Analysis of potential risks between acetaminophen and ibuprofen use during pregnancy via the FAERS database

Abstract

Abstract Purpose: The aim of this study was to compare the potential risks of acetaminophen and ibuprofen use during pregnancy in relation to adverse events (AEs) from real-world practice via the FAERS database. Methods: We detected signals of the AEs of acetaminophen and ibuprofen use during pregnancy by data mining using FAERS database. Disproportionality analysis was used to the FAERS for the suspected pregnancy data from January 2017 to December 2022. Results: On the basis of 51,936 acetaminophen reports, the reports of 331 (0.64% of total adverse drug reactions, ADRs) were associated with pregnancy; On the basis of 84,810 ibuprofen reports, the reports of 530 (0.62%) were associated with pregnancy. Among acetaminophen reports, the most AE was exposure during pregnancy (59.52%) that belongs to injury, poisoning and procedural complications. The associated pregnancy outcome of those reports was missing may suggest no cause serious consequences. Among ibuprofen reports, the major AE was abortion spontaneous (26.79%), and oligohydramnios (17.74%). Conclusion: This is the first study of comprehensively compare and analyze the potential risks between acetaminophen and ibuprofen for drug-associated adverse fetal and pregnancy outcomes by assessing the reported AEs from the real-world database. The results suggested acetaminophen may be the better choice during pregnancy.