[Adverse drug reactions in children: 10 years of pharmacovigilance]

Arch Pediatr. 2016 May;23(5):468-76. doi: 10.1016/j.arcped.2016.01.015. Epub 2016 Apr 6.
[Article in French]


Background: Knowledge of drug tolerance and safety in children is limited. The study of spontaneous notifications of adverse events (AEs) can be an important source of information.

Objective: Describe the characteristics of drug adverse effects (DAEs) in children 0-17 years of age reported to the pharmacovigilance center of Saint-Étienne in 2004-2013.

Methods: This retrospective descriptive study was conducted based on DAE notifications, classified according to age, sex, severity of organ affected (using classification by the System organ class [SOC]) and by suspected drug (Anatomical therapeutic chemical [ATC] drugs).

Results: A total of 371 notifications were analyzed. The male:female ratio was 1. Serious cases accounted for 36%, of which 73% resulted in hospitalization or prolongation of hospitalization. The most frequent DAEs were cutaneous (21.1%), infection (13.5%) and general (11.5%). The most frequently involved therapeutic classes were anti-infectives for systemic use (38.7%), mainly vaccines and antibiotics, as well as antineoplastic and immunomodulatory therapy (19.2%) and drugs acting on the nervous system (12.5%).

Conclusions: The analysis of notifications of adverse drug reactions is an important source of information and is underutilized in pediatrics. The data from this study confirm those of European databases with spontaneous reporting. The majority of anti-infectives including antibiotics raises the question of the proper use of this class in this population. Larger studies focused on the drugs at risk would improve the knowledge and safe use of medicines in children.

MeSH terms

  • Adolescent
  • Anti-Bacterial Agents / adverse effects*
  • Anti-Infective Agents / adverse effects
  • Antineoplastic Agents / adverse effects*
  • Child
  • Child, Preschool
  • Drug-Related Side Effects and Adverse Reactions / epidemiology*
  • Female
  • France / epidemiology
  • Humans
  • Immunologic Factors / adverse effects*
  • Infant
  • Male
  • Pharmacovigilance*
  • Retrospective Studies
  • Risk Factors
  • Sex Distribution
  • Vaccines / adverse effects*


  • Anti-Bacterial Agents
  • Anti-Infective Agents
  • Antineoplastic Agents
  • Immunologic Factors
  • Vaccines