Promethazine Safety in Children Under 1 Year of Age
Promethazine is contraindicated and should not be used in children under 2 years of age due to the risk of fatal respiratory depression. 1
Evidence and Rationale
Promethazine, a phenothiazine derivative with antihistaminic, sedative, and antiemetic properties, carries significant safety concerns for young children:
- The FDA drug label explicitly states that promethazine is contraindicated for use in pediatric patients less than two years of age 1
- Promethazine carries a "black box warning" regarding fatal respiratory depression in children younger than 2 years 2
- The American Academy of Pediatrics guidelines for sedation and analgesia specifically mention that promethazine has fallen out of favor due to unpredictable responses and prolonged recovery 2
Risks and Adverse Effects
When used in infants and very young children, promethazine can cause:
- Fatal respiratory depression 2
- Airway obstruction, especially concerning for infants transported in car safety seats 2
- Significant sedation that may lead to apparent life-threatening events 3
- Possible association with sudden infant death syndrome 3
- Agitation, hallucinations, and seizures 3
- Dystonic reactions 3
Alternative Approaches
For conditions where promethazine might be considered in older patients:
For allergic conditions: Consult with a pediatric allergist for age-appropriate alternatives
For nausea/vomiting: Consider ondansetron (if age-appropriate) after consulting with a pediatrician
For sedation: Use alternatives recommended by pediatric specialists for the specific indication
Important Clinical Considerations
- Even in children aged 2-6 years, the FDA and pediatric guidelines recommend caution with promethazine use 1
- The risk of respiratory depression is particularly high in children with neurological conditions 4
- Over-the-counter cough and cold medications containing antihistamines (including promethazine) are generally not recommended for children under 6 years due to safety concerns and lack of efficacy 2
Conclusion
The evidence is clear and definitive: promethazine should not be administered to infants under 1 year of age under any circumstances due to the risk of potentially fatal respiratory depression. This contraindication extends to all children under 2 years of age according to FDA labeling and pediatric guidelines.