Background:　Relugolix　has　been　used　to　treat　advanced　prostate　cancer.　This　study　assessed　adverse　events　(AEs)　associated　with　relugolix　from　the　US　Food　and　Drug　Administration　Adverse　Event　Reporting　System　(FAERS).　Methods:　Disproportionality　analysis,　including　the　reporting　odds　ratio　(ROR),　the　proportional　reporting　ratio　(PRR),　the　Bayesian　confidence　propagation　neural　network　(BCPNN),　and　the　multi-item　gamma　Poisson　shrinker　(MGPS)　algorithms,　were　employed　to　quantify　the　signals　of　relugolix-associated　AEs.　Results:　A　total　of　5,059,213　reports　of　AEs　were　collected　from　the　FAERS　database,　of　which　5,662　reports　were　identified　with　relugolix　as　the　“primary　suspect　(PS)”.　A　total　of　70　significant　disproportionality　PTs　conforming　to　the　four　algorithms　were　simultaneously　retained.　Unexpected　new　AEs,　such　as　erectile　dysfunction,　gynaecomastia,　testicular　atrophy,　male　genital　atrophy,　libido　decreased　might　also　occur.　Conclusion:　This　study　found　potential　new　AEs　signals　and　might　provide　important　support　for　clinical　monitoring　and　risk　identification　of　relugolix.　©　The　Author(s),　under　exclusive　licence　to　Springer　Science+Business　Media,　LLC,　part　of　Springer　Nature　2024.