What is rivaroxaban?

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.

Rivaroxaban side effects

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.

Warnings

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.

Before taking this medicine

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.

How should I take rivaroxaban?

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).

What happens if I miss a dose?

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.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

An overdose may cause excessive bleeding.

What should I avoid while taking rivaroxaban?

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

What other drugs will affect rivaroxaban?

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.

What is apixaban?

Apixaban is used to lower the risk of stroke caused by a blood clot in people with a heart rhythm disorder called atrial fibrillation.

Apixaban is also used after hip or knee replacement surgery to prevent a type of blood clot called deep vein thrombosis (DVT), which can lead to blood clots in the lungs (pulmonary embolism).

Apixaban is also used to treat DVT or pulmonary embolism (PE), and to lower your risk of having a repeat DVT or PE.

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

Apixaban side effects

Get emergency medical help if you have signs of an allergic reaction: hives; chest pain, wheezing, difficult breathing; feeling light-headed; swelling of your face, lips, tongue, or throat.

Also seek emergency medical attention if you have symptoms of a spinal blood clot such as tingling, numbness, or muscle weakness especially in your legs and feet.

Apixaban may cause serious side effects. Call your doctor at once if you have:

• easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), bleeding from wounds or needle injections, any bleeding that will not stop;
• heavy menstrual bleeding;
• headache, dizziness, weakness, feeling like you might pass out;
• urine that looks red, pink, or brown; or
• black or bloody stools, coughing up blood or vomit that looks like coffee grounds.

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 .

Warnings

Apixaban increases your risk of severe or fatal bleeding, especially if you take certain medicines at the same time (including some over-the-counter medicines). Tell your doctor about all medicines you have recently used.

Call your doctor at once if you have signs of bleeding such as: easy bruising, unusual bleeding, unexpected pain or swelling, feeling very weak or dizzy, bleeding gums, nosebleeds, heavy menstrual bleeding, blood in your urine or stools, coughing up blood or vomit that looks like coffee grounds, or any bleeding that will not stop.

Apixaban can cause a very serious blood clot around your spinal cord that can lead to long-term or permanent paralysis. This type of blood clot can occur during a spinal tap or spinal anesthesia (epidural), especially if you have a genetic spinal defect, if you use a spinal catheter, if you’ve had spinal surgery or repeated spinal taps, or if you use other drugs that can affect blood clotting.

Get emergency medical help if you have symptoms of a spinal cord blood clot such as tingling, numbness, or muscle weakness especially in your legs and feet.

Do not stop taking apixaban unless your doctor tells you to. Stopping suddenly can increase your risk of blood clot or stroke.

Before taking this medicine

You should not take apixaban if you are allergic to it, or if you have active bleeding from a surgery, injury, or other cause.

Apixaban may cause you to bleed more easily, especially if you have a bleeding disorder that is inherited or caused by disease.

Tell your doctor if you have an artificial heart valve, or if you have ever had:

• bleeding problems;
• antiphospholipid syndrome, especially if you have a triple positive antibody test; or
• liver or kidney disease.

Apixaban can cause a very serious blood clot around your spinal cord if you undergo a spinal tap or receive spinal anesthesia (epidural). This type of blood clot could cause long-term paralysis, and may be more likely to occur if:

• you have a spinal catheter in place or if a catheter has been recently removed;
• you have a history of spinal surgery or repeated spinal taps;
• you have recently had a spinal tap or epidural anesthesia;
• you take aspirin or other NSAIDs (nonsteroidal anti-inflammatory drugs)–ibuprofen (Advil, Motrin), naproxen (Aleve), diclofenac, indomethacin, meloxicam, and others; or
• you are using other medicines to treat or prevent blood clots.

Taking apixaban may increase the risk of bleeding while you are pregnant or during your delivery. Tell your doctor if you are pregnant or plan to become pregnant.

Do not breastfeed.

How should I take apixaban?

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.

You may take apixaban with or without food.

If you cannot swallow a tablet whole, crush it and mix with water, apple juice, or applesauce. Swallow the mixture right away without chewing.

A crushed tablet mixture may also be given through a nasogastric (NG) feeding tube. Read and carefully follow any Instructions for Use provided with your medicine.

Apixaban can make it easier for you to bleed, even from a minor injury. Seek medical attention if you have bleeding that will not stop.

Tell your doctor if you have a planned surgery or dental work. You may need to stop taking apixaban for a short time.

Do not stop taking apixaban unless your doctor tells you to.

If you stop taking apixaban for any reason, your doctor may prescribe another medicine to prevent blood clots.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose on the same day you remember it. Take your next dose at the regular time and stay on your twice-daily schedule. Do not take two doses at one time.

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

What should I avoid while taking apixaban?

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

What other drugs will affect apixaban?

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

Many other drugs (including some over-the-counter medicines) can increase your risk of bleeding or blood clots. Tell your doctor about all medicines you have recently used, especially:

• any other medicines to treat or prevent blood clots;
• a blood thinner such as heparin or warfarin (Coumadin, Jantoven);
• an antidepressant; or
• aspirin or other NSAID (nonsteroidal anti-inflammatory drug) used long term.