Recommended Topic Related To:

Allegra

"March 5, 2013 -- Spring allergy season is again off to an early start in many parts of the country, and doctors say there are some signs it may be even more miserable than usual this year.

Last year was the fourth warmest winter on re"...

Allegra

Side Effects
Interactions

SIDE EFFECTS

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

The frequency and magnitude of laboratory abnormalities were similar in ALLEGRA (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 ALLEGRA (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 reactions 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 reaction Fexofenadine 30 mg Twice Daily
(n=209)
Frequency
Placebo
(n=229)
Frequency
Cough 3.8% 1.3%
Upper Respiratory Tract Infection 2.9% 0.9%
Pyrexia 2.4% 0.9%
Otitis Media 2.4% 0.0%

Table 3 lists adverse reactions in subjects 6 months to 5 years of age which were reported by greater than 2% of subjects treated with ALLEGRA (fexofenadine hydrochloride) in 3 open single- and multiple-dose pharmacokinetic studies and 3 placebo-controlled safety studies with ALLEGRA (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 reactions 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 reaction Fexofenadine 15 mg Twice Daily
(n=108)
Frequency
Fexofenadine 30 mg Twice Daily
(n=426)
Frequency
Fexofenadine Total
Twice Daily
(n=534)
Frequency
Placebo
(n=430)
Frequency
Vomiting 12.0% 4.2% 5.8% 8.6%
Diarrhea 3.7% 2.8% 3.0% 2.6%
Somnolence/Fatigue 2.8% 0.9% 1.3% 0.2%
Rhinorrhea 0.9% 2.1% 1.9% 0.9%

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 ALLEGRA (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 ALLEGRA (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 ALLEGRA (fexofenadine hydrochloride) 180 mg tablets. Table 4 also lists adverse reactions that were reported by greater than 2% of subjects treated with ALLEGRA (fexofenadine hydrochloride) tablets at doses of 180 mg once daily.

Table 4: Adverse reactions reported in subjects 12 years of age and older in placebo-controlled chronic idiopathic urticaria studies

Twice-daily dosing with ALLEGRA (fexofenadine hydrochloride) in studies in the UnitedStates and Canada at rates of greater than 2%
Adverse reaction Fexofenadine 60 mg Twice Daily
(n=191)
Frequency
Placebo
(n=183)
Frequency
Dizziness 2.1% 1.1%
Back Pain 2.1% 1.1%
Stomach discomfort 2.1% 0.6%
Pain in extremity 2.1% 0.0%
Once-daily dosing with ALLEGRA (fexofenadine hydrochloride) in a study in the United States at rates of greater than 2%
Adverse reaction Fexofenadine 180 mg Once Daily
(n=167)
Frequency
Placebo
(n=92)
Frequency
Headache 4.8% 3.3%

The safety of ALLEGRA (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 ALLEGRA (fexofenadine hydrochloride) in adults and pediatric patients at doses equal to or higher than the recommended dose [see Use in Specific Populations].

Postmarketing Experience

In addition to the adverse reactions reported during clinical studies and listed above, the following adverse events have been identified during post-approval use of ALLEGRA (fexofenadine hcl). Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Events that have been reported rarely during postmarketing experience include: insomnia, nervousness, sleep disorders or paroniria, and hypersensitivity reactions (including anaphylaxis, urticaria, angioedema, chest tightness, dyspnea, flushing, pruritus, and rash).

Read the Allegra (fexofenadine hcl) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

Antacids

ALLEGRA (fexofenadine hydrochloride) should not be taken closely in time with aluminum and magnesium containing antacids. In healthy adult subjects, administration of 120 mg of ALLEGRA (fexofenadine hydrochloride) (2 x 60 mg capsule) within 15 minutes of an aluminum and magnesium containing antacid (Maalox® ) decreased fexofenadine AUC by 41% and Cmax by 43%.

Erythromycin and Ketoconazole

Fexofenadine has been shown to exhibit minimal (ca. 5%) metabolism. However, co- administration of ALLEGRA (fexofenadine hydrochloride) with either ketoconazole or erythromycin led to increased plasma concentrations of fexofenadine in healthy adult subjects. Fexofenadine had no effect on the pharmacokinetics of either erythromycin or ketoconazole. In 2 separate studies in healthy adult subjects, ALLEGRA (fexofenadine hydrochloride) 120 mg twice daily (240 mg total daily dose) was co-administered with either erythromycin 500 mg every 8 hours or ketoconazole 400 mg once daily under steady-state conditions to healthy adult subjects (n=24, each study). No differences in adverse events or QTc interval were observed when subjects were administered ALLEGRA (fexofenadine hydrochloride) alone or in combination with either erythromycin or ketoconazole. The findings of these studies are summarized in the following table:

Table 5: Effects on steady-state fexofenadine pharmacokinetics after 7 days of co-administration with ALLEGRA (fexofenadine hydrochloride) 120 mg every 12 hours in healthy adult subjects (n=24)

Concomitant Drug CmaxSS
(Peak plasma concentration)
AUCss(0-12h)
(Extent of systemic exposure)
Erythromycin (500 mg every 8 hrs) +82% +109%
Ketoconazole (400 mg once daily) +135% +164%

The changes in plasma levels were within the range of plasma levels achieved in adequate and well-controlled clinical trials.

The mechanism of these interactions has been evaluated in in vitro, in situ, and in vivo animal models. These studies indicate that ketoconazole or erythromycin co-administration enhances fexofenadine gastrointestinal absorption. This observed increase in the bioavailability of fexofenadine may be due to transport-related effects, such as p-glycoprotein. In vivo animal studies also suggest that in addition to enhancing absorption, ketoconazole decreases fexofenadine gastrointestinal secretion, while erythromycin may also decrease biliary excretion.

Fruit Juices

Fruit juices such as grapefruit, orange and apple may reduce the bioavailability and exposure of fexofenadine. This is based on the results from 3 clinical studies using histamine induced skin wheals and flares coupled with population pharmacokinetic analysis. The size of wheal and flare were significantly larger when ALLEGRA (fexofenadine hydrochloride) was administered with either grapefruit or orange juices compared to water. Based on the literature reports, the same effects may be extrapolated to other fruit juices such as apple juice. The clinical significance of these observations is unknown. In addition, based on the population pharmacokinetics analysis of the combined data from grapefruit and orange juices studies with the data from a bioequivalence study, the bioavailability of fexofenadine was reduced by 36%. Therefore, to maximize the effects of fexofenadine, it is recommended that ALLEGRA (fexofenadine hcl) tablets should be taken with water [see CLINICAL PHARMACOLOGY and DOSAGE AND ADMINISTRATION].

ALLEGRA (fexofenadine hcl) ODT can be taken with or without water [see CLINICAL PHARMACOLOGY and DOSAGE AND ADMINISTRATION].

Read the Allegra Drug Interactions Center for a complete guide to possible interactions

Last reviewed on RxList: 11/1/2010
This monograph has been modified to include the generic and brand name in many instances.

Side Effects
Interactions
A A A

Allegra - User Reviews

Allegra User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Allegra sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


Allergies & Asthma

Improve treatments & prevent attacks.


NIH talks about Ebola on WebMD