OBJECTIVE： To conduct bibliometric analysis of off-label use in domestic and foreign. METHODS： Retrieved from CNKI， Wanfang database， VIP， PubMed， Embase and Web of Science during Jan. 1991 （in foreign） or Jan. 2007 （in domestic） to Dec. 2018， related literatures of off-label use were collected. General information （publication numbers distribution， journals distribution）， article cooperation （core researchers， research content） and keywords of domestic and foreign literatures were analyzed and summarized. RESULTS： A total of 1 647 domestic and 4 418 foreign literatures were retrieved， including 1 570 domestic and 4 238 foreign valid literatures. Publications increased over the past decade， with the largest number of domestic and foreign publication numbers in 2017 （355 in domestic and 465 in foreign）. The most published domestic and foreign journals were China Pharmacy （105 literatures） and European Journal of Clinical Pharmacology （51 literatures）. The core researchers in domestic and foreign were Li Youping and de la Torre JC. The contents of domestic researches included off-label use policy， current situation of off-label use in children， off-label use in ophthalmology， off-label use of Chinese patent medicine， etc. The contents of foreign researches included off-label use in antiviral drugs， off-label use in special population （children， alcoholic dependence patients， etc.）. Off-label use， rational drug use and drug instructions as well as human， off-label use and article were the top 3 keywords in domestic and foreign literatures， respectively. CONCLUSIONS： Off-label use research at home and abroad is increasing year by year. Research teams carry out co-operations actively. Bibliometric methods can help researchers broaden research directions， track research hotspots and select contributing journals.