What are the guidelines for the use of antihistamines (anti-histamine medications) in children less than 2 years old?

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Antihistamine Use in Children Under 2 Years Old

Antihistamines should generally be avoided in children under 2 years of age due to safety concerns, with no over-the-counter antihistamines recommended for this age group. 1, 2

Safety Concerns and Guidelines

  • The FDA and pediatric advisory committees recommend against using OTC cough and cold medications (including antihistamines) in children under 6 years of age due to significant safety concerns 1
  • FDA-approved labeling for diphenhydramine (a first-generation antihistamine) explicitly states "Do not use" for children under 6 years of age 2
  • Between 1969 and 2006, there were 69 fatalities associated with antihistamines in children under 6 years, with 41 reported in children under 2 years 1
  • Common causes of serious adverse events include:
    • Drug overdose
    • Medication errors
    • Accidental exposures
    • Use of multiple cold/cough products simultaneously 1

First vs. Second Generation Antihistamines

First-Generation Antihistamines

  • Not recommended for children under 2 years due to:
    • Significant sedation (occurs in >50% of patients) 3
    • Impaired learning ability 3
    • Risk of accidental overdose 4
    • Potential cardiotoxicity in overdose 3
    • Antimuscarinic side effects 5

Second-Generation Antihistamines

  • Have better safety profiles than first-generation antihistamines 5, 3
  • Some second-generation antihistamines (cetirizine, desloratadine, fexofenadine, levocetirizine, and loratadine) have been shown to be well-tolerated in young children 1
  • However, most are not FDA-approved for children under 2 years 6

Specific Antihistamine Options

When antihistamines must be used in children under 2 years (in exceptional circumstances and under medical supervision):

  • Cetirizine and loratadine are the only second-generation antihistamines approved for children under 5 years in some countries 7
  • Dosing must be carefully adjusted based on:
    • Age and weight
    • Renal function (cetirizine dose should be halved in moderate renal impairment) 8
    • Hepatic function

Common Pitfalls to Avoid

  1. Using OTC antihistamines without medical supervision in children under 2 years
  2. Administering adult doses to young children
  3. Combining multiple products containing antihistamines
  4. Using first-generation antihistamines when second-generation options are available
  5. Not recognizing signs of overdose including:
    • Excessive sedation
    • Paradoxical excitation
    • Respiratory depression
    • Cardiovascular effects

When Medical Consultation is Required

  • Always consult a physician before administering any antihistamine to a child under 2 years 8
  • Seek immediate medical attention for any adverse reactions
  • Emergency care is needed for suspected overdose

In summary, antihistamines should generally be avoided in children under 2 years of age unless specifically prescribed by a physician, with second-generation antihistamines preferred when treatment is necessary due to their better safety profile.

References

Guideline

Guideline Directed Topic Overview

Dr.Oracle Medical Advisory Board & Editors, 2025

Research

Antihistamine use in children.

Archives of disease in childhood. Education and practice edition, 2015

Research

Antihistamines: ABC for the pediatricians.

Pediatric allergy and immunology : official publication of the European Society of Pediatric Allergy and Immunology, 2020

Research

Clinical prescribing of allergic rhinitis medication in the preschool and young school-age child: what are the options?

BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy, 2001

Guideline

Allergic Rhinitis and Urticaria Treatment

Praxis Medical Insights: Practical Summaries of Clinical Guidelines, 2025

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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