Highlights for edoxaban

  1. Edoxaban oral tablet is only available as a brand-name drug. There is no generic version. Brand name: Savaysa.
  2. Edoxaban comes only as a tablet you take by mouth.
  3. Edoxaban is a blood thinner drug. It’s used to reduce the risk of stroke and blood clots in people with an irregular heart rate called nonvalvular atrial fibrillation. Edoxaban is also used to treat blood clots in your legs or lungs after you’ve been treated with an injectable blood thinner drug for 5–10 days.

FDA warning

  • This drug has black box warnings. A black box warning is the most serious warning from the Food and Drug Administration (FDA). A black box warning alerts doctors and patients about drug effects that may be dangerous.
  • Decreased effectiveness in people with atrial fibrillation and good kidney function: Your doctor should check how well your kidneys are working before you start taking edoxaban. They’ll do a test called creatinine clearance (CrCl). People with good kidney function (CrCl greater than 95 mL/min) who have nonvalvular atrial fibrillation shouldn’t take this drug, because it may not work well to prevent a stroke.
  • Warning for stopping treatment early: Don’t stop taking edoxaban without talking to your doctor first. Stopping this drug before your treatment is done will increase your risk of blood clots, which raises your risk of stroke. Your doctor may have you stop taking this drug for a short time before a surgery or a medical or dental procedure. Your doctor will tell you when to start taking edoxaban again. If you have to stop taking edoxaban, your doctor may prescribe another drug to help prevent blood clots.
  • Spinal or epidural blood clots (hematoma) risk: Certain people who take edoxaban are at risk of forming a dangerous blood clot. This blood clot can cause long-term or permanent paralysis (loss of your ability to move). You’re at risk of a blood clot if you have a thin tube called an epidural catheter placed in your back to give you medication. You’re also at risk if you take nonsteroidal anti-inflammatory drugs (NSAIDs) or another medication to prevent blood from clotting, if you have a history of epidural or spinal punctures or problems with your spine, or if you’ve had spinal surgery.
  • If you have any of these risk factors, your doctor should watch you closely for symptoms of spinal or epidural blood clots. Tell your doctor right away if you have back pain or tingling or numbness in your legs and feet. Also call your doctor if you have incontinence (loss of control of your bowels or bladder) or muscle weakness, especially in your legs and feet.

Other warnings

  • Serious bleeding risk warning: Edoxaban can cause serious bleeding that can sometimes be fatal. This is because edoxaban is a blood thinner drug that reduces blood clotting. While taking this drug, you may bruise more easily and bleeding may take longer to stop. Call your doctor or go to the emergency room right away if you have any of these symptoms of serious bleeding:
    • unexpected bleeding or bleeding that lasts a long time, such as:
      • frequent nose bleeds
      • unusual bleeding from your gums
      • menstrual bleeding that’s heavier than normal
    • bleeding that is severe or that you can’t control
    • red-, pink-, or brown-colored urine
    • bright red- or black-colored stools that look like tar
    • coughing up blood or blood clots
    • vomiting blood, or vomit that looks like coffee grounds
    • headaches, dizziness, or weakness

You may have a higher risk of bleeding if you take edoxaban and take other drugs that increase your risk of bleeding, including:

  • aspirin or products that contain aspirin
  • nonsteroidal anti-inflammatory drugs (NSAIDs) used long-term
  • other blood thinner drugs used long-term, such as:
    • warfarin sodium (Coumadin, Jantoven)
    • any drugs that contains heparin
    • other drugs to prevent or treat blood clots
  • selective serotonin reuptake inhibitors or serotonin norepinephrine reuptake inhibitors commonly used for depression

Tell your doctor if you take any of these medicines.

  • Heart valve/mitral stenosis warning: If you have a mechanical heart valve or moderate to severe narrowing (stenosis) of your mitral valve, you shouldn’t use edoxaban. It isn’t known if edoxaban will work or be safe for you.

    • Edoxaban is a prescription drug. It comes as an oral tablet.

    Edoxaban is only available as the brand-name drug Savaysa.

    Why it’s used

    Edoxaban is used to reduce the risk of stroke and blood clots in people with nonvalvular atrial fibrillation. This type of irregular heartbeat is not caused by a heart valve problem.

    Edoxaban is also used to treat deep vein thrombosis (blood clots in the veins of your legs) or pulmonary embolism (blood clots in your lungs) after you’ve been treated with an injectable blood thinner medication for 5–10 days.

    How it works

    Edoxaban belongs to a class of drugs called anticoagulants, specifically factor Xa inhibitors (blockers). A class of drugs is a group of medications that work in a similar way. These drugs are often used to treat similar conditions.

    Edoxaban helps prevent blood clots from forming by blocking the substance factor Xa. This is a blood clotting factor that’s needed for your blood to clot. When a drug like edoxaban blocks factor Xa, it decreases the amount of an enzyme called thrombin. Thrombin is a substance in your blood that’s needed to form clots. Thrombin also makes platelets in your blood stick together, causing clots to form. When thrombin is decreased, this prevents a clot (thrombus) from forming in your body.

    With atrial fibrillation, part of the heart doesn’t beat the way it should. This may lead to blood clots forming in your heart. These clots can travel to your brain, causing a stroke, or to other parts of the body. Edoxaban is a blood thinner that decreases your chance of having a stroke by helping to prevent clots from forming.

    Edoxaban oral tablet can cause certain side effects.

    More common side effects

    The most common side effects that occur with edoxaban include:

    • bleeding that takes longer to stop
    • bruising more easily
    • skin rash
    • reduced liver function
    • low red blood cell count (anemia). Symptoms may include:
      • shortness of breath
      • feeling very tired
      • confusion
      • fast heart rate and palpitations
      • pale skin
      • trouble concentrating
      • headache
      • chest pain
      • cold hands and feet

    If these effects are mild, they may go away within a few days or a couple of weeks. If they’re more severe or don’t go away, talk to your doctor or pharmacist.

    Serious side effects

    Call your doctor right away if you have serious side effects. Call 911 if your symptoms feel life threatening or if you think you’re having a medical emergency. Serious side effects and their symptoms can include the following:

    • Serious bleeding: Symptoms can include:
      • unexpected bleeding or bleeding that lasts a long time, such as:
        • frequent nose bleeds
        • unusual bleeding from your gums
        • menstrual bleeding that’s heavier than normal
      • bleeding that’s severe or that you can’t control
      • red, pink, or brown-colored urine
      • bright red or black-colored stools that look like tar
      • coughing up blood or blood clots
      • vomiting blood or vomit that looks like coffee grounds
      • headaches, dizziness, or weakness
    • Spinal or epidural blood clots (hematoma). If you take this drug and also receive spinal anesthesia or have a spinal puncture, you’re at risk for spinal or epidural blood clots that may cause paralysis. Symptoms can include:
      • back pain
      • tingling or numbness in your legs and feet
      • muscle weakness, especially in your legs and feet
      • loss of control of your bowels or bladder (incontinence)

    Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs affect each person differently, we can not guarantee that this information includes all possible side effects. This information is not a substitute for medical advice. Always discuss possible side effects with a healthcare provider who knows your medical history.

    Edoxaban oral tablet can interact with other medications, vitamins, or herbs you may be taking. An interaction is when a substance changes the way a drug works. This can be harmful or prevent the drug from working well.

    To help avoid interactions, your doctor should manage all of your medications carefully. Be sure to tell your doctor about all medications, vitamins, or herbs you’re taking. To find out how this drug might interact with something else you’re taking, talk to your doctor or pharmacist.

    Examples of drugs that can cause interactions with edoxaban are listed below.

    Non-steroidal anti-inflammatory drugs (NSAIDs)

    Taking NSAIDs with this drug may increase your risk of bleeding. Use caution when taking these drugs with edoxaban. Examples of these drugs include:

    Aspirin

    Taking aspirin with this drug may increase your risk of bleeding. Use caution when taking aspirin with edoxaban.

    Antiplatelet drugs

    Taking antiplatelet drugs with this drug may increase your risk of bleeding. Use caution when taking these drugs with edoxaban. Examples of these drugs include:

    Blood thinners

    Don’t take edoxaban with other blood thinners long-term. It increases your chance of bleeding. It may be OK to use these medications together briefly when you’re switching from one to another. Examples of these drugs include:

    • warfarin (Coumadin, Jantoven)
    • heparin

    Drugs that affect how your body processes edoxaban

    Don’t take edoxaban with rifampin. It reduces the levels of edoxaban in your blood. This makes it less effective.

    Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs interact differently in each person, we can not guarantee that this information includes all possible interactions. This information is not a substitute for medical advice. Always speak with your healthcare provider about possible interactions with all prescription drugs, vitamins, herbs and supplements, and over-the-counter drugs that you are taking.

    This drug comes with several warnings.

    Warnings for people with certain health conditions

    For people with bleeding problems: If you currently have abnormal bleeding, you shouldn’t take edoxaban. Edoxaban is a blood thinner and may increase your risk for serious bleeding. Talk to your doctor if you have unusual bleeding, such as frequent nose bleeds, unusual bleeding from your gums, bleeding that’s severe or that you can’t control, coughing up blood or blood clots, or vomiting blood.

    For people with liver problems: If you have liver problems, you may be prone to bleeding problems. Taking edoxaban may increase this risk even more. Edoxaban is not recommended in people with moderate to severe liver problems. Your doctor will do a blood test to see how well your liver is working and decide if this drug is safe for you to take.

    For people with kidney problems: You may not be able to take edoxaban or your doctor may give you a lower dose depending on how well your kidneys are working. If your kidneys aren’t working properly, your body won’t be able to clear out the drug as well. This causes more of the drug to stay in your body, which may increase your risk for bleeding.

    For people with mechanical heart valves: If you have a mechanical heart valve, don’t use edoxaban. It isn’t known if edoxaban will work or be safe for you to take.

    For people with moderate to severe mitral stenosis: If you have moderate to severe narrowing (stenosis) of your mitral valve, don’t use edoxaban. It isn’t known if edoxaban will work or be safe for you to take.

    For people with antiphospholipid syndrome (APS): If you have APS and a history of blood clots, do not take edoxaban. This drug may increase your risk of developing reoccurring blood clots. Your risk may be increased if you are positive for all three antiphospholipid antibodies (lupus anticoagulant, anticardiolipin, and anti-beta 2-glycoprotein I).

    Warnings for other groups

    For pregnant women: Edoxaban is a category C pregnancy drug. That means two things:

    1. Research in animals has shown adverse effects to the fetus when the mother takes the drug.
    2. There haven’t been enough studies done in humans to be certain how the drug might affect the fetus.

    Tell your doctor if you’re pregnant or plan to become pregnant. Edoxaban should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

    For women who are breastfeeding: It isn’t known if edoxaban passes through breast milk. If it does, it may cause serious effects in a breastfeeding child. You and your doctor may need to decide if you’ll take edoxaban or breastfeed.

    For children: The safety and effectiveness of edoxaban haven’t been established in people younger than 18 years old.

    When to call the doctor

    • Call your doctor right away if you fall or hurt yourself while taking this drug, especially if you hit your head. Your doctor may need to check you for possible bleeding that might be happening inside your body.

    All possible dosages and forms may not be included here. Your dose, form, and how often you take it will depend on:

    • your age
    • the condition being treated
    • how severe your condition is
    • other medical conditions you have
    • how you react to the first dose

    Drug form and strength

    Brand: Savaysa

    • Form: oral tablet
    • Strengths: 15 mg, 30 mg, and 60 mg

    Dosage to reduce the risk of stroke and blood clots in people with nonvalvular atrial fibrillation

    Adult dosage (ages 18 years and older)

    • CrCl greater than 95 mL/min: You shouldn’t use edoxaban.
    • CrCl between 51–95 mL/min: The recommended dose is 60 mg taken once per day.
    • CrCl between 15–50 mL/min: The recommended dose is 30 mg taken once per day.
    • CrCl less than 15 mL/min: This drug isn’t recommended.

    Child dosage (ages 0–17 years)

    This medication has not been studied in children and shouldn’t be used in people under the age of 18 years.

    Dosage to treat deep vein thrombosis or pulmonary embolism after treatment with an injectable blood thinner for 5–10 days

    Adult dosage (ages 18 years and older)

    • The recommended dose is 60 mg taken once per day.
    • The recommended dose is 30 mg taken once per day if you meet any of these criteria:
      • CrCl between 15–50 mL/min
      • You weigh 132 lbs. (60 kg) or less
      • You are also on P-gp inhibitor medications, such as:
        • verapamil
        • quinidine
        • azithromycin
        • clarithromycin
        • erythromycin
        • oral itraconazole
        • oral ketoconazole
    • CrCl less than 15 mL/min: This drug isn’t recommended.

    Child dosage (ages 0–17 years)

    This drug has not been studied in children and shouldn’t be used in people under the age of 18 years.

    Special dosage considerations

    • For people with kidney problems: If your kidneys aren’t working properly, your body won’t be able to clear out the drug as well. This causes more of the drug to stay in your body. This may increase your risk for bleeding. Your doctor will do a blood test to check how well your kidneys are working before starting you on this drug. If your kidneys aren’t working well, you may be started on a lower dose of edoxaban.

    For people with liver problems: If you have liver problems, you may be prone to bleeding problems. Edoxaban may increase your risk even more. This drug isn’t recommended in people with moderate or severe liver problems. Your doctor will do a blood test to check how well your liver is working and decide if this drug is safe for you to take.

    Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs affect each person differently, we can not guarantee that this list includes all possible dosages. This information is not a substitute for medical advice. Always speak with your doctor or pharmacist about dosages that are right for you.

    Before you have surgery

    • If you plan to have surgery or a medical or a dental procedure, tell your doctor or dentist that you’re taking edoxaban. You may have to stop taking it for a short time. Ask your doctor who prescribed edoxaban how to stop taking the drug and when to start taking it again. Your doctor may prescribe another medication to help prevent blood clots from forming.

    Edoxaban can be used for short-term or long-term treatment. It comes with serious risks if you don’t take it as prescribed.

    If you skip or miss doses: Don’t stop taking edoxaban without talking to your doctor first. If you stop taking this drug, miss doses, or don’t take it on schedule, it may increase your risk of blood clots or stroke. Make sure to refill your prescription of this drug before you run out.

    Don’t take more than one dose of edoxaban at a time to make up for the missed dose. This could result in dangerous side effects, including bleeding.

    If you take too much: If you take more than your prescribed dose of edoxaban, you have a greater risk of bleeding, which can be fatal. If you think that you’ve taken too much edoxaban, call your doctor or go to the emergency room right away.

    What to do if you miss a dose: If you forget to take your dose, take it as soon as you remember on the same day. Then take your next dose at your usual time the next day.

    How to tell if the drug is working:

    • If you’re being treated for a blood clot in your leg, your swelling, pain, warmth, and redness may improve.
    • If you’re being treated for a blood clot in your lungs, your shortness of breath and chest pain when breathing should get better.

    Keep these considerations in mind if your doctor prescribes edoxaban for you.

    General

    • Edoxaban can be taken with or without food.
    • If you have trouble swallowing tablets, you can crush the tablet and mix it in applesauce. Be sure to consume all of the applesauce right away.

    Storage

    • Store edoxaban at room temperature between 68°F and 77°F (20°C and 25°C).
    • Don’t freeze this drug.
    • Keep it away from light.
    • Don’t store this medication in moist or damp areas, such as bathrooms.

    Refills

    A prescription for this medication is refillable. You should not need a new prescription for this medication to be refilled. Your doctor will write the number of refills authorized on your prescription.

    Travel

    When traveling with your medication:

    • Always carry your medication with you. When flying, never put it into a checked bag. Keep it in your carry-on bag.
    • Don’t worry about airport X-ray machines. They won’t damage your medication.
    • You may need to show airport staff the pharmacy label for your medication. Always carry the original prescription-labeled box with you.
    • Don’t put this medication in your car’s glove compartment or leave it in the car. Be sure to avoid doing this when the weather is very hot or very cold.

    Clinical monitoring

    During your treatment with this drug, your doctor may check your:

    • symptoms of bleeding. If you have signs of bleeding, your doctor may do tests to see if you’re actively bleeding.
    • kidney function. If your kidneys aren’t working properly, your body won’t be able to clear out this drug as well. This causes more of the drug to stay in your body, which may increase your risk for bleeding. Your doctor will do a blood test to check how well your kidneys are working. This test will help your doctor decide if your dose of edoxaban needs to be decreased or if you should stop taking the drug.
    • liver function. If you have liver problems, you may be prone to bleeding problems. Edoxaban may increase your risk even more. This drug isn’t recommended in people with moderate or severe liver problems. Your doctor will do a blood test to see how well your liver is working and decide if edoxaban is safe for you to take. Your liver will also be checked during treatment.

    Availability

    Not every pharmacy stocks this drug. When filling your prescription, be sure to call ahead to make sure they carry it.

    Prior authorization

    Many insurance companies require a prior authorization for this drug. This means your doctor will need to get approval from your insurance company before your insurance company will pay for the prescription.

    There are other drugs available to treat your condition. Some may be better suited for you than others. Talk to your doctor about other drug options that may work for you.

    Disclaimer: Healthline has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or other healthcare professional before taking any medication. The drug information contained here in is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.