{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,16]],"date-time":"2026-10-16T03:00:48Z","timestamp":1792119648209,"version":"4.4.0"},"reference-count":35,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"1","content-domain":{"domain":["lww.com","ovid.com"],"crossmark-restriction":true},"short-container-title":[],"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background:<\/jats:title>\n                    <jats:p>Sirolimus is a potent immunosuppressive in renal transplantation. However, its use is limited by some reported side effects. The objective of this study was to determine the side effect profile of sirolimus in renal transplant patients.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Materials and Methods:<\/jats:title>\n                    <jats:p>\n                      In the present study, we retrospectively reviewed the medical records of 116 renal transplant patients treated with sirolimus alone or in combination with other immunosuppressive agents at private therapeutic centers in Isfahan, Iran, between March 2009 and February 2020. A checklist was used to collect data on demographic and clinical variables. Data were analyzed with independent samples\n                      <jats:italic toggle=\"yes\">t<\/jats:italic>\n                      -test and Chi-squared test.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>\n                      Our findings indicated that the most prevalent sirolimus-related side effects were edema (42.3%), proteinuria (37.5%), cytopenia (26.9%), abnormal level of liver enzymes (11.7%), and pneumonitis (9.7%). Stratification of side effects by sirolimus dose (&lt;2 mg and \u22652 mg) demonstrated their dose-independent occurrence (\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      &gt; 0.05). Pneumonitis was the most frequent reason for sirolimus cessation (58.7%). No significant differences were observed between males and females regarding the frequency of reasons for sirolimus cessation (\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      &gt; 0.05).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion:<\/jats:title>\n                    <jats:p>Edema, proteinuria, cytopenia, abnormal level of liver enzymes, and pneumonitis were the most prevalent sirolimus-related side effects in renal transplant patients. Further prospective cohort studies are warranted to detect underlying mechanisms and determinants of these side effects in renal transplant patients treated with sirolimus.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.4103\/jrms.jrms_531_22","type":"journal-article","created":{"date-parts":[[2023,8,1]],"date-time":"2023-08-01T01:45:30Z","timestamp":1690854330000},"update-policy":"https:\/\/doi.org\/10.1097\/lww.0000000000001000","source":"Crossref","is-referenced-by-count":5,"title":["The side effect profile of sirolimus and its relationship with some variables: A retrospective study of Iranian renal transplant patients"],"prefix":"10.4103","volume":"28","author":[{"given":"Shahrzad","family":"Shahidi","sequence":"first","affiliation":[{"name":"Isfahan Kidney Diseases Research Center, Khorshid Hospital, Isfahan University of Medical Sciences, Isfahan, Iran"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sahar","family":"Vahdat","sequence":"additional","affiliation":[{"name":"Isfahan Kidney Diseases Research Center, Khorshid Hospital, Isfahan University of Medical Sciences, Isfahan, Iran"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Abdolamir","family":"Atatpour","sequence":"additional","affiliation":[{"name":"Isfahan Kidney Diseases Research Center, Khorshid Hospital, Isfahan University of Medical Sciences, Isfahan, Iran"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shirin","family":"Meshkinfar","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine, Medical School, Isfahan University of Medical Sciences, Isfahan, Iran"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"276","published-online":{"date-parts":[[2023,7]]},"reference":[{"key":"R1-20240830","doi-asserted-by":"crossref","first-page":"573","DOI":"10.2165\/00003088-200140080-00002","article-title":"Clinical pharmacokinetics of sirolimus","volume":"40","author":"Mahalati","year":"2001","journal-title":"Clin Pharmacokinet"},{"issue":"Suppl 8","key":"R2-20240830","first-page":"61","article-title":"Sirolimus in renal transplantation","volume":"22","author":"Morath","year":"2007","journal-title":"Nephrol Dial Transplant"},{"key":"R3-20240830","doi-asserted-by":"crossref","first-page":"436","DOI":"10.1034\/j.1600-6143.2002.20507.x","article-title":"Sirolimus does not exhibit nephrotoxicity compared to cyclosporine in renal transplant recipients","volume":"2","author":"Morales","year":"2002","journal-title":"Am J Transplant"},{"key":"R4-20240830","doi-asserted-by":"crossref","first-page":"1385","DOI":"10.1111\/j.1600-6143.2009.02997.x","article-title":"Switch to a sirolimus-based immunosuppression in long-term renal transplant recipients: Reduced rate of (pre-) malignancies and nonmelanoma skin cancer in a prospective, randomized, assessor-blinded, controlled clinical trial","volume":"10","author":"Salgo","year":"2010","journal-title":"Am J Transplant"},{"key":"R5-20240830","doi-asserted-by":"crossref","first-page":"303","DOI":"10.1097\/TP.0b013e3182247ae2","article-title":"Lower malignancy rates in renal allograft recipients converted to sirolimus-based, calcineurin inhibitor-free immunotherapy: 24-month results from the convert trial","volume":"92","author":"Alber\u00fa","year":"2011","journal-title":"Transplantation"},{"key":"R6-20240830","doi-asserted-by":"crossref","first-page":"175","DOI":"10.1097\/TP.0b013e3181e11798","article-title":"Renal function, efficacy, and safety of sirolimus and mycophenolate mofetil after short-term calcineurin inhibitor-based quadruple therapy in de novo renal transplant patients: One-year analysis of a randomized multicenter trial","volume":"90","author":"Guba","year":"2010","journal-title":"Transplantation"},{"key":"R7-20240830","doi-asserted-by":"crossref","first-page":"1115","DOI":"10.1111\/j.1600-6143.2009.02615.x","article-title":"Efficacy on renal function of early conversion from cyclosporine to sirolimus 3 months after renal transplantation: Concept study","volume":"9","author":"Lebranchu","year":"2009","journal-title":"Am J Transplant"},{"key":"R8-20240830","doi-asserted-by":"crossref","first-page":"403280","DOI":"10.1155\/2013\/403280","article-title":"Systemic and nonrenal adverse effects occurring in renal transplant patients treated with mTOR inhibitors","volume":"2013","author":"Zaza","year":"2013","journal-title":"Clin Dev Immunol"},{"key":"R9-20240830","first-page":"813","article-title":"Sirolimus and mTOR inhibitors: A review of side effects and specific management in solid organ transplantation","volume":"42","author":"Nguyen","year":"2019","journal-title":"Drug Saf"},{"key":"R10-20240830","doi-asserted-by":"crossref","first-page":"S23","DOI":"10.1097\/TP.0b013e3181a05b7a","article-title":"Management of side effects of sirolimus therapy","volume":"87","author":"Stallone","year":"2009","journal-title":"Transplantation"},{"key":"R11-20240830","doi-asserted-by":"crossref","first-page":"449","DOI":"10.1016\/j.transproceed.2007.01.038","article-title":"Proteinuria in transplant patients associated with sirolimus","volume":"39","author":"Franco","year":"2007","journal-title":"Transplant Proc"},{"key":"R12-20240830","doi-asserted-by":"crossref","first-page":"788","DOI":"10.1097\/01.TP.0000056639.74982.F9","article-title":"Oral ulcers in kidney transplant recipients treated with sirolimus and mycophenolate mofetil","volume":"75","author":"van","year":"2003","journal-title":"Transplantation"},{"key":"R13-20240830","doi-asserted-by":"crossref","first-page":"1215","DOI":"10.1097\/01.TP.0000118413.92211.B6","article-title":"Sirolimus-associated pulmonary toxicity","volume":"77","author":"Pham","year":"2004","journal-title":"Transplantation"},{"key":"R14-20240830","doi-asserted-by":"crossref","first-page":"2348","DOI":"10.1016\/j.transproceed.2012.07.010","article-title":"Sirolimus in renal transplantation: Analysis of safety and efficacy in a nonprotocol conversion group","volume":"44","author":"Gois","year":"2012","journal-title":"Transplant Proc"},{"key":"R15-20240830","doi-asserted-by":"crossref","first-page":"3308","DOI":"10.1016\/j.transproceed.2009.08.049","article-title":"Conversion from calcineurin inhibitors to sirolimus in kidney transplant recipients: A retrospective cohort study","volume":"41","author":"Cardinal","year":"2009","journal-title":"Transplant Proc"},{"key":"R16-20240830","doi-asserted-by":"crossref","first-page":"616","DOI":"10.1111\/ctr.12361","article-title":"The incidence, management, and evolution of rapamycin-related side effects in kidney transplant recipients","volume":"28","author":"Verhave","year":"2014","journal-title":"Clin Transplant"},{"key":"R17-20240830","doi-asserted-by":"crossref","first-page":"3631","DOI":"10.1093\/ndt\/gfm420","article-title":"Pneumonitis associated with sirolimus: Clinical characteristics, risk factors and outcome \u2013 A single-centre experience and review of the literature","volume":"22","author":"Weiner","year":"2007","journal-title":"Nephrol Dial Transplant"},{"key":"R18-20240830","doi-asserted-by":"crossref","first-page":"505","DOI":"10.7326\/0003-4819-144-7-200604040-00009","article-title":"Brief communication: Sirolimus-associated pneumonitis: 24 cases in renal transplant recipients","volume":"144","author":"Champion","year":"2006","journal-title":"Ann Intern Med"},{"key":"R19-20240830","doi-asserted-by":"crossref","first-page":"428","DOI":"10.1111\/tri.12275","article-title":"Interstitial pneumonitis caused by everolimus: A case-cohort study in renal transplant recipients","volume":"27","author":"Baas","year":"2014","journal-title":"Transpl Int"},{"key":"R20-20240830","doi-asserted-by":"crossref","first-page":"264","DOI":"10.1097\/01.TP.0000128628.31556.B1","article-title":"Aretrospective review of liver transplant patients treated with sirolimus from a single center: An analysis of sirolimus-related complications","volume":"78","author":"Montalbano","year":"2004","journal-title":"Transplantation"},{"key":"R21-20240830","doi-asserted-by":"crossref","first-page":"153","DOI":"10.2165\/00002018-200528020-00006","article-title":"Benefit-risk assessment of sirolimus in renal transplantation","volume":"28","author":"Kuypers","year":"2005","journal-title":"Drug Saf"},{"key":"R22-20240830","doi-asserted-by":"crossref","first-page":"369","DOI":"10.2165\/00003495-200767030-00004","article-title":"Use of sirolimus in solid organ transplantation","volume":"67","author":"Augustine","year":"2007","journal-title":"Drugs"},{"key":"R23-20240830","doi-asserted-by":"crossref","first-page":"130","DOI":"10.1111\/j.1399-0012.2004.00314.x","article-title":"An open-label, pilot study evaluating the safety and efficacy of converting from calcineurin inhibitors to sirolimus in established renal allograft recipients with moderate renal insufficiency","volume":"19","author":"Peddi","year":"2005","journal-title":"Clin Transplant"},{"key":"R24-20240830","doi-asserted-by":"crossref","first-page":"409","DOI":"10.1016\/0009-9120(93)90118-P","article-title":"Comparison of the effect of rapamycin and FK506 on release of prostacyclin and endothelin in vitro","volume":"26","author":"Yatscoff","year":"1993","journal-title":"Clin Biochem"},{"key":"R25-20240830","doi-asserted-by":"crossref","first-page":"1198","DOI":"10.1097\/01.tp.0000185200.17589.74","article-title":"Proteinuria following a switch from calcineurin inhibitors to sirolimus","volume":"80","author":"Letavernier","year":"2005","journal-title":"Transplantation"},{"key":"R26-20240830","doi-asserted-by":"crossref","first-page":"3833","DOI":"10.1016\/j.transproceed.2005.09.127","article-title":"Evolution of proteinuria after conversion from calcineurin inhibitors (CNI) to sirolimus (SRL) in renal transplant patients: A multicenter study","volume":"37","author":"Ruiz","year":"2005","journal-title":"Transplant Proc"},{"key":"R27-20240830","doi-asserted-by":"crossref","first-page":"2517","DOI":"10.1093\/ndt\/gfh957","article-title":"Long-term results in renal transplant patients with allograft dysfunction after switching from calcineurin inhibitors to sirolimus","volume":"20","author":"Bumbea","year":"2005","journal-title":"Nephrol Dial Transplant"},{"key":"R28-20240830","doi-asserted-by":"crossref","first-page":"1355","DOI":"10.1038\/sj.ki.5001792","article-title":"Proteinuria following conversion from azathioprine to sirolimus in renal transplant recipients","volume":"70","author":"van","year":"2006","journal-title":"Kidney Int"},{"key":"R29-20240830","doi-asserted-by":"crossref","first-page":"2085","DOI":"10.1097\/00007890-200005270-00019","article-title":"Sirolimus-induced thrombocytopenia and leukopenia in renal transplant recipients: Risk factors, incidence, progression, and management","volume":"69","author":"Hong","year":"2000","journal-title":"Transplantation"},{"key":"R30-20240830","doi-asserted-by":"crossref","first-page":"2001","DOI":"10.1111\/j.1600-6143.2004.00612.x","article-title":"Comparative effects of sirolimus and mycophenolate mofetil on erythropoiesis in kidney transplant patients","volume":"4","author":"Augustine","year":"2004","journal-title":"Am J Transplant"},{"key":"R31-20240830","doi-asserted-by":"crossref","first-page":"1252","DOI":"10.1097\/00007890-200004150-00009","article-title":"Sirolimus in association with mycophenolate mofetil induction for the prevention of acute graft rejection in renal allograft recipients","volume":"69","author":"Kreis","year":"2000","journal-title":"Transplantation"},{"key":"R32-20240830","doi-asserted-by":"crossref","first-page":"1991","DOI":"10.1111\/j.1600-6143.2006.01398.x","article-title":"Mycophenolate mofetil and sirolimus combination in renal transplantation","volume":"6","author":"Griny\u00f3","year":"2006","journal-title":"Am J Transplant"},{"key":"R33-20240830","doi-asserted-by":"crossref","first-page":"560","DOI":"10.1111\/j.1365-2125.2005.02473.x","article-title":"Relationships between sirolimus dosing, concentration and outcomes in renal transplant recipients","volume":"60","author":"Dansirikul","year":"2005","journal-title":"Br J Clin Pharmacol"},{"key":"R34-20240830","doi-asserted-by":"crossref","first-page":"1036","DOI":"10.1097\/00007890-199904150-00017","article-title":"Sirolimus (rapamycin)-based therapy in human renal transplantation: Similar efficacy and different toxicity compared with cyclosporine. Sirolimus European renal transplant study group","volume":"67","author":"Groth","year":"1999","journal-title":"Transplantation"},{"key":"R35-20240830","doi-asserted-by":"crossref","first-page":"1560","DOI":"10.1097\/00007890-200212150-00013","article-title":"Improved renal function in sirolimus-treated renal transplant patients after early cyclosporine elimination","volume":"74","author":"Gonwa","year":"2002","journal-title":"Transplantation"}],"container-title":["Journal of Research in Medical Sciences"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.ovid.com\/10.4103\/jrms.jrms_531_22","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,8,26]],"date-time":"2026-08-26T16:17:59Z","timestamp":1787761079000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.ovid.com\/10.4103\/jrms.jrms_531_22"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,7]]},"references-count":35,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2023]]}},"URL":"https:\/\/doi.org\/10.4103\/jrms.jrms_531_22","relation":{},"ISSN":["1735-1995","1735-7136"],"issn-type":[{"value":"1735-1995","type":"print"},{"value":"1735-7136","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,7]]},"assertion":[{"value":"2022-07-25","name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2023-04-18","name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}}]}}