The most commonly reported side effects of dabigatran include gastrointestinal haemorrhage, cerebrovascular accident, and fall, based on 79,395 FDA adverse event reports from 2004 to 2025. 1.7% of reports found the drug to be ineffective.
Percentages show how often each reaction appears relative to total reports for dabigatran.
These are voluntary reports and do not establish that dabigatran caused these reactions.
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Other drugs that appear in adverse event reports alongside dabigatran. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.
Also suspected
Taken alongside
Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.
42.8% of dabigatran adverse event reports involve female patients and 47.1% involve male patients. The largest age group is elderly at 83%. These figures reflect who reports side effects, not underlying risk.
Sex
Age group
Conditions and purposes for which patients were taking dabigatran when the adverse event was reported.
Showing 15 of 716 indications
Dabigatran is sold under the brand name Pradaxa.
An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.
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