Pharmacovigilance study of the association between progestogen and depression based on the FDA Adverse Event Reporting System (FAERS)

Abstract Background: Progestogen commonly used in clinic include levonorgestrel, etonogestrel, medroxyprogesterone, hydroxyprogesterone, progesterone, desogestrel, megestrol. Progestogenare widely used in the treatment of contraception, endometriosis, threatened abortion and other diseases. However, the correlation between progestogenand depression is not clear. Therefore, this study used the FDA Adverse Event Reporting System (FAERS) database to assess the relationship between progestogenand depression. Methods:In this study, all data from the first quarter of 2004 to the secondquarter of 2024were extracted and imported into SAS9.4 software for data cleaning and analysis. Report Odds ratio (ROR), Proportional Report ratio (PRR), Bayesian confidence propagation neural network (BCPNN) and Multi-item Gamma Poisson Contraction-machine (MGPS) were used for Bayesian analysis and disproportionation analysis. Results: Levonorgestrel, medroxyprogesterone, etonogestrel and desogestrel showed positive signs of depression, and medroxyprogesterone also showed positive signs of major depression. Although none of the progestogenshowed a positive sign for suicide and self-harm, medroxyprogesterone showed a positive sign for suicidal thoughts. Conclusion: Analysis of data from FAERS database showed that levonorgestrel, medroxyprogesterone, etonogestrel, desogestrel were correlated with depression. These findings provide real-world evidence of the potential risk of progestogen-related depression.