Allegra

[Fexofenadine]

Three clinical safety studies in 845 children aged 6 months to 5 years comparing 15 mg BID (n=85) and 30 mg BID (n=330) of an experimental formulation of fexofenadine to placebo (n=430) have been conducted. In general, fexofenadine hydrochloride was well tolerated in these studies.

No unexpected adverse events were seen given the known safety profile of fexofenadine and likely adverse reactions for this patient population. (See PRECAUTIONS Pediatric Use.)

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Chronic Idiopathic Urticaria

Adverse events reported by patients 12 years of age and older in placebo-controlled chronic idiopathic urticaria studies were similar to those reported in placebo-controlled seasonal allergic rhinitis studies. In placebo-controlled chronic idiopathic urticaria clinical trials, which included 726 patients 12 years of age and older receiving fexofenadine hydrochloride tablets at doses of 20 to 240 mg twice daily, adverse events were similar in fexofenadine hydrochloride and placebo-treated patients.

Table 3 lists adverse experiences in patients aged 12 years and older which were reported by greater than 2% of patients treated with fexofenadine hydrochloride 60 mg tablets twice daily in controlled clinical studies in the United States and Canada and that were more common with fexofenadine hydrochloride than placebo. The safety of fexofenadine hydrochloride in the treatment of chronic idiopathic urticaria in pediatric patients 6 to 11 years of age is based on the safety profile of fexofenadine hydrochloride in adults and adolescent patients at doses equal to or higher than the recommended dose (see Pediatric Use).

Events that have been reported during controlled clinical trials involving seasonal allergic rhinitis and chronic idiopathic urticaria patients with incidences less than 1% and similar to placebo and have been rarely reported during postmarketing surveillance include: insomnia, nervousness, and sleep disorders or paroniria. In rare cases, rash, urticaria, pruritus and hypersensitivity reactions with manifestations such as angioedema, chest tightness, dyspnea, flushing and systemic anaphylaxis have been reported.

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