Note: This document contains side effect information about dabigatran. Some dosage forms listed on this page may not apply to the brand name Pradaxa.
Applies to dabigatran: oral capsule, oral packet.
Warning
Oral route (Capsule; Pellet)
Premature Discontinuation Increases The Risk Of Thrombotic EventsPremature discontinuation of any oral anticoagulant, including dabigatran etexilate, increases the risk of thrombotic events. If anticoagulation with dabigatran etexilate is discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant.Spinal/Epidural HematomaEpidural or spinal hematomas may occur in patients treated with dabigatran etexilate who are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. Consider these risks when scheduling patients for spinal procedures. Factors that can increase the risk of developing epidural or spinal hematomas in these patients include: use of indwelling epidural catheters; concomitant use of other drugs that affect hemostasis, such as NSAIDs, platelet inhibitors, other anticoagulants; a history of traumatic or repeated epidural or spinal punctures; a history of spinal deformity or spinal surgery; optimal timing between administration of dabigatran etexilate and neuraxial procedures is not known. Monitor patients frequently for signs and symptoms of neurological impairment. If neurological compromise is noted, urgent treatment is necessary. Consider the risks and benefits before neuraxial intervention in patients anticoagulated or to be anticoagulated.
Serious side effects of Pradaxa
Along with its needed effects, dabigatran (the active ingredient contained in Pradaxa) 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:
More common
- Acid or sour stomach
- belching
- black, tarry stools
- bloody stools
- constipation
- diarrhea
- heartburn
- indigestion
- nausea
- pain or burning in the throat
- stomach discomfort, upset, burning, or pain
- vomiting
- vomiting of blood or material that looks like coffee grounds
Rare
- Chest pain, discomfort, or tightness
- cough
- difficulty with swallowing
- dizziness
- fainting or loss of consciousness
- fast or irregular breathing
- pain or discomfort in the arms, jaw, back, or neck
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- redness of the skin
- skin rash, hives, welts, or itching skin
- sweating
- trouble breathing
- unusual tiredness or weakness
Incidence not known
- Bleeding gums
- blood in the urine
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- pinpoint red spots on the skin
- unusual bleeding or bruising
Other side effects of Pradaxa
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:
Incidence not known
- Hair loss or thinning of the hair
For Healthcare Professionals
Applies to dabigatran: oral capsule, oral granule.
General
Bleeding is the most serious side effect reported with dabigatran (the active ingredient contained in Pradaxa) Major or severe bleeding may occur and, regardless of location, may lead to disabling, life-threatening or even fatal outcomes.[Ref]
Cardiovascular
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]
Very common (10% or more): Bleeding up to 16.5%
Uncommon (0.1% to 1%): Hematoma, hemorrhage[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]
