{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,26]],"date-time":"2026-09-26T19:40:21Z","timestamp":1790451621509,"version":"4.1.0"},"reference-count":18,"publisher":"Wiley","issue":"7","license":[{"start":{"date-parts":[[2024,5,21]],"date-time":"2024-05-21T00:00:00Z","timestamp":1716249600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Brit J Clinical Pharma"],"published-print":{"date-parts":[[2024,7]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>To our knowledge, no prior study has analysed a possible association between acetazolamide and pulmonary oedema. The aim of this study was to use data from the EudraVigilance to detect a safety signal for acetazolamide\u2010induced pulmonary oedema. We performed a disproportionality analysis (case\u2013noncase method), calculating reporting odds ratios (RORs) up to 22 February 2024. Among 11\u2009684\u2009208 spontaneous cases of adverse reactions registered in EudraVigilance, 38\u2009275 were pulmonary oedemas. Acetazolamide was involved in 31 cases. In more than half of those cases, the patients received a single dose of acetazolamide after undergoing cataract surgery: latency was 10\u201390\u2009min. Remarkably, there were five cases of positive rechallenge and six cases resulted in death. The ROR for acetazolamide was 3.63 (95% CI 2.55\u20135.17). Disproportionality was also observed in VigiBase\u00ae: ROR 4.44 (95% CI 3.34\u20135.90). Our study confirms a signal that suggests a risk of serious pulmonary oedema associated with acetazolamide.<\/jats:p>","DOI":"10.1111\/bcp.16117","type":"journal-article","created":{"date-parts":[[2024,5,21]],"date-time":"2024-05-21T08:09:22Z","timestamp":1716278962000},"page":"1751-1755","source":"Crossref","is-referenced-by-count":4,"title":["Acetazolamide\u2010induced pulmonary oedema: A disproportionality analysis from the EudraVigilance database"],"prefix":"10.1111","volume":"90","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7026-1079","authenticated-orcid":false,"given":"Montserrat","family":"Garc\u00eda","sequence":"first","affiliation":[{"name":"Biobizkaia Health Research Institute Osakidetza Basque Health Service, Galdakao\u2010Usansolo Hospital, Basque Country Pharmacovigilance Unit  Galdakao Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5927-8715","authenticated-orcid":false,"given":"Itziar","family":"Albizua Madariaga","sequence":"additional","affiliation":[{"name":"Osakidetza Basque Health Service, Pharmacy Service Urduliz Hospital  Urduliz Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4353-055X","authenticated-orcid":false,"given":"Mar\u00eda","family":"Sainz\u2010Gil","sequence":"additional","affiliation":[{"name":"Centro de Estudios sobre la Seguridad de los Medicamentos (CESME). Departamento de Biolog\u00eda Celular, Histolog\u00eda, Farmacolog\u00eda y Gen\u00e9tica. Facultad de Medicina Universidad de Valladolid  Valladolid Spain"},{"name":"Grupo de Investigaci\u00f3n Reconocido \u2018Pharmacogenetics, Cancer Genetics, Genetic Polymorphisms and Pharmacoepidemiology\u2018 Universidad de Valladolid  Valladolid Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9575-1602","authenticated-orcid":false,"given":"Unax","family":"Lertxundi","sequence":"additional","affiliation":[{"name":"Bioaraba Health Research Institute, Osakidetza Basque Health Service, Araba Mental Health Network, Araba Psychiatric Hospital, Pharmacy Service  Gasteiz Alava Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2024,5,21]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMcp052699"},{"key":"e_1_2_10_3_1","first-page":"385","article-title":"Non\u2010cardiogenic pulmonary edema","volume":"44","author":"Kakouros N","year":"2003","journal-title":"Hellenic J Cardiol"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamaophthalmol.2021.5977"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1186\/1471\u20102415\u20105\u201024"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1136\/bcr\u20102016\u2010214829"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ajoc.2023.101827"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.1080\/17512433.2018.1526676"},{"key":"e_1_2_10_9_1","unstructured":"Screening for adverse reactions in EudraVigilance. 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