Safety of cetirizine in infants 6 to 11 months of age: a randomized, double-blind, placebo-controlled study

J Allergy Clin Immunol. 2003 Jun;111(6):1244-8. doi: 10.1067/mai.2003.1496.


Background: H(1)-antihistamines are widely used for symptom relief in allergic disorders in infants and children; however, there are few prospective, randomized, double-blind, controlled studies of these medications in young children, and to date, no such studies have been conducted in infants.

Objective: This prospective, randomized, parallel-group, double-blind, placebo-controlled study was designed to evaluate the safety of the H(1)-antihistamine cetirizine, particularly with regard to central nervous system and cardiac effects, in infants age 6 to 11 months, inclusive.

Methods: Infants who met the entry criteria for age and had a history of treatment with an H(1)-antihistamine for an allergic or other disorder were randomized to receive 0.25 mg/kg cetirizine orally or matching placebo twice daily orally for 1 week.

Results: The mean daily dose in cetirizine-treated infants was 4.5 +/- 0.7 mg (SD). No differences in all-cause or treatment-related adverse events were observed between the cetirizine- and placebo-treated groups. A trend was observed toward fewer adverse events and sleep-related disturbances in the cetirizine group compared with the placebo group. No prolongation in the linear corrected QT interval was observed in cetirizine-treated infants compared with either baseline values or with values in placebo-treated infants.

Conclusions: We have documented the safety of cetirizine in this short-term investigation, the first randomized, double-blind, placebo-controlled study of any H(1)-antihistamine in infants. Additional prospective, randomized, double-blind, placebo-controlled, long-term studies of cetirizine and other H(1)-antihistamines are needed in this population.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Cetirizine / adverse effects*
  • Double-Blind Method
  • Electrocardiography
  • Female
  • Hemodynamics / drug effects
  • Histamine H1 Antagonists, Non-Sedating / adverse effects*
  • Humans
  • Hypersensitivity / diagnosis
  • Hypersensitivity / drug therapy
  • Infant
  • Male


  • Histamine H1 Antagonists, Non-Sedating
  • Cetirizine