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.

Fexofenadine Side Effects - for the Professional

Fexofenadine

The most common adverse reactions (≥ 2%) in subjects age 12 years and older were headache, back pain, dizziness, stomach discomfort, and pain in extremity. In subjects aged 6 to 11 years, cough, upper respiratory tract infection, pyrexia and otitis media were more frequently reported. In subjects aged 6 months to 5 years, vomiting, diarrhea, somnolence/fatigue and rhinorrhea were more frequently reported. (6.1). Other adverse reactions have been reported. (6)

To report SUSPECTED ADVERSE REACTIONS, contact Dr. Reddy’s Laboratories, Inc. at 1-888-375-3784 or FDA at 1-800-FDA-1088 or 1

Side 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.

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