Association between opioid analgesics and learning disorders: a disproportionality analysis of the FDA Adverse Event Reporting System (FAERS) and EudraVigilance databases

This large-scale analysis identifies a strong and persistent signal of disproportionate reporting for learning disorders associated with opioids. In the pediatric population, these reports are frequently linked to prenatal exposure and severe outcomes. These hypothesis-generating findings highlight a potential safety concern that warrants further investigation in controlled epidemiological studies. While causality cannot be established, the results suggest the importance of cautious prescribing in women of childbearing potential and support considering neurodevelopmental follow-up for prenatally exposed children.