{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"omics_type":["Unknown"],"volume":["28(4)"],"submitter":["Yoo WH"],"pubmed_abstract":["<h4>Objective</h4>Tacrolimus, a macrolide immunosuppressant, is approved in Korea for the treatment of rheumatoid arthritis (RA), lupus nephritis (LN) and myasthenia gravis (MG) We report three prospective post-marketing surveillance studies of tacrolimus conducted in South Korea in these indications.<h4>Methods</h4>Studies were conducted according to South Korean Ministry of Food and Drug Safety requirements Patients were followed up for the duration of the study (up to 4 years) or until treatment discontinuation Occurrence and likely relationship with tacrolimus of adverse events (AEs), adverse drug reactions (ADRs; defined as AEs where causal relationship to tacrolimus could not be excluded) and serious AEs were recorded Association of AEs with demographic and medical factors was evalua"],"journal":["Journal of rheumatic diseases"],"pagination":["202-215"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC10324909"],"repository":["biostudies-literature"],"pubmed_title":["Safety of Tacrolimus in Autoimmune Disease: Results From Post-marketing Surveillance in South Korea."],"pmcid":["PMC10324909"],"pubmed_authors":["Kim TH","Lee SI","Sumarsono B","Yoo WH","Hua F","Park SH","Sung JJ","Kim SM"],"additional_accession":[]},"is_claimable":false,"name":"Safety of Tacrolimus in Autoimmune Disease: Results From Post-marketing Surveillance in South Korea.","description":"<h4>Objective</h4>Tacrolimus, a macrolide immunosuppressant, is approved in Korea for the treatment of rheumatoid arthritis (RA), lupus nephritis (LN) and myasthenia gravis (MG) We report three prospective post-marketing surveillance studies of tacrolimus conducted in South Korea in these indications.<h4>Methods</h4>Studies were conducted according to South Korean Ministry of Food and Drug Safety requirements Patients were followed up for the duration of the study (up to 4 years) or until treatment discontinuation Occurrence and likely relationship with tacrolimus of adverse events (AEs), adverse drug reactions (ADRs; defined as AEs where causal relationship to tacrolimus could not be excluded) and serious AEs were recorded Association of AEs with demographic and medical factors was evalua","dates":{"release":"2021-01-01T00:00:00Z","publication":"2021 Oct","modification":"2025-07-10T03:08:17.548Z","creation":"2025-04-06T17:23:01.934Z"},"accession":"S-EPMC10324909","cross_references":{"pubmed":["37476363"],"doi":["10.4078/jrd.2021.28.4.202"]}}