{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,30]],"date-time":"2026-07-30T10:19:08Z","timestamp":1785406748330,"version":"3.56.0"},"reference-count":108,"publisher":"MDPI AG","issue":"5","license":[{"start":{"date-parts":[[2026,4,28]],"date-time":"2026-04-28T00:00:00Z","timestamp":1777334400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100001691","name":"Japan Society for the Promotion of Science","doi-asserted-by":"crossref","award":["JP22K06707"],"award-info":[{"award-number":["JP22K06707"]}],"id":[{"id":"10.13039\/501100001691","id-type":"DOI","asserted-by":"crossref"}]},{"award":["JP22K06707"],"award-info":[{"award-number":["JP22K06707"]}],"id":[{"id":"https:\/\/ror.org\/00hhkn466","id-type":"ROR","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Pharmaceuticals"],"abstract":"<jats:p>Background: Guillain\u2013Barr\u00e9 syndrome (GBS) is an autoimmune peripheral neuropathy that can lead to paralysis and respiratory failure. In addition to infections, several drugs have been suggested as potential triggers of GBS. This study investigated drug-associated GBS using a spontaneous adverse event reporting database through disproportionality analysis for signal detection and time-to-onset analysis. Methods: The Japanese Adverse Drug Event Report (JADER) database was analyzed to assess more than 4000 drugs for potential associations with GBS. Signal detection was performed using reporting odds ratios, Fisher\u2019s exact test, and total report counts. For vaccines and immune checkpoint inhibitors, time-to-onset patterns were further evaluated using Weibull distribution analysis. Results: Disproportionality signals suggesting potential associations with GBS were identified for 45 drugs, including vaccines, immune checkpoint inhibitors, tumor necrosis factor-\u03b1 inhibitors, other anticancer drugs, antifungal agents, and interferons. Reports following vaccination were most frequently observed within 1\u20133 weeks after administration of coronavirus disease 2019 (COVID-19), influenza, and pneumococcal vaccines, and within 1\u20133 months after human papillomavirus 2-valent vaccination, with a gradual decrease thereafter. Reports following immune checkpoint inhibitor use were most frequently observed 1\u20133 months after nivolumab, ipilimumab, and pembrolizumab administration, whereas atezolizumab showed a peak in reporting within 1\u20133 weeks. In contrast to vaccine-related reports, no clear temporal trend in reporting was observed. Conclusions: Drugs that modulate immune function, including vaccines and immune checkpoint inhibitors, may be associated with reported GBS events. Vaccine-related reports showed an early concentration in time to onset, whereas immune checkpoint inhibitor-related reports did not demonstrate a clear temporal pattern. These findings should be interpreted as hypothesis-generating and warrant further investigation.<\/jats:p>","DOI":"10.3390\/ph19050688","type":"journal-article","created":{"date-parts":[[2026,4,29]],"date-time":"2026-04-29T10:34:42Z","timestamp":1777458882000},"page":"688","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Disproportionality Analysis and Timing of Drug-Associated Guillain\u2013Barr\u00e9 Syndrome Onset Based on the Japanese Adverse Drug Event Report Database"],"prefix":"10.3390","volume":"19","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5521-0820","authenticated-orcid":false,"given":"Shinya","family":"Toriumi","sequence":"first","affiliation":[{"name":"Department of Medical Molecular Informatics, Meiji Pharmaceutical University, Kiyose 204-8588, Tokyo, Japan"},{"name":"Department of Pharmacy, National Hospital Organization Kanagawa Hospital, Hadano 257-8585, Kanagawa, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yousuke","family":"Kurihara","sequence":"additional","affiliation":[{"name":"Department of Pharmacy, National Hospital Organization Kanagawa Hospital, Hadano 257-8585, Kanagawa, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Komei","family":"Shimokawa","sequence":"additional","affiliation":[{"name":"Department of Pharmacy, National Hospital Organization Kanagawa Hospital, Hadano 257-8585, Kanagawa, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Arihito","family":"Tanaka","sequence":"additional","affiliation":[{"name":"Department of Respiratory Medicine, National Hospital Organization Kanagawa Hospital, Hadano 257-8585, Kanagawa, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Norito","family":"Araki","sequence":"additional","affiliation":[{"name":"Department of Respiratory Medicine, National Hospital Organization Kanagawa Hospital, Hadano 257-8585, Kanagawa, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Osamu","family":"Kawai","sequence":"additional","affiliation":[{"name":"Department of Respiratory Medicine, National Hospital Organization Kanagawa Hospital, Hadano 257-8585, Kanagawa, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3534-1799","authenticated-orcid":false,"given":"Yasoo","family":"Sugiura","sequence":"additional","affiliation":[{"name":"Department of General Thoracic Surgery, National Hospital Organization Saitama Hospital, Wako 351-0102, Saitama, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5773-991X","authenticated-orcid":false,"given":"Yoshihiro","family":"Uesawa","sequence":"additional","affiliation":[{"name":"Department of Medical Molecular Informatics, Meiji Pharmaceutical University, Kiyose 204-8588, Tokyo, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2026,4,28]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"3646","DOI":"10.1111\/ene.16073","article-title":"European Academy of Neurology\/Peripheral Nerve Society Guideline on diagnosis and treatment of Guillain-Barr\u00e9 syndrome","volume":"30","author":"Hadden","year":"2023","journal-title":"Eur. 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