Fexofenadine Side Effects

Brand Names: Allegra, Allegra ODT

Please note - some side effects for Fexofenadine 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 Fexofenadine - for the consumer

Fexofenadine

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 Fexofenadine:

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.

Fexofenadine/Pseudoephedrine 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 Fexofenadine/Pseudoephedrine 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.

Fexofenadine/Pseudoephedrine 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 Fexofenadine/Pseudoephedrine 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.

Fexofenadine 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 Fexofenadine 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.

Fexofenadine 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 Fexofenadine 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

Fexofenadine

Seasonal Allergic Rhinitis

In placebo-controlled seasonal allergic rhinitis clinical trials in subjects 12 years of age and older, which included 2461 subjects receiving Fexofenadine hydrochloride capsules at doses of 20 mg to 240 mg twice daily, adverse events were similar in Fexofenadine hydrochloride- and placebo-treated subjects. All adverse events that were reported by greater than 1% of subjects 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 subjects 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 subjects. Table 1 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 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 subjects.

Table 2 lists adverse experiences in subjects aged 6 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 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 twice daily (n=85) and 30 mg twice daily (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 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 patients. 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 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 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.

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