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This systematic review aims to provide a comprehensive and updated analysis of AEs related to this new regimen by combining safety data from clinical trials, implementation and pharmacovigilance studies. We conducted a search using PubMed, Medline and Web of Science to identify studies that reported AE data for bedaquiline\u2013pretomanid\u2010based regimens. In total, 14 studies from various countries were included in the analysis, comprising seven clinical trials, six implementation studies and one pharmacovigilance study. AE detection methods differed between clinical trials and implementation studies. Clinical trials utilised structured and standardised detection methods, whereas implementation and pharmacovigilance studies relied on spontaneous reporting with a higher prevalence of AEs reported in clinical trials (62.2\u2013100%) compared to implementation studies (41.8\u201372.8%). Serious AEs developed in 2.2\u201330.2% of patients. Among those with serious AEs, 7.7\u201354.3% required interruption of TB drugs, while 3.5\u201313% required withdrawal of TB drugs. AE outcomes showed full recovery in 79.2%. However, 23\u201332% of patients reported AEs even after completing their treatment. Understanding AEs is crucial for healthcare professionals to enhance patient care, as early detection and appropriate management of AEs is essential in TB treatment to increase tolerability, minimise complications and optimise clinical outcomes. Further research is necessary to implement active monitoring for this new TB regimen in real\u2010world settings.<\/jats:p>","DOI":"10.1002\/bcp.70541","type":"journal-article","created":{"date-parts":[[2026,5,13]],"date-time":"2026-05-13T04:04:57Z","timestamp":1778645097000},"page":"2607-2623","source":"Crossref","is-referenced-by-count":0,"title":["Adverse events in bedaquiline\u2010 and pretomanid\u2010based regimens for drug\u2010resistant tuberculosis from trial, implementation and pharmacovigilance studies"],"prefix":"10.1002","volume":"92","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-9075-8939","authenticated-orcid":false,"given":"Nisa","family":"Maria","sequence":"first","affiliation":[{"name":"School of Pharmacy, Faculty of Medicine and Health University of Sydney  Sydney Australia"},{"name":"Faculty of Pharmacy Universitas Indonesia  Depok Indonesia"},{"name":"Sydney Infectious Diseases Institute University of Sydney  Sydney Australia"},{"name":"Westmead Hospital  Sydney Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0005-5973-5946","authenticated-orcid":false,"given":"Annisa Lazuardi","family":"Larasati","sequence":"additional","affiliation":[{"name":"Faculty of Pharmacy Universitas Indonesia  Depok Indonesia"},{"name":"Departement of Pharmacy Universitas Indonesia Hospital  Jawa Barat Indonesia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0006-6394-9901","authenticated-orcid":false,"given":"Indri Yuliani","family":"Hamdani","sequence":"additional","affiliation":[{"name":"Faculty of Pharmacy Universitas Indonesia  Depok Indonesia"},{"name":"Departement of Pharmacy Universitas Indonesia Hospital  Jawa Barat Indonesia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0735-4691","authenticated-orcid":false,"given":"Jin\u2010Gun","family":"Cho","sequence":"additional","affiliation":[{"name":"Department of Respiratory and Sleep Medicine Westmead Hospital  Sydney Australia"},{"name":"Sydney Medical School, Faculty of Medicine and Health University of Sydney  Sydney Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6703-0288","authenticated-orcid":false,"given":"Jan\u2010Willem C.","family":"Alffenaar","sequence":"additional","affiliation":[{"name":"School of Pharmacy, Faculty of Medicine and Health University of Sydney  Sydney Australia"},{"name":"Sydney Infectious Diseases Institute University of Sydney  Sydney Australia"},{"name":"Westmead Hospital  Sydney Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,5,12]]},"reference":[{"key":"e_1_2_10_2_1","unstructured":"World Health Organization.Global TB Rep 20242024."},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.cmi.2022.07.026"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/s2213\u20102600(20)30047\u20103"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/S2213\u20102600(24)00300\u2010X"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1901814"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2119430"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.1002\/phar.2909"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2117166"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.1016\/s2213\u20102600(19)30366\u20102"},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1473\u20103099(24)00223\u20108"},{"key":"e_1_2_10_12_1","volume-title":"WHO operational handbook on tuberculosis. 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