ADVERSE REACTIONS
Seasonal Allergic Rhinitis
Adults
In placebo-controlled seasonal allergic rhinitis clinical trials in subjects 12 years of age and older, which included 2461 subjects receiving fexofenadine hydrochloride capsules at doses of 20 mg to 240 mg twice daily, adverse events were similar in fexofenadine hydrochloride- and placebo-treated subjects. All adverse events that were reported by greater than 1% of subjects 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 subjects 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 subjects. Table 1 also lists adverse experiences that were reported by greater than 2% of subjects 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 subjects aged 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 experience | Fexofenadine 60 mg
Twice Daily
(n=679) | Placebo
Twice Daily
(n=671) |
| Viral Infection (cold, flu) | 2.5% | 1.5% |
| Nausea | 1.6% | 1.5% |
| Dysmenorrhea | 1.5% | 0.3% |
| Drowsiness | 1.3% | 0.9% |
| Dyspepsia | 1.3% | 0.6% |
| Fatigue | 1.3% | 0.9% |
| | | |
Once daily dosing with fexofenadine hydrochloride tablets
at rates of greater than 2% |
| Adverse experience | Fexofenadine 180 mg
Once Daily
(n=283) | Placebo
(n=293) |
| Headache | 10.6% | 7.5% |
| Upper Respiratory Tract Infection | 3.2% | 3.1% |
| Back Pain | 2.8% | 1.4% |
The frequency and magnitude of laboratory abnormalities were similar in fexofenadine hydrochloride- and placebo-treated subjects.
Pediatrics
Table 2 lists adverse experiences in subjects aged 6 to 11 years of age which were reported by greater than 2% of subjects 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 subjects aged 6 to 11 in the United States and Canada at rates of greater than 2% | Adverse experience | Fexofenadine 30 mg
Twice Daily
(n=209) | Placebo
(n=229) |
| Headache | 7.2% | 6.6% |
| Accidental Injury | 2.9% | 1.3% |
| Coughing | 3.8% | 1.3% |
| Fever | 2.4% | 0.9% |
| Pain | 2.4% | 0.4% |
| Otitis Media | 2.4% | 0.0% |
| Upper Respiratory Tract Infection | 4.3% | 1.7% |
Three clinical safety studies in 845 children aged 6 months to 5 years comparing 15 mg twice daily (n=85) and 30 mg twice daily (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.)
Chronic Idiopathic Urticaria
Adverse events 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, which included 726 subjects 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 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 and that were more common with fexofenadine hydrochloride than placebo.
In a placebo-controlled clinical study in the United States, which included 167 subjects aged 12 years and older receiving fexofenadine hydrochloride 180 mg tablets, adverse events were similar in fexofenadine hydrochloride- and placebo-treated subjects. Table 3 also lists adverse experiences that were reported by greater than 2% of subjects treated with fexofenadine hydrochloride tablets at doses of 180 mg once daily 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 subjects 12 years of age and older in placebo-controlled chronic idiopathic urticaria studies Twice-daily dosing with fexofenadine hydrochloride in studies
in the United States and Canada at rates of greater than 2% |
| Adverse experience | Fexofenadine 60 mg
Twice Daily
(n=191) | Placebo
(n=183) |
| Dyspepsia | 4.7% | 4.4% |
| Myalgia | 2.6% | 2.2% |
| Back Pain | 2.1% | 1.1% |
| Dizziness | 2.1% | 1.1% |
| Pain in extremity | 2.1% | 0.0% |
| | | |
Once-daily dosing with fexofenadine hydrochloride in a study
in the United States at rates of greater than 2% |
| Adverse experience | Fexofenadine 180 mg
Once Daily
(n=167) | Placebo
(n=92) |
| Headache | 4.8% | 3.3% |
| Nasopharyngitis | 2.4% | 2.2% |
| Upper respiratory tract infection | 2.4% | 2.2% |
Events that have been reported during controlled clinical trials involving seasonal allergic rhinitis and chronic idiopathic urticaria subjects 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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