Signal Mining and Risk Analysis of Olanzapine Adverse Events in the FAERS Database.

Objective: This study aims to assess the safety profile of Olanzapine by analyzing adverse events (AEs) reported in the FAERS database, particularly focusing on newly identified risks.

Method: The study involved adverse events (AEs) related to Olanzapine from January 1, 2004, to June 30, 2023. Four signal mining methods were used for a comprehensive analysis of the frequency and strength of AEs, including ROR, PRR, BCPNN, and EBGM.

Results: A total of 43,664 reports with Olanzapine as the primary suspect drug were collected. 776 PT signals involving 27 SOCs were identified. The main affected groups were females and the age group of 18 to 45 years. Psychiatric disorders and Nervous system disorders were the most common adverse reactions. Moreover, the analysis revealed some adverse reactions not recorded in the manual, including cardiovascular risks like Pancreatitis, Chylomicron increased, Hyperchylomicronaemia, and Myocardial reperfusion injury, as well as rare but serious adverse reactions like Neuroleptic malignant syndrome and Anosognosia.

Conclusion: This study identified new cardiovascular risks associated with Olanzapine, including pancreatitis and myocardial reperfusion injury, which require further investigation.