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What the label lists and what reports show

Dabigatran side effects

Dabigatran's FDA label: “Most common adverse reactions (> 15%) are gastrointestinal adverse reactions and bleeding ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Boehringer Ingelheim Pharmaceuticals, Inc.” FAERS holds 78,424 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is gastrointestinal haemorrhage (8,341 reports).

  • Generic listed
  • Boxed warning

Check it at the source: the dabigatran FDA label on DailyMed (effective June 25, 2025, Boehringer Ingelheim Pharmaceuticals Inc.); the FDA FAERS public dashboard.

What does the patient leaflet say about side effects?

From the patient leaflet: What are the possible side effects of PRADAXA?

PRADAXA can cause serious side effects. See " What is the most important information I should know about PRADAXA? " Allergic Reactions. Some adults taking PRADAXA Capsules have developed symptoms of an allergic reaction. […]

Source: FDA drug label, Boehringer Ingelheim Pharmaceuticals Inc., effective June 25, 2025 (SPL set ba74e3cd-b06f-4145-b284-5fd6b84ff3c9), via openFDA; the full label on DailyMed

What does the label list?

From the label: adverse reactions

Most common adverse reactions (> 15%) are gastrointestinal adverse reactions and bleeding ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Boehringer Ingelheim Pharmaceuticals, Inc.

Table 3 Adjudicated Major Bleeding Events in Treated Patients a

EventPRADAXA Capsules 150 mg N = 6,059 n (%/year b )Warfarin N = 5,998 n (%/year b )PRADAXA Capsules 150 mg vs Warfarin HR (95% CI)
Major Bleeding c350 (3.47)374 (3.58)0.97 (0.84, 1.12)
Intracranial Hemorrhage (ICH) d23 (0.22)82 (0.77)0.29 (0.18, 0.46)
Hemorrhagic Stroke e6 (0.06)40 (0.37)0.16 (0.07, 0.37)
Other ICH17 (0.17)46 (0.43)0.38 (0.22, 0.67)
Gastrointestinal162 (1.59)111 (1.05)1.51 (1.19, 1.92)
Fatal Bleeding f7 (0.07)16 (0.15)0.45 (0.19, 1.10)
ICH3 (0.03)9 (0.08)0.35 (0.09, 1.28)
Non-intracranial g4 (0.04)7 (0.07)0.59 (0.17, 2.02)

Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.

From the label: adverse reactions, continued

The following clinically significant adverse reactions are described elsewhere in the labeling: Increased Risk of Thrombotic Events after Premature Discontinuation [see Warnings and Precautions (5.1) ] Risk of Bleeding [see Warnings and Precautions (5.2) ] Spinal/Epidural Anesthesia or Puncture [see Warnings and Precautions (5.3) ] Thromboembolic and Bleeding Events in Patients with Prosthetic Heart Valves [see Warnings and Precautions (5.4) ] Increased Risk of Thrombosis in Patients with Triple-Positive Antiphospholipid Syndrome [see Warnings and Precautions (5.6) ] The most serious adverse reactions reported with PRADAXA were related to bleeding [see Warnings and Precautions (5.2) ]. Most common adverse reactions (> 15%) are gastrointestinal adverse reactions and bleeding ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Boehringer Ingelheim Pharmaceuticals, Inc. at (800) 542-6257 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reactions rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. …

Source: FDA drug label, Boehringer Ingelheim Pharmaceuticals Inc., effective June 25, 2025 (SPL set ba74e3cd-b06f-4145-b284-5fd6b84ff3c9), via openFDA; the full label on DailyMed

What do FAERS reports show?

78,424 reports list dabigatran among the medicines taken, each a report of something that happened, not proof the medicine caused it; 11,539 are coded as a death and 40,215 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 20 reactions below, 7 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.

Reports received each year

The 25 most reported reactions

  • Gastrointestinal Haemorrhage (named in the label)8,341
  • Cerebrovascular Accident4,085
  • Fall3,314
  • Haemorrhage (named in the label)3,274
  • Anaemia2,880
  • Dyspnoea2,325
  • Ischaemic Stroke2,303
  • Dizziness2,243
  • Death (an outcome recorded in the report)2,227
  • Rectal Haemorrhage2,140
  • Atrial Fibrillation (a use or a product term, not a reaction)2,056
  • Diarrhoea (named in the label)1,828
  • Asthenia1,803
  • Nausea (named in the label)1,694
  • Fatigue1,661
  • Drug Interaction (a use or a product term, not a reaction)1,642
  • Dyspepsia (named in the label)1,612
  • Off Label Use (a use or a product term, not a reaction)1,565
  • Headache (named in the label)1,556
  • Drug Ineffective (a use or a product term, not a reaction)1,468
  • Cerebral Haemorrhage1,461
  • Melaena1,454
  • Hypotension1,398
  • Coagulopathy1,391
  • Epistaxis (named in the label)1,363

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Dabigatran: the full record
label, generics, price, shortages, recalls
Side effects hub
the most reported medicines and reactions