TOLERABILITY PROFILE

Skin Application-Site Reactions (%)6

  • Six-week, double-blind phases of two 6-week, multicentre trials in patients aged 2 to 17 years with mild to moderate eczema
    (N=403).6
  • Data from a 1-year safety study in pediatric patients aged 2 to 17 years with mild to moderate eczema (N=347).6
  • § Data from an active-controlled adult study.6
  • Overall application-site reactions were mild to moderate, occurred early in treatment, and were transient in nature.3
  • The most common adverse reactions seen in clinical studies included application-site burning, headache, pharyngitis, nasopharyngitis, cough, influenza, pyrexia, and viral infection.6
  • There were no reported adverse reactions (≥1%) of HPA axis suppression, atrophy or telangiectasia in clinical studies.6
  • In clinical trials, 48 (4%) of the 1,171 ELIDEL patients and 13 (3%) of 408 vehicle-treated patients discontinued therapy due to adverse events. Discontinuations for AEs were primarily due to application-site reactions and cutaneous infections.6
  • In clinical studies, skin papillomas or warts were observed in 1% of ELIDEL patients.

Always refer to full prescribing information.