Objective: To identify the risks in automated dispensing cabinet use in order to improve routine procedure safety. Methods: We used the Failure Mode Effect Analysis (FMEA) methodology. A multidisciplinary team identified potential failure modes of the procedure through a brainstorming session. We assessed the impact associated with each failure mode with the Risk Priority Number (RPN), which involves three variables: occurrence, severity, and detectability. Improvement measures were established for failure modes with RPN > 100 considered critical. The final RPN (theoretical) that would result from the proposed measures was also calculated. Results: The process was divided into five sub-processes: automatic delivery of order replacement, to prepare order in a pyramidal cart, transport of the pyramidal cart from the pharmacy service to the automated dispensing cabinet, replacement of the automated dispensing cabinet by the pharmacy technician and dispensing/returning by nursing staff. Twenty-two failure modes, with 25 cases and with varying effects (severity 2-8) were evaluated. The sub-process with more failure modes with NPR > 100 was dispensing/returning by nursing staff. Conclusions: The FMEA methodology was a useful tool when applied to automated dispensing cabinet system use. The implementation of improvement actions significantly reduced the risk. (C) 2020 FECA. Published by Elsevier Espana, S.L.U. All rights reserved.