dabigatran

What is the most important information I should know about dabigatran?

Some drugs can increase your risk of bleeding when used with dabigatran. Tell your doctor about all other medicines you use.

What is dabigatran?

Dabigatran is used to treat blood clots deep in the body (deep vein thrombosis, DVT) and lungs (pulmonary embolism, PE) in adults who have received blood thinners by injection for 5 to 10 days.

Dabigatran is used to treat blood clots in children aged 3 months to less than 18 years of age who have been treated with an injectable blood thinner for at least 5 days.

Dabigatran is used in adults and children aged 3 months to less than 18 years of age to lower the risk of a blood clot coming back after receiving treatment for blood clots.

Dabigatran is also used after hip replacement surgery to prevent a blood clot deep in the body (deep vein thrombosis, DVT) or lungs (pulmonary embolism, PE).

Dabigatran is also used to lower the risk of stroke and blood clots in adults with atrial fibrillation (a heart rhythm disorder). This medicine is used when the atrial fibrillation is not caused by a heart valve problem.

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

What should I discuss with my healthcare provider before taking dabigatran?

• a mechanical prosthetic heart valve; or
• active bleeding from a surgery, injury, or other cause.

Dabigatran 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 have ever had:

• a genetic spinal defect;
• a thin tube (catheter) placed in your back to give you certain medicine;
• a history of problems with your spine or a spinal surgery;
• a history of difficult or repeated spinal taps;
• bleeding problems;
• a stomach ulcer or bleeding in your stomach or intestines;
• take certain other medicines that can increase bleeding risk;
• antiphospholipid syndrome, an immune system disorder that increases the risk of blood clots;
• plan for surgery, or a medical or a dental procedure; or
• kidney disease.

It is not known if dabigatran will harm an unborn baby. Taking dabigatran during pregnancy may cause bleeding in the mother or the unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

How should I take dabigatran?

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.

Doses are based on weight in children and teenagers. Your child's dose may change if the child gains or loses weight.

Give dabigatran oral pellets before a meal to make sure your child takes the full dose.

You may also mix the pellets with apple juice or soft food (apple sauce or apple juice, mashed carrots, or mashed bananas) at room temperature. Do not mix oral pellets with any other food, milk, milk products or any other liquid.

Mixed medicine should be used right away or within 30 minutes after mixing. Do not give this medicine using a syringe or through a feeding tube.

Your kidney function may need to be checked often.

Tell any doctor who treats you that you are taking dabigatran. If you need surgery or dental work, tell the surgeon or dentist ahead of time that you are taking this medication. If you need anesthesia for a medical procedure or surgery, you may need to stop taking dabigatran for a short time.

If your child does not take all of the dabigatran oral pellets, do not give another dose at that time and go back to the regular schedule.

Do not open more than one bottle of dabigatran capsules at a time. Only open a new bottle after all the capsules in the previous bottle are gone.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if your next dose is due in less than 6 hours. Do not use two doses at one time.

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

What happens if I overdose?

An overdose may cause excessive bleeding.

What should I avoid while taking dabigatran?

What are the possible side effects of dabigatran?

• bruising or bleeding that will not stop (nosebleeds, bleeding gums, heavy menstrual or vaginal bleeding);
• headache, weakness, dizziness, or feeling like you might pass out;
• bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
• urine that looks red, pink, or brown; or
• unexpected pain, joint pain or swelling.

Common side effects may include:

• stomach pain or discomfort;
• upset stomach, burning;
• bleeding;
• heavy menstrual bleeding; or
• nausea, vomiting, diarrhea.

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.

What other drugs will affect dabigatran?

Tell your doctor about all your current medicines. Many drugs can affect dabigatran, especially:

• dronedarone;
• rifampin;
• ketoconazole;
• medicine used to prevent blood clots --enoxaparin, warfarin, heparin, clopidogrel, dipyridamole, prasugrel, and others; or
• NSAIDs (nonsteroidal anti-inflammatory drugs) --aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others.

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

Where can I get more information?

Your doctor or pharmacist can provide more information about dabigatran.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2023 Cerner Multum, Inc. Version: 16.02. Revision date: 6/12/2023.