Utilization of the Naranjo scale to evaluate adverse drug reactions at a free-standing children's hospital

PLoS One. 2021 Jan 13;16(1):e0245368. doi: 10.1371/journal.pone.0245368. eCollection 2021.


The relationship between the Naranjo scaling system and pediatric adverse drug reactions (ADR) is poorly understood. We performed a retrospective review of 1,676 pediatric ADRs documented at our hospital from 2014-2018. We evaluated patient demographics, implicated medication, ADR severity, calculated Naranjo score, associated symptoms, and location within the hospital in which the ADR was documented. ADR severity was poorly correlated with Naranjo interpretation. Out of the 10 Naranjo scale questions, 4 had a response of "unknown" greater than 85% of the time. Cardiovascular and oncological/immunologic agents were more likely to have a probable or definite Naranjo interpretation compared to antimicrobials. Further strategies are needed to enhance the causality assessment of pediatric ADRs in clinical care.

MeSH terms

  • Adolescent
  • Adverse Drug Reaction Reporting Systems
  • Child
  • Child, Preschool
  • Drug-Related Side Effects and Adverse Reactions / diagnosis*
  • Drug-Related Side Effects and Adverse Reactions / etiology
  • Female
  • Hospitals, Pediatric
  • Humans
  • Male
  • Retrospective Studies
  • Risk Factors
  • Severity of Illness Index

Grant support

The author(s) received no specific funding for this work.