Allegra Side Effects & Drug Interactions - Fexofenadine

[Fexofenadine]

ADVERSE REACTIONS

Adults.

In placebo-controlled seasonal allergic rhinitis clinical trials in patients 12 years of age and older, which included 2461 patients receiving fexofenadine hydrochloride capsules at doses of 20 mg to 240 mg twice daily, adverse events were similar in fexofenadine hydrochloride and placebo-treated patients.

All adverse events that were reported by greater than 1% of patients who received the recommended daily dose of fexofenadine hydrochloride (60 mg capsules twice daily), and that were more common with fexofenadine hydrochloride than placebo, are listed in Table 1. In a placebo-controlled clinical study in the United States, which included 570 patients aged 12 years and older receiving fexofenadine hydrochloride tablets at doses of 120 or 180 mg once daily, adverse events were similar in fexofenadine hydrochloride and placebo-treated patients.

Table 1 also lists adverse experiences that were reported by greater than 2% of patients treated with fexofenadine hydrochloride tablets at doses of 180 mg once daily and that were more common with fexofenadine hydrochloride than placebo. The incidence of adverse events, including drowsiness, was not dose-related and was similar across subgroups defined by age, gender, and race.

The frequency and magnitude of laboratory abnormalities were similar in fexofenadine hydrochloride and placebo-treated patients. Pediatric. Table 2 lists adverse experiences in patients aged 6 to 11 years of age which were reported by greater than 2% of patients treated with fexofenadine hydrochloride tablets at a dose of 30 mg twice daily in placebo-controlled seasonal allergic rhinitis studies in the United States and Canada that were more common with fexofenadine hydrochloride than placebo.

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.