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.

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 this medicine. Ask your doctor about the risks.

Use Xarelto Starter Pack (Oral) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

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 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.

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