adverse reactions
ADVERSE REACTIONS Seasonal Allergic Rhinitis: 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. Table 1 Adverse experiences in patients ages 12 years and older reported in placebo-controlled seasonal allergic rhinitis clinical trials in the United States Twice daily dosing with fexofenadine capsules at rates of greater than 1% Adverse ExperienceFexofenadine 60 mg Twice Daily (n=679)Placebo Twice Daily (n=671)Viral Infection (cold, flu)2.5%1.5%Nausea1.6%1.5%Dysmenorrhea1.5%0.3%Drowsiness1.3%0.9%Dyspepsia1.3%0.6%Fatigue1.3%0.9%Once daily dosing with fexofenadine hydrochloride tablets at rates of greater than 2%Adverse ExperienceFexofenadine 180 mg Once Daily (n=283)Placebo (n=293)Headache10.6%7.5%Upper Respiratory Tract Infection3.2%3.1%Back Pain2.8%1.4%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. Table 2 Adverse experiences reported in placebo-controlled seasonal allergic rhinitis studies in pediatric patients ages 6 to 11 in the United States and Canada at rates of greater than 2% Adverse ExperienceFexofenadine 30 mg Twice Daily (n=209)Placebo (n=229)Headache7.2%6.6%Accidental Injury2.9%1.3%Coughing3.8%1.3%Fever2.4%0.9%Pain2.4%0.4%Otitis Media2.4%0.0%Upper Respiratory Tract Infection4.3%1.7%Additional clinical study information related to safety of fexofenadine in pediatric patients is approved for Aventis Pharmaceuticals'fexofenadine hydrochloride drug products. However, due to Aventis Pharmaceuticals'marketing exclusivity rights, this drug product in not labeled for use in children less than 6 years of age. 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). Table 3 Adverse experiences reported in patients 12 years and older in placebo-controlled chronic idiopathic urticaria studies in the United States and Canada at rates of greater than 2% Adverse ExperienceFexofenadine 60 mg Twice Daily (n=186)Placebo (n=178)Back Pain2.2%1.1%Sinusitis2.2%1.1%Dizziness2.2%0.6%Drowsiness2.2%0.0%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 paranoia. In rare cases, rash, urticaria, pruritis, and hypersensitivty reactions with manifestations such as angioedema, chest tightness, dyspnea, flushing and systemic anaphylaxis have been reported.