Signal mining of adverse reactions in the antiemetic drug ondansetron during pregnancy: A real-world analysis of the FDA adverse event reporting system (FAERS).

BACKGROUND

The aim of this study is to assess the risks associated with the use of ondansetron in pregnant women in real-world based on the Food and Drug Administration adverse Event Reporting System (FAERS).

METHODS

The FAERS data from the 2017Q1 to the 2023Q1, which was used by the ratio-of-reporting (ROR) and Bayesian confidence interval progressive neural network (BCPNN) to assess the safety of ondansetron in pregnancy.

RESULTS

A total of 15,727 pregnancy population reports were reported, with a total of 1,064 reports of adverse reactions with ondansetron as the primary suspected drug. Ondansetron was involved in a total of 10 system organ classifications (SOCs) of signal generation, and the top three signal intensities were Congenital, familial, and genetic disorders (ROR = 19.1, ROR025 = 17.03; IC = 1.23, IC025 = 1.16), Ear and labyrinth disorders (ROR = 17.11, ROR025 = 12.46; IC = 1.22, IC025 = 1.03), and Cardiac disorders (ROR = 9.48, ROR025 = 8.38; IC = 1.12, IC025 = 1.03); signals of adverse reactions obtained of 216, of which the main ones were Anhedonia (IC = 1.34, IC025 = 1.08), Injury (IC = 1.34, IC025 = 1.19), Left-to-right cardiac shunt (IC = 1.33, IC025 = 1.05).

CONCLUSION

The adverse reactions of Ondansetron involve multiple systems and organs, which should cause clinical vigilance. However, due to the limitations of the data, the causal relationship and risk level of adverse reactions cannot be accurately inferred.