Stevens-johnson syndrome associated with drugs and vaccines in children: a case-control study

PLoS One. 2013 Jul 16;8(7):e68231. doi: 10.1371/journal.pone.0068231. Print 2013.


Objective: Stevens-Johnson Syndrome (SJS) is one of the most severe muco-cutaneous diseases and its occurrence is often attributed to drug use. The aim of the present study is to quantify the risk of SJS in association with drug and vaccine use in children.

Methods: A multicenter surveillance of children hospitalized through the emergency departments for acute conditions of interest is currently ongoing in Italy. Cases with a diagnosis of SJS were retrieved from all admissions. Parents were interviewed on child's use of drugs and vaccines preceding the onset of symptoms that led to the hospitalization. We compared the use of drugs and vaccines in cases with the corresponding use in a control group of children hospitalized for acute neurological conditions.

Results: Twenty-nine children with a diagnosis of SJS and 1,362 with neurological disorders were hospitalized between 1(st) November 1999 and 31(st) October 2012. Cases were more frequently exposed to drugs (79% vs 58% in the control group; adjusted OR 2.4; 95% CI 1.0-6.1). Anticonvulsants presented the highest adjusted OR: 26.8 (95% CI 8.4-86.0). Significantly elevated risks were also estimated for antibiotics use (adjusted OR 3.3; 95% CI 1.5-7.2), corticosteroids (adjusted OR 4.2; 95% CI 1.8-9.9) and paracetamol (adjusted OR 3.2; 95% CI 1.5-6.9). No increased risk was estimated for vaccines (adjusted OR: 0.9; 95% CI 0.3-2.8).

Discussion: Our study provides additional evidence on the etiologic role of drugs and vaccines in the occurrence of SJS in children.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Anti-Bacterial Agents / adverse effects
  • Anticonvulsants / adverse effects
  • Case-Control Studies
  • Child
  • Child, Preschool
  • Female
  • Humans
  • Infant
  • Male
  • Odds Ratio
  • Stevens-Johnson Syndrome / etiology*
  • Vaccines / adverse effects*
  • Young Adult


  • Anti-Bacterial Agents
  • Anticonvulsants
  • Vaccines

Grants and funding

During the period 1999–2012, the study received different funding from Italian public institutions: National Institute of Health (ISS), Ministry of Health, Italian Medicines Agency (AIFA). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.