Objective  To explore the adverse drug event signal of piperacillin-tazobactam (TZP) and promote rational and safe use of drugs in clinic.

Methods  The proportional unbalance method was used to mine the signals of all TZP adverse events (ADE) reports from the inception of FDA adverse event reporting system (FAERS) to March 2024. The basic situation of the the reported cases and the relevant information of adverse reactions were analyzed.

Results  A total of 20 620 513 ADE reports were obtained for the main suspected drugs, and 6 489 ADE reports were reported for TZP as the main suspected drug. 543 ADE signals were mined, involving 25 system organ classifications (SOC). 43 ADE signals were detected by secondary screening, and 17 ADE signals were new ADR signals. The top 5 ADE signals involved in SOC classification were skin and subcutaneous tissue disorders, general disorders and administration site reactions, various examinations, infections and infectious disease, and blood and lymphatic system disorders. The top 5 preferred terms for ADE signal number were rash, pyrexia, acute kidney injury, pruritus and thrombocytopenia. Penicillins had several ADE signals on blood and lymphatic system diseases. TZP led to thrombocytopenia with the largest number of cases, and oxacillin led to agranulocytosis with the highest proportional reporting ratio. The median treatment course of TZP induced leukopenia was 11.00 days, and the median accumulated dose was 148.50 g. The median treatment course of TZP induced agranulocytosis was 14.00 days, and the median accumulated dose was 216.00 g. The median treatment course of TZP induced thrombocytopenia was 7.00 days, and the median accumulated dose was 87.00 g.

Conclusion  The adverse reactions related to skin and subcutaneous tissue diseases should be paid close attention to during medication, which may be more common than those of gastrointestinal diseases. When large doses or long courses of TZP are clinically used, close attention should be paid to the adverse reactions related to blood and lymphatic system disorders to avoid serious ADE.

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