Objective  To mine temozolomide-related adverse drug event (ADE) signals in the real world and to provide a reference for the safe clinical use of temozolomide.

Methods  The U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) was used to collect the ADE reporting data of temozolomide in the FAERS database from January 1, 2004 to December 31, 2022. The signal mining was performed using the report ratio method and Bayesian confidence interval progressive neural network method to analyze the occurrence of ADE.

Results  In the database, there were 24 725 ADE reports with temozolomide as the primary suspected drug, and a total of 300 ADE signals were identified, involving 23 system organ categories, and the top 5 were blood and lymphatic system diseases, systemic diseases and various reactions of administration sites, various examinations, various neurological diseases, various injuries, poisoning and procedural complications etc.  the most frequently reported ADE signals included thrombocytopenia, low platelet count, neutral granulocytopenia, pancytopenia, convulsive attacks, and febrile neutropenia. 42 new suspected adverse reactions were discovered, which were not recorded in the instructions, such as pseudomonas skin infection, herpetic meningoencephalitis, hypoglossal nerve paralysis, porokeratosis, etc.

Conclusion  The common adverse reactions of temozolomide in the real world are generally consistent with the instructions, but some new suspicious adverse reactions have been discovered. During clinical drug use, special attention should be paid to these new adverse reactions, and it is recommended to monitor patients' adverse reactions and take appropriate measures in a timely manner.

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