{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,18]],"date-time":"2026-08-18T04:53:04Z","timestamp":1787028784128,"version":"build-2736575974"},"reference-count":32,"publisher":"MDPI AG","issue":"8","license":[{"start":{"date-parts":[[2025,8,7]],"date-time":"2025-08-07T00:00:00Z","timestamp":1754524800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Life"],"abstract":"<jats:p>People with cystic fibrosis may experience polypharmacy, which can increase the risk of drug induced complications such as adverse events and drug\u2013drug interactions. This study aimed to examine the prevalence of adverse events and to identify potential drug\u2013drug interactions associated with elexacaftor\/tezacaftor\/ivacaftor (ETI). Three databases, the Australian Therapeutic Goods Administration Database of Adverse Event Notification (TGA DAEN), the Canada Vigilance Adverse Reaction Online Database (CVAROD), and the USA Food and Drug Administration Adverse Event Reporting System (FAERS) Database were searched for spontaneous ETI adverse events between 2019 and 2024. Descriptive analysis of the data was undertaken. The FAERS database was analysed to identify adverse events of interest such as anxiety and depression and concomitant drugs prescribed with ETI. A total of 10,628 ETI associated adverse events were identified in all system organ classes. The incidence of psychiatric adverse events ranged from 7 to 15% across the three databases. Potential drug\u2013drug interactions with CYP 3A4\/5 strong inhibitors and strong inducers were identified from the FAERS database and azole antifungals were implicated in several ETI dose modifications. The prevalence and types of ETI adverse events were varied and use of concomitant drugs with potential drug interactions was significant, requiring more research to manage them.<\/jats:p>","DOI":"10.3390\/life15081256","type":"journal-article","created":{"date-parts":[[2025,8,8]],"date-time":"2025-08-08T08:09:35Z","timestamp":1754640575000},"page":"1256","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":7,"title":["Adverse Events and Drug Interactions Associated with Elexacaftor\/Tezacaftor\/Ivacaftor Treatment: A Descriptive Study Across Australian, Canadian, and American Adverse Event Databases"],"prefix":"10.3390","volume":"15","author":[{"given":"Theeba","family":"Thiruchelvam","sequence":"first","affiliation":[{"name":"Discipline of Pharmacy, School of Health and Biomedical Sciences, RMIT University, Bundoora, VIC 3083, Australia"},{"name":"John Hunter Hospital, Newcastle, NSW 2305, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5543-8411","authenticated-orcid":false,"given":"Chiao Xin","family":"Lim","sequence":"additional","affiliation":[{"name":"Discipline of Pharmacy, School of Health and Biomedical Sciences, RMIT University, Bundoora, VIC 3083, Australia"},{"name":"Medicine Department, School of Clinical Sciences, Monash University, Clayton, VIC 3168, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6941-7670","authenticated-orcid":false,"given":"Courtney","family":"Munro","sequence":"additional","affiliation":[{"name":"Murdoch Children\u2019s Research Institute, Parkville, VIC 3010, Australia"},{"name":"Department of Pediatric and Adolescent Gynaecology, The Royal Children\u2019s Hospital Melbourne, Parkville, VIC 3010, Australia"},{"name":"Department of Pediatrics, University of Melbourne, Melbourne, VIC 3004, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5536-1565","authenticated-orcid":false,"given":"Vincent","family":"Chan","sequence":"additional","affiliation":[{"name":"Discipline of Pharmacy, School of Health and Biomedical Sciences, RMIT University, Bundoora, VIC 3083, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Geshani","family":"Jayasuria","sequence":"additional","affiliation":[{"name":"John Hunter Hospital, Newcastle, NSW 2305, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kingsley P.","family":"Coulthard","sequence":"additional","affiliation":[{"name":"Clinical and Health Sciences, University of South Australia, Adelaide, SA 5000, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5676-6126","authenticated-orcid":false,"given":"Peter A. B.","family":"Wark","sequence":"additional","affiliation":[{"name":"School of Translational Medicine, Monash University, Melbourne, VIC 3004, Australia"},{"name":"Respiratory and Sleep Medicine, Alfred Health, Melbourne, VIC 3004, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5496-935X","authenticated-orcid":false,"given":"Vijayaprakash","family":"Suppiah","sequence":"additional","affiliation":[{"name":"Clinical and Health Sciences, University of South Australia, Adelaide, SA 5000, Australia"},{"name":"Australian Centre for Precision Health, University of South Australia, Adelaide, SA 5000, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2025,8,7]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"1859","DOI":"10.1001\/jama.2023.8120","article-title":"Cystic Fibrosis a review","volume":"329","author":"Ong","year":"2023","journal-title":"JAMA"},{"key":"ref_2","doi-asserted-by":"crossref","unstructured":"Lopes-Pacheco, M. (2020). CFTR modulators: The changing face of cystic fibrosis in the era of precision medicine. Front. Pharmacol., 10.","DOI":"10.3389\/fphar.2019.01662"},{"key":"ref_3","doi-asserted-by":"crossref","first-page":"1940","DOI":"10.1016\/S0140-6736(19)32597-8","article-title":"VX17-445-103 Trial Group. Efficacy and safety of the elexacaftor plus tezacaftor plus ivacaftor combination regimen in people with cystic fibrosis homozygous for the F508del mutation: A double-blind, randomised, phase 3 trial","volume":"394","author":"Heijerman","year":"2019","journal-title":"Lancet"},{"key":"ref_4","doi-asserted-by":"crossref","first-page":"1809","DOI":"10.1056\/NEJMoa1908639","article-title":"Elexacaftor-tezacaftor-ivacaftor for cystic fibrosis with a single Phe508del allele","volume":"381","author":"Middleton","year":"2019","journal-title":"N. Engl. J. 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From ivacaftor to triple combination: A systematic review of efficacy and safety of CFT modulators in people with cystic fibrosis. Int. J. Mol. Sci., 21.","DOI":"10.3390\/ijms21165882"},{"key":"ref_12","doi-asserted-by":"crossref","unstructured":"Kapouni, N., Moustaki, M., Douros, K., and Loukou, I. (2023). Efficacy and safety of elexacaftor-tezacaftor-ivacaftor in the treatment of cystic fibrosis: A systematic review. Children, 10.","DOI":"10.3390\/children10030554"},{"key":"ref_13","doi-asserted-by":"crossref","first-page":"3626","DOI":"10.1002\/ppul.26673","article-title":"Prevalence of adverse events in cystic fibrosis patients treated with elexacaftor\/tezacaftor\/ivacaftor: Experience of the regional referral center in Tuscany, Italy","volume":"58","author":"Manciulli","year":"2023","journal-title":"Pediatr. 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Pharmacol., 14.","DOI":"10.3389\/fphar.2023.1156621"}],"container-title":["Life"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/2075-1729\/15\/8\/1256\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,9]],"date-time":"2025-10-09T18:25:46Z","timestamp":1760034346000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/2075-1729\/15\/8\/1256"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,8,7]]},"references-count":32,"journal-issue":{"issue":"8","published-online":{"date-parts":[[2025,8]]}},"alternative-id":["life15081256"],"URL":"https:\/\/doi.org\/10.3390\/life15081256","relation":{},"ISSN":["2075-1729"],"issn-type":[{"value":"2075-1729","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,8,7]]}}}