Safety and tolerability of fexofenadine hydrochloride, 15 and 30 mg, twice daily in children aged 6 months to 2 years with allergic rhinitis

Ann Allergy Asthma Immunol. 2007 Dec;99(6):549-54. doi: 10.1016/S1081-1206(10)60385-7.


Background: Antihistamines are an established first-line treatment for allergic rhinitis and are widely prescribed in infants for allergic symptoms.

Objective: To establish the safety and tolerability of fexofenadine hydrochloride in children aged 6 months to 2 years in 2 studies (T/3001 and T/3002).

Methods: Both studies had a multicenter, randomized, placebo-controlled design. Mean treatment duration was 8 days. Subjects were randomized (T/3001, n = 174; and T/3002, n = 219) to twice-daily fexofenadine hydrochloride, 15 or 30 mg, or placebo mixed with a standard vehicle.

Results: In the combined population, the incidence of treatment-emergent adverse events (TEAEs) was comparable between groups (placebo, 48.2% [96/199]; fexofenadine hydrochloride, 15 mg, 40.0% [34/85]; and fexofenadine hydrochloride, 30 mg, 35.2% [38/108]). Vomiting was the most common TEAE (placebo, 13.6%; fexofenadine hydrochloride, 15 mg, 14.1%; and fexofenadine hydrochloride, 30 mg, 5.6%). Most TEAEs were unrelated to study medication, as evaluated by investigators; those possibly related to study medication were mild or moderate in intensity. No clinical differences were seen between fexofenadine and placebo for vital signs, electrocardiographic results, or physical examination results.

Conclusion: Fexofenadine hydrochloride, 15 or 30 mg, given for a mean duration of 8 days is well tolerated, with a good safety profile, in children aged 6 months to 2 years.

Publication types

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

MeSH terms

  • Administration, Oral
  • Blood Pressure / drug effects
  • Body Temperature / drug effects
  • Body Weight / drug effects
  • Child, Preschool
  • Electrocardiography / drug effects
  • Histamine H1 Antagonists, Non-Sedating / administration & dosage*
  • Histamine H1 Antagonists, Non-Sedating / adverse effects
  • Humans
  • Infant
  • Male
  • Rhinitis, Allergic, Perennial / drug therapy*
  • Statistics, Nonparametric
  • Terfenadine / administration & dosage
  • Terfenadine / adverse effects
  • Terfenadine / analogs & derivatives*


  • Histamine H1 Antagonists, Non-Sedating
  • Terfenadine
  • fexofenadine