{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,22]],"date-time":"2026-06-22T09:46:54Z","timestamp":1782121614830,"version":"3.54.5"},"reference-count":27,"publisher":"Wiley","license":[{"start":{"date-parts":[[2026,6,22]],"date-time":"2026-06-22T00:00:00Z","timestamp":1782086400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2026,6,22]],"date-time":"2026-06-22T00:00:00Z","timestamp":1782086400000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Asia-Pac J Clncl Oncology"],"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>This study aimed to compare the real\u2010world safety profiles of approved fibroblast growth factor receptor (FGFR) inhibitors and to identify drug\u2010specific adverse event patterns using data from the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>A retrospective pharmacovigilance analysis was conducted using FAERS reports submitted between January 1, 2014, and October 31, 2025. Adverse event reports involving erdafitinib, pemigatinib, futibatinib, and infigratinib were included when an FGFR inhibitor was listed as the primary suspect drug. Adverse events were coded according to the Medical Dictionary for Regulatory Activities (MedDRA) version 28.0 and categorized by System Organ Class. Disproportionality analyses were performed using reporting odds ratios (RORs) with 95% confidence intervals (CIs).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>A total of 2081 FGFR inhibitor\u2010related adverse event reports were identified. Erdafitinib accounted for the largest proportion of reports (53.8%), followed by pemigatinib (34.8%), futibatinib (8.2%), and infigratinib (3.2%). Overall, 69.8% of reported events were classified as serious. Infigratinib showed a markedly increased reporting likelihood for blurred vision (ROR 8.92; 95% CI: 3.73\u201321.36) and oral mucosal toxicity (ROR 3.38; 95% CI: 1.80\u20136.34). Hyperphosphatemia was most strongly associated with futibatinib (ROR 3.11; 95% CI: 1.93\u20135.01), whereas erdafitinib demonstrated a reduced reporting likelihood for this event (ROR 0.43; 95% CI: 0.29\u20130.63). Ocular adverse events, including dry eye, exhibited variable reporting patterns across agents.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>FGFR inhibitors demonstrated differences in adverse event reporting patterns rather than a uniform class effect, although pharmacovigilance data do not allow estimation of true incidence, risk, or causal relationships.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/ajco.70133","type":"journal-article","created":{"date-parts":[[2026,6,22]],"date-time":"2026-06-22T08:46:42Z","timestamp":1782118002000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Comparative Real\u2010World Safety Profiles of Fibroblast Growth Factor Receptor Inhibitors: A Pharmacovigilance Study"],"prefix":"10.1111","author":[{"given":"Seda Jeral","family":"Evin\u00e7","sequence":"first","affiliation":[{"name":"Faculty of Medicine Istanbul University\u2010Cerrahpa\u015fa, Department of Medical Oncology  Istanbul Turkey"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"\u00c7a\u011fla Ey\u00fcpler","family":"Akmercan","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology G\u00f6ztepe Prof. Dr. S\u00fcleyman Yal\u00e7\u0131n City Hospital  Istanbul Turkey"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zeliha","family":"Birsin","sequence":"additional","affiliation":[{"name":"Faculty of Medicine Istanbul University\u2010Cerrahpa\u015fa, Department of Medical Oncology  Istanbul Turkey"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Selin","family":"Cebeci","sequence":"additional","affiliation":[{"name":"Faculty of Medicine Istanbul University\u2010Cerrahpa\u015fa, Department of Medical Oncology  Istanbul Turkey"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emir","family":"\u00c7erme","sequence":"additional","affiliation":[{"name":"Faculty of Medicine Istanbul University\u2010Cerrahpa\u015fa, Department of Medical Oncology  Istanbul Turkey"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vali","family":"Aliyev","sequence":"additional","affiliation":[{"name":"Faculty of Medicine Istanbul University\u2010Cerrahpa\u015fa, Department of Medical Oncology  Istanbul Turkey"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hamza","family":"Abbasov","sequence":"additional","affiliation":[{"name":"Faculty of Medicine Istanbul University\u2010Cerrahpa\u015fa, Department of Medical Oncology  Istanbul Turkey"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ebru","family":"\u00c7i\u00e7ek","sequence":"additional","affiliation":[{"name":"Faculty of Medicine Istanbul University\u2010Cerrahpa\u015fa, Department of Medical Oncology  Istanbul Turkey"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"S\u00fcheyla","family":"Atak","sequence":"additional","affiliation":[{"name":"Faculty of Medicine Istanbul University\u2010Cerrahpa\u015fa, Department of Medical Oncology  Istanbul Turkey"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nebi Serkan","family":"Demirci","sequence":"additional","affiliation":[{"name":"Faculty of Medicine Istanbul University\u2010Cerrahpa\u015fa, Department of Medical Oncology  Istanbul Turkey"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"\u00c7i\u011fdem","family":"Papila","sequence":"additional","affiliation":[{"name":"Faculty of Medicine Istanbul University\u2010Cerrahpa\u015fa, Department of Medical Oncology  Istanbul Turkey"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"\u00d6zkan","family":"Alan","sequence":"additional","affiliation":[{"name":"Faculty of Medicine Istanbul University\u2010Cerrahpa\u015fa, Department of Medical Oncology  Istanbul Turkey"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,6,22]]},"reference":[{"issue":"2","key":"e_1_2_12_2_1","doi-asserted-by":"crossref","first-page":"116","DOI":"10.1038\/nrc2780","article-title":"Fibroblast Growth Factor Signalling: From Development to Cancer","volume":"10","author":"Turner N.","year":"2010","journal-title":"Nature Reviews Cancer"},{"issue":"5","key":"e_1_2_12_3_1","doi-asserted-by":"crossref","first-page":"318","DOI":"10.1038\/nrc.2017.8","article-title":"Advances and Challenges in Targeting FGFR Signalling in Cancer","volume":"17","author":"Babina I. S.","year":"2017","journal-title":"Nature Reviews Cancer"},{"issue":"1","key":"e_1_2_12_4_1","doi-asserted-by":"crossref","first-page":"259","DOI":"10.1158\/1078-0432.CCR-14-3212","article-title":"The FGFR Landscape in Cancer: Analysis of 4,853 Tumors by Next\u2010Generation Sequencing","volume":"22","author":"Helsten T.","year":"2016","journal-title":"Clinical Cancer Research"},{"issue":"3","key":"e_1_2_12_5_1","doi-asserted-by":"crossref","first-page":"276","DOI":"10.1200\/JCO.2017.75.5009","article-title":"Phase II Study of BGJ398 in Patients with FGFR\u2010Altered Advanced Cholangiocarcinoma","volume":"36","author":"Javle M.","year":"2018","journal-title":"Journal of Clinical Oncology"},{"issue":"4","key":"e_1_2_12_6_1","doi-asserted-by":"crossref","first-page":"338","DOI":"10.1056\/NEJMoa1817323","article-title":"Erdafitinib in Locally Advanced or Metastatic Urothelial Carcinoma","volume":"381","author":"Loriot Y.","year":"2019","journal-title":"New England Journal of Medicine"},{"issue":"1","key":"e_1_2_12_7_1","doi-asserted-by":"crossref","DOI":"10.1038\/s41598-025-11411-1","article-title":"Data Mining and Safety Analysis of FGFR Tyrosine Kinase Inhibitors Based on the FAERS Database","volume":"15","author":"Li P.","year":"2025","journal-title":"Scientific Reports"},{"issue":"4","key":"e_1_2_12_8_1","doi-asserted-by":"crossref","first-page":"764","DOI":"10.1158\/1078-0432.CCR-19-2035","article-title":"Facts and New Hopes on Selective FGFR Inhibitors in Solid Tumors","volume":"26","author":"Facchinetti F.","year":"2020","journal-title":"Clinical Cancer Research"},{"issue":"1","key":"e_1_2_12_9_1","doi-asserted-by":"crossref","first-page":"34","DOI":"10.1016\/j.survophthal.2023.09.007","article-title":"Ocular Toxicities of Fibroblast Growth Factor Receptor Inhibitors: A Review","volume":"69","author":"Hsu J.","year":"2024","journal-title":"Survey of Ophthalmology"},{"issue":"10","key":"e_1_2_12_10_1","doi-asserted-by":"crossref","DOI":"10.1016\/j.xcrm.2023.101204","article-title":"Clinical Development and Management of Adverse Events Associated With FGFR Inhibitors","volume":"4","author":"Subbiah V.","year":"2023","journal-title":"Cell Reports Medicine"},{"key":"e_1_2_12_11_1","doi-asserted-by":"publisher","DOI":"10.1002\/cpt.3701"},{"key":"e_1_2_12_12_1","doi-asserted-by":"publisher","DOI":"10.1111\/bcp.13468"},{"key":"e_1_2_12_13_1","doi-asserted-by":"crossref","first-page":"599","DOI":"10.1080\/14740338.2024.2338250","article-title":"Adverse Events With Pemigatinib in the Real World: A Pharmacovigilance Study Based on the FDA Adverse Event Reporting System","volume":"23","author":"Zhao D.","year":"2024","journal-title":"Expert Opinion on Drug Safety"},{"key":"e_1_2_12_14_1","doi-asserted-by":"crossref","DOI":"10.3389\/fphar.2023.1266890","article-title":"Adverse Events in Patients With Advanced Urothelial Carcinoma Treated With erdafitinib: A Retrospective Pharmacovigilance Study","volume":"14","author":"Yuan T.","year":"2023","journal-title":"Frontiers in Pharmacology"},{"key":"e_1_2_12_15_1","doi-asserted-by":"crossref","DOI":"10.3389\/fphar.2023.1194545","article-title":"Safety Analysis of Pemigatinib Leveraging the US Food and Drug Administration Adverse Event Reporting System","volume":"14","author":"Zhang Y.","year":"2023","journal-title":"Frontiers in Pharmacology"},{"key":"e_1_2_12_16_1","unstructured":"U.S. Food and Drug Administration. FDA Adverse Event Reporting System (FAERS) Public Dashboard Silver Spring (MD): U.S. Food and Drug Administration; 2025."},{"key":"e_1_2_12_17_1","unstructured":"U.S. Food and Drug Administration. FDA Withdraws Approval of infigratinib (Truseltiq\u00ae) for Previously Treated Unresectable Locally Advanced or Metastatic Cholangiocarcinoma With Fibroblast Growth Factor Receptor 2 (FGFR2) Fusions or Rearrangements U.S. Food and Drug Administration; 2024 [updated 16 May 2024.https:\/\/www.fda.gov\/drugs\/resources\u2010information\u2010approved\u2010drugs\/withdrawn\u2010fda\u2010grants\u2010accelerated\u2010approval\u2010infigratinib\u2010metastatic\u2010cholangiocarcinoma."},{"key":"e_1_2_12_18_1","unstructured":"International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. Medical Dictionary for Regulatory Activities (MedDRA) version 28.0: International Council for Harmonisation; 2025.https:\/\/alt.meddra.org\/files_acrobat\/intguide_28_0_English.pdf."},{"issue":"16","key":"e_1_2_12_19_1","doi-asserted-by":"crossref","first-page":"4888","DOI":"10.1158\/1078-0432.CCR-18-3334","article-title":"Multicenter Phase I Study of Erdafitinib (JNJ\u201042756493), Oral Pan\u2010Fibroblast Growth Factor Receptor Inhibitor, in Patients With Advanced or Refractory Solid Tumors","volume":"25","author":"Bahleda R.","year":"2019","journal-title":"Clinical Cancer Research"},{"issue":"5","key":"e_1_2_12_20_1","doi-asserted-by":"crossref","first-page":"671","DOI":"10.1016\/S1470-2045(20)30109-1","article-title":"Pemigatinib for Previously Treated, Locally Advanced or Metastatic Cholangiocarcinoma: A Multicentre, Open\u2010Label, Phase 2 Study","volume":"21","author":"Abou\u2010Alfa G. K.","year":"2020","journal-title":"The Lancet Oncology"},{"issue":"10","key":"e_1_2_12_21_1","doi-asserted-by":"crossref","first-page":"803","DOI":"10.1016\/S2468-1253(21)00196-5","article-title":"Infigratinib (BGJ398) in Previously Treated Patients With Advanced or Metastatic Cholangiocarcinoma With FGFR2 Fusions or Rearrangements: Mature Results From a Multicentre, Open\u2010Label, Single\u2010Arm, Phase 2 Study","volume":"6","author":"Javle M.","year":"2021","journal-title":"Lancet Gastroenterol Hepatol"},{"issue":"3","key":"e_1_2_12_22_1","doi-asserted-by":"crossref","first-page":"228","DOI":"10.1056\/NEJMoa2206834","article-title":"Futibatinib for FGFR2\u2010Rearranged Intrahepatic Cholangiocarcinoma","volume":"388","author":"Goyal L.","year":"2023","journal-title":"New England Journal of Medicine"},{"issue":"12","key":"e_1_2_12_23_1","doi-asserted-by":"crossref","DOI":"10.3390\/cancers13122968","article-title":"FGFR Inhibitors in Oncology: Insight on the Management of Toxicities in Clinical Practice","volume":"13","author":"Kommalapati A.","year":"2021","journal-title":"Cancers (Basel)"},{"issue":"1","key":"e_1_2_12_24_1","doi-asserted-by":"crossref","first-page":"5","DOI":"10.1038\/s42004-021-00623-x","article-title":"Structural Insights Into the Potency and Selectivity of Covalent Pan\u2010FGFR Inhibitors","volume":"5","author":"Qu L.","year":"2022","journal-title":"Communications Chemistry"},{"issue":"3","key":"e_1_2_12_25_1","doi-asserted-by":"crossref","first-page":"581","DOI":"10.1111\/bjd.19677","article-title":"The Value of Case Reports and Spontaneous Reporting Systems for Pharmacovigilance and Clinical Practice","volume":"184","author":"Raschi E.","year":"2021","journal-title":"British Journal of Dermatology"},{"issue":"10","key":"e_1_2_12_26_1","doi-asserted-by":"crossref","first-page":"921","DOI":"10.1007\/s40264-023-01345-w","article-title":"Challenges and Opportunities in Accessing and Analysing FAERS Data: A Call Towards a Collaborative Approach","volume":"46","author":"Giunchi V.","year":"2023","journal-title":"Drug Safety"},{"issue":"10","key":"e_1_2_12_27_1","doi-asserted-by":"crossref","first-page":"891","DOI":"10.2165\/00002018-200730100-00007","article-title":"Impact of Safety Alerts on Measures of Disproportionality in Spontaneous Reporting Databases: The Notoriety Bias","volume":"30","author":"Pariente A.","year":"2007","journal-title":"Drug Safety"},{"issue":"3","key":"e_1_2_12_28_1","doi-asserted-by":"crossref","first-page":"176","DOI":"10.14744\/ejmi.2025.30686","article-title":"Immune Checkpoint Inhibitor Associated Kidney Transplant Rejection: A Real World Pharmacovigilance Analysis Using the FAERS Database","volume":"9","author":"Alan A. M.","year":"2025","journal-title":"Eurasian Journal of Medical Investigation"}],"container-title":["Asia-Pacific Journal of Clinical Oncology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/ajco.70133","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/ajco.70133","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/ajco.70133","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,6,22]],"date-time":"2026-06-22T08:46:52Z","timestamp":1782118012000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/ajco.70133"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,6,22]]},"references-count":27,"alternative-id":["10.1111\/ajco.70133"],"URL":"https:\/\/doi.org\/10.1111\/ajco.70133","archive":["Portico"],"relation":{},"ISSN":["1743-7555","1743-7563"],"issn-type":[{"value":"1743-7555","type":"print"},{"value":"1743-7563","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,6,22]]},"assertion":[{"value":"2026-01-22","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-06-08","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-06-22","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"ajco.70133"}}