Edoxaban Oral Tablet

• 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: People who take edoxaban and have another drug injected into their spinal and epidural area, or have a spinal puncture, have a risk of forming a dangerous blood clot. This blood clot can cause long-term or permanent loss of your ability to move (paralysis). Your risk is higher if:
  • a thin tube called an epidural catheter is placed into your back to give you a medication.
  • you take nonsteroidal anti-inflammatory drugs (NSAIDs) or another medication to prevent blood from clotting.
  • you have a history of epidural or spinal punctures.
  • you have a history of problems with your spine or have had surgery on your spine.

  If you take edoxaban and receive spinal anesthesia or have a spinal puncture, your doctor should watch you closely for symptoms of spinal or epidural blood clots. Tell your doctor right away if you have these symptoms:

  • back pain
  • tingling or numbness in your legs and feet
  • muscle weakness, especially in your legs and feet
  • loss of control of the bowels or bladder (incontinence)

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 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.

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.

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.

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

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.
• 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.

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.