Safety of Direct Amoxicillin Challenges to Evaluate Penicillin Allergy in Infants and Toddlers

Rasa Tiano1, Ellen Ruan2, Devangi Shah3

  • 1Department of Pediatrics, Phoenix Children's Hospital, Phoenix, AZ.

The Journal of Pediatrics
|October 25, 2025
PubMed

Insights

Direct amoxicillin challenges are safe for young children with a low-risk penicillin allergy label. This finding supports early penicillin allergy delabeling for this group, improving antibiotic options.

Area of Science:

  • Pediatric Allergy and Immunology
  • Clinical Pharmacology
  • Infectious Diseases

Background:

  • Penicillin allergy labels are common in children but often inaccurate.
  • Unnecessary avoidance of penicillin-class antibiotics can lead to broader-spectrum antibiotic use.
  • Limited data exist on the safety of direct amoxicillin challenges in infants and toddlers with non-high-risk penicillin allergy labels.

Purpose of the Study:

  • To evaluate the safety and outcomes of direct amoxicillin challenges in infants and toddlers with a non-high-risk penicillin allergy label.
  • To assess the feasibility of penicillin allergy delabeling in this pediatric population.

Main Methods:

  • Retrospective cohort study conducted at two pediatric referral centers.
  • Inclusion of infants and toddlers with a non-high-risk penicillin allergy label.
  • Review of medical records for reactions following direct amoxicillin challenges.

Main Results:

  • Direct amoxicillin challenges were well-tolerated in the studied pediatric population.
  • No significant adverse reactions were observed during or after the amoxicillin challenges.
  • The study supports the safety of this approach for allergy delabeling.

Conclusions:

  • Direct amoxicillin challenges are a safe strategy for infants and toddlers with non-high-risk penicillin allergy labels.
  • Early penicillin allergy delabeling can be safely extended to this younger population.
  • This approach may help optimize antibiotic selection and reduce the use of alternative agents.

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