{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,27]],"date-time":"2025-10-27T17:38:03Z","timestamp":1761586683640,"version":"build-2065373602"},"reference-count":44,"publisher":"Public Library of Science (PLoS)","issue":"10","license":[{"start":{"date-parts":[[2025,10,27]],"date-time":"2025-10-27T00:00:00Z","timestamp":1761523200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["www.plosone.org"],"crossmark-restriction":false},"short-container-title":["PLoS One"],"abstract":"<jats:sec id=\"sec001\">\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>This study utilized the FDA Adverse Event Reporting System (FAERS) to assess signals of adverse events (AEs) associated with cinacalcet, aiming to enhance its safe and rational clinical application.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"sec002\">\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Adverse event reports related to cinacalcet were extracted from the FAERS database from the first quarter of 2004 to the first quarter of 2025. The AE reports were categorized by Preferred Terms (PTs) and System Organ Classes (SOCs), and risk signals were analyzed using disproportionality analysis.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"sec003\">\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Among 30,540 AE reports where cinacalcet was the primary suspect drug, females exhibited a higher reporting frequency than males (47.30% vs. 39.80%). The highest proportion of reports was observed in the 60\u201374 age group (23.85%). Most AEs predominantly occurred within &lt;7 days (11.14%) or \u226560 days (26.35%) of drug administration. A total of 78 significant PT signals were detected, including known AEs such as nausea, vomiting, loss of appetite, abdominal discomfort, hypocalcemia and epigastric pain, aligning with the drug\u2019s prescribing information. Additionally, several AEs previously undocumented in the drug\u2019s specifications were observed, including precocious puberty, parathyroid hemorrhage, hypoproteinemia, pancreatic atrophy, monocytopenia, cardiac death and arrhythmia.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"sec004\">\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>Patient evaluation should be conducted prior to the clinical use of cinacalcet, particularly for individuals with heart failure, hepatic or renal insufficiency, and hypocalcemia. Close monitoring of electrolytes and vigilance for gastrointestinal, cardiovascular, and endocrine-related AEs are recommended. Prompt interventions should be implemented in cases of adverse reactions or disease progression to prevent serious complications or deterioration.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1371\/journal.pone.0331510","type":"journal-article","created":{"date-parts":[[2025,10,27]],"date-time":"2025-10-27T17:32:46Z","timestamp":1761586366000},"page":"e0331510","update-policy":"https:\/\/doi.org\/10.1371\/journal.pone.corrections_policy","source":"Crossref","is-referenced-by-count":0,"title":["Safety evaluation of cinacalcet: Signal mining and analysis of adverse events based on the FAERS database"],"prefix":"10.1371","volume":"20","author":[{"given":"Junxia","family":"Cao","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0008-3139-7422","authenticated-orcid":true,"given":"Na","family":"Yang","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Cheng","family":"Huang","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"340","published-online":{"date-parts":[[2025,10,27]]},"reference":[{"key":"pone.0331510.ref001","doi-asserted-by":"crossref","first-page":"41","DOI":"10.1016\/bs.acc.2020.06.005","article-title":"Parathyroid hormone","volume":"101","author":"EKY Leung","year":"2021","journal-title":"Adv Clin Chem"},{"issue":"1","key":"pone.0331510.ref002","doi-asserted-by":"crossref","first-page":"87","DOI":"10.1186\/s12880-021-00616-1","article-title":"Efficacy of ultrasonography and Tc-99m MIBI SPECT\/CT in preoperative localization of parathyroid adenomas causing primary hyperthyroidism","volume":"21","author":"R Lu","year":"2021","journal-title":"BMC Med Imag"},{"issue":"35","key":"pone.0331510.ref003","doi-asserted-by":"crossref","DOI":"10.1097\/MD.0000000000034622","article-title":"The evolution of primary hyperparathyroidism publications and global productivity from past to present: A bibliometric analysis during 1980 to 2022","volume":"102","author":"H G\u00f6b\u00fct","year":"2023","journal-title":"Medicine (Baltimore)"},{"issue":"5","key":"pone.0331510.ref004","doi-asserted-by":"crossref","first-page":"527","DOI":"10.1530\/EJE-14-0877","article-title":"Cinacalcet normalizes serum calcium in a double-blind randomized, placebo-controlled study in patients with primary hyperparathyroidism with contraindications to surgery","volume":"172","author":"A Khan","year":"2015","journal-title":"Eur J Endocrinol"},{"issue":"9","key":"pone.0331510.ref005","doi-asserted-by":"crossref","first-page":"1679","DOI":"10.1007\/s00467-020-04516-4","article-title":"Cinacalcet studies in pediatric subjects with secondary hyperparathyroidism receiving dialysis","volume":"35","author":"BA Warady","year":"2020","journal-title":"Pediatr Nephrol"},{"issue":"5","key":"pone.0331510.ref006","doi-asserted-by":"crossref","first-page":"479","DOI":"10.15537\/smj.2020.5.25072","article-title":"Cinacalcet use in pediatric chronic kidney disease. 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