Purpose: The case of a patient who experienced major gynecological bleeding after initiation of dabigatran therapy for atrial fibrillation is reported. Summary: A 33-year-old Hispanic female with multiple medical problems presented to the emergency department (ED) with a 5-day history of menorrhagia and a 3-day history of dizziness, fatigue, and weakness. Prior to ED presentation, she had been initiated on dabigatran 150 mg twice daily for atrial fibrillation. Four days later, she began having profuse vaginal bleeding. She discontinued all of her home medications including dabigatran, and her bleeding subsided the next day. Upon presentation to the ED, her hemoglobin was 7.1 g/dL, for which she was transfused 2 units of packed red blood cells, increasing her hemoglobin to 9.6 g/dL. Because the patient was in atrial fibrillation, warfarin was initiated once she was clinically stable and she was never restarted on dabigatran. Her hemoglobin was stable throughout admission with no further bleeding. She was discharged on warfarin and closely followed without incident. Conclusion: A 33-year-old Hispanic female with no pre-existing gynecologic abnormalities had a major gynecological bleed shortly after starting dabigatran that resolved after discontinuation.Key Words-dabigatran, gynecologic bleed, major hemorrhage Hosp Pharm-2013;48(3):227-230 A trial fibrillation is the most common significant cardiac rhythm disorder. It is estimated that about 12 million people will have atrial fibrillation by the year 2050.1 The incidence of stroke in people with atrial fibrillation increases with the elderly; patients with diabetes, hypertension, and congestive heart failure; and patients with a history of stroke or transient ischemic attacks (TIAs).2 Warfarin had been the only oral anticoagulant for more than 50 years proven effective in preventing ischemic stroke in patients with atrial fibrillation. It has been the standard of care for many years for this purpose. However, warfarin has many disadvantages, including the need for frequent monitoring, the variability of dose response, and drug-drug and drug-food interactions. Thus, the development of newer agents without many of these disadvantages has been the priority of researchers.Dabigatran etexilate is a direct thrombin inhibitor approved by the US Food and Drug Administration (FDA) in 2010 for the prevention of embolic stroke in patients with non-valvular atrial fibrillation.3 Dabigatran inhibits both free and fibrin-bound forms of thrombin, thereby inhibiting thrombin-mediated effects, such as activation of factors V, VII, IX, and X, cleavage of fibrinogen to fibrin, and thrombininduced platelet aggregation. 4,5 As seen in other anticoagulants, dabigatran possesses inherent bleeding risks as shown in large, randomized clinical trials such as the RE-LY and RE-COVER trials. 6,7 However to our knowledge, no published studies or case reports citing specifically major gynecological bleeding exist.Here, we present a case of dabigatran-induced gynecological bleeding and t...