{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,4]],"date-time":"2026-09-04T08:12:56Z","timestamp":1788509576315,"version":"build-2803163510"},"reference-count":28,"publisher":"SAGE Publications","issue":"5","license":[{"start":{"date-parts":[[2026,4,30]],"date-time":"2026-04-30T00:00:00Z","timestamp":1777507200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Journal of Pharmacy Technology"],"published-print":{"date-parts":[[2026,10]]},"abstract":"<jats:sec>\n                    <jats:title>Background:<\/jats:title>\n                    <jats:p>Posterior reversible encephalopathy syndrome (PRES) is a rare but potentially life-threatening neurological condition characterized by seizures, headache, visual disturbances, and altered mental status, typically associated with vasogenic edema on neuroimaging. Although several anticancer therapies have been implicated in PRES, evidence regarding its association with lenvatinib remains limited.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Purpose:<\/jats:title>\n                    <jats:p>The aim of this study was to investigate a potential safety signal between lenvatinib and PRES using a pharmacovigilance approach and evaluate whether reports of PRES are disproportionately associated with lenvatinib in a large spontaneous reporting database.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>A retrospective pharmacovigilance study was conducted using the FDA Adverse Event Reporting System (FAERS) database. Individual Case Safety Reports (ICSRs) mentioning lenvatinib and PRES were identified and extracted. Disproportionality analysis was performed by calculating the reporting odds ratio (ROR), proportional reporting ratio (PRR), and chi-square statistic. According to Evans\u2019 criteria (n &gt; 2, PRR &gt; 2, chi-square &gt; 4), a drug-event combination is considered suggestive of a potential safety signal.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>The disproportionality analysis revealed a statistically significant signal for PRES associated with lenvatinib. The PRR was 5.79 (95% CI: 4.80-6.98), and the ROR was 5.81 (95% CI: 4.81-7.00), both exceeding commonly accepted signal detection thresholds. These findings suggest that reports of PRES occur more frequently with lenvatinib than with other drugs in the database.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion:<\/jats:title>\n                    <jats:p>This pharmacovigilance analysis identified a significant disproportionality signal suggesting a potential association between lenvatinib and PRES. Although spontaneous reporting systems cannot establish causality, these findings highlight the importance of clinical awareness and further investigation to better characterize this rare but serious adverse event.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/87551225261446468","type":"journal-article","created":{"date-parts":[[2026,4,30]],"date-time":"2026-04-30T17:44:41Z","timestamp":1777571081000},"page":"229-234","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":0,"title":["Posterior Reversible Encephalopathy Syndrome (PRES) Associated With Lenvatinib: A Disproportionality Analysis"],"prefix":"10.1177","volume":"42","author":[{"ORCID":"https:\/\/orcid.org\/0009-0006-9092-6588","authenticated-orcid":false,"given":"Eleonora","family":"Castellana","sequence":"first","affiliation":[{"name":"Hospital Pharmacy, Azienda Ospedaliero Universitaria Citt\u00e0 della Salute e della Scienza di Torino, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria Rachele","family":"Chiappetta","sequence":"additional","affiliation":[{"name":"Hospital Pharmacy, Azienda Ospedaliero Universitaria Citt\u00e0 della Salute e della Scienza di Torino, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2026,4,30]]},"reference":[{"key":"e_1_3_3_2_2","doi-asserted-by":"publisher","DOI":"10.2169\/internalmedicine.7520-21"},{"key":"e_1_3_3_3_2","doi-asserted-by":"crossref","unstructured":"Proc Singapore Healthcare Lam JYC Ng MCH. 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Chemotherapy-associated hemorrhagic posterior reversible encephalopathy syndrome (PRES) with considerations for circle of Willis variants on cerebral blood flow and autoregulation: a case report. Medicine. 2024;23:e37250.","journal-title":"Medicine"},{"key":"e_1_3_3_10_2","doi-asserted-by":"publisher","DOI":"10.1002\/psp4.13130"},{"key":"e_1_3_3_11_2","volume-title":"Abstract 1374: Lenvatinib, Tri-Specific Targeted Therapy to VEGFR\/FGFR\/RET, Suppresses Angiogenesis Through the Inhibition of Both VEGFR and FGFR Signaling Pathways","author":"Ichikawa K","year":"2015","unstructured":"Ichikawa K, Miyano SW, Adachi Y, et al. Abstract 1374: Lenvatinib, Tri-Specific Targeted Therapy to VEGFR\/FGFR\/RET, Suppresses Angiogenesis Through the Inhibition of Both VEGFR and FGFR Signaling Pathways. 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Front Pharmacol. 2024;15:1399172.","journal-title":"Front Pharmacol"},{"key":"e_1_3_3_18_2","unstructured":"FDA Adverse Event Reporting System (FAERS) Public dashboard 2026. Accessed March 1 2026. https:\/\/www.fda.gov\/drugs\/fdas-adverse-event-reporting-system-faers\/fda-adverse-event-reporting-system-faers-public-dashboard"},{"key":"e_1_3_3_19_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.orcp.2025.01.011"},{"key":"e_1_3_3_20_2","doi-asserted-by":"publisher","DOI":"10.1002\/pds.677"},{"key":"e_1_3_3_21_2","doi-asserted-by":"publisher","DOI":"10.1177\/20420986241312497"},{"key":"e_1_3_3_22_2","doi-asserted-by":"publisher","DOI":"10.2169\/internalmedicine.9593-17"},{"issue":"9","key":"e_1_3_3_23_2","article-title":"Atypical posterior reversible encephalopathy syndrome associated with Lenvatinib therapy in a patient with metastatic thyroid cancer\u2013A case report","volume":"5","author":"Abhishek M","year":"2022","unstructured":"Abhishek M, Renuka A, Ujjwal A, et al. 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