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

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:

• NSAIDs
• acetaminophen
• ibuprofen
• drug safety
• FAERS; clinical pharmacists

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Supplementary material

Supplemental data for this article can be accessed online at https://doi.org/10.1080/14740338.2024.2348614

Author contributions

J Wang conducted the data analysis, drafted the initial manuscript, and reviewed and revised the manuscript; G Feng, D Li and X Zhou assisted in data analysis, and critically reviewed the manuscript; J Chen and F Wang managed and checked all the data, and critically reviewed the manuscript; L Chen contributed to the design of the study, directed the data analysis, and critically reviewed and revised the manuscript; and all authors approved the final manuscript as submitted and agree to be accountable for all aspects of the work.

Additional information

Funding

This work was supported by the National Natural Science Foundation of China [82073921].