biostudies-literatureUnknown28(4)Yoo WH<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 evaluaJournal of rheumatic diseases202-215https://www.ebi.ac.uk/biostudies/studies/S-EPMC10324909biostudies-literatureSafety of Tacrolimus in Autoimmune Disease: Results From Post-marketing Surveillance in South Korea.PMC10324909Kim THLee SISumarsono BYoo WHHua FPark SHSung JJKim SMfalseSafety of Tacrolimus in Autoimmune Disease: Results From Post-marketing Surveillance in South Korea.<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 evalua2021-01-01T00:00:00Z2021 Oct2025-07-10T03:08:17.548Z2025-04-06T17:23:01.934ZS-EPMC103249093747636310.4078/jrd.2021.28.4.202