Lixiana (Edoxaban)

Edoxaban 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)

Edoxaban may interact with other medications

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:

• diclofenac
• etodolac
• fenoprofen
• flurbiprofen
• ibuprofen
• indomethacin

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:

• clopidogrel

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 

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.

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:

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.

How and when to take it

• It's important to take edoxaban as your doctor advises.
• You'll usually take it once a day. Try to take it at the same time every day.

How much to take

The usual dose of edoxaban is 60mg a day. Your doctor may prescribe 30mg a day if you:

• have kidney disease
• have a low body weight
• are taking ciclosporin (to treat psoriasis and rheumatoid arthritis)
• are taking dronedarone (to treat atrial fibrillation)
• are taking erythromycin or ketoconazole (to treat fungal or bacterial infections)

If you're unsure what dose you need to take, check with your pharmacist or doctor.

What if I forget to take it?

Take your tablet as soon as you remember. If you only remember the following day, leave out the forgotten dose. Take your next dose at the usual time, and then carry on as normal.
Never take more than 1 dose in a single day.

How long to take it for

• How long you need to take edoxaban will depend on why you are taking it.
• If you've had a blood clot (DVT or pulmonary embolism) you'll normally take edoxaban for at least 3 months. Depending on what caused the blood clot, you might need to take it for longer.
• If you have atrial fibrillation you might need to take edoxaban long term or even for the rest of your life.

Important considerations for taking edoxaban

• Edoxaban can be taken with or without food.
• If you or your child has 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.

References:

https://www.ema.europa.eu/en/documents/product-information/lixiana-epar-product-information_en.pdf

https://www.medicines.org.uk/emc/product/6905/smpc

https://www.hpra.ie/docs/default-source/3rd-party-documents/educational-materials/lixiana_hcp_prescriber-guide_v1-09-15.pdf?sfvrsn=2

https://www.nhs.uk/medicines/edoxaban/

https://www.ema.europa.eu/en/documents/overview/lixiana-epar-summary-public_en.pdf

https://www.healthline.com/health/edoxaban-oral-tablet#important-considerations

https://www.sps.nhs.uk/wp-content/uploads/2015/08/Edoxaban-aphasia-60mg-17-07-2017.pdf