Fexofenadine - Side Effects

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety data described below reflect exposure to fexofenadine hydrochloride in 5083 patients in trials for allergic rhinitis and chronic idiopathic urticaria. In these trials, 3010 patients 12 years of age and older with seasonal allergic rhinitis were exposed to fexofenadine hydrochloride at doses of 20 to 240 mg twice daily or 120 to 180 mg once daily. A total of 646 patients 6 to 11 years of age with seasonal allergic rhinitis were exposed to fexofenadine hydrochloride at doses of 15 to 60 mg twice daily. The duration of treatment in these trials was 2 weeks. A total of 534 patients 6 months to 5 years of age with allergic rhinitis were exposed to fexofenadine hydrochloride at doses of 15 to 30 mg twice daily. The duration of treatment in these trials ranged from 1 day to 2 weeks. There were 893 patients 12 years of age and older with chronic idiopathic urticaria exposed to fexofenadine hydrochloride at doses of 20 to 240 mg twice daily or 180 mg once daily. The duration of treatment in these trials was 4 weeks.
Seasonal Allergic Rhinitis

Adults and Adolescents: In placebo-controlled seasonal allergic rhinitis clinical trials in subjects 12 years of age and older, 2439 subjects received fexofenadine hydrochloride capsules at doses of 20 mg to 240 mg twice daily. All adverse reactions that were reported by greater than 1% of subjects who received the recommended daily dose of fexofenadine hydrochloride (60 mg capsules twice daily) are listed in Table 1.

In another placebo-controlled clinical study in the United States, 571 subjects aged 12 years and older received fexofenadine hydrochloride tablets at doses of 120 or 180 mg once daily. Table 1 also lists adverse reactions that were reported by greater than 2% of subjects treated with fexofenadine hydrochloride tablets at doses of 180 mg once daily.

Chronic Idiopathic Urticaria

Adverse reactions reported by subjects 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, 726 subjects 12 years of age and older received fexofenadine hydrochloride tablets at doses of 20 to 240 mg twice daily. Table 4 lists adverse reactions in subjects aged 12 years and older which were reported by greater than 2% of subjects treated with fexofenadine hydrochloride 60 mg tablets twice daily in controlled clinical studies in the United States and Canada.

In a placebo-controlled clinical study in the United States, 167 subjects aged 12 years and older received fexofenadine hydrochloride 180 mg tablets. Table 4 also lists adverse reactions that were reported by greater than 2% of subjects treated with fexofenadine hydrochloride tablets at doses of 180 mg once daily.