Diphenhydramine Safety in Pediatric Acute Cough
Diphenhydramine should NOT be used in children under 6 years of age for acute cough relief, and its use should be avoided in all pediatric patients regardless of age due to lack of efficacy and potential for adverse events. 1, 2, 3
Age-Based Contraindications
- Children under 6 years: The FDA drug label explicitly states "Do not use" for children under 6 years of age 3
- Children under 4 years: The American Academy of Pediatrics and FDA strongly recommend against OTC cold medications due to potential toxicity and complete lack of proven efficacy 2
- All pediatric patients: The American Academy of Pediatrics advises against diphenhydramine for cough relief in children, as it has minimal to no efficacy and is associated with adverse events 1
Evidence Against Efficacy
- Honey provides more relief for cough symptoms than diphenhydramine or placebo in children over 1 year of age 1, 4, 5
- Controlled trials demonstrate that antihistamine-decongestant combinations are ineffective for upper respiratory tract infection symptoms in young children 2
- Published research supporting the efficacy of diphenhydramine for URI-associated pediatric cough is absent 6
Safety Concerns and Mortality Data
- Between 1969-2006, there were 69 deaths associated with antihistamines in children under 6 years, with the majority occurring in the most vulnerable age groups 2
- Common adverse events from diphenhydramine include tachycardia (53.4%), hallucinations (46.5%), somnolence (34.7%), agitation (33.9%), and mydriasis (26.3%) 7
- Seizures occurred in 5.5% of diphenhydramine exposure cases reviewed 7
- The majority (74.7%) of diphenhydramine-only cases involved accidental unsupervised ingestions, most commonly in children 2 to under 4 years of age (79.5%) 7
- Medication errors from incorrect dosing are common in young children and can lead to unintentional overdose 2
Recommended Alternative: Honey
- For children over 1 year of age with acute cough, honey is the first-line treatment 1, 4
- Honey provides superior relief compared to no treatment, diphenhydramine, or placebo 1, 5
- Critical safety warning: Never give honey to infants under 12 months due to risk of infant botulism 1, 4
When to Re-evaluate
- Most acute coughs are self-limiting viral infections requiring only supportive care 1
- Re-evaluate if cough persists beyond 2-4 weeks for emergence of specific etiological pointers 1, 4
- Seek immediate evaluation if cough is accompanied by difficulty breathing, persistent fever, changes in mental status, or refusal to eat/drink 4
Common Pitfalls to Avoid
- Prescribing OTC medications due to parental pressure despite lack of efficacy 1
- Assuming all cough medications have similar safety profiles across age groups 2
- Using multiple cold/cough products containing the same ingredients, which increases risk of adverse events 2
- Failure to educate parents about proper storage to prevent accidental unsupervised ingestions 7