ORIGINAL RESEARCH article
Front. Pharmacol.
Sec. Obstetric and Pediatric Pharmacology
This article is part of the Research TopicExploring Adverse Drug Reactions, Medication Adherence, and Forensic Markers in Pediatrics and ObstetricsView all 13 articles
Pediatric safety of methylphenidate: disproportionality analysis of adverse event profiles and gender differences from the FAERS database
Provisionally accepted
- Children’s Hospital Affiliated to Shandong University, Jinan, China
Select one of your emails
You have multiple emails registered with Frontiers:
Notify me on publication
Please enter your email address:
If you already have an account, please login
You don't have a Frontiers account ? You can register here
Background: Methylphenidate is a widely prescribed medication for attention-deficit/hyperactivity disorder (ADHD) in pediatric patients, and it has been associated with a high frequency of reported adverse events. Its safety profile remains a subject of significant clinical and regulatory concern. This study aims to conduct an in-depth real-world evaluation of the safety of methylphenidate in children and adolescents, utilizing the FDA Adverse Event Reporting System (FAERS) database. Methods: The study extracted adverse drug event (ADE) data for individuals aged 6 to 18 years from the FAERS database, covering the period from 2004 to 2024, by utilizing the OpenVigil 2.1 platform. Signal detection for methylphenidate was conducted using disproportionality analysis, with a specific focus on identifying gender-specific risk signals. Results: A total of 10,644 ADE reports associated with methylphenidate use in pediatric patients were collected. Through the application of disproportionality analysis, 223 adverse drug reaction (ADR) signals were identified, covering 20 System Organ Classes (SOC). The most frequently implicated categories included psychiatric disorders, general disorders and administration site conditions, nervous system disorders, cardiac disorders, and metabolism and nutrition disorders. This study revealed several positive signals not previously documented in drug labels, including abnormal behaviour, disturbance in social behaviour, dystonia, psychotic disorder, coronary artery dissection, dermal absorption impaired, Huntington's disease, compulsive sexual behaviour, nail picking, zinc deficiency, polydipsia psychogenic, trigeminal neuralgia, morose, and selective mutism. Gender-based analysis indicated that female patients were at higher risk of application site erythema, tachycardia, mydriasis, apathy, tachypnoea, body temperature increased, precocious puberty, application site discolouration, hyperthyroidism, and urticaria. In contrast, the risk of tic was found to be higher in male patients compared to females. This is a provisional file, not the final typeset article Conclusion: This study identified ADR signals, including coronary artery dissection which are not included in drug labels. Healthcare professionals, including clinicians and pharmacists, should remain vigilant in monitoring such potential risk. Furthermore, significant gender differences in ADR signals associated with methylphenidate were observed, highlighting the need for continued pharmacovigilance. These findings provide valuable insights for clinicians in monitoring and managing pediatric patients with methylphenidate.
Keywords: Methylphenidate, pediatric patients, Adverse drug events, FDA adverse eventreporting system, gender differences
Received: 11 Sep 2025; Accepted: 30 Oct 2025.
Copyright: © 2025 Wang, Gao, Zhang, Wang, Wang, Zhang and Hao. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Lina Hao, haolina1984@163.com
Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.