Title:Adverse Drug Reactions of Acetaminophen and Ibuprofen in the Paediatric Population: Analysis of the Italian Spontaneous Reporting Database
Volume: 18
Issue: 1
Author(s): Valentina Pelliccia, Serena Rossi , Ilaria Zollino, Francesco Quagliarella *Giuseppe Buonocore
Affiliation:
- Department of Molecular and Developmental Medicine, University of Siena, Siena, Italy
Keywords:
Acetaminophen, ibuprofen, adverse drug reactions, pharmacovigilance, fever, pediatric.
Abstract: Background: Acetaminophen and ibuprofen are the only antipyretics drugs approved in
children, and are considered safe and well tolerated. However, data regarding the adverse drug reaction
(ADR) profile of these drugs in children are scattered.
Aim: The aim of our study is to evaluate the ADRs of acetaminophen and ibuprofen through an observational
study over a period of 15 years (January 2005-April 2020). Reports of suspected ADRs
to the active substances ‘acetaminophen’ and ‘ibuprofen’ are listed and accessible through the
Italian spontaneous reporting database (RAM system) by AIFA (Pharmacovigilance of the Italian
Drug Agency).
Methods: Acetaminophen ADRs in paediatric populations were 15% of cases, with more frequent
involvement of skin and soft tissue (54.36%) and gastrointestinal apparatus (44.09%); liver dysfunction
accounts for 5.67%.
Results: Ibuprofen paediatric ADRs were 26%: skin and soft tissues in 63.16% of cases, gastrointestinal
tract in 47.75%, hematemesis and melena in 6.38%; kidney injury in 2.25% of cases.
Conclusion: Children aged 2 to 11 are more frequently affected by ADRs than infants and adolescents.
The risk of gastrointestinal and renal side effects is significantly higher with ibuprofen. Hepatobiliary
side effects are more frequently linked to acetaminophen. Potentially fatal ADRs have
been reported sporadically for both drugs.
