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Allegra

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Allegra

Allegra

Allegra Side Effects Center

Medical Editor: Charles Patrick Davis, MD, PhD

Allegra (fexofenadine hydrochloride) is an antihistamine used to treat allergic symptoms of seasonal allergic rhinitis (sneezing, runny nose, itchy or watery eyes), and urticaria (hives). Allegra is available as a generic drug termed fexofenadine hydrochloride. Allegra is used in adults and children (2 years and older for allergies, 6 months and older for hives) for the control and reduction of the above symptoms. Some common side effects of Allegra include GI symptoms of nausea or diarrhea, muscle or back discomfort or pain, sleepiness, and menstrual cramps.

Allegra is available in several strengths and forms; as tablets in strengths of 30, 60 and 180 mg, as 30 mg fast orally disintegrating tablets (available in foil blister packs and labeled "ODT"; the drug should not be touched by skin as it may begin to dissolve and reduce the oral dose) and as an oral suspension of 30mg per 5 ml. The dosage is dependent on the age, weight and effectiveness of the drug; special care should be taken when prescribing this drug to infants and children to make sure the recommended dosage is given. Drugs like ketoconazole and erythromycin may markedly increase the availability of the drug in the body while fruit juices can reduce the concentration. Follow the recommendations of the prescribing doctor to avoid these interactions. There are no studies of Allegra in pregnant or lactating women; the use in the pediatric population is described above. Note that the Allegra ODT tablets (orally disintegrating tablets) contain 5.3 mg of phenylalanine and should not be used by individuals with phenylketonuria.

Our Allegra Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Allegra in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking fexofenadine and call your doctor if you have fever, chills, body aches, cough, or other flu symptoms.

Less serious side effects may include:

  • nausea, diarrhea, upset stomach;
  • menstrual cramps;
  • drowsiness, tired feeling;
  • headache; or
  • muscle or back pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Allegra (Fexofenadine Hcl) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Allegra Overview - Patient Information: Side Effects

SIDE EFFECTS: Cough, fever, or stomach upset may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

If your doctor has prescribed this medication, remember that he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Allegra (Fexofenadine Hcl)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Allegra FDA Prescribing Information: Side Effects
(Adverse Reactions)

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 entire FDA prescribing information for Allegra (Fexofenadine Hcl) »

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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.


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