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Article History

Received: 10 October 2025

Accepted: 3 March 2026

First Online: 21 March 2026

Declarations

:

: JKA has written papers on adverse drug reactions in peer-reviewed journals and has received royalties from textbooks that he has edited or co-edited; he has often acted as an expert witness in cases involving adverse drug reactions, most often in coroners’ courts. DS has communicated signals of adverse drug reactions, some of which may have also been included in product information of one or more countries. GNN is an Editorial Board member of Drug Safety ; GNN was not involved in the selection of peer reviewers for the manuscript nor any of the subsequent editorial decisions. MF and IJO have no relevant competing interests.

: The views expressed are those of the authors and not necessarily those of the Uppsala Monitoring Centre or the University of Oxford.

: The original research data are part of the electronic supplementary materials. The product information documents we retrieved are available on request.

: The R code is publicly available at .

: DS conceptualized and designed the study with support from IJO, JKA, and GNN. MF joined the research team after registration of the protocol on MedrXiv, took part in cross-validation of scores, designed the scripts for data analysis, and provided suggestions on data presentation and analysis. DS wrote the manuscript with support from all co-authors, who also reviewed and approved drafts and the final version.

: This research did not involve human participants, tissues, and/or personal data. As such, ethics approval was not required.

: Not applicable.

: Not applicable.