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Article History

Received: 28 August 2024

Accepted: 14 October 2025

First Online: 11 December 2025

Declarations

:

: The authors have no competing interests to declare that are relevant to the content of this article.

: Not applicable because spontaneous reports of FAERS are anonymous and publicly available.

: Not applicable because spontaneous reports of FAERS are anonymous and publicly available.

: The data that support the findings of this study are publicly available in their raw form at , and in their clean version through DiAna. An open-access toolkit for DIsproportionality ANAlysis and other pharmacovigilance investigations in FAERS ( ).

: The script, using functions from the DiAna and PVdagger R packages, is made available as supplementary material, and as a tutorial at the website of the DiAna package ( ).

: MF, RF conceptualised and designed the study. The formal analyses and visualisation were performed by MF. MF, RF wrote the original draft. MF, JM, AR, ER, RF strongly contributed to the systematisation of the framework, and to the review and editing of the draft. MF, JM, AR, ER, RF read and approved the final version. MF was the creator of the related Pvdagger R package.

: We followed the checklist from the READUS-PV guidelines [ , ] as much as applicable, taking into account that this is a methodological study, using several drug-event combinations as examples.