Allegra Side Effects

Generic name: fexofenadine

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:

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):

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):

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:

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:

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.

For the professional

Allegra Capsules Tablets

Seasonal Allergic Rhinitis

In placebo-controlled seasonal allergic rhinitis clinical trials in patients 12 years of age and older, which included 2461 patients receiving fexofenadine hydrochloride capsules at doses of 20 mg to 240 mg twice daily, adverse events were similar in fexofenadine hydrochloride and placebo-treated patients. All adverse events that were reported by greater than 1% of patients who received the recommended daily dose of fexofenadine hydrochloride (60 mg capsules twice daily), and that were more common with fexofenadine hydrochloride than placebo, are listed in Table 1.

In a placebo-controlled clinical study in the United States, which included 570 patients 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 patients. Table 1 also lists adverse experiences that were reported by greater than 2% of patients treated with fexofenadine hydrochloride tablets at doses of 180 mg once daily and that were more common with fexofenadine hydrochloride than placebo.

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

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

Table 2 lists adverse experiences in patients aged 6 to 11 years of age which were reported by greater than 2% of patients 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 that were more common with fexofenadine hydrochloride than placebo.

Three clinical safety studies in 845 children aged 6 months to 5 years comparing 15 mg BID (n=85) and 30 mg BID (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.

Chronic Idiopathic Urticaria

Adverse events reported by patients 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 patients 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. Table 3 lists adverse experiences in patients aged 12 years and older which were reported by greater than 2% of patients 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. 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.

Events that have been reported during controlled clinical trials involving seasonal allergic rhinitis and chronic idiopathic urticaria patients 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.

By body system

Gastrointestinal side effects

Gastrointestinal side effects have included nausea and dyspepsia in approximately 1.5% of patients.

Nervous system side effects

Nervous system side effects have included drowsiness in 1.3% of patients. Dizziness and headache have also been reported.

Genitourinary side effects

Genitourinary side effects have included dysmenorrhea at a rate of 1.3%.

Hypersensitivity side effects

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 side effects

Respiratory side effects have included nasopharyngitis and upper respiratory tract infection.

Musculoskeletal side effects

Musculoskeletal side effects have included myalgia, back pain, and pain in extremity.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This information does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug of drug combination is safe, effective, or appropriate for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of information provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.