Dabigatran Side Effects

Medically reviewed by Drugs.com. Last updated on Sep 15, 2024.

Applies to dabigatran: oral capsule, oral packet.

Precautions

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to decide if you should continue to take it. Blood tests may be needed to check for unwanted effects.

It is important to tell your doctor if you are pregnant or planning to become pregnant before using this medicine. Using this medicine while you are pregnant may increase the risk of severe bleeding from your uterus.

Make sure any doctor who treats you knows that you are using this medicine. You may need to stop using this medicine for several days before having surgery, including dental procedures.

You may bleed and bruise more easily while you are using this medicine. Be extra careful to avoid injuries. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Gently brush and floss your teeth. Be careful when using sharp objects, including razors and fingernail clippers. Avoid picking your nose. If you need to blow your nose, blow it gently.

Check with your doctor right away if you have any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, headache, dizziness, or weakness, pain, swelling, or discomfort in a joint, pinpoint red spots on your skin, unusual nosebleeds, or unusual vaginal bleeding that is heavier than normal. These may be signs of bleeding problems.

Do not suddenly stop using this medicine without asking first your doctor. Doing so may increase risk of blood clots and stroke.

This medicine may increase your risk of developing spinal or epidural blood clot. This usually occurs if you have an epidural catheter placed in your back to give you certain medicine, are taking NSAIDs or medicine to prevent blood clotting, or have a history of spinal problems or have had surgery on your spine. Check with your doctor if you have midline back pain, loss of bladder or bowel control, or numbness, tingling, or weakness of your legs or feet while you are using this medicine.

Check with your doctor right away if you have stomach pain or upset, nausea, heartburn, or indigestion while you are taking this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Serious side effects of dabigatran

Along with its needed effects, dabigatran may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking dabigatran:

Other side effects of dabigatran

Some side effects of dabigatran may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

For healthcare professionals

Applies to dabigatran: oral capsule, oral granule.

General adverse events

Bleeding is the most serious side effect reported with dabigatran. Major or severe bleeding may occur and, regardless of location, may lead to disabling, life-threatening or even fatal outcomes.^[Ref]

Cardiovascular

• Very common (10% or more): Bleeding up to 16.5%
• Uncommon (0.1% to 1%): Hematoma, hemorrhage^[Ref]

Major bleeds have occurred in critical areas or organs such as, intraocular, intracranial, intraspinal or intramuscular with compartment syndrome, retroperitoneal, intra-articular, or pericardial.^[Ref]

Gastrointestinal

• Very common (10% or more): Dyspepsia: upper abdominal pain, abdominal discomfort, epigastric discomfort; gastritis like symptoms, esophagitis, erosive gastritis, gastric hemorrhage, hemorrhagic gastritis, hemorrhagic erosive gastritis, and gastrointestinal ulcer
• Common (1% to 10%): Diarrhea, nausea
• Uncommon (0.1% to 1%): rectal hemorrhage, hemorrhoidal hemorrhage, vomiting, dysphagia
• Postmarketing reports: Esophageal ulcer^[Ref]

Dermatologic

• Common (1% to 10%): Skin hemorrhage
• Postmarketing reports: Angioedema, alopecia^[Ref]

Hematologic

• Common (1% to 10%): Anemia
• Uncommon (0.1% to 1%): Hemoglobin decreased, thrombocytopenia, occult blood positive
• Rare (less than 0.1%): Hematocrit decreased
• Postmarketing reports: Agranulocytosis, neutropenia^[Ref]

Other

• Common (1% to 10%): Wound secretion (5%)
• Rare (less than 0.1%): Traumatic hemorrhage^[Ref]

Renal

• Common (1% to 10%): Urogenital hemorrhage (including hematuria 1.2%)
• Uncommon (0.1% to 1%): Positive blood urine tests^[Ref]

Respiratory

• Common (1% to 10%): Epistaxis (0.6% to 0.7%)
• Uncommon (0.1% to 1%): Hemoptysis^[Ref]

Hepatic

• Uncommon (0.1% to 1%): Abnormal hepatic function/liver function test, ALT increased, AST increased, hepatic enzyme increased
• Rare (less than 0.1%): Hyperbilirubinemia, transaminases increased^[Ref]

Hypersensitivity

• Uncommon (0.1% to 1%): Urticaria, rash, pruritus, allergic edema, anaphylactic reaction, anaphylactic shock
• Frequency not reported: Bronchospasm^[Ref]

Musculoskeletal

• Uncommon (0.1% to 1%): Hemarthrosis^[Ref]

Nervous system

• Uncommon (0.1% to 1%): Intracranial hemorrhage
• Frequency not reported: Intracerebral hemorrhage (Hemorrhagic stroke), subarachnoid and subdural bleeds^[Ref]

Local

• Rare (less than 0.1%): Injection site hemorrhage, catheter site hemorrhage, incision site hemorrhage^[Ref]

See also:

Further information

Dabigatran side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer