Edoxaban blocks the activity of certain clotting substances in the blood.

Edoxaban is used to lower the risk of stroke caused by a blood clot in people with a heart rhythm disorder called atrial fibrillation. edoxaban is used when the atrial fibrillation is not caused by a heart valve problem.

Edoxaban is also used to treat a type of blood clot called deep vein thrombosis (DVT), which can lead to blood clots in the lungs (pulmonary embolism). A DVT can sometimes occur after a person has been treated with an injectable blood thinner for 5 to 10 days.

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

Edoxaban can cause you to bleed more easily. Call your doctor at once if you have signs of bleeding such as: bleeding gums, nosebleeds, heavy menstrual periods or abnormal vaginal bleeding, blood in your urine, bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds.

Many other drugs can increase your risk of bleeding when used with edoxaban. Tell your doctor about all medicines you have recently used.

Edoxaban 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 edoxaban.

Do not stop taking edoxaban without first talking to your doctor. Stopping suddenly can increase your risk of blood clot or stroke.

Your kidney function may need to be checked before you start edoxaban.

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 edoxaban with or without food.

If you cannot swallow a tablet whole, crush the tablet and mix it with 2 or 3 ounces of water or applesauce. Swallow the mixture right away without chewing. Do not save it for later use.

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

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

Do not change your dose or stop taking this medication without first talking to your doctor. Stopping suddenly can increase your risk of blood clot or stroke.

Store at room temperature away from moisture and heat.

Usual Adult Dose for Atrial Fibrillation:

60 mg orally once a day

Use: Prevention of stroke and systemic embolism in nonvalvular atrial fibrillation.

Usual Adult Dose for Deep Vein Thrombosis:

60 mg orally once a day following 5 to 10 days of initial therapy with a parenteral anticoagulant

Use: Treatment of deep vein thrombosis and pulmonary embolism following 5 to 10 days of initial parenteral anticoagulant therapy.

Usual Adult Dose for Pulmonary Embolism:

60 mg orally once a day following 5 to 10 days of initial therapy with a parenteral anticoagulant

Use: Treatment of deep vein thrombosis and pulmonary embolism following 5 to 10 days of initial parenteral anticoagulant therapy.

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

Edoxaban 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 genetic spinal defect;

• you have a spinal catheter in place;

• you have a history of spinal surgery or repeated spinal taps;

• you have recently had a spinal tap or epidural anesthesia;

• you are taking an NSAID--Advil, Aleve, Motrin, and others; or

• you are using other medicines to treat or prevent blood clots.

Edoxaban may cause you to bleed more easily, especially if you have:

• a bleeding disorder that is inherited or caused by disease;

• hemorrhagic stroke;

• uncontrolled high blood pressure;

• stomach or intestinal bleeding or ulcer; or

• if you take certain medicines such as aspirin, enoxaparin, heparin, warfarin (Coumadin, Jantoven), clopidogrel (Plavix), or certain antidepressants.

Tell your doctor if you have ever had:

• an artificial heart valve;

• bleeding problems; or

• liver or kidney disease.

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

You should not breast-feed while using edoxaban.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take 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.

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).

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.

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

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

Avoid activities that may increase your risk of bleeding or injury. Use extra care to prevent bleeding 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 or muscle weakness in your lower body, or loss of bladder or bowel control.

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

• easy bruising or bleeding (nosebleeds, bleeding gums, heavy menstrual bleeding);

• pain, swelling, or drainage from a wound or where a needle was injected in your skin;

• bleeding from wounds or needle injections, any bleeding that will not stop;

• 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 edoxaban may include:

• bleeding; or

• low red blood cells (anemia)--pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet.

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.

Tell your doctor about all your other medicines, especially:

• any other medications to treat or prevent blood clots;

• a blood thinner--heparin warfarin (Coumadin, Jantoven);

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

• an antidepressant--citalopram, duloxetine, fluoxetine, sertraline, paroxetine, venlafaxine, Cymbalta, Prozac, Pristiq, Paxil, Zoloft, and others.

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

Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking edoxaban.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

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.