Pediatric Diphenhydramine Dosing
The recommended pediatric dose of diphenhydramine is 1-2 mg/kg per dose (maximum 50 mg per dose), administered every 4-6 hours as needed, but should NOT be used in children under 6 years of age for routine allergic symptoms due to significant safety concerns. 1, 2, 3
Standard Dosing by Age and Weight
Children 6 Years and Older
- Dose: 1-2 mg/kg per dose 1, 2
- Maximum single dose: 50 mg regardless of weight 1, 2, 3
- Frequency: Every 4-6 hours 3
- Maximum: 6 doses in 24 hours 3
- FDA-approved dosing: 10 mL (25 mg) for children 6 to under 12 years 3
Children Under 6 Years
- FDA labeling explicitly states "Do not use" for children under 6 years 3
- Critical safety warning: Between 1969-2006, diphenhydramine was responsible for 33 deaths in children under 6 years of age 4
- The American Academy of Pediatrics recommends avoiding OTC cough and cold medications (including first-generation antihistamines like diphenhydramine) in all children under 6 years due to lack of proven efficacy and potential toxicity 4
Clinical Context Considerations
For Acute Allergic Reactions/Anaphylaxis (Ages 6+ Only)
- Dose: 1-2 mg/kg or 25-50 mg per dose 2
- Route: Oral liquid formulations are more readily absorbed than tablets 1, 2
- Critical caveat: Diphenhydramine is second-line therapy only and should never replace epinephrine as first-line treatment 1, 2
- Combination with H2-antihistamine (ranitidine 1 mg/kg) is superior to diphenhydramine alone 2
Dosing Adjustments
- Infants and young children (if used under direct medical supervision): Use the lower end of the dosing range (1 mg/kg) 2
- Older children and adolescents: The full 1-2 mg/kg dose can be used, not exceeding 50 mg maximum 2
- Renal impairment: Reduce dose by 50% 2
Route-Specific Administration
Oral Administration
- Liquid formulations preferred over tablets for acute reactions due to faster absorption 1, 2
- Administer every 4-6 hours as needed 3
Intravenous Administration
- Same weight-based dosing: 1-2 mg/kg per dose, maximum 50 mg 1
- Must administer slowly to prevent seizures 2
- Monitor for sedation and respiratory suppression, especially with concurrent sedative agents 2
Safety Warnings and Monitoring
Common Adverse Effects
- Sedation is expected in 95% of patients 5
- Paradoxical excitation or agitation may occur in some pediatric patients 2
- Monitor for respiratory depression, particularly with rapid IV administration or concurrent sedatives 2
Toxicity Thresholds
- Children under 6 years: Ingestions ≥7.5 mg/kg warrant emergency department referral 6
- Children 6 years and older: Ingestions ≥7.5 mg/kg or ≥300 mg (whichever is less) warrant emergency department referral 6
Preferred Alternatives for Routine Allergic Symptoms
For children under 6 years with routine allergic symptoms, second-generation antihistamines are strongly preferred: 4
- Cetirizine: 2.5 mg once or twice daily for ages 2-5 years 4
- Loratadine: 5 mg once daily for ages 2-5 years 4
- These agents have superior safety profiles with significantly lower rates of serious adverse events and fewer sedating effects 4
Key Clinical Pitfalls to Avoid
- Never use diphenhydramine "to make a child sleepy" - this is explicitly contraindicated per FDA labeling 4
- Never use for anticholinergic delirium - may worsen symptoms 2
- Never use as monotherapy for anaphylaxis - epinephrine is always first-line 1, 2
- Avoid topical formulations in young children - fatal toxicity has been reported from topical application 7
- Do not administer activated charcoal at home due to risk of loss of consciousness or seizures 6