{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,10]],"date-time":"2026-06-10T06:02:26Z","timestamp":1781071346008,"version":"3.54.1"},"reference-count":40,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2026,6,10]],"date-time":"2026-06-10T00:00:00Z","timestamp":1781049600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Pharmacol."],"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Anthracyclines are key for acute myeloid leukemia (AML) but carry serious side effects. This study identifies their side effects across drugs and patient populations using the FDA Adverse Event Reporting System (FAERS).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Materials and methods<\/jats:title>\n                    <jats:p>We analyzed 1,079 AML cases and 3,622 adverse events (AEs) from FAERS (2004\u20132024). Disproportionality analyses (PRR, ROR, BCPNN, MGPS) detected AE signals; Kruskal\u2013Wallis tests evaluated time-to-onset by age\/sex.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Distinct risks emerged: epirubicin (strongest cardiotoxicity, ROR = 10.57), doxorubicin (highest pregnancy-related AEs, ROR = 9.97), daunorubicin (vascular disorders, ROR = 2.38), idarubicin (myelosuppression\/infections). Most AEs occurred within 180 days. Idarubicin showed delayed onset in elderly (P &amp;lt; 0.05); males had delayed doxorubicin toxicity (P = 0.04) but accelerated idarubicin onset (P = 0.049) vs. females.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>This analysis identifies distinct safety profiles. Epirubicin and doxorubicin were associated with cardiac and pregnancy-related risks, while idarubicin showed signals suggesting potentially delayed onset in elderly patients. Observed sex differences indicate possible variations in AE patterns.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.3389\/fphar.2026.1759201","type":"journal-article","created":{"date-parts":[[2026,6,10]],"date-time":"2026-06-10T05:20:07Z","timestamp":1781068807000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":0,"title":["Post-marketing safety evaluation of anthracycline for acute myeloid leukemia treatment: a real-world pharmacovigilance analysis"],"prefix":"10.3389","volume":"17","author":[{"given":"Yong","family":"Wang","sequence":"first","affiliation":[{"name":"Department of Hematology and Oncology, Kunshan Third People\u2019s Hospital","place":["Suzhou, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Qian","family":"Liu","sequence":"additional","affiliation":[{"name":"Department of Hematology and Oncology, Kunshan Third People\u2019s Hospital","place":["Suzhou, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jing","family":"Xu","sequence":"additional","affiliation":[{"name":"Department of Hematology and Oncology, Kunshan Third People\u2019s Hospital","place":["Suzhou, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fei","family":"Yang","sequence":"additional","affiliation":[{"name":"Department of Hematology and Oncology, Kunshan Third People\u2019s Hospital","place":["Suzhou, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Meiyan","family":"Wang","sequence":"additional","affiliation":[{"name":"Department of Hematology and Oncology, Kunshan Third People\u2019s Hospital","place":["Suzhou, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Haoxiang","family":"Lu","sequence":"additional","affiliation":[{"name":"Department of Hematology and Oncology, Kunshan Third People\u2019s Hospital","place":["Suzhou, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jie","family":"Wu","sequence":"additional","affiliation":[{"name":"Department of Hematology and Oncology, Kunshan Third People\u2019s Hospital","place":["Suzhou, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ao","family":"Zhang","sequence":"additional","affiliation":[{"name":"Department of Hematology and Oncology, Kunshan Third People\u2019s Hospital","place":["Suzhou, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xingli","family":"Zhang","sequence":"additional","affiliation":[{"name":"Department of Hematology and Oncology, Kunshan Third People\u2019s Hospital","place":["Suzhou, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dehong","family":"Wu","sequence":"additional","affiliation":[{"name":"Department of Hematology and Oncology, Kunshan Third People\u2019s Hospital","place":["Suzhou, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hongchun","family":"Qiu","sequence":"additional","affiliation":[{"name":"Department of Hematology and Oncology, Kunshan Third People\u2019s Hospital","place":["Suzhou, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1965","published-online":{"date-parts":[[2026,6,10]]},"reference":[{"key":"B1","doi-asserted-by":"publisher","first-page":"181","DOI":"10.1007\/978-3-030-43032-0_15","article-title":"Anthracycline-induced cardiotoxicity: causes, mechanisms, and prevention","volume":"1257","author":"Bhagat","year":"2020","journal-title":"Adv. Exp. Med. Biol."},{"key":"B2","doi-asserted-by":"publisher","first-page":"248","DOI":"10.1007\/s12012-024-09952-4","article-title":"Doxorubicin or epirubicin versus liposomal doxorubicin therapy-differences in cardiotoxicity","volume":"25","author":"Buchalska","year":"2025","journal-title":"Cardiovasc Toxicol."},{"key":"B3","doi-asserted-by":"publisher","first-page":"915","DOI":"10.1007\/s10741-019-09820-2","article-title":"Sex differences in anthracycline-induced cardiotoxicity: the benefits of estrogens","volume":"24","author":"Cadeddu Dessalvi","year":"2019","journal-title":"Heart Fail Rev."},{"key":"B4","doi-asserted-by":"publisher","first-page":"655","DOI":"10.1016\/j.jaccao.2024.07.016","article-title":"Anthracycline cardiotoxicity in adult cancer patients: JACC: cardiooncology state-of-the-art review","volume":"6","author":"Camilli","year":"2024","journal-title":"JACC CardioOncol"},{"key":"B5","doi-asserted-by":"publisher","first-page":"665","DOI":"10.1002\/clc.4960210911","article-title":"Comparison of epirubicin and doxorubicin cardiotoxicity induced by low doses: evolution of the diastolic and systolic parameters studied by radionuclide angiography","volume":"21","author":"Cottin","year":"1998","journal-title":"Clin. Cardiol."},{"key":"B6","doi-asserted-by":"publisher","first-page":"e33417","DOI":"10.1016\/j.heliyon.2024.e33417","article-title":"Adverse events associated with eteplirsen: a disproportionality analysis using the 2016-2023 FAERS data","volume":"10","author":"Dai","year":"2024","journal-title":"Heliyon"},{"key":"B7","first-page":"322","article-title":"Comparative microscopic study of cardiotoxicity and skin toxicity of anthracycline analogs","volume":"38","author":"Dantchev","year":"1984","journal-title":"Biomed. Pharmacother."},{"key":"B8","doi-asserted-by":"publisher","first-page":"963","DOI":"10.1023\/a:1011196910325","article-title":"Anthracycline-induced acute cardiotoxicity in adults treated for leukaemia. Analysis of the clinico-pathological aspects of documented acute anthracycline-induced cardiotoxicity in patients treated for acute leukaemia at the university hospital of Z\u00fcrich, Switzerland, between 1990 and 1996","volume":"12","author":"Dazzi","year":"2001","journal-title":"Ann. Oncol."},{"key":"B9","doi-asserted-by":"publisher","first-page":"2768","DOI":"10.1200\/JCO.20.03736","article-title":"Venetoclax combined with FLAG-IDA induction and consolidation in newly diagnosed and relapsed or refractory acute myeloid leukemia","volume":"39","author":"DiNardo","year":"2021","journal-title":"J. Clin. Oncol."},{"key":"B10","doi-asserted-by":"publisher","first-page":"47","DOI":"10.1016\/j.ijcard.2019.03.013","article-title":"Risk prediction model for long-term heart failure incidence after epirubicin chemotherapy for breast cancer - a real-world data-based, nationwide classification analysis","volume":"285","author":"Fogarassy","year":"2019","journal-title":"Int. J. Cardiol."},{"key":"B11","doi-asserted-by":"publisher","first-page":"120","DOI":"10.1038\/s41375-025-02753-w","article-title":"Heart failure in patients with acute myeloid leukemia (AML) treated with anthracycline agents during remission induction therapy: a systematic review and meta-analysis","volume":"40","author":"Geels","year":"2026","journal-title":"Leukemia"},{"key":"B12","doi-asserted-by":"publisher","DOI":"10.3390\/ijms21041279","article-title":"Sexual dimorphism in doxorubicin-induced systemic inflammation: implications for hepatic cytochrome P450 regulation","volume":"21","author":"Grant","year":"2020","journal-title":"Int. J. Mol. Sci."},{"key":"B13","doi-asserted-by":"publisher","first-page":"1140","DOI":"10.1002\/pds.5265","article-title":"More extreme duplication in the U.S. FDA FAERS database and a suggested check point for disproportionality analysis","volume":"30","author":"Hauben","year":"2021","journal-title":"Pharmacoepidemiol Drug Saf."},{"key":"B14","doi-asserted-by":"publisher","first-page":"5","DOI":"10.1007\/s12012-015-9307-1","article-title":"Anthracycline-related cardiotoxicity in patients with acute myeloid leukemia and Down syndrome: a literature review","volume":"16","author":"Hefti","year":"2016","journal-title":"Cardiovasc Toxicol."},{"key":"B15","doi-asserted-by":"publisher","first-page":"259","DOI":"10.1188\/21.CJON.259-266","article-title":"Cardiac toxicity: using angiotensin-converting enzyme inhibitors to prevent anthracycline-induced left ventricular dysfunction and cardiomyopathy","volume":"25","author":"Kobza","year":"2021","journal-title":"Clin. J. Oncol. Nurs."},{"key":"B16","doi-asserted-by":"publisher","first-page":"133","DOI":"10.1186\/s12872-021-01936-4","article-title":"Epirubicin-induced kounis syndrome","volume":"21","author":"Liang","year":"2021","journal-title":"BMC Cardiovasc Disord."},{"key":"B17","doi-asserted-by":"publisher","first-page":"e0330659","DOI":"10.1371\/journal.pone.0330659","article-title":"Analyzing real-world adverse events of spironolactone with the FAERS database","volume":"20","author":"Lin","year":"2025","journal-title":"PLoS One"},{"key":"B18","doi-asserted-by":"publisher","first-page":"533","DOI":"10.2165\/00002018-200023060-00004","article-title":"A retrospective evaluation of a data mining approach to aid finding new adverse drug reaction signals in the WHO international database","volume":"23","author":"Lindquist","year":"2000","journal-title":"Drug Saf."},{"key":"B19","doi-asserted-by":"publisher","first-page":"101205","DOI":"10.1016\/j.mam.2023.101205","article-title":"Doxorubicin and other anthracyclines in cancers: activity, chemoresistance and its overcoming","volume":"93","author":"Mattioli","year":"2023","journal-title":"Mol. Asp. Med."},{"key":"B20","doi-asserted-by":"publisher","first-page":"63","DOI":"10.1007\/s10557-016-6711-0","article-title":"Anthracycline chemotherapy and cardiotoxicity","volume":"31","author":"McGowan","year":"2017","journal-title":"Cardiovasc Drugs Ther."},{"key":"B21","doi-asserted-by":"publisher","first-page":"659","DOI":"10.1080\/10428194.2020.1839650","article-title":"Impact of combinations of single-nucleotide polymorphisms of anthracycline transporter genes upon the efficacy and toxicity of induction chemotherapy in acute myeloid leukemia","volume":"62","author":"Meg\u00edas-Vericat","year":"2021","journal-title":"Leuk. Lymphoma"},{"key":"B22","doi-asserted-by":"publisher","first-page":"e20436","DOI":"10.7717\/peerj.20436","article-title":"Retrospective study on the clinical outcomes and characteristics of acute myeloid leukemia: different outcomes in the same risk group","volume":"13","author":"Meng","year":"2025","journal-title":"PeerJ"},{"key":"B23","doi-asserted-by":"publisher","first-page":"2347","DOI":"10.1007\/s00520-020-05766-6","article-title":"Acute toxicity and tolerability of anthracycline-based chemotherapy regimens in older versus younger patients with breast cancer: real-world data","volume":"29","author":"Monteiro","year":"2021","journal-title":"Support Care Cancer"},{"key":"B24","doi-asserted-by":"publisher","first-page":"1311","DOI":"10.1042\/CS20200301","article-title":"Molecular mechanisms of anthracycline cardiovascular toxicity","volume":"135","author":"Narezkina","year":"2021","journal-title":"Clin. Sci. (Lond)"},{"key":"B25","doi-asserted-by":"publisher","first-page":"762","DOI":"10.1182\/bloodadvances.2019000955","article-title":"Anthracycline-related cardiotoxicity in older patients with acute myeloid leukemia: a young SIOG review paper","volume":"4","author":"Neuendorff","year":"2020","journal-title":"Blood Adv."},{"key":"B26","doi-asserted-by":"publisher","first-page":"283","DOI":"10.1097\/HCO.0000000000000619","article-title":"Risk factors for chemotherapy-related cardiac toxicity","volume":"34","author":"Polonsky","year":"2019","journal-title":"Curr. Opin. Cardiol."},{"key":"B27","doi-asserted-by":"publisher","first-page":"109","DOI":"10.1186\/s13643-019-1011-y","article-title":"Evaluation of the impact of single-nucleotide polymorphisms on treatment response, survival and toxicity with cytarabine and anthracyclines in patients with acute myeloid leukaemia: a systematic review protocol","volume":"8","author":"Puty","year":"2019","journal-title":"Syst. Rev."},{"key":"B28","doi-asserted-by":"publisher","first-page":"120","DOI":"10.1186\/s12943-024-02034-7","article-title":"Diversifying the anthracycline class of anti-cancer drugs identifies aclarubicin for superior survival of acute myeloid leukemia patients","volume":"23","author":"Qiao","year":"2024","journal-title":"Mol. Cancer"},{"key":"B29","doi-asserted-by":"publisher","first-page":"796","DOI":"10.7150\/ijms.6048","article-title":"Data mining of the public version of the FDA adverse event reporting system","volume":"10","author":"Sakaeda","year":"2013","journal-title":"Int. J. Med. Sci."},{"key":"B30","doi-asserted-by":"publisher","first-page":"289","DOI":"10.1007\/s00280-020-04203-z","article-title":"Pegylated liposomal doxorubicin-induced renal toxicity in retroperitoneal liposarcoma: a case report and literature review","volume":"87","author":"Savani","year":"2021","journal-title":"Cancer Chemother. Pharmacol."},{"key":"B31","doi-asserted-by":"publisher","first-page":"306","DOI":"10.3324\/haematol.2022.280803","article-title":"Acute myeloid leukemia: introduction to a series highlighting progress and ongoing challenges","volume":"108","author":"Schlenk","year":"2023","journal-title":"Haematologica"},{"key":"B32","doi-asserted-by":"publisher","first-page":"292","DOI":"10.1007\/s12012-022-09721-1","article-title":"Doxorubicin-induced cardiotoxicity: an overview on pre-clinical therapeutic approaches","volume":"22","author":"Sheibani","year":"2022","journal-title":"Cardiovasc Toxicol."},{"key":"B33","doi-asserted-by":"publisher","first-page":"61","DOI":"10.1186\/s12964-023-01077-5","article-title":"Role of oxidative stress and inflammation-related signaling pathways in doxorubicin-induced cardiomyopathy","volume":"21","author":"Shi","year":"2023","journal-title":"Cell Commun. Signal"},{"key":"B34","doi-asserted-by":"publisher","first-page":"110140","DOI":"10.1016\/j.abb.2024.110140","article-title":"Mechanisms of doxorubicin-induced cardiac inflammation and fibrosis; therapeutic targets and approaches","volume":"761","author":"Song","year":"2024","journal-title":"Arch. Biochem. Biophys."},{"key":"B35","doi-asserted-by":"publisher","first-page":"749","DOI":"10.1111\/imj.70010","article-title":"Ratifying the efficacy and safety of intensive induction chemotherapy for acute myeloid leukaemia by the australasian leukaemia and lymphoma group consensus approach","volume":"55","author":"Tedjaseputra","year":"2025","journal-title":"Intern Med. J."},{"key":"B36","doi-asserted-by":"publisher","first-page":"922","DOI":"10.1111\/echo.13871","article-title":"Natural history of myocardial deformation in children, adolescents, and young adults exposed to anthracyclines: systematic review and meta-analysis","volume":"35","author":"Tuzovic","year":"2018","journal-title":"Echocardiography"},{"key":"B37","doi-asserted-by":"publisher","first-page":"1417","DOI":"10.1001\/jamaoncol.2024.2662","article-title":"Contemporary management of acute myeloid leukemia: a review","volume":"10","author":"Venugopal","year":"2024","journal-title":"JAMA Oncol."},{"key":"B38","doi-asserted-by":"publisher","first-page":"182","DOI":"10.1053\/j.seminoncol.2004.08.007","article-title":"Liposomal anthracycline administration and toxicity management: a nursing perspective","volume":"31","author":"Wood","year":"2004","journal-title":"Semin. Oncol."},{"key":"B39","doi-asserted-by":"publisher","first-page":"263","DOI":"10.4161\/cbt.78","article-title":"Variable sensitivity of endothelial cells to epirubicin in xenografts of human nasopharyngeal carcinoma CNE-2 cells","volume":"1","author":"Zhang","year":"2002","journal-title":"Cancer Biol. Ther."},{"key":"B40","doi-asserted-by":"publisher","first-page":"182","DOI":"10.1177\/03008916211032724","article-title":"Efficacy and safety of induction chemotherapy with daunorubicin or idarubicin in the treatment of an adult with acute lymphoblastic leukemia","volume":"108","author":"Zhang","year":"2022","journal-title":"Tumori"}],"container-title":["Frontiers in Pharmacology"],"original-title":[],"link":[{"URL":"https:\/\/www.frontiersin.org\/articles\/10.3389\/fphar.2026.1759201\/full","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,6,10]],"date-time":"2026-06-10T05:20:08Z","timestamp":1781068808000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.frontiersin.org\/articles\/10.3389\/fphar.2026.1759201\/full"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,6,10]]},"references-count":40,"alternative-id":["10.3389\/fphar.2026.1759201"],"URL":"https:\/\/doi.org\/10.3389\/fphar.2026.1759201","relation":{},"ISSN":["1663-9812"],"issn-type":[{"value":"1663-9812","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,6,10]]},"article-number":"1759201"}}