{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,26]],"date-time":"2026-09-26T16:44:58Z","timestamp":1790441098870,"version":"4.1.0"},"reference-count":35,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2025,9,20]],"date-time":"2025-09-20T00:00:00Z","timestamp":1758326400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"},{"start":{"date-parts":[[2025,9,20]],"date-time":"2025-09-20T00:00:00Z","timestamp":1758326400000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"funder":[{"DOI":"10.13039\/100009619","name":"Japan Agency for Medical Research and Development","doi-asserted-by":"publisher","award":["22mk0101228h0001"],"award-info":[{"award-number":["22mk0101228h0001"]}],"id":[{"id":"10.13039\/100009619","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Br J Clin Pharmacol"],"published-print":{"date-parts":[[2026,2]]},"abstract":"<jats:sec>\n                    <jats:title>Aims<\/jats:title>\n                    <jats:p>Spontaneous reporting of adverse drug reactions (ADR) after a product has reached the market is essential for drug safety. This study analysed patient ADR reports and compared them with reports from the Japanese Adverse Drug Event Report (JADER) database to identify differences and trends.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>ADR reports from the Pharmaceuticals and Medical Devices Agency website, including patient reports from March 2019 to March 2024, and JADER reports from January 2019 to March 2024, were utilized. Information on demographics, drugs, ADR types and outcomes was analysed. Frequencies and comparisons between the two reporting groups were performed.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>A total of 2913 patient reports and 343\u2009894 JADER reports were analysed. Patients were often younger (30\u201350 years) and mostly female, whereas JADER reports included older patients (60\u201380 years) and mostly male. Patients reported subjective symptoms, such as fatigue and headache, often associated with drugs targeting the central nervous system. In contrast, JADER reports focused on serious conditions, such as interstitial lung disease and pneumonia, which are commonly associated with anticancer drugs. Patient and professional ADR reports differed in focus. Patients highlighted quality\u2010of\u2010life\u2010related symptoms, whereas professionals reported more serious medical conditions. Differences in demographics and reporting methods indicate that these systems are complementary. Offering more reporting options, such as telephone\u2010based submissions, can make the system more inclusive.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>The study highlights how patient ADR reports provide valuable insights into drug safety. Although differences exist, patient and professional reports improve monitoring after drug approval.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/bcp.70291","type":"journal-article","created":{"date-parts":[[2025,9,20]],"date-time":"2025-09-20T09:58:42Z","timestamp":1758362322000},"page":"515-524","source":"Crossref","is-referenced-by-count":3,"title":["Comparative analysis of the characteristics and trends of adverse drug reaction reports from patients in Japan and the Japanese Adverse Drug Event Report database"],"prefix":"10.1002","volume":"92","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3846-0435","authenticated-orcid":false,"given":"Masami","family":"Tsuchiya","sequence":"first","affiliation":[{"name":"Division of Drug Informatics Keio University Faculty of Pharmacy  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1897-9689","authenticated-orcid":false,"given":"Ryohkan","family":"Funakoshi","sequence":"additional","affiliation":[{"name":"Department of Pharmacy Kameda General Hospital  Kamogawa Chiba Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Koichi","family":"Masuyama","sequence":"additional","affiliation":[{"name":"Regulatory Science Laboratory, School of Pharmacy Tokyo University of Pharmacy and Life Sciences  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1679-9024","authenticated-orcid":false,"given":"Nariyasu","family":"Mano","sequence":"additional","affiliation":[{"name":"Laboratory of Biomolecule and Pathophysiological Chemistry, Graduate School of Pharmaceutical Sciences Tohoku University  Sendai Miyagi Japan"},{"name":"Department of Pharmaceutical Sciences Tohoku University Hospital  Sendai Miyagi Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4596-5418","authenticated-orcid":false,"given":"Satoko","family":"Hori","sequence":"additional","affiliation":[{"name":"Division of Drug Informatics Keio University Faculty of Pharmacy  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3674-1674","authenticated-orcid":false,"given":"Taku","family":"Obara","sequence":"additional","affiliation":[{"name":"Department of Pharmaceutical Sciences Tohoku University Hospital  Sendai Miyagi Japan"},{"name":"Division of Preventive Medicine and Epidemiology, Tohoku University Tohoku Medical Megabank Organization  Sendai Miyagi Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2025,9,20]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40801\u2010022\u201000306\u20106"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.2165\/11594320\u2010000000000\u201000000"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40264\u2010014\u20100162\u2010y"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40264\u2010013\u20100021\u20102"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.2478\/folmed\u20102018\u20100016"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.2165\/00002018\u2010200831060\u201000006"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00228\u2010022\u201003422\u2010y"},{"key":"e_1_2_10_9_1","unstructured":"Pharmaceuticals and Medical Devices Agency.Patient adverse drug reaction reporting: summary of trials and future developments. Accessed December 30 2024.https:\/\/www.pmda.go.jp\/files\/000228628.pdf"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.31662\/jmaj.2023\u20100037"},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.vaccine.2021.08.085"},{"key":"e_1_2_10_12_1","doi-asserted-by":"publisher","DOI":"10.3390\/vaccines8030357"},{"key":"e_1_2_10_13_1","doi-asserted-by":"publisher","DOI":"10.1007\/s43441\u2010022\u201000397\u2010x"},{"key":"e_1_2_10_14_1","doi-asserted-by":"publisher","DOI":"10.3310\/hta15200"},{"key":"e_1_2_10_15_1","doi-asserted-by":"publisher","DOI":"10.2165\/11316680\u2010000000000\u201000000"},{"key":"e_1_2_10_16_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.eclinm.2019.10.001"},{"key":"e_1_2_10_17_1","doi-asserted-by":"publisher","DOI":"10.31351\/vol30iss2pp249\u2010260"},{"key":"e_1_2_10_18_1","doi-asserted-by":"publisher","DOI":"10.1089\/jwh.2012.3972"},{"key":"e_1_2_10_19_1","doi-asserted-by":"publisher","DOI":"10.3390\/ph16060869"},{"key":"e_1_2_10_20_1","doi-asserted-by":"publisher","DOI":"10.1002\/pds.4944"},{"key":"e_1_2_10_21_1","doi-asserted-by":"publisher","DOI":"10.1002\/pds.2117"},{"key":"e_1_2_10_22_1","doi-asserted-by":"publisher","DOI":"10.3390\/ijerph19084447"},{"key":"e_1_2_10_23_1","first-page":"5","article-title":"A comparison of adverse drug reaction reports from professionals and users, relating to risk of dependence and suicidal behaviour with paroxetine","volume":"16","author":"Medawar C","year":"2003","journal-title":"Int J Risk Saf Med"},{"key":"e_1_2_10_24_1","doi-asserted-by":"publisher","DOI":"10.3233\/JRS\u20102002\u2010286"},{"key":"e_1_2_10_25_1","doi-asserted-by":"publisher","DOI":"10.1517\/14740338.3.4.363"},{"key":"e_1_2_10_26_1","doi-asserted-by":"publisher","DOI":"10.3390\/jcm11175104"},{"key":"e_1_2_10_27_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40264\u2010023\u201001359\u20104"},{"key":"e_1_2_10_28_1","doi-asserted-by":"publisher","DOI":"10.21873\/invivo.13085"},{"key":"e_1_2_10_29_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40264\u2010023\u201001346\u20109"},{"key":"e_1_2_10_30_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41598\u2010023\u201046275\u2010w"},{"key":"e_1_2_10_31_1","doi-asserted-by":"publisher","DOI":"10.2147\/PPA.S75761"},{"key":"e_1_2_10_32_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365\u20102125.2009.03400.x"},{"key":"e_1_2_10_33_1","doi-asserted-by":"publisher","DOI":"10.1080\/09581596.2017.1329520"},{"key":"e_1_2_10_34_1","doi-asserted-by":"publisher","DOI":"10.1177\/009286159002400316"},{"key":"e_1_2_10_35_1","doi-asserted-by":"publisher","DOI":"10.1038\/ajg.2012.300"},{"key":"e_1_2_10_36_1","doi-asserted-by":"publisher","DOI":"10.1542\/peds.2004\u20102687"}],"container-title":["British Journal of Clinical Pharmacology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/bpspubs.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/bcp.70291","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/bpspubs.onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/bcp.70291","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/bpspubs.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/bcp.70291","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,2,12]],"date-time":"2026-02-12T14:54:23Z","timestamp":1770908063000},"score":1,"resource":{"primary":{"URL":"https:\/\/bpspubs.onlinelibrary.wiley.com\/doi\/10.1002\/bcp.70291"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,9,20]]},"references-count":35,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2026,2]]}},"alternative-id":["10.1002\/bcp.70291"],"URL":"https:\/\/doi.org\/10.1002\/bcp.70291","archive":["Portico"],"relation":{},"ISSN":["0306-5251","1365-2125"],"issn-type":[{"value":"0306-5251","type":"print"},{"value":"1365-2125","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,9,20]]}}}