Adverse reactions to acetaminophen and ibuprofen in pediatric patients: a narrative review

Acetaminophen and ibuprofen are among the most commonly used over-the-counter (OTC) medications for managing fever and pain in children. Although their safety profiles are well established, there has been a progressive increase in reports of suspected adverse drug reactions (ADRs) in pediatric populations in recent years. This trend may be partly attributable to improved reporting systems, but also to increased consumption. For example, the proportion of pediatric ibuprofen packages purchased without a prescription rose from 28% in 2008 to 70% in 2015. From 2020 to 2024, pediatric ibuprofen use grew by over 60%, and accordingly, the number of reported ADRs also increased. This rise may be due to specific pharmacovigilance programs targeting pediatric populations and the fact that, since 2009, ibuprofen in Italy no longer requires a prescription, making it more accessible and widely perceived as safe.To provide a narrative review of suspected ADRs related to Acetaminophen and ibuprofen use in children.A literature search was conducted using PubMed and Embase databases, employing the following terms: (Children OR Pediatrics) AND (Acetaminophen OR Ibuprofen OR NSAID OR Nonsteroidal Anti-Inflammatory Drugs) AND (Adverse Events OR ADRs).A total of 337 records were identified, of which 15 studies were eligible for inclusion. According to Italian consumption data from the last five years, acetaminophen use declined from 68.8% in 2019 to 63.5% in 2024, while ibuprofen use increased from 31.2% to 36.7% (2). Additionally, the number of pediatric ibuprofen packages purchased increased by 61% between 2019 and 2024. Data from the European spontaneous reporting database (EudraVigilance) also showed a significant rise in reported ADRs in children receiving either drug. However, for comparable levels of use, ibuprofen appears to be associated with a higher rate of potentially serious adverse events.Our analysis shows a marked increase in reported ADRs related to antipyretic use in children, likely linked to the rising use of ibuprofen in recent years. These findings emphasize the need for better parental education and healthcare provider guidance on the safe and appropriate use of antipyretics in pediatric patients.