Allegra (Fexofenadine Hydrochloride) - Side Effects and Adverse Reactions

ADVERSE REACTIONS

Clinical Studies Experience

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.

The incidence of adverse reactions, including somnolence/fatigue, was not dose-related and was similar across subgroups defined by age, gender, and race.

Table 1 Adverse reactions 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 reaction	Fexofenadine 60 mg Twice Daily	Placebo Twice Daily
	(n=680)	(n=674)
	Frequency	Frequency
Dysmenorrhea	1.5%	0.3%
Once-daily dosing with fexofenadine hydrochloride tablets at rates of greater than 2%
Adverse experience	Fexofenadine 180 mg Once Daily	Placebo
	(n=283)	(n=293)
	Frequency	Frequency
Headache	10.3%	7.2%
Back Pain	2.5%	1.4%

The frequency and magnitude of laboratory abnormalities were similar in fexofenadine hydrochloride- and placebo-treated subjects.

Pediatrics: Table 2 lists adverse reactions in subjects aged 6 years 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.

Table 2 Adverse experiences reported in placebo-controlled seasonal allergic rhinitis studies in pediatric subjects aged 6 years to 11 years 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%

Table 3 lists adverse events in subjects 6 months to 5 years of age in 3 open single- and multiple-dose pharmacokinetic studies and 3 placebo-controlled safety studies with fexofenadine hydrochloride capsule content (484 subjects) and suspension (50 subjects) at doses of 15 mg (108 subjects) and 30 mg (426 subjects) given twice a day.

Table 3 Adverse experiences reported in placebo-controlled studies in pediatric subjects with allergic rhinitis aged 6 months to 5 years of age at rates greater than 2%

Adverse experience	Fexofenadine 15 mg Twice Daily	Fexofenadine 30 mg Twice Daily	Total	Placebo
	(n=108)	(n=426)	(n=534)	(n=430)
Vomiting	12.0%	4.2%	5.8%	8.6%
Pyrexia	1.9%	4.5%	3.9%	7.0%
Cough	1.9%	4.0%	3.6%	3.3%
Otitis media	2.8%	3.8%	3.6%	3.3%
Diarrhoea	3.7%	2.8%	3.0%	2.6%
Rhinorrhoea	0.9%	2.1%	1.9%	0.9%
Upper respiratory tract infection	0.9%	2.1%	1.9%	4.0%
Somnolence	2.8%	0.7%	1.1%	0.2%

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 subjects. 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 months to 11 years of age is based on the safety profile of fexofenadine hydrochloride in adults and pediatric patients at doses equal to or higher than the recommended dose (see Pediatric Use).

Table 4 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.

REPORTS OF SIDE EFFECTS / ADVERSE REACTIONS RELATED TO ALLEGRA

Possible Allegra side effects / adverse reactions in 41 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2007-01-16

Patient: 41 year old female weighing 50.8 kg (111.8 pounds)

Reactions: Wrong Drug Administered, Hypoglycaemia, Hyperhidrosis, Anxiety, Medication Error, Dizziness, Asthenia, Drug Dispensing Error

Suspect drug(s):
Allegra

Other drugs received by patient: Glucophage/glyburide

Possible Allegra side effects / adverse reactions in 40 year old female

Reported by a physician from Japan on 2007-01-19

Patient: 40 year old female

Reactions: Stevens-Johnson Syndrome

Adverse event resulted in: hospitalization

Suspect drug(s):
Allegra

Other drugs received by patient: Chinese Herbal Medicine

Possible Allegra side effects / adverse reactions in 79 year old female

Reported by a physician from Japan on 2007-01-19

Patient: 79 year old female weighing 42.0 kg (92.4 pounds)

Reactions: Haemoglobin Decreased, Dyspnoea, Malaise, RED Blood Cell Count Decreased, Platelet Count Decreased, Neutropenia, Lymphocyte Stimulation Test Positive

Adverse event resulted in: life threatening event, hospitalization

Suspect drug(s):
Allegra
    Administration route: Oral
    Indication: Rhinitis
    Start date: 2006-11-02
    End date: 2006-11-03

Ebastel
    Administration route: Oral
    Indication: Eczema
    Start date: 2006-11-02
    End date: 2006-11-05

Zantac
    Administration route: Oral
    Indication: Gastritis
    Start date: 2006-09-19
    End date: 2006-11-10

Other drugs received by patient: Prednisolone; Calonal