Allegra Side Effects
Generic Name: fexofenadine
Please note - some side effects for Allegra may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).
Side Effects of Allegra - for the Consumer
Allegra
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Allegra:
Seek medical attention right away if any of these SEVERE side effects occur when using Allegra:Dizziness; headache; stomach upset.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); earache; fever; severe or persistent coughing or vomiting.
Allegra-D Extended-Release Tablets (12 Hour)
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Allegra-D Extended-Release Tablets (12 Hour):
Seek medical attention right away if any of these SEVERE side effects occur when using Allegra-D Extended-Release Tablets (12 Hour):Dizziness; dry mouth; headache; nausea; nervousness; trouble sleeping.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; difficult urination; fast/irregular heartbeat; hallucinations; mental or mood changes; seizures; shaking or tremor.
Allegra-D 24 Hour Extended-Release Tablets (24 Hour)
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Allegra-D 24 Hour Extended-Release Tablets (24 Hour):
Seek medical attention right away if any of these SEVERE side effects occur when using Allegra-D 24 Hour Extended-Release Tablets (24 Hour):Dizziness; dry mouth; headache; nausea; nervousness; trouble sleeping.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; difficult urination; fast/irregular heartbeat; hallucinations; mental or mood changes; seizures; involuntary shaking or tremor.
Allegra ODT Orally Disintegrating Tablets
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Allegra ODT Orally Disintegrating Tablets:
Seek medical attention right away if any of these SEVERE side effects occur when using Allegra ODT Orally Disintegrating Tablets:Dizziness; headache; stomach upset.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); earache; fever; severe or persistent coughing or vomiting.
Allegra Suspension
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Allegra Suspension:
Seek medical attention right away if any of these SEVERE side effects occur when using Allegra Suspension:Dizziness; headache; stomach upset.
TopSevere allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); earache; fever; severe or persistent coughing or vomiting.
Allegra Side Effects - for the Professional
Allegra
6.1 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 RhinitisAdults 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.
| 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.
| 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.
| 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% |
6.2 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.
| 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.
TopSide Effects by Body System
Gastrointestinal
Gastrointestinal side effects have included nausea and dyspepsia in approximately 1.5% of patients.
Nervous system
Nervous system side effects have included drowsiness in 1.3% of patients. Dizziness and headache have also been reported.
Genitourinary
Genitourinary side effects have included dysmenorrhea at a rate of 1.3%.
Hypersensitivity
Hypersensitivity side effects have included rare reports of rash, urticaria, and pruritus. Other hypersensitivity reactions have included angioedema, chest tightness, dyspnea, flushing, and systemic anaphylaxis.
Respiratory
Respiratory side effects have included nasopharyngitis and upper respiratory tract infection.
Musculoskeletal
Musculoskeletal side effects have included myalgia, back pain, and pain in extremity.
TopMore Allegra resources
- Allegra Detailed Consumer Information (PDR)
- Allegra Prescribing Information (FDA)
- Allegra Consumer Overview
- Allegra Advanced Consumer (Micromedex) - Includes Dosage Information
- Allegra Medfacts Consumer Leaflet (Wolters Kluwer)
- Fexofenadine Prescribing Information (FDA)
- Allegra ODT Orally Disintegrating Tablets Medfacts Consumer Leaflet (Wolters Kluwer)
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