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Due to their low incidence, DI-ILDs may be detected only after a drug has been marketed, notably through adverse drug reaction (ADR) reports to pharmacovigilance centres. The aim of our study was to describe drug-induced diffuse lung disease cases notified to and recorded by the French Pharmacovigilance Database (FPVD), reported clinical pictures and the potentially causal drugs.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>This retrospective study included cases registered in the FPVD from 1 January 1985 to 1 April 2022 which had ADRs coded in MedDRA with a High-Level Group Term \u201cLower respiratory tract disorders (excluding obstruction and infection)\u201d involving patients aged \u226518\u2005years.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>We analysed 7234 cases involving 13\u2009059 suspect medications and 1112 specific molecules. Cases were categorised as serious in 96.7% and death ensued in 13.3%. Males accounted for 54.4% of the cases. Median (range) age was 69 (18\u2013103)\u2005years. The most prevalent ADRs were \u201cInterstitial lung disease\u201d (51.0%), \u201cPulmonary oedema\u201d (acute\/non-acute) (15.6%) and \u201cPulmonary fibrosis\u201d (10.5%). Anti-cancer drugs (31.2%) and cardiovascular drugs (29.1%) were the most prominent therapeutic classes involved, with amiodarone being the most commonly reported suspected drug (10.0%), followed by methotrexate (3.1%).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>This study from a large nationwide dataset spanning 37\u2005years is the largest known to date. Drug-induced diffuse lung diseases are serious with a potentially fatal outcome. Accurate diagnoses remain essential to identify the diseases properly and discontinue the culprit drug urgently.<\/jats:p><\/jats:sec>","DOI":"10.1183\/13993003.00756-2024","type":"journal-article","created":{"date-parts":[[2024,11,7]],"date-time":"2024-11-07T16:10:24Z","timestamp":1730995824000},"page":"2400756","update-policy":"https:\/\/doi.org\/10.1183\/ers-crossmark-policy","source":"Crossref","is-referenced-by-count":9,"title":["Diffuse lung diseases ascribed to drugs: a nationwide observational study over 37\u2005years using the French Pharmacovigilance Database"],"prefix":"10.1183","volume":"65","author":[{"given":"Sophie","family":"Yavordios","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2830-5642","authenticated-orcid":false,"given":"Guillaume","family":"Beltramo","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Romane","family":"Freppel","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Fr\u00e9d\u00e9rique","family":"Beau Salinas","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Christine","family":"Le Beller","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kevin","family":"Bihan","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Pierre","family":"Mouillot","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marjolaine","family":"Georges","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Aur\u00e9lie","family":"Grandvuillemin","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3670-5622","authenticated-orcid":false,"given":"Philippe","family":"Bonniaud","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"81","published-online":{"date-parts":[[2024,11,7]]},"reference":[{"key":"2025020604450491000_65.2.2400756.1","doi-asserted-by":"publisher","DOI":"10.1164\/rccm.201308-1483ST"},{"key":"2025020604450491000_65.2.2400756.2","doi-asserted-by":"publisher","DOI":"10.1164\/ajrccm.150.4.7921471"},{"key":"2025020604450491000_65.2.2400756.3","doi-asserted-by":"publisher","DOI":"10.1183\/13993003.02419-2016"},{"key":"2025020604450491000_65.2.2400756.4","doi-asserted-by":"publisher","DOI":"10.1016\/j.ccm.2004.05.006"},{"key":"2025020604450491000_65.2.2400756.5","doi-asserted-by":"publisher","DOI":"10.1183\/13993003.02776-2021"},{"key":"2025020604450491000_65.2.2400756.6","unstructured":"Camus P . 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