Study links methylphenidate in youths to diverse adverse reactions, highlighting sex and formulation differences

A Frontiers in Psychiatry study analysing FAERS data reveals broad adverse drug reaction signals associated with methylphenidate use in children and adolescents, emphasising the need for tailored monitoring based on sex and medication formulation.

A Frontiers in Psychiatry study has found that methylphenidate in children and adolescents is linked in FAERS reports to a broad spread of adverse drug reaction signals, with psychiatric, general and nervous system disorders the most common categories. The analysis drew on 8,585 reports for patients aged 6 to 17 and identified 16 system organ classes, including several signals not listed in current drug labels such as abnormal behaviour, disturbance in social behaviour and coronary artery dissection. According to the journal, the findings are based on disproportionality analysis, which can point to reporting patterns but cannot prove causation.

The clearest signal in the dataset was application site erythema, while abnormal behaviour, aggression, decreased appetite and insomnia were also frequently reported. The researchers found 86 positive signals in boys and 90 in girls, with boys more often linked to aggression, tics and growth retardation, and girls more often linked to tachycardia and local skin reactions. Some signals were exclusive to one sex, including arrhythmia, coronary artery dissection and acute myocardial infarction in boys, while girls showed more reports of application site reactions.

Differences also emerged by formulation. The immediate-release product was associated with more acute and severe signals, including sudden death and syncope, while the oral extended-release form produced the largest number of unique signals overall, at 63. The transdermal patch was dominated by local skin reactions such as erythema and pruritus. The study’s authors said the pattern supports more tailored monitoring by sex and dosage form, but they also cautioned that FAERS data are subject to reporting bias and lack the exposure data needed to estimate true risk.