{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,11]],"date-time":"2026-08-11T15:00:24Z","timestamp":1786460424448,"version":"build-2736575974"},"reference-count":22,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"3","content-domain":{"domain":["lww.com","ovid.com"],"crossmark-restriction":true},"short-container-title":[],"published-print":{"date-parts":[[2026,3]]},"abstract":"\n Objective:<\/jats:title>\n The objective of the review is to chart clinical signs and symptoms presented by solid organ recipients when serum levels of tacrolimus are supratherapeutic.<\/jats:p>\n <\/jats:sec>\n \n Introduction:<\/jats:title>\n Tacrolimus is the worldwide standard immunosuppressive agent used in post-solid organ transplantation. However, this narrow-index therapeutic drug can lead to acute toxicity at supratherapeutic serum levels (\u226520 ng\/mL). This clinical scenario evolves dynamically, making its diagnosis and urgent treatment difficult for transplant teams, while its sequelae are potentially serious and even fatal.<\/jats:p>\n <\/jats:sec>\n \n Eligibility criteria:<\/jats:title>\n Studies on solid organ recipients (heart, lung, kidney, liver) who had tacrolimus serum levels of \u226520 ng\/mL and are aged \u226518 years will be considered for inclusion. There will be no limits on the care setting or geographic location. Studies on other types of transplants or studies where tacrolimus serum levels are not reported will be excluded.<\/jats:p>\n <\/jats:sec>\n \n Methods:<\/jats:title>\n This review will follow the JBI methodology for scoping reviews, and the results will be reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR). The following databases will be searched: MEDLINE (Ovid), Web of Science, Scielo (BIREME), LILACS (BVS), Embase (Ovid), CINAHL (EBSCOhost), Scopus, Cochrane CENTRAL, and the Cochrane Database of Systematic Reviews. Gray literature sources will also be searched. No date or language limits will be applied. Reports will be independently screened by 2 researchers. Signs and symptoms presented by patients during acute toxicity will be extracted from studies using a modified JBI data extraction tool. Data will be analyzed using descriptive statistics and the results presented in tabular and graphical formats, accompanied by narrative summaries.<\/jats:p>\n <\/jats:sec>\n \n Review registration:<\/jats:title>\n OSF osf.io\/f7tzu\/<\/jats:p>\n <\/jats:sec>","DOI":"10.11124\/jbies-24-00420","type":"journal-article","created":{"date-parts":[[2025,12,23]],"date-time":"2025-12-23T10:00:17Z","timestamp":1766484017000},"page":"598-606","update-policy":"https:\/\/doi.org\/10.1097\/lww.0000000000001000","source":"Crossref","is-referenced-by-count":0,"title":["Signs and symptoms of acute tacrolimus toxicity in solid organ transplant recipients: a scoping review protocol"],"prefix":"10.11124","volume":"24","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-5222-233X","authenticated-orcid":false,"given":"L\u00eddia","family":"Einsfeld","sequence":"first","affiliation":[{"name":"Postgraduate Program in Pharmaceutical Services and Policies, Federal University of Rio Grande do Sul, Porto Alegre, Brazil"},{"name":"Clinical Pharmacy Section, Hospital de Cl\u00ednicas de Porto Alegre, Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3433-0385","authenticated-orcid":false,"given":"Kathleen","family":"Asturian","sequence":"additional","affiliation":[{"name":"Postgraduate Program in Pharmaceutical Services and Policies, Federal University of Rio Grande do Sul, Porto Alegre, Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8171-2688","authenticated-orcid":false,"given":"Diogo","family":"Pilger","sequence":"additional","affiliation":[{"name":"Postgraduate Program in Pharmaceutical Services and Policies, Federal University of Rio Grande do Sul, Porto Alegre, Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"276","published-online":{"date-parts":[[2026,3,6]]},"reference":[{"issue":"2, Suppl 1","key":"R1-20260317","first-page":"S12","article-title":"OPTN\/SRTR 2021 annual data report [internet]","volume":"23","year":"2023","journal-title":"OPTN"},{"key":"R2-20260317","doi-asserted-by":"crossref","first-page":"599","DOI":"10.1002\/phar.2716","article-title":"Consensus recommendations for use of maintenance immunosuppression in solid organ transplantation: Endorsed by the American College of Clinical Pharmacy, American Society of Transplantation, and the International Society for Heart and Lung Transplantation","volume":"42","author":"Nelson","year":"2022","journal-title":"Pharmacotherapy"},{"issue":"1","key":"R3-20260317","doi-asserted-by":"crossref","first-page":"41","DOI":"10.1097\/01.TP.0000162980.68628.5A","article-title":"A randomized, prospective, pharmacoeconomic trial of tacrolimus versus cyclosporine in combination with thymoglobulin in renal transplant recipients","volume":"80","author":"Hardinger","year":"2005","journal-title":"Transplantation"},{"issue":"9340","key":"R4-20260317","doi-asserted-by":"crossref","first-page":"1119","DOI":"10.1016\/S0140-6736(02)11196-2","article-title":"Tacrolimus versus micro emulsified cyclosporine in liver transplantation: the TMC randomized controlled trial","volume":"360","author":"O\u2019Grady","year":"2002","journal-title":"Lancet"},{"issue":"4","key":"R5-20260317","doi-asserted-by":"crossref","first-page":"434","DOI":"10.1016\/j.healun.2005.11.452","article-title":"Five-year results of a randomized, single-center study of tacrolimus vs microemulsion cyclosporine in heart transplant patients","volume":"25","author":"Kobashigawa","year":"2006","journal-title":"J Heart Lung Transplant"},{"issue":"5","key":"R6-20260317","doi-asserted-by":"crossref","first-page":"511","DOI":"10.1016\/S1053-2498(01)00244-3","article-title":"Tacrolimus versus cyclosporine after lung transplantation: a prospective, open, randomized two-center trial comparing two different immunosuppressive protocols","volume":"20","author":"Treede","year":"2001","journal-title":"J Heart Lung Transplant"},{"issue":"2","key":"R9-20260317","doi-asserted-by":"crossref","first-page":"100610","DOI":"10.1016\/j.trre.2021.100610","article-title":"Identifying the association between tacrolimus exposure and toxicity in heart and lung transplant recipients: a systematic review","volume":"35","author":"Braithwaite","year":"2021","journal-title":"Transplant Rev (Orlando)"},{"key":"R10-20260317","doi-asserted-by":"crossref","first-page":"311","DOI":"10.1007\/s13318-017-0453-7","article-title":"Association of whole blood tacrolimus concentrations with kidney injury in heart transplantation patients","volume":"43","author":"Sikma","year":"2018","journal-title":"Eur J Drug Metab Pharmacokinet"},{"issue":"5","key":"R11-20260317","doi-asserted-by":"crossref","first-page":"216","DOI":"10.5414\/CN111137","article-title":"Elevated tacrolimus levels among COVID-19 kidney transplant recipients are associated with worse disease severity and clinical outcomes","volume":"100","author":"Yango","year":"2023","journal-title":"Clin Nephrol"},{"issue":"7","key":"R12-20260317","doi-asserted-by":"crossref","first-page":"2193","DOI":"10.3390\/jcm9072193","article-title":"Impacts of high intra- and inter-individual variability in tacrolimus pharmacokinetics and fast tacrolimus metabolism on outcomes of solid organ transplant recipients","volume":"9","author":"Thongprayoon","year":"2020","journal-title":"J Clin Med"},{"key":"R13-20260317","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1016\/j.jhlto.2023.100043","article-title":"Erratic tacrolimus levels at 6 to 12 months post-lung transplant predicts poor outcomes","volume":"3","author":"Walters","year":"2024","journal-title":"JHLT Open"},{"issue":"9","key":"R14-20260317","doi-asserted-by":"crossref","first-page":"1376","DOI":"10.1097\/00007890-199611150-00040","article-title":"Acute overdoses of tacrolimus","volume":"62","author":"Curran","year":"1996","journal-title":"Transplantation"},{"issue":"8","key":"R15-20260317","doi-asserted-by":"crossref","first-page":"1063-6","DOI":"10.1592\/phco.22.12.1063.33604","article-title":"Severe prolonged tacrolimus overdose with minimal consequences","volume":"22","author":"Hardwick","year":"2002","journal-title":"Pharmacotherapy"},{"issue":"Suppl 3","key":"R16-20260317","doi-asserted-by":"crossref","first-page":"S1","DOI":"10.1111\/j.1600-6143.2009.02834.x","article-title":"Special issue: KDIGO clinical practice guideline for the care of kidney transplant recipients","volume":"9","author":"Eckardt","year":"2009","journal-title":"Am J Transplant"},{"issue":"6","key":"R17-20260317","first-page":"284","article-title":"Neurotoxicity of calcineurin inhibitors: tacrolimus","volume":"20","author":"Flores-Aldama","year":"2019","journal-title":"Rev Mex Neurocienc"},{"key":"R19-20260317","first-page":"e221223224799","article-title":"Tacrolimus pharmacotherapy: infectious complications and toxicity in organ transplant recipients: an updated review","volume":"16","author":"Tolou-Ghamari","year":"2023","journal-title":"Curr Drug Res Rev"},{"issue":"5","key":"R20-20260317","doi-asserted-by":"crossref","first-page":"ytad193","DOI":"10.1093\/ehjcr\/ytad193","article-title":"Case report: tacrolimus toxicity in the setting of concurrent Paxlovid use in a heart-transplant recipient","volume":"7","author":"Modi","year":"2023","journal-title":"Eur Heart J Case Rep"},{"key":"R21-20260317","doi-asserted-by":"crossref","first-page":"218.e5-7","DOI":"10.1016\/j.ajem.2023.04.045","article-title":"Tacrolimus toxicity due to enzyme inhibition from ritonavir","volume":"69","author":"Snee","year":"2023","journal-title":"Am J Emerg Med"},{"issue":"1","key":"R22-20260317","doi-asserted-by":"crossref","first-page":"33","DOI":"10.3390\/pharma3010002","article-title":"Rescue therapy for supratherapeutic concentrations of calcineurin inhibitors using potent cytochrome p450 inducers","volume":"3","author":"Duwor","year":"2024","journal-title":"Pharmacoepidemiology"},{"key":"R24-20260317","doi-asserted-by":"crossref","first-page":"404-18","DOI":"10.1093\/fampra\/cmad015","article-title":"A scoping review of evidence-based guidance and guidelines published by general practice professional organizations","volume":"41","author":"O\u2019Brien","year":"2024","journal-title":"Fam Pract"},{"key":"R25-20260317","doi-asserted-by":"crossref","first-page":"467-73","DOI":"10.7326\/M18-0850","article-title":"PRISMA extension for Scoping Reviews (PRISMA-ScR): checklist and explanation","volume":"169","author":"Tricco","year":"2018","journal-title":"Ann Intern Med"},{"issue":"1","key":"R29-20260317","doi-asserted-by":"crossref","first-page":"36","DOI":"10.1097\/XEB.0000000000000152","article-title":"The development of software to support multiple systematic review types: the Joanna Briggs Institute System for the Unified Management, Assessment and Review of Information (JBI SUMARI)","volume":"17","author":"Munn","year":"2019","journal-title":"Int J Evid Based Healthc"}],"container-title":["JBI Evidence Synthesis"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.ovid.com\/10.11124\/JBIES-24-00420","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,8,11]],"date-time":"2026-08-11T12:50:49Z","timestamp":1786452649000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.ovid.com\/10.11124\/JBIES-24-00420"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,3]]},"references-count":22,"journal-issue":{"issue":"3","published-print":{"date-parts":[[2026]]}},"URL":"https:\/\/doi.org\/10.11124\/jbies-24-00420","relation":{},"ISSN":["2689-8381"],"issn-type":[{"value":"2689-8381","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,3]]}}}