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Four disproportionality algorithms were simultaneously applied: the reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN), and multi-item gamma Poisson shrinker (MGPS). A total of 397 positive signals were identified across 25 system organ classes (SOCs). The SOCs with concordant positive signals across all four algorithms were identified for infections and infestations and surgical and medical procedures. High-frequency signals included pneumonia, lower respiratory tract infection, influenza, nasopharyngitis, sinusitis and cellulitis. Comparison with the current prescribing information revealed several previously undocumented ADEs, including urinary tract infection, ear infection, flavivirus infection, Zika virus infection and Dengue fever. Twenty-nine positive malignancy signals absent from the prescribing information were identified, including basal cell carcinoma, colorectal cancer, cervical cancer and breast cancer. Time-to-onset analysis revealed that the risk of ADEs was the highest within the first few months of treatment initiation. Clinicians should rigorously monitor for infectious complications and malignancies when prescribing golimumab to ensure patient safety.<\/jats:p>","DOI":"10.2478\/acph-2026-0022","type":"journal-article","created":{"date-parts":[[2026,10,13]],"date-time":"2026-10-13T14:22:10Z","timestamp":1791901330000},"source":"Crossref","is-referenced-by-count":0,"title":["Adverse event reporting of golimumab: A disproportionality analysis of the FDA Adverse Event Reporting System (FAERS) database"],"prefix":"10.2478","author":[{"ORCID":"https:\/\/orcid.org\/0009-0006-7126-0733","authenticated-orcid":false,"given":"Wenjie","family":"Ma","sequence":"first","affiliation":[{"name":"1 Department of Pharmacy Southern University of Science and Technology Hospital Shenzhen , , Guangdong China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0007-6291-8764","authenticated-orcid":false,"given":"Nuan","family":"Jia","sequence":"additional","affiliation":[{"name":"1 Department of Pharmacy Southern University of Science and Technology Hospital Shenzhen , , Guangdong China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0006-1033-6263","authenticated-orcid":false,"given":"Hui","family":"Liao","sequence":"additional","affiliation":[{"name":"1 Department of Pharmacy Southern University of Science and Technology Hospital Shenzhen , , Guangdong China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0008-9929-2643","authenticated-orcid":false,"given":"Zhilei","family":"Li","sequence":"additional","affiliation":[{"name":"1 Department of Pharmacy Southern University of Science and Technology Hospital Shenzhen , , Guangdong China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0004-0523-9851","authenticated-orcid":false,"given":"Xiaodan","family":"Li","sequence":"additional","affiliation":[{"name":"1 Department of Pharmacy Southern University of Science and Technology Hospital Shenzhen , , Guangdong China"},{"name":"2 Department of Pharmacy People\u2019s Hospital of Longhua Shenzhen , , Guangdong China"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"374","published-online":{"date-parts":[[2026,10,13]]},"reference":[{"key":"2026101314061008462_j_acph-2026-0022_ref_001","doi-asserted-by":"crossref","unstructured":"Q-Q. 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