Pseudoephedrine Use in Pediatric Patients
Contraindication in Young Children
Pseudoephedrine should NOT be used in children under 6 years of age due to lack of proven efficacy and significant safety concerns including risk of death, agitated psychosis, ataxia, and hallucinations. 1, 2
The FDA drug label explicitly states "do not use this product in children under 6 years of age" 2, and this restriction is strongly supported by guideline evidence showing that between 1969-2006, there were 46 fatalities associated with pseudoephedrine in children ≤6 years, with 43 occurring in infants under 1 year 1. The FDA's Nonprescription Drugs and Pediatric Advisory Committees recommended in 2007 that OTC cough and cold medications containing pseudoephedrine no longer be used for children below 6 years of age 1.
Recommended Dosing for Children ≥6 Years
For children who meet the age requirement, the following dosing applies:
Children 6-11 Years
- Dose: 30 mg (1 tablet) every 4-6 hours 2
- Maximum daily dose: 4 tablets (120 mg) in 24 hours 2
- This dosing has been validated in clinical trials showing efficacy for temporary relief of nasal congestion with acceptable safety 3
Children ≥12 Years (Adolescents)
Absolute Contraindications and High-Risk Conditions
Use pseudoephedrine with extreme caution or avoid entirely in pediatric patients with:
- Cardiac conditions: History of cardiac arrhythmia, angina pectoris, or any structural heart disease 1
- Hypertension: Even controlled hypertension warrants careful consideration 1
- Cerebrovascular disease 1
- Hyperthyroidism: α-adrenergic stimulation can precipitate thyroid storm 1
- Bladder neck obstruction 1
- Glaucoma 1
The guideline explicitly states that "oral and topical decongestant agents should be used with caution in older adults and young children, and in patients of any age who have a history of cardiac arrhythmia, angina pectoris, cerebrovascular disease, hypertension, bladder neck obstruction, glaucoma, or hyperthyroidism" 1.
Expected Adverse Effects
Common side effects that should be anticipated and discussed with families include:
- Somnolence: Reported in 71.9% of children in clinical trials 3
- Insomnia: Occurs in approximately 34% of pediatric users 3
- Nervousness/irritability: Affects about 20% of children 1, 3
- Palpitations 1
- Tremor 1
- Loss of appetite 1
Cardiovascular effects are generally mild in normotensive children, with meta-analyses showing pseudoephedrine increases systolic blood pressure by approximately 1 mmHg and heart rate by 2-4 beats per minute 1, 4.
Duration of Treatment
- Maximum duration: 3-7 days for symptomatic relief 3
- Prolonged use beyond 7 days has not been adequately studied and should be avoided 3
- The medication should be used "as needed" for symptom relief rather than on a fixed schedule 3
Critical Clinical Pitfalls to Avoid
Never use in children <6 years: This is the most important safety consideration, as efficacy is unproven and serious adverse events including death have been documented 1, 2
Avoid concurrent use of multiple decongestant products: 7.5% of pediatric pseudoephedrine users take more than one pseudoephedrine-containing product simultaneously, leading to unintentional overdose 5
Do not combine with caffeine: Additive stimulant effects significantly increase risk of adverse events 1
Screen for underlying cardiac conditions: Even in children >6 years, undiagnosed cardiac abnormalities increase risk of serious arrhythmias 1
Recognize limited efficacy data: While a 2019 study demonstrated efficacy in 6-11 year olds 3, the overall evidence base remains limited, and the risk-benefit ratio must be carefully considered for each patient 1
Alternative Considerations
For children <6 years requiring nasal congestion relief, consider:
- Intranasal corticosteroids: These are the most effective medication class for allergic rhinitis and have excellent safety profiles in young children 1
- Second-generation antihistamines: Cetirizine, desloratadine, fexofenadine, levocetirizine, and loratadine have been shown to be well-tolerated with very good safety profiles in young children 1
- Saline nasal irrigation: Non-pharmacologic approach with no systemic effects
The evidence clearly demonstrates that "the efficacy of cold and cough medications for symptomatic treatment of upper respiratory tract infections has not been established for children younger than 6 years" and "because of the potential toxicity of these medications, the use of these OTC drugs generally should be avoided in all children below 6 years of age" 1.