Comparison of safety of acetaminophen and ibuprofen in minors: based on the FAERS database

Expert Opin Drug Saf. 2024 May 12:1-9. doi: 10.1080/14740338.2024.2348614. Online ahead of print.

Abstract

Objective: To investigate adverse events(ADEs) associated with the use of paracetamol and ibuprofen in people under 18 years of age.

Background: The use of NSAIDs reached a peak as a result of the spread of COVID-19 in previous years. Minors, as a special population, need to pay more attention to the use of corresponding drugs and the occurrence of adverse events (ADEs).

Methods: ADEs report data of the two drugs were extracted from the FDA Adverse Event Reporting System(FAERS) from the first quarter of 2014 to the third quarter of 2022.

Results: The use of the two drugs in this population was primarily associated with injury, poisoning and surgical complications. The psychiatric disorders produced by the use of acetaminophen(12.6%) and ibuprofen(9.2%) in the adolescent group were significantly higher than those in the other age groups. The use of acetaminophen in the four age groups involved hepatobiliary disorders was more significantly (10.3%, 8.1%, 9.1%, 11.5%), while the use of ibuprofen was more obviously involved in renal and urinary disorders(5.0%, 6.2%, 9.6%, 7.1%).

Conclusions: The use of acetaminophen and ibuprofen in children of different age groups has different characteristics. Pediatric clinical pharmacists can provide medication monitoring to minimize ADEs based on these characteristics.

Keywords: FAERS; clinical pharmacists; NSAIDs; acetaminophen; drug safety; ibuprofen.