OBJECTIVE: To offer the literature basis for clinical safe drug use by literature research about ADR induced by Yishen juanbi pill. METHODS: Using “Yishen juanbi pill” as searching word, related literatures about ADR induced by Yishen juanbi pill were collected from CNKI, and then the occurrence of ADR was summarized and analyzed. RESULTS: A total of 15 literatures were included, involving 58 patients. Primary disease were mainly rheumatoid arthritis (28 cases, 48.28%); organs/systems involved in ADR were digestive system (77 cases, 76.24%). Main clinical manifestations were epigastric discomfort, pernicious vomiting, diarrhea, etc. No obvious ADR was found. ADR-inducing dose was mainly 8 g, tid (47 cases, 92.16%); ADR-inducing drug combination were two-drug combination (33 cases,56.90%). Fifty-eight cases of ADR were recovered after treatment, and main treatment was drug withdrawal or symptomatic treatment. CONCLUSIONS: Although Yishen juanbi pill may induce ADR, those ADR can disappear spontaneously after drug withdrawal or the symptoms are recovered after symptomatic treatment. Yishen juanbi pill is a relatively safe Chinese patent medicine of anti-inflammatory, but ADR monitoring should be strengthened during application.