Promethazine Cough Syrup Should NOT Be Used in Children
Promethazine cough syrup is not recommended for pediatric patients with cough, as over-the-counter cough and cold medicines (including antihistamines like promethazine) have not been shown to reduce cough severity or duration, and are associated with significant morbidity and even mortality in children. 1
Why Promethazine Should Be Avoided
Lack of Efficacy
- The American Academy of Pediatrics specifically advises against the use of antihistamines (including promethazine) for cough relief in children, as they have minimal to no efficacy and are associated with adverse events 1
- Systematic reviews demonstrate that over-the-counter cough medications provide little to no benefit in symptomatic control of acute cough in children 1, 2
Serious Safety Concerns
- Promethazine has been reported to cause significant sedation, agitation, hallucinations, seizures, dystonic reactions, and possibly apparent life-threatening events or sudden infant death syndrome 3
- Over-the-counter cough medicines are common causes of unintentional ingestion in children under 5 years and have been linked to significant morbidity and mortality 1, 4
- The FDA does not recommend cough and cold products containing antihistamines in children younger than 2 years 5
Risk of Inappropriate Use
- Research shows that over-the-counter medications like promethazine will likely be used inappropriately by parents, including in children under 2 years who are most vulnerable to adverse reactions 3
- The liquid formulation and over-the-counter status falsely imply safety, increasing likelihood of misuse in all age groups 3
What TO Use Instead
First-Line Treatment: Honey
- The American Academy of Pediatrics recommends honey as the first-line treatment for cough in children over 1 year old, as it provides more relief than no treatment, diphenhydramine, or placebo 1
- Critical safety warning: Never give honey to infants under 12 months due to risk of infant botulism 1
Supportive Care Only
- Most acute coughs are self-limiting viral infections requiring only supportive care 1
- The management approach should be "wait, watch, review" rather than medication-based 6
When to Re-evaluate
- Review the child if deteriorating or not improving after 48 hours 1
- Re-evaluate if cough persists beyond 2-4 weeks for emergence of specific etiological pointers 1
- All children with chronic cough (>4 weeks) require thorough clinical review using pediatric-specific cough management protocols, including chest radiograph and spirometry if age-appropriate 1, 7
Common Pitfalls to Avoid
- Do not prescribe over-the-counter medications due to parental pressure despite lack of efficacy 1
- Avoid using adult cough management approaches in pediatric patients 1
- Do not provide empirical treatment for asthma, GERD, or upper airway cough syndrome without clinical features consistent with these conditions 1
- Evaluate and address tobacco smoke exposure and other environmental pollutants in all children with cough 1