Objective  To mine ADE signals of olanzapine based on the FAERS database and provide references for clinical medication safety.

Methods  ADE reports with olanzapine as the primary suspected drug were retrieved from the database between January 1, 2004, and March 1, 2025. The reporting odds ratio (ROR) method and Bayesian confidence propagation neural network (BCPNN) method were used for signal mining. The basic characteristics of the reports, SOC distribution, PT frequency, and temporal characteristics of ADE occurrence were analyzed.

Results  A total of 49,970 ADE reports with olanzapine as the primary suspected drug were included, mainly involving individuals aged 18–64 years, and there were slightly more male patients than female patients. A total of 1,144 valid PT signals were identified, covering 26 SOCs, predominantly in the psychiatric, nervous system, and various examination categories. The top five PTs with the highest reporting frequencies were weight increase, diabetes, somnolence, drug overdose, and confusional state. PTs with the highest signal intensity included post-injection delirium sedation syndrome, increased chylomicrons, hyperinsulinism, psychogenic visual disturbance, and hyperchylomicronemia. The median occurrence time was 118 days, with more than one-third of events occurring within 30 days of medication, and another one-third occurring after one year, showing a "bimodal" distribution.

Conclusion  ADEs associated with olanzapine are widely distributed. In addition to paying attention to the known adverse reactions listed in the package insert, vigilance should also be maintained for ADEs not detailed in the insert, such as disturbances of consciousness, metabolic damage, and electrocardiographic abnormalities. Clinical practice should strengthen early and long-term monitoring, especially during long-term maintenance therapy and combined medication, to improve the level of medication safety management.

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