Nomenclature on Immune‐Mediated Drug Reactions: An <scp>EAACI</scp> Position Paper
Over the past several decades, there have been significant advances in our understanding of both immunological and pharmacological mechanisms of adverse drug reactions (ADRs). Immune-mediated drug reactions (IMDRs) represent a small proportion of ADRs and are caused by a pathological activation of the immune system or inflammatory pathways. Drugs can act as an antigen or may directly interact with the immune system or inflammatory pathways, making immune-mediated drug reactions observed in contemporary practice not sufficiently explained by the Gell and Coombs (G&C) framework. Moreover, the phenotype alone is neither pathognomonic nor sufficient to infer the endotype. The proposed nomenclature integrates chrono-morphological phenotypes, mechanistic endotypes and characteristics of the involved drug. In this nomenclature, IMDRs are classified, according to the nature of interaction with the immune system, in: (i) drug allergy that encompasses antigen-driven reactions-diagnosed by tests detecting sensitisation-and (ii) drug hypersensitivity that includes the heterogeneous broad group of drug-directly-driven reactions. This framework supports precision medicine, aligns terminology with mechanisms, and provides a common language for interdisciplinary communication, pharmacovigilance, and drug development. It accommodates emerging therapeutic classes and remains adaptable to future discoveries in immunopathogenesis and biomarker development.
Authors
- Mariana Castells
- Gülfem Çelík (ORCID: https://orcid.org/0000-0001-8654-513X)
- Francesca Mori (ORCID: https://orcid.org/0000-0001-7483-0128)
- Ingrid Terreehorst (ORCID: https://orcid.org/0000-0002-3264-2740)
- Philip Hei Li (ORCID: https://orcid.org/0000-0002-9155-9162)
- Knut Brockow (ORCID: https://orcid.org/0000-0002-2775-3681)
- Jean Christoph Caubet (ORCID: https://orcid.org/0000-0002-3130-095X)
- Jason A. Trubiano (ORCID: https://orcid.org/0000-0002-5111-6367)
- Antonino Romano (ORCID: https://orcid.org/0000-0001-9742-9898)
- A. Barbaud (ORCID: https://orcid.org/0000-0001-8889-1589)
- Vito Sabato (ORCID: https://orcid.org/0000-0002-1321-314X)
- Giorgia Marta
- Patrizia Bonadonna (ORCID: https://orcid.org/0000-0002-5703-5314)
- Cristobalina Mayorga (ORCID: https://orcid.org/0000-0001-8852-8077)
- Lene H. Garvey (ORCID: https://orcid.org/0000-0002-7777-4501)
- Asli Akkor Gelincik (ORCID: https://orcid.org/0000-0002-3524-9952)
- Inmaculada Doña (ORCID: https://orcid.org/0000-0002-5309-4878)
- Elizabeth Jane Phillips (ORCID: https://orcid.org/0000-0002-7623-3383)
- Adriana Ariza (ORCID: https://orcid.org/0000-0003-1524-9602)
- Marı́a José Torres (ORCID: https://orcid.org/0000-0001-5228-471X)
Institutions
- University of Verona (IT)
- Brigham and Women's Hospital (US)
- Amsterdam University College (NL)
- Ankara University (TR)
- Inserm (FR)
- Gentofte Hospital (DK)
- Sorbonne Université (FR)
- Antwerp University Hospital (BE)
- University Hospital of Geneva (CH)
- Hospital Regional Universitario de Málaga (ES)
- Meyer Children's Hospital (IT)
- Azienda Ospedaliera S.Maria (IT)
- Institut Pierre Louis d‘Épidémiologie et de Santé Publique (FR)
- Casa di Cura Città di Roma (IT)
- Andalusian Centre for Nanomedicine and Biotechnology (ES)
- Istituti di Ricovero e Cura a Carattere Scientifico (IT)
- Austin Health (AU)
- Technical University of Munich (DE)
- Geneva College (US)
- Istanbul University (TR)
- Universidad de Málaga (ES)
- University of Hong Kong (HK)
- Vanderbilt University Medical Center (US)
Publication Details
- Journal
- Allergy
- Published
- 2026-08-17
- DOI
- https://doi.org/10.1111/all.70480
- Primary Topic
- Drug-Induced Adverse Reactions
- Type
- article
- Field-Weighted Citation Impact
- 0.00
Funders
- European Academy of Allergy and Clinical Immunology