Pseudoephedrine Use in Pediatric Patients

Contraindications and Precautions

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, as recommended by the American Academy of Allergy, Asthma, and Immunology 1, 2
The FDA recommends that pseudoephedrine not be used in children under 6 years of age, with 46 fatalities associated with pseudoephedrine in children ≤6 years between 1969-2006, and 43 occurring in infants under 1 year 2

Pseudoephedrine should be used with extreme caution or avoided entirely in pediatric patients with cardiac conditions, such as history of cardiac arrhythmia, angina pectoris, or any structural heart disease, as well as hypertension, cerebrovascular disease, hyperthyroidism, bladder neck obstruction, and glaucoma, according to the American Heart Association 1

Nervousness/irritability affects about 20% of children taking pseudoephedrine, with other common side effects including palpitations, tremor, and loss of appetite, as reported by the American Academy of Pediatrics 1
Cardiovascular effects are generally mild in normotensive children, with pseudoephedrine increasing systolic blood pressure by approximately 1 mmHg and heart rate by 2-4 beats per minute, according to the American College of Cardiology 1

For children <6 years requiring nasal congestion relief, consider intranasal corticosteroids, second-generation antihistamines, or saline nasal irrigation, as recommended by the American Academy of Allergy, Asthma, and Immunology 1, 2
Intranasal corticosteroids are the most effective medication class for allergic rhinitis and have excellent safety profiles in young children, according to the American Academy of Pediatrics 2