Fexofenadine side effects

List of side effects
Seasonal allergic rhinitis Chronic idiopathic urticaria'''
 * Adults
 * Incidence of adverse events
 * Laboratory abnormalities (compared to placebo)
 * Pediatrics
 * Safety
 * Adverse events

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. 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. Return to top

Incidence of adverse events
The incidence of adverse events, including drowsiness, was not dose-related and was similar across subgroups defined by age, gender, and race. Return to top

Laboratory abnormalities (compared to placebo)
The frequency and magnitude of laboratory abnormalities were similar in Fexofenadine hydrochloride- and placebo-treated subjects. Return to top

Pediatrics
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. Return to top

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. 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. Return to top

Safety
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. Return to top

Adverse events
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. Return to top