{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,22]],"date-time":"2026-08-22T15:59:18Z","timestamp":1787414358946,"version":"build-2736575974"},"reference-count":55,"publisher":"Public Library of Science (PLoS)","issue":"12","license":[{"start":{"date-parts":[[2021,12,2]],"date-time":"2021-12-02T00:00:00Z","timestamp":1638403200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100001691","name":"japan society for the promotion of science","doi-asserted-by":"publisher","award":["19K16424"],"award-info":[{"award-number":["19K16424"]}],"id":[{"id":"10.13039\/501100001691","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["www.plosone.org"],"crossmark-restriction":false},"short-container-title":["PLoS ONE"],"abstract":"<jats:sec id=\"sec001\"><jats:title>Introduction<\/jats:title><jats:p>Anticholinergic adverse effects (AEs) are a problem for elderly people. This study aimed to answer the following questions. First, is an analysis of anticholinergic AEs using spontaneous adverse drug event databases possible? Second, what is the main drug suspected of inducing anticholinergic AEs in the databases? Third, do database differences yield different results?<\/jats:p><\/jats:sec><jats:sec id=\"sec002\"><jats:title>Methods<\/jats:title><jats:p>We used two databases: the US Food and Drug Administration Adverse Event Reporting System database (FAERS) and the Japanese Adverse Drug Event Report database (JADER) recorded from 2004 to 2020. We defined three types of anticholinergic AEs: central nervous system (CNS) AEs, peripheral nervous system (PNS) AEs, and a combination of these AEs. We counted the number of cases and evaluated the ratio of drug\u2013anticholinergic AE pairs between FAERS and JADER. We computed reporting odds ratios (RORs) and assessed the drugs using Beers Criteria<jats:sup>\u00ae<\/jats:sup>.<\/jats:p><\/jats:sec><jats:sec id=\"sec003\"><jats:title>Results<\/jats:title><jats:p>Constipation was the most reported AE in FAERS. The ratio of drug\u2013anticholinergic AE pairs was statistically significantly larger in FAERS than JADER. Overactive bladder agents were suspected drugs common to both databases. Other drugs differed between the two databases. CNS AEs were associated with antidementia drugs in FAERS and opioids in JADER. In the assessment using Beers Criteria<jats:sup>\u00ae<\/jats:sup>, signals were detected for almost all drugs. Between the two databases, a significantly higher positive correlation was observed for PNS AEs (correlation coefficient 0.85,<jats:italic>P<\/jats:italic>= 0.0001). The ROR was significantly greater in JADER.<\/jats:p><\/jats:sec><jats:sec id=\"sec004\"><jats:title>Conclusions<\/jats:title><jats:p>There are many methods to investigate AEs. This study shows that the analysis of anticholinergic AEs using spontaneous adverse drug event databases is possible. From this analysis, various suspected drugs were detected. In particular, FAERS had many cases. The differences in the results between the two databases may reflect differences in the reporting countries. Further study of the relationship between drugs and CNS AEs should be conducted.<\/jats:p><\/jats:sec>","DOI":"10.1371\/journal.pone.0260980","type":"journal-article","created":{"date-parts":[[2021,12,2]],"date-time":"2021-12-02T19:40:04Z","timestamp":1638474004000},"page":"e0260980","update-policy":"https:\/\/doi.org\/10.1371\/journal.pone.corrections_policy","source":"Crossref","is-referenced-by-count":15,"title":["Analysis of anticholinergic adverse effects using two large databases: The US Food and Drug Administration Adverse Event Reporting System database and the Japanese Adverse Drug Event Report database"],"prefix":"10.1371","volume":"16","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-9069-5752","authenticated-orcid":true,"given":"Junko","family":"Nagai","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yoichi","family":"Ishikawa","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"340","published-online":{"date-parts":[[2021,12,2]]},"reference":[{"key":"pone.0260980.ref001","first-page":"69","volume-title":"Pharmacotherapy: a pathophysiologic approach","author":"ER Hajjar","year":"2020","edition":"11"},{"key":"pone.0260980.ref002","first-page":"67","volume-title":"Pharmacotherapy: a pathophysiologic approach","author":"KL Donohoe","year":"2020","edition":"11"},{"key":"pone.0260980.ref003","doi-asserted-by":"crossref","first-page":"358","DOI":"10.3389\/fphar.2016.00358","article-title":"Hospitalizations Due to Adverse Drug Events in the Elderly-A Retrospective Register Study.","volume":"7","author":"O Laatikainen","year":"2016","journal-title":"Front Pharmacol"},{"issue":"1","key":"pone.0260980.ref004","doi-asserted-by":"crossref","first-page":"6","DOI":"10.1046\/j.1365-2125.2003.02007.x","article-title":"Age-related changes in pharmacokinetics and pharmaco-dynamics: basic principles and practical applications","volume":"57","author":"AA Mangoni","year":"2004","journal-title":"Br J Clin Pharmacol"},{"key":"pone.0260980.ref005","first-page":"1","article-title":"Systematic review on the use of anticholinergic scales in polypathological patients [published correction appears in Arch Gerontol Geriatr. 2016 May-Jun;64:178\u201380].","volume":"62","author":"AM Villalba-Moreno","year":"2016","journal-title":"Arch Gerontol Geriatr"},{"issue":"4","key":"pone.0260980.ref006","doi-asserted-by":"crossref","first-page":"335","DOI":"10.2165\/00002512-199303040-00004","article-title":"The problems of anticholinergic adverse effects in older patients","volume":"3","author":"M. 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