OBJECTIVE To statistically analyze and detect signals for the adverse drug reactions (ADRs) related to tigecycline based on the ADR spontaneous reporting system, so as to provide reference for the prevention of medication risks of tigecycline.

METHODS ADR reports of tigecycline were extracted from the ADR spontaneous reporting system of the hospital from Oct. 2013 to Mar. 2024. Statistical analysis was conducted by Microsoft Excel and Free Statistics 2.1. 1. The data mining and analysis were performed using the reporting odds ratio (ROR), the proportional reporting ratio (PRR) and the composite criteria of UK Medicines and Healthcare products Regulatory Agency (MHRA).

RESULTS Among the 574 ADR reports with tigecycline as the primarily suspected drug, elderly patients accounted for over 50%. The ADRs mainly occurred within one week after medication administration, involving 12 organ systems and 57 adverse reaction signals. Through comprehensive analysis using three methods, 20 positive risk signals related to tigecycline were identified, mainly affecting the gastrointestinal system, hepatobiliary system and hematological system. The top 5 frequent ADR signals were nausea, vomiting, diarrhea, thrombocytopenia and hyperbilirubinemia. According to the ROR method, the top five ranked ADR signals were hyperbilirubinemia (ROR=330.55), hepatocellular injury (ROR=110.22), elevated amylase (ROR=78.90), cholestasis (ROR=73.32), and decreased fibrinogen (ROR=43.65).

CONCLUSIONS The adverse reactions of tigecycline mainly occur during the initial stage of medication, and special caution is required when used in elderly patients. High-intensity risk signals for ADRs are hyperbilirubinemia, liver injury, and others related to hematological system and gastrointestinal system. Close monitoring of these ADRs and timely intervention are necessary during medication.