{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,25]],"date-time":"2026-09-25T04:40:24Z","timestamp":1790311224890,"version":"4.1.0"},"reference-count":48,"publisher":"SAGE Publications","license":[{"start":{"date-parts":[[2026,6,11]],"date-time":"2026-06-11T00:00:00Z","timestamp":1781136000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"funder":[{"DOI":"10.13039\/100008460","name":"National Center for Complementary and Integrative Health","doi-asserted-by":"crossref","award":["U54AT008909-06"],"award-info":[{"award-number":["U54AT008909-06"]}],"id":[{"id":"10.13039\/100008460","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Journal of Integrative and Complementary Medicine"],"abstract":"<jats:sec>\n                    <jats:title>Background:<\/jats:title>\n                    <jats:p>Dietary and herbal supplements are widely utilized around the world. These products can cause adverse effects, including nephrotoxicity, through pharmacologically active ingredients, contaminants, or drug\u2013herb interactions, even though they may be perceived as safe. While nephrotoxicity is well documented for certain pharmaceuticals, there are limited studies regarding safety concerns of nephrotoxicity associated with natural products.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objective:<\/jats:title>\n                    <jats:p>To identify signals for possible nephrotoxicity involving natural products using the Food and Drug Administration Adverse Event Reporting System (FAERS) database.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>A retrospective analysis of FAERS data (2004\u20132021) was conducted using the medical dictionary for regulatory activities (MedDRA) terminology to identify possible signals of nephrotoxicity with natural products. Disproportionality analysis was completed by calculating the reporting odds ratio (ROR) for signal detection. Significant signals (ROR \u2265 2.0 with 95% CI lower bound \u2265 1.0) with a case count greater than one were then supplemented by a literature review for clinical and preclinical evidence.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>\n                      The analysis identified 231 nephrotoxic event\u2013natural product pairs, representing disproportionate reporting signals for 63 natural products. Three significant signals were detected from a total of 15 cases, including ginger (\n                      <jats:italic toggle=\"yes\">n<\/jats:italic>\n                      = 11) with an ROR (95% CI) of 6.21 (3.85\u201310), butcher\u2019s broom (\n                      <jats:italic toggle=\"yes\">n<\/jats:italic>\n                      = 2) with an ROR (95% CI) of 7.99 (2.56\u201324.94), and valerian (\n                      <jats:italic toggle=\"yes\">n<\/jats:italic>\n                      = 2) with an ROR (95% CI) of 2.03 (1.09\u20133.78).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion:<\/jats:title>\n                    <jats:p>While definitive associations between natural products and nephrotoxicity could not be established using a disproportionality analysis, the presence of significant signals for ginger, butcher\u2019s broom, and valerian with respect to kidney-related adverse events highlights the need for further investigations and monitoring by clinicians.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/27683605261456017","type":"journal-article","created":{"date-parts":[[2026,6,11]],"date-time":"2026-06-11T11:13:57Z","timestamp":1781176437000},"update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":1,"title":["A Retrospective Pharmacovigilance Disproportionality Analysis of Possible Nephrotoxicity and Natural Products Using Data from the FDA Adverse Event Reporting System"],"prefix":"10.1177","author":[{"given":"Caiden J.","family":"Lukan","sequence":"first","affiliation":[{"name":"Department of Pharmacy and Therapeutics, School of Pharmacy, University of Pittsburgh, Pittsburgh, Pennsylvania, USA."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Iman","family":"Karimzadeh","sequence":"additional","affiliation":[{"name":"Department of Pharmacy and Therapeutics, School of Pharmacy, University of Pittsburgh, Pittsburgh, Pennsylvania, USA."},{"name":"Department of Clinical Pharmacy, School of Pharmacy, Shiraz University of Medical Sciences, Shiraz, Iran."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tiffany L.","family":"Tran","sequence":"additional","affiliation":[{"name":"Department of Pharmacy and Therapeutics, School of Pharmacy, University of Pittsburgh, Pittsburgh, Pennsylvania, USA."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maryann R.","family":"Sestito","sequence":"additional","affiliation":[{"name":"Department of Pharmacy and Therapeutics, School of Pharmacy, University of Pittsburgh, Pittsburgh, Pennsylvania, USA."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kojo","family":"Abanyie","sequence":"additional","affiliation":[{"name":"Department of Biomedical Informatics, School of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USA."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Richard D.","family":"Boyce","sequence":"additional","affiliation":[{"name":"Department of Biomedical Informatics, School of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USA."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7523-4846","authenticated-orcid":false,"given":"Sandra L.","family":"Kane-Gill","sequence":"additional","affiliation":[{"name":"Department of Pharmacy and Therapeutics, School of Pharmacy, University of Pittsburgh, Pittsburgh, Pennsylvania, USA."},{"name":"Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA."},{"name":"Program for Critical Care Nephrology, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA."}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2026,6,11]]},"reference":[{"key":"e_1_3_2_2_1","unstructured":"1.United States Food and Drug Administration. FDA 101: Dietary supplements. 2022. Available from: https:\/\/www.fda.gov\/consumers\/consumer-updates\/fda-101-dietary-supplements"},{"key":"e_1_3_2_3_1","doi-asserted-by":"publisher","DOI":"10.1159\/000517693"},{"key":"e_1_3_2_4_1","unstructured":"3.Mishra S Stierman B Gahche JJ Potischman N. Statistics CfDCNCfH. Dietary supplement use among adults: United States 2017\u20132018. 2021. 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Herbal supplements and chronic kidney disease. National Kidney Foundation; 2024."},{"key":"e_1_3_2_15_1","doi-asserted-by":"publisher","DOI":"10.2215\/cjn.02140215"},{"key":"e_1_3_2_16_1","unstructured":"15.United States Food and Drug Administration. FDA Adverse Events Reporting System. 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Guidelines on safety monitoring of herbal medicines in pharmacovigilance systems. World Health Organization; 2004. Available from: https:\/\/www.who.int\/publications\/i\/item\/9241592214"},{"key":"e_1_3_2_29_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1440-1797.2010.01305.x"},{"key":"e_1_3_2_30_1","doi-asserted-by":"publisher","DOI":"10.3390\/ijms22084132"},{"key":"e_1_3_2_31_1","doi-asserted-by":"publisher","DOI":"10.1007\/978-3-319-43806-1"},{"key":"e_1_3_2_32_1","doi-asserted-by":"publisher","DOI":"10.1186\/s40816-021-00248-6"},{"issue":"8","key":"e_1_3_2_33_1","first-page":"1755","article-title":"Valerian","volume":"67","author":"Hadley S","year":"2003","unstructured":"32.Hadley S, , Petry JJ. Valerian. Am Fam Physician 2003;67(8):1755\u20131758.","journal-title":"Am Fam Physician"},{"key":"e_1_3_2_34_1","volume-title":"LiverTox: Clinical and Research Information on Drug-Induced Liver Injury","author":"Valerian","year":"2012","unstructured":"33.Valerian. 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