. When rivaroxaban is used to prevent DVT or PE in adults, it is usually taken once daily with or without food after at least 6 months of anticoagulation (blood thinner) treatment. When rivaroxaban is used to prevent a stroke in those who have atrial fibrillation, it is usually taken once daily with the evening meal. When rivaroxaban is taken to prevent DVT and PE after hip or knee replacement surgery, it is usually taken with or without food once daily. The first dose should be taken at least 6 to 10 hours after surgery. Rivaroxaban is usually taken for 35 days after a hip replacement surgery and for 12 days after knee replacement surgery. When rivaroxaban is taken to prevent DVT and PE in adults who are hospitalized for serious illnesses and are at risk of developing a clot due to decreased ability to move around, it is usually taken with or without food once daily starting when you are in the hospital and then continuing for a total of 31 to 39 days. When rivaroxaban is taken along with aspirin in adults with coronary artery disease or peripheral arterial disease, it is usually taken twice daily with or without food. When rivaroxaban is used in children and infants to treat or prevent DVT or PE, it is usually given 1 to 3 times a day with food after at least 5 days of anticoagulation (blood thinner) treatment. When rivaroxaban is taken in children 2 years of age or older who have congenital heart disease, it is usually given 1 to 3 times a day with or without food after heart surgery.

Take rivaroxaban at around the same time(s) every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take rivaroxaban exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

For adults, if you are unable to swallow the tablets, you can crush them and mix with applesauce. Swallow the mixture right after you prepare it. Rivaroxaban can also be given in certain types of feeding tubes. Ask your doctor if you should take this medication in your feeding tube. Follow your doctor's directions carefully.

For children taking rivaroxaban tablets, swallow the tablets whole; do not split them.

If you or your child vomits or spits up within 30 minutes of taking a dose of rivaroxaban oral suspension, take another full dose as soon as possible after the vomiting episode and then take your next dose at the regularly scheduled time.

To measure rivaroxaban oral suspension, follow these steps:

1. Use the oral syringe that came with the medication for measuring the liquid. Do not use a household spoon to measure your dose. Household teaspoons are not accurate measuring devices, and you may receive too much medication or not enough medication if you measure your dose with a household teaspoon.
2. Shake the bottle gently for 10 seconds before use. If there are remaining granules at the bottom of the bottle, shake gently again for another 10 seconds. Do not shake the bottle to avoid foaming.
3. Remove the bottle cap by pushing down on the cap, then turn it counterclockwise (to the left). Do not remove the adaptor from the top of the bottle.
4. Push all the air from the oral syringe into the bottle by pushing down on the plunger. Then insert the open tip of the oral syringe into the adaptor.
5. While holding the oral syringe in place, carefully turn the bottle upside down. Draw some of the medication out of the bottle into the oral syringe by pulling back on the plunger. Be careful not to pull the plunger all the way out.
6. You will see a small amount of air near the end of the plunger in the oral syringe. Push on the plunger so the medication goes back into the bottle and the air disappears. Pull back on the plunger to draw your correct medication dose into the oral syringe.
7. While still holding the oral syringe in the bottle, carefully turn the bottle upwards so the syringe is on top. Remove the oral syringe from the bottle neck adaptor without pushing on the plunger. Take the medication right after you draw it into the oral syringe.
8. Place the open tip of the oral syringe into one side of your child's mouth and push on the plunger slowly as the liquid goes into your child's mouth; have your child swallow the medication slowly as it goes into their mouth.
9. If your dose is more than 5 mL, you will need to use the same syringe more than one time and you will need to repeat steps 3 through 7.
10. Leave the adaptor in the bottle. Place the cap back on the bottle and turn it clockwise (to the right) to tighten it.
11. Rinse the oral syringe with clean tap water and allow it to air dry after each use.

Continue to take rivaroxaban even if you feel well. Do not stop taking rivaroxaban without talking to your doctor. If you stop taking rivaroxaban, your risk of a blood clot may increase.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Do not change your dose or stop taking this medication without your doctor's advice. Stopping suddenly can increase your risk of blood clots or stroke.

Tell any doctor who treats you that you are using rivaroxaban. If you need surgery or dental work, tell the surgeon or dentist ahead of time that you are using this medication. If you need anesthesia for a medical procedure or surgery, you may need to stop using rivaroxaban for a short time.

For some conditions, rivaroxaban should be taken with food. Whether you take the medicine with or without food may also depend on the tablet strength you take. Follow your doctor's dosing instructions very carefully.

If you cannot swallow a rivaroxaban tablet whole, crush it and mix the medicine with a small amount of applesauce. Swallow the mixture right away without chewing. If you are taking the 15 mg or 20 mg tablet, the dose should be immediately followed by food.

Follow your healthcare provider's instructions about giving rivaroxaban through a feeding tube if needed.

Doses are based on weight in children and teenagers. Your child's dose may change if the child gains or loses weight.

If your child is taking the tablet, make sure it is swallowed whole. Rivaroxaban should not be split to provide a smaller dose. Talk to your doctor about switching to the oral suspension (liquid).

If your child vomits within 30 minutes of taking the oral suspension (liquid), give a new full dose. If your child vomits more than 30 minutes after taking the oral suspension (liquid), do not give another dose. Give the next dose as scheduled.

Shake the oral suspension (liquid). Measure a dose with the supplied measuring device (not a kitchen spoon).

Store at room temperature away from moisture and heat. Do not freeze the oral suspension (liquid).

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

Rivaroxaban can make it easier for you to bleed, even from a minor injury. Call your doctor if you have bleeding that will not stop.

Rivaroxaban can cause a serious blood clot if you undergo a procedure such as a spinal tap or receive spinal anesthesia (epidural). This type of blood clot could cause permanent or long-term paralysis.

Tell your doctor if you have or ever had:

• a history of problems with your spine or a spinal surgery;

• a history of difficult or repeated spinal taps;

• a thin tube (catheter) placed in your back to give you certain medicine;

• bleeding problems;

• an artificial heart valve;

• antiphospholipid syndrome, an immune system disorder that increases the risk of blood clots;

• taken NSAIDs (nonsteroidal anti-inflammatory drugs)--aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), and other medicines that prevent blood from clotting; or

• liver or kidney disease.

Taking rivaroxaban during pregnancy may cause bleeding in the mother or the unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It may not be safe to breastfeed a baby while you are using rivaroxaban. Ask your doctor about the risks.

If you take rivaroxaban 1 time each day: Take the medicine as soon as you remember, and then go back to your regular schedule. Do not take two doses in the same day.

If you take the 15-milligram tablet 2 times each day: Take the missed dose on the same day you remember it. You may take the missed morning dose with the evening dose. Take your next dose at the regular time and stay on your two times a day schedule.

If you take the 2.5-milligram tablet 2 times each day: Skip the missed dose and take your next dose at the regular time. Do not use two doses at one time.

If your child takes rivaroxaban 2 times each day: give the missed morning dose as soon as you remember. You may give the missed morning dose with the evening dose. If you miss an evening dose, skip the missed dose and then go back to the regular schedule.

If your child takes rivaroxaban 3 times each day: skip the missed dose and give the next dose at the regular time. Do not give two doses at one time.

Get your prescription refilled before you run out of medicine completely.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

An overdose may cause excessive bleeding.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Unless your doctor tells you otherwise, continue your normal diet.

Avoid activities that may increase your risk of bleeding or injury. Use extra care while shaving or brushing your teeth.

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

Also seek emergency medical attention if you have symptoms of a spinal blood clot: back pain, numbness, tingling, muscle weakness in your lower body, or loss of bladder or bowel control.

Rivaroxaban can cause you to bleed more easily. Call your doctor at once if you have signs of bleeding such as:

• bruising or bleeding that will not stop (nosebleeds, bleeding gums, heavy menstrual bleeding);

• pain, swelling, new drainage, or excessive bleeding from a wound;

• headaches, dizziness, weakness, feeling like you might pass out;

• urine that looks red, pink, or brown; or

• bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds.

Common side effects of rivaroxaban may include:

• bleeding;

• vomiting;

• cough; or

• stomach or gut inflammation.

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.

Sometimes it is not safe to use certain medicines at the same time. Some drugs can affect your blood levels of other drugs you use, which may increase side effects or make the medicines less effective.

Tell your doctor about all your current medicines. Many drugs can affect rivaroxaban, especially:

• ketoconazole;

• ritonavir;

• erythromycin, rifampin;

• carbamazepine, phenytoin;

• St. John's wort;

• medicine used to prevent blood clots--enoxaparin, warfarin, alteplase, clopidogrel, dipyridamole, ticlopidine, and others; or

• NSAIDs (nonsteroidal anti-inflammatory drugs)--aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others.

This list is not complete and many other drugs may affect rivaroxaban. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to rivaroxaban.

Do not let anyone else take your medication. Your prescription is probably not refillable.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.