{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,24]],"date-time":"2026-02-24T11:10:25Z","timestamp":1771931425167,"version":"3.50.1"},"reference-count":32,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2026,2,11]],"date-time":"2026-02-11T00:00:00Z","timestamp":1770768000000},"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. Med."],"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Hypercholesterolemia is a significant risk factor for severe cardiovascular diseases. Cholestyramine lowers serum low-density lipoprotein cholesterol (LDL-C) levels and is clinically indicated for the treatment of primary hypercholesterolemia, relieve itching symptoms caused by bile acid accumulation in cholestatic diseases (such as primary biliary cirrhosis), as well as to manage bile acid diarrhea resulting from bile acid metabolic disorders. With its widespread clinical application, it is essential to understand its safety in real-world settings.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>This study evaluated the clinical safety of cholestyramine by analyzing all adverse event reports since 2004 in the FDA Adverse Event Reporting System (FAERS), where cholestyramine was identified as the primary suspected drug. Bayesian Confidence Propagation Neural Network (BCPNN), the Medicines and Healthcare Products Regulatory Agency (MHRA) composite criteria method, Multi-Item Gamma Poisson Shrinker (MGPS), Proportional Reporting Ratio (PRR), and Reporting Odds Ratio (ROR) were used to analyze adverse events associated with cholestyramine.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>The study results confirmed known adverse reactions of cholestyramine, such as constipation, abdominal discomfort, bloating, steatorrhea, bleeding tendencies, night blindness, hyperchloremic acidosis, osteoporosis, rashes, and local irritation caused by deficiencies in vitamins K, A, and D, which are also listed in the drug\u2019s package insert. Additionally, adverse reactions not documented in the package insert were identified, including off-label use, administration for unapproved indications, gastroesophageal reflux disease (GERD), irritable bowel syndrome (IBS), fecal abnormalities (color changes, softening, hardening), blood glucose fluctuations, tooth fracture, and exacerbation of concurrent medical conditions. This study also underscores the importance of early detection of adverse reactions associated with cholestyramine.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>By providing insights into both known and potential adverse reactionsin real-world settings, the findings offer enhanced safety information to assist clinicians in prescribing cholestyramine for conditions such as hypercholesterolemia, cholestasis-associated pruritus, and bile acid diarrhea.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.3389\/fmed.2026.1765949","type":"journal-article","created":{"date-parts":[[2026,2,11]],"date-time":"2026-02-11T05:22:18Z","timestamp":1770787338000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":0,"title":["Evaluating the real-world safety of cholestyramine for the treatment of hyperlipidemia: disproportionality analysis of FAERS data"],"prefix":"10.3389","volume":"13","author":[{"given":"Qiang","family":"Li","sequence":"first","affiliation":[{"name":"Department of Cardiology, Affiliated Hospital of Shandong Second Medical University","place":["Weifang, Shandong, China"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mengmeng","family":"Fan","sequence":"additional","affiliation":[{"name":"Department of Neonatology, Weifang Maternal and Child Health Hospital","place":["Weifang, Shandong, China"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Anbang","family":"Gao","sequence":"additional","affiliation":[{"name":"Department of Emergency, Affiliated Hospital of Shandong Second Medical University","place":["Weifang, Shandong, China"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Limin","family":"Qin","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Affiliated Hospital of Shandong Second Medical University","place":["Weifang, Shandong, China"]}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"1965","published-online":{"date-parts":[[2026,2,11]]},"reference":[{"key":"ref1","doi-asserted-by":"publisher","first-page":"1082","DOI":"10.1001\/jamainternmed.2022.3171","article-title":"Incremental value of polygenic risk scores in primary prevention of coronary heart disease: a review","volume":"182","author":"Groenendyk","year":"2022","journal-title":"JAMA Intern Med"},{"key":"ref2","doi-asserted-by":"publisher","first-page":"181","DOI":"10.1016\/j.tcm.2021.04.002","article-title":"Coronary heart disease risk: low-density lipoprotein and beyond","volume":"32","author":"Shaya","year":"2022","journal-title":"Trends Cardiovasc Med"},{"key":"ref3","doi-asserted-by":"publisher","first-page":"385","DOI":"10.1016\/j.jacc.2023.10.039","article-title":"Lipoprotein(a) is markedly more atherogenic than LDL: an apolipoprotein B-based genetic analysis","volume":"83","author":"Bjornson","year":"2024","journal-title":"J Am Coll Cardiol"},{"key":"ref4","doi-asserted-by":"publisher","first-page":"1330","DOI":"10.1016\/S0140-6736(11)61476-1","article-title":"Homozygous familial hypercholesterolaemia","volume":"379","author":"Macchiaiolo","year":"2012","journal-title":"Lancet"},{"key":"ref5","doi-asserted-by":"publisher","first-page":"E167","DOI":"10.1152\/ajpendo.00416.2016","article-title":"Cholestyramine treatment of healthy humans rapidly induces transient hypertriglyceridemia when treatment is initiated","volume":"313","author":"Sjoberg","year":"2017","journal-title":"Am J Physiol Endocrinol Metab"},{"key":"ref6","doi-asserted-by":"publisher","first-page":"26","DOI":"10.1038\/s41575-022-00687-7","article-title":"Mechanisms of pruritus in cholestasis: understanding and treating the itch","volume":"20","author":"Beuers","year":"2023","journal-title":"Nat Rev Gastroenterol Hepatol"},{"key":"ref7","doi-asserted-by":"publisher","first-page":"205","DOI":"10.1007\/s11739-011-0653-0","article-title":"Use and indications of cholestyramine and bile acid sequestrants","volume":"8","author":"Scaldaferri","year":"2013","journal-title":"Intern Emerg Med"},{"key":"ref8","doi-asserted-by":"publisher","first-page":"47","DOI":"10.1016\/j.cld.2022.08.011","article-title":"Pruritus in chronic liver disease","volume":"27","author":"Selim","year":"2023","journal-title":"Clin Liver Dis"},{"key":"ref9","doi-asserted-by":"publisher","first-page":"823","DOI":"10.1001\/jama.1979.03290340041024","article-title":"Postcholecystectomy diarrhea","volume":"241","author":"Hutcheon","year":"1979","journal-title":"JAMA"},{"key":"ref10","doi-asserted-by":"publisher","first-page":"137","DOI":"10.1093\/toxsci\/kfae053","article-title":"Short-term treatment with cholestyramine increases long-acting anticoagulant rodenticide clearance from rabbits without affecting plasma vitamin K1 levels or blood coagulation","volume":"200","author":"Muchiri","year":"2024","journal-title":"Toxicol Sci"},{"key":"ref11","doi-asserted-by":"publisher","first-page":"1860","DOI":"10.3390\/jcm14061860","article-title":"Assessing the real-world safety of regadenoson for myocardial perfusion imaging: insights from a comprehensive analysis of FAERS data","volume":"14","author":"Xu","year":"2025","journal-title":"J Clin Med"},{"key":"ref12","doi-asserted-by":"publisher","first-page":"1022","DOI":"10.1056\/NEJMoa1803917","article-title":"Safety and efficacy of bempedoic acid to reduce LDL cholesterol","volume":"380","author":"Ray","year":"2019","journal-title":"N Engl J Med"},{"key":"ref13","doi-asserted-by":"publisher","first-page":"381","DOI":"10.1007\/s40256-020-00421-1","article-title":"Rosuvastatin\/ezetimibe: a review in hypercholesterolemia","volume":"20","author":"Lamb","year":"2020","journal-title":"Am J Cardiovasc Drugs"},{"key":"ref14","doi-asserted-by":"publisher","first-page":"120","DOI":"10.1006\/exmp.2000.2339","article-title":"Coronary heart disease, hypercholesterolemia, and atherosclerosis. II. Misrepresented data","volume":"70","author":"Stehbens","year":"2001","journal-title":"Exp Mol Pathol"},{"key":"ref15","doi-asserted-by":"publisher","first-page":"291","DOI":"10.1002\/jps.22770","article-title":"Assessment of cholesterol absorption inhibitors nanostructured aluminosilicate and cholestyramine using in vitro lipolysis model","volume":"101","author":"Gershkovich","year":"2012","journal-title":"J Pharm Sci"},{"key":"ref16","doi-asserted-by":"publisher","first-page":"505","DOI":"10.1007\/s00228-011-1173-6","article-title":"Off-label use of anti-cancer drugs between clinical practice and research: the Italian experience","volume":"68","author":"Lerose","year":"2012","journal-title":"Eur J Clin Pharmacol"},{"key":"ref17","doi-asserted-by":"publisher","first-page":"251","DOI":"10.1111\/jcpt.12507","article-title":"Off-label drug use in oncology: a systematic review of literature","volume":"42","author":"Saiyed","year":"2017","journal-title":"J Clin Pharm Ther"},{"key":"ref18","doi-asserted-by":"publisher","first-page":"55","DOI":"10.1038\/s41572-021-00287-w","article-title":"Gastro-oesophageal reflux disease","volume":"7","author":"Fass","year":"2021","journal-title":"Nat Rev Dis Primers"},{"key":"ref19","doi-asserted-by":"publisher","first-page":"282","DOI":"10.1038\/s41575-023-00883-z","article-title":"Pathophysiology of gastro-oesophageal reflux disease: implications for diagnosis and management","volume":"21","author":"Arg\u00fcero","year":"2024","journal-title":"Nat Rev Gastroenterol Hepatol"},{"key":"ref20","doi-asserted-by":"publisher","first-page":"632","DOI":"10.1016\/s0254-6272(15)30151-5","article-title":"Efficacy and safety of Aloe vera syrup for the treatment of gastroesophageal reflux disease: a pilot randomized positive-controlled trial","volume":"35","author":"Panahi","year":"2015","journal-title":"J Tradit Chin Med"},{"key":"ref21","doi-asserted-by":"publisher","first-page":"949","DOI":"10.1001\/jama.2015.0954","article-title":"Irritable bowel syndrome: a clinical review","volume":"313","author":"Chey","year":"2015","journal-title":"JAMA"},{"key":"ref22","doi-asserted-by":"publisher","first-page":"709","DOI":"10.20452\/pamw.16067","article-title":"Recent advances in the treatment of irritable bowel syndrome","volume":"131","author":"Bonetto","year":"2021","journal-title":"Pol Arch Intern Med"},{"key":"ref23","doi-asserted-by":"publisher","first-page":"1647","DOI":"10.3390\/nu15071647","article-title":"Constipation-predominant irritable bowel syndrome (IBS-C): effects of different nutritional patterns on intestinal dysbiosis and symptoms","volume":"15","author":"Di Rosa","year":"2023","journal-title":"Nutrients"},{"key":"ref24","doi-asserted-by":"publisher","first-page":"391","DOI":"10.1055\/s-0040-1716723","article-title":"Anal fissure in children","volume":"30","author":"Patkova","year":"2020","journal-title":"Eur J Pediatr Surg"},{"key":"ref25","doi-asserted-by":"publisher","first-page":"1083","DOI":"10.1016\/s2468-1253(22)00276-x","article-title":"Faecal microbiota transplantation for first or second Clostridioides difficile infection (EarlyFMT): a randomised, double-blind, placebo-controlled trial","volume":"7","author":"Baunwall","year":"2022","journal-title":"Lancet Gastroenterol Hepatol"},{"key":"ref26","doi-asserted-by":"publisher","first-page":"1","DOI":"10.5507\/bp.2017.057","article-title":"Irritable bowel syndrome\u2014from etiopathogenesis to therapy","volume":"162","author":"Radovanovic-Dinic","year":"2018","journal-title":"Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub"},{"key":"ref27","doi-asserted-by":"publisher","first-page":"254","DOI":"10.1053\/j.ajkd.2023.06.001","article-title":"Long-term glycemic variability: a variable glycemic metric entangled with glycated hemoglobin","volume":"82","author":"Tang","year":"2023","journal-title":"Am J Kidney Dis"},{"key":"ref28","doi-asserted-by":"publisher","first-page":"449","DOI":"10.1007\/s13300-018-0384-6","article-title":"EADSG guidelines: insulin therapy in diabetes","volume":"9","author":"Silver","year":"2018","journal-title":"Diabetes Ther"},{"key":"ref29","doi-asserted-by":"publisher","first-page":"1555","DOI":"10.1016\/j.burns.2024.03.037","article-title":"Effect of glycemic variability on infectious outcomes in critically ill burn patients","volume":"50","author":"Hoang","year":"2024","journal-title":"Burns J Int Soc Burn Inj"},{"key":"ref30","doi-asserted-by":"publisher","first-page":"637","DOI":"10.17219\/dmp\/145895","article-title":"Management of transverse root fractures in dental trauma","volume":"59","author":"Marasca","year":"2022","journal-title":"Dent Med Probl"},{"key":"ref31","doi-asserted-by":"publisher","first-page":"20140484","DOI":"10.1098\/rsbl.2014.0484","article-title":"Sea otter dental enamel is highly resistant to chipping due to its microstructure","volume":"10","author":"Ziscovici","year":"2014","journal-title":"Biol Lett"},{"key":"ref32","doi-asserted-by":"crossref","DOI":"10.1101\/2020.07.30.20165456","volume-title":"The ontario neurodegenerative disease research initiative","author":"Sunderland","year":"2020"}],"container-title":["Frontiers in Medicine"],"original-title":[],"link":[{"URL":"https:\/\/www.frontiersin.org\/articles\/10.3389\/fmed.2026.1765949\/full","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,2,24]],"date-time":"2026-02-24T10:21:59Z","timestamp":1771928519000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.frontiersin.org\/articles\/10.3389\/fmed.2026.1765949\/full"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,2,11]]},"references-count":32,"alternative-id":["10.3389\/fmed.2026.1765949"],"URL":"https:\/\/doi.org\/10.3389\/fmed.2026.1765949","relation":{},"ISSN":["2296-858X"],"issn-type":[{"value":"2296-858X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,2,11]]},"article-number":"1765949"}}