RESULTS: We appraised 794 suspected ADR (78% related to NOACs). The annual number of ADRs increased overtime with 9 ADRs/million Defined Daily Dose (DDD) at the end of 2014. The incidence of NOACs ADRs decreased from 2012 onwards. VKA showed a disproportion in \'Investigation\' (ROR 0.10, 99%CI 0.05-0.22) and \'Injury, poisoning and procedural complications\' (ROR 0.36, 99%CI 0.19-0.69) ADRs compared with NOACs. NOACs had a higher significant disproportion of \'Nervous system disorders\' related ADRs (ROR 3.98, 99%CI 1.50-10.53).
CONCLUSIONS: Reporting of ADRs associated with oral anticoagulants (mainly NOACs), is increasing. Exploratory disproportion analyses showed an increase of reports of nervous system ADRs with NOACs, and INR-related ADRs with VKA.