{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,4]],"date-time":"2026-05-04T07:44:37Z","timestamp":1777880677496,"version":"3.51.4"},"reference-count":51,"publisher":"SAGE Publications","license":[{"start":{"date-parts":[[2020,1,1]],"date-time":"2020-01-01T00:00:00Z","timestamp":1577836800000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100001691","name":"Japan Society for the Promotion of Science","doi-asserted-by":"publisher","award":["17K08452"],"award-info":[{"award-number":["17K08452"]}],"id":[{"id":"10.13039\/501100001691","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100001691","name":"Japan Society for the Promotion of Science","doi-asserted-by":"publisher","award":["20K10408"],"award-info":[{"award-number":["20K10408"]}],"id":[{"id":"10.13039\/501100001691","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["SAGE Open Medicine"],"published-print":{"date-parts":[[2020,1]]},"abstract":"<jats:sec>\n                    <jats:title>Objectives:<\/jats:title>\n                    <jats:p>Reye\u2019s syndrome is a rare and potentially fatal illness that is defined as encephalopathy accompanied by liver failure. The aim of this study was to assess Reye\u2019s syndrome profiles by analyzing data from the spontaneous reporting system database.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>We analyzed reports of Reye\u2019s syndrome using the US Food and Drug Administration Adverse Event Reporting System and the Japanese Adverse Drug Event Report databases. The reporting odds ratio and proportional reporting rate were used to detect the pharmacovigilance signal.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>The US Food and Drug Administration Adverse Event Reporting System contains 12,201,620 reports from January 2004 to June 2020, of which 186 are on Reye\u2019s syndrome. The Japanese Adverse Drug Event Report contains 646,779 reports from April 2004 to September 2020, of which 30 are on Reye\u2019s syndrome. In the US Food and Drug Administration Adverse Event Reporting System database, the reporting odds ratios (95% confidence interval, number of cases) of aspirin, diclofenac, ibuprofen, acetaminophen, and valproate sodium were 404.6 (302.6\u2013541.0, n = 80), 15.1 (6.7\u201334.1, n = 6), 26.2 (16.1\u201342.6, n = 18), 10.7 (5.5\u201320.9, n = 9), and 47.1 (26.2\u201384.6, n = 12), respectively. In the Japanese Adverse Drug Event Report database, the reporting odds ratios (95% confidence interval, number of cases) of aspirin, diclofenac, ibuprofen, loxoprofen, acetaminophen, and valproate sodium were 14.1 (5.4\u201336.8, n = 5), 51.7 (22.2\u2013120.5, n = 7), 135.0 (40.8\u2013446.2, n = 3), 17.6 (6.7\u201346.0, n = 5), 24.0 (9.2\u201362.6, n = 5), and 13.8 (3.3\u201357.9, n = 2), respectively. The reported number of female patients aged 30\u201339 years was the highest in the Japanese Adverse Drug Event Report.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion:<\/jats:title>\n                    <jats:p>Although the frequency of the occurrence of Reye\u2019s syndrome is low, the possible risk of the disease occurring in adult females should be considered.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/2050312120974176","type":"journal-article","created":{"date-parts":[[2020,11,20]],"date-time":"2020-11-20T04:11:30Z","timestamp":1605845490000},"update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":5,"title":["Assessment of Reye\u2019s syndrome profile with data from the US Food and Drug Administration Adverse Event Reporting System and the Japanese Adverse Drug Event Report databases using the disproportionality analysis"],"prefix":"10.1177","volume":"8","author":[{"given":"Kiyoka","family":"Matsumoto","sequence":"first","affiliation":[{"name":"Laboratory of Drug Informatics, Gifu Pharmaceutical University, Gifu, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shiori","family":"Hasegawa","sequence":"additional","affiliation":[{"name":"Laboratory of Drug Informatics, Gifu Pharmaceutical University, Gifu, Japan"},{"name":"Department of Pharmacy, Kobe City Medical Center General Hospital, Hyogo, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Satoshi","family":"Nakao","sequence":"additional","affiliation":[{"name":"Laboratory of Drug Informatics, Gifu Pharmaceutical University, Gifu, Japan"},{"name":"Department of Pharmacy, Kyusyu University Hospital, Fukuoka, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kazuyo","family":"Shimada","sequence":"additional","affiliation":[{"name":"Laboratory of Drug Informatics, Gifu Pharmaceutical University, Gifu, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ririka","family":"Mukai","sequence":"additional","affiliation":[{"name":"Laboratory of Drug Informatics, Gifu Pharmaceutical University, Gifu, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mizuki","family":"Tanaka","sequence":"additional","affiliation":[{"name":"Laboratory of Drug Informatics, Gifu Pharmaceutical University, Gifu, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Riko","family":"Satake","sequence":"additional","affiliation":[{"name":"Laboratory of Drug Informatics, Gifu Pharmaceutical University, Gifu, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yu","family":"Yoshida","sequence":"additional","affiliation":[{"name":"Laboratory of Drug Informatics, Gifu Pharmaceutical University, Gifu, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Fumiya","family":"Goto","sequence":"additional","affiliation":[{"name":"Laboratory of Drug Informatics, Gifu Pharmaceutical University, Gifu, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Misaki","family":"Inoue","sequence":"additional","affiliation":[{"name":"Laboratory of Drug Informatics, Gifu Pharmaceutical University, Gifu, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hiroaki","family":"Ikesue","sequence":"additional","affiliation":[{"name":"Department of Pharmacy, Kobe City Medical Center General Hospital, Hyogo, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kazuhiro","family":"Iguchi","sequence":"additional","affiliation":[{"name":"Laboratory of Community Pharmacy, Gifu Pharmaceutical University, Gifu, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tohru","family":"Hashida","sequence":"additional","affiliation":[{"name":"Department of Pharmacy, Kobe City Medical Center General Hospital, Hyogo, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5062-5522","authenticated-orcid":false,"given":"Mitsuhiro","family":"Nakamura","sequence":"additional","affiliation":[{"name":"Laboratory of Drug Informatics, Gifu Pharmaceutical University, Gifu, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"179","published-online":{"date-parts":[[2020,11,20]]},"reference":[{"key":"bibr1-2050312120974176","unstructured":"Chapman J, Arnold JK. Reye syndrome. Treasure Island, FL: Stat Pearls Publishing, 2020, https:\/\/www.ncbi.nlm.nih.gov\/books\/NBK526101\/ (accessed 31 August 2020)."},{"key":"bibr2-2050312120974176","doi-asserted-by":"publisher","DOI":"10.1136\/adc.58.9.670"},{"key":"bibr3-2050312120974176","doi-asserted-by":"publisher","DOI":"10.1136\/adc.63.7.857"},{"key":"bibr4-2050312120974176","unstructured":"Ministry of Health Labour Welfare. Pharmaceuticals and medical devices safety information No. 151 (1998), https:\/\/www.pmda.go.jp\/safety\/info-services\/drugs\/calling-attention\/safety-info\/0086.html#9 (accessed 31 August 2020)."},{"key":"bibr5-2050312120974176","unstructured":"Ministry of Health Labour Welfare. Pharmaceuticals and medical devices safety information No. 167 (2001), https:\/\/www.pmda.go.jp\/safety\/info-services\/drugs\/calling-attention\/safety-info\/0098.html (accessed 31 August 2020)."},{"key":"bibr6-2050312120974176","doi-asserted-by":"publisher","DOI":"10.1016\/j.taap.2009.04.014"},{"key":"bibr7-2050312120974176","doi-asserted-by":"publisher","DOI":"10.1001\/jama.1982.03320470035029"},{"key":"bibr8-2050312120974176","volume":"7","author":"Hongo T","year":"2019","journal-title":"Acute Med Surg"},{"key":"bibr9-2050312120974176","doi-asserted-by":"publisher","DOI":"10.1111\/j.1469-0691.2010.03196.x"},{"key":"bibr10-2050312120974176","doi-asserted-by":"publisher","DOI":"10.1007\/PL00008399"},{"key":"bibr11-2050312120974176","doi-asserted-by":"publisher","DOI":"10.1111\/pan.12398"},{"key":"bibr12-2050312120974176","doi-asserted-by":"publisher","DOI":"10.1097\/PEC.0000000000000504"},{"key":"bibr13-2050312120974176","unstructured":"Ministry of Health Labour Welfare. Jutoku fukusayo shikkanbetsu taiou manual: syouni kyuusei nousyou, https:\/\/www.info.pmda.go.jp\/juutoku\/file\/jfm1104007.pdf (accessed 31 August 2020)."},{"key":"bibr14-2050312120974176","doi-asserted-by":"publisher","DOI":"10.1111\/epi.14591"},{"key":"bibr15-2050312120974176","doi-asserted-by":"publisher","DOI":"10.1016\/j.alit.2015.01.002"},{"key":"bibr16-2050312120974176","doi-asserted-by":"publisher","DOI":"10.1186\/s40780-016-0048-5"},{"key":"bibr17-2050312120974176","doi-asserted-by":"publisher","DOI":"10.1080\/14740338.2016.1198775"},{"key":"bibr18-2050312120974176","doi-asserted-by":"publisher","DOI":"10.1186\/s40780-017-0088-5"},{"key":"bibr19-2050312120974176","doi-asserted-by":"publisher","DOI":"10.1186\/s40780-015-0035-2"},{"key":"bibr20-2050312120974176","doi-asserted-by":"publisher","DOI":"10.1093\/nar\/gkm958"},{"key":"bibr21-2050312120974176","doi-asserted-by":"publisher","DOI":"10.1093\/nar\/gkq1126"},{"key":"bibr22-2050312120974176","unstructured":"US Food and Drug Administration. FDA adverse event reporting system (FAERS). Silver Spring, MD: US Food and Drug Administration, 2020, http:\/\/www.fda.gov\/Drugs\/GuidanceComplianceRegulatoryInformation\/Surveillance\/AdverseDrugEffects\/default.htm (accessed 31 August 2020)."},{"key":"bibr23-2050312120974176","unstructured":"Pharmaceuticals Medical Devices Agency. Kobetsu syourei annzennsei houkoku wo densou surutameno data koumoku oyobi messe-gi siyou nitsuite; Notification No. 39 of iyaku-ann, Notification No. 334 of iyaku-shinn, https:\/\/www.pmda.go.jp\/files\/000145474.pdf (accessed 31 August 2020)."},{"key":"bibr24-2050312120974176","doi-asserted-by":"publisher","DOI":"10.1007\/s11060-019-03273-1"},{"key":"bibr25-2050312120974176","doi-asserted-by":"publisher","DOI":"10.1002\/pds.668"},{"key":"bibr26-2050312120974176","doi-asserted-by":"crossref","unstructured":"Poluzzi E, Raschi E, Piccinni C, et al. Data mining techniques in pharmacovigilance: analysis of the publicly accessible FDA Adverse Event Reporting System (AERS). INTECH. 2012; 265\u2013302, https:\/\/www.intechopen.com\/books\/data-mining-applications-in-engineering-and-medicine\/data-mining-techniques-in-pharmacovigilance-analysis-of-the-publicly-accessible-fda-adverse-event-re (accessed 31 August 2020).","DOI":"10.5772\/50095"},{"key":"bibr27-2050312120974176","doi-asserted-by":"publisher","DOI":"10.1002\/pds.677"},{"key":"bibr28-2050312120974176","doi-asserted-by":"publisher","DOI":"10.1002\/pds.1002"},{"key":"bibr29-2050312120974176","doi-asserted-by":"publisher","DOI":"10.1056\/NEJM199905063401801"},{"key":"bibr30-2050312120974176","doi-asserted-by":"publisher","DOI":"10.1136\/adc.59.3.230"},{"key":"bibr31-2050312120974176","unstructured":"Chaie M, Fujiwara M, Abe T. Seijinn Rai Syoukougunn no Itirei. RIGAKU RYOHO GAKU, 2009 (Suppl 2) P3-078, https:\/\/www.jstage.jst.go.jp\/article\/cjpt\/2009\/0\/2009_0_B4P3078\/_pdf\/-char\/ja (accessed 31 August 2020)."},{"key":"bibr32-2050312120974176","doi-asserted-by":"publisher","DOI":"10.1093\/oxfordjournals.epirev.a036229"},{"key":"bibr33-2050312120974176","doi-asserted-by":"publisher","DOI":"10.1056\/NEJM198307213090309"},{"key":"bibr34-2050312120974176","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.286.6383.1999"},{"key":"bibr35-2050312120974176","doi-asserted-by":"publisher","DOI":"10.1007\/BF01070761"},{"key":"bibr36-2050312120974176","doi-asserted-by":"publisher","DOI":"10.1016\/0002-9343(79)90255-9"},{"key":"bibr37-2050312120974176","doi-asserted-by":"publisher","DOI":"10.1001\/jama.1979.03300130017011"},{"key":"bibr38-2050312120974176","first-page":"5","author":"Sougoukikakusennta-Osaka","year":"2011","journal-title":"Osaka: Sougoukikakusennta-osaka"},{"key":"bibr39-2050312120974176","first-page":"785","volume":"35","author":"Kawai S.","year":"2007","journal-title":"Jpn Pharmacol Ther"},{"key":"bibr40-2050312120974176","doi-asserted-by":"publisher","DOI":"10.3820\/jjpe.17.75"},{"key":"bibr41-2050312120974176","doi-asserted-by":"publisher","DOI":"10.1007\/s11606-012-2098-1"},{"key":"bibr42-2050312120974176","doi-asserted-by":"publisher","DOI":"10.1136\/adc.87.6.462"},{"key":"bibr43-2050312120974176","doi-asserted-by":"publisher","DOI":"10.2165\/00002018-200730100-00007"},{"key":"bibr44-2050312120974176","doi-asserted-by":"publisher","DOI":"10.1046\/j.1365-2125.2002.01569.x"},{"key":"bibr45-2050312120974176","doi-asserted-by":"publisher","DOI":"10.2165\/00002018-200831070-00006"},{"key":"bibr46-2050312120974176","doi-asserted-by":"publisher","DOI":"10.2165\/00002018-200124030-00006"},{"key":"bibr47-2050312120974176","doi-asserted-by":"publisher","DOI":"10.1592\/phco.24.8.743.36068"},{"key":"bibr48-2050312120974176","doi-asserted-by":"publisher","DOI":"10.1002\/pds.1633"},{"key":"bibr49-2050312120974176","doi-asserted-by":"publisher","DOI":"10.1001\/archinte.167.16.1752"},{"key":"bibr50-2050312120974176","doi-asserted-by":"publisher","DOI":"10.1001\/archinternmed.2011.89"},{"key":"bibr51-2050312120974176","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0217951"}],"container-title":["SAGE Open Medicine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/2050312120974176","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/full-xml\/10.1177\/2050312120974176","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/2050312120974176","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,5,1]],"date-time":"2026-05-01T00:18:42Z","timestamp":1777594722000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1177\/2050312120974176"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020,1]]},"references-count":51,"alternative-id":["10.1177\/2050312120974176"],"URL":"https:\/\/doi.org\/10.1177\/2050312120974176","relation":{},"ISSN":["2050-3121","2050-3121"],"issn-type":[{"value":"2050-3121","type":"print"},{"value":"2050-3121","type":"electronic"}],"subject":[],"published":{"date-parts":[[2020,1]]},"article-number":"2050312120974176"}}