Background: The concomitant administration of opioids and non-steroidal anti-inflammatory drugs is used to manage pain in clinical practice, given their synergistic analgesic effect. Among their possible combinations, tramadol and celecoxib are routinely used. The aim of this study was to explore the safety profile of tramadol and celecoxib administered individually compared to their concomitant administration in clinical practice.
Methods: Retrospective analysis of adverse-drug-reactions from the safety database Vigibase, The WHO global individual case safety report database system.A case was defined as an adverse-drug-reaction included in a report of Vigibase between January 2000 and March 2012. Three groups were studied: ‘tramadol-no-celecoxib’ (tramadol was only reported as suspected or interacting drug), ‘celecoxib-no-tramadol’ (celecoxib was only reported as suspected or interacting drug) and ‘celecoxib+tramadol’ (both drugs co-administered and reported as suspected or interacting drug). MedDRA dictionary was used to code adverse-drug-reactions. Reporting proportions were calculated as the number of adverse-drugreactions of a given type divided by the overall total number of reported adverse-drug-reaction in each drug-group.