OBJECTIVES:  Dabigatran is indicated to reduce stroke/ systemic embolism risk in patients with non-valvular atrial fibrillation (AFIB).  Post approval, there has been much focus on dabigatran safety. Thus, we evaluated dabigatran real world use and safety in the United States in the context of approved labeling relating to safety. METHODS: A retrospective evaluation was conducted of de-identified, pharmacy/medical claims in patients with a new dabigatran prescription claim during 11/2010-08/2011 and continuous eligibility of 12 months prior and 4-months after initiation of treatment. Demographic/clinical characteristics of patients, prescriber specialty, and adoption of approved labeling recommendations (renal function testing, drug interactions, and dosage recommendations) were assessed. RESULTS: A total of 1,424 patients, mostly males (61.5%), 73±11 years old, received a dabigatran dose of 150mg BID (93.8%), prescribed primarily by a cardiologist (60.7%).  In regards to label guidance, 1090 (77%) patients had a claims history for AFIB, 19.2% were exposed to medications that increase the serum concentration of dabigatran, and 20.2% were exposed to medications listed as inhibitors of dabigatran metabolism. Renal function assessment within the prior year was evident in 22.8% of patients (11.3% in pts >75 years old), and over 4 months of f/u in 12.3% (6.1% in pts >75 years old). Additionally, only 48.8% of patients with a creatinine clearance <30 mL/min received 75 mg BID. CONCLUSIONS: Despite specific dabigatran labeling recommendations, a high percentage of prescribers are not following the guidance for: indications; dosage adjustment for interacting drugs, renal function, or age; or, renal function monitoring, which may adversely affect stroke or bleeding outcomes. Ongoing review and action on dabigatran prescribing and monitoring to optimize safe clinical outcomes in a real world population are needed.