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Fexofenadine is a second‑generation, non‑sedating antihistamine that selectively blocks peripheral histamine H1 receptors without significant penetration into the central nervous system. It provides rapid, long‑lasting relief from seasonal allergy symptoms such as sneezing, runny nose, itchy/watery eyes, and itching of the nose or throat, and is also used for chronic hives.
Usual adult dose: For seasonal allergic rhinitis, 60 mg twice daily or 180 mg once daily; for chronic idiopathic urticaria, 180 mg once daily. The 120 mg strength is also available and may be used in certain patients under the direction of a healthcare provider.
Dosage form: Oral tablets (120 mg, 180 mg; also available as 60 mg tablets).
Onset of action: Symptom relief typically begins within 1‑2 hours, with peak effect at approximately 2‑4 hours.
Duration of action: A single 180 mg dose provides 24‑hour symptom control.
Alcohol consumption is considered acceptable in moderation; fexofenadine does not enhance the sedative effects of alcohol, though heavy drinking may worsen allergy symptoms or cause dehydration.
Most common side effects: headache, dizziness, nausea, and diarrhea; these occur infrequently and are usually mild.
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General Information about Fexofenadine

• INN (International Nonproprietary Name): Fexofenadine hydrochloride
• Brand names available in the USA: Allegra® (Sanofi Consumer Healthcare). Generic fexofenadine tablets are available over‑the‑counter from manufacturers such as Teva Pharmaceuticals USA, Inc., Mylan Pharmaceuticals Inc., Perrigo Company plc, and many store‑brand labels.
• ATC code: R06AX26
• Dosage forms and strengths: Film‑coated tablets: 60 mg, 120 mg, and 180 mg. (Also available as oral suspension and orally disintegrating tablets in other strengths.)
• Manufacturers in USA: Sanofi Consumer Healthcare (brand Allegra®); generic manufacturers include Teva Pharmaceuticals USA, Inc., Mylan Pharmaceuticals Inc., Perrigo Company plc, and numerous private‑label producers.
• Registration status in USA: Originally approved by the FDA under NDA 020872 (1996); switched to OTC status in 2011. Currently marketed under the OTC monograph system.
• OTC / Rx classification: Over‑the‑counter (OTC) – no prescription required.

Mechanism of Action and Pharmacology

Fexofenadine is a selective, peripheral H1‑receptor antagonist. It binds to histamine H1 receptors on effector cells in the skin, respiratory tract, and gastrointestinal system, preventing histamine from triggering the allergic cascade. Unlike first‑generation antihistamines, fexofenadine does not readily cross the blood‑brain barrier due to its substrate affinity for the P‑glycoprotein (P‑gp) efflux transporter, which actively pumps it out of the central nervous system. This peripheral selectivity results in effective antihistaminic action without significant sedation or impairment of cognitive function. Fexofenadine is not metabolized by the cytochrome P450 system; it undergoes negligible hepatic biotransformation. After oral administration, peak plasma concentrations are reached within 2‑3 hours. The presence of food, especially a high‑fat meal, or fruit juices (grapefruit, orange, apple) can reduce its bioavailability by up to 50%, so it is best taken on an empty stomach. The elimination half‑life is approximately 14‑15 hours, and the drug is primarily eliminated unchanged in the feces and urine. Its once‑daily dosing with 180 mg provides 24‑hour relief from allergic symptoms.

Indications

• Temporary relief of symptoms due to seasonal allergic rhinitis (hay fever) including sneezing, runny or itchy nose, and itchy, watery eyes.
• Treatment of chronic idiopathic urticaria (hives) to reduce itching and the number of wheals.
• Also used for perennial allergic rhinitis and other histamine‑mediated skin allergies.

Important Warnings and Precautions

Fexofenadine is generally well tolerated, but it should be used with caution in patients with renal impairment, as the drug is partly eliminated by the kidneys. Dose reduction is recommended for patients with decreased kidney function. Although it has a very low sedative potential, some individuals may experience dizziness or drowsiness; patients should determine their individual response before driving or operating heavy machinery. Fruit juices (grapefruit, orange, apple) and large amounts of certain antacids containing aluminum or magnesium can significantly reduce the absorption of fexofenadine; doses should be separated by at least 2 hours from these substances. Do not exceed the recommended dose. If symptoms persist or worsen, consult a healthcare provider. There is no evidence of cardiac toxicity or QT prolongation with fexofenadine, even at high doses, unlike some earlier antihistamines. Stop use and seek medical advice if an allergic reaction (rash, swelling, difficulty breathing) occurs.

At‑risk groups

• Elderly: No dose adjustment is required based solely on age. However, elderly patients are more likely to have reduced renal function; monitoring is prudent.
• Pregnancy: Fexofenadine is considered Pregnancy Category C. There are no adequate, well‑controlled studies in pregnant women. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
• Breastfeeding: Fexofenadine is excreted into human milk in small amounts. Caution is advised; a decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the mother.
• Renal impairment: Dosing adjustment is recommended. For adults with creatinine clearance ≤30 mL/min, the recommended dose is 60 mg once daily. In children with renal impairment, a similar proportionally reduced dose should be used.
• Hepatic impairment: No dose adjustment is required; fexofenadine undergoes minimal hepatic metabolism.
• Pediatric: For seasonal allergies, children 6‑11 years: 30 mg twice daily; children 12 years and older: same as adult doses (60 mg twice daily or 180 mg once daily). For chronic urticaria, children 6‑11 years: 30 mg twice daily; children 12 and older: 180 mg once daily. Safety and efficacy in children under 6 years have not been established for the tablet strengths; the oral suspension is used.

Driving and alcohol

Fexofenadine is considered a non‑sedating antihistamine and is not expected to impair driving ability at recommended doses. However, rare cases of dizziness or drowsiness can occur. Patients should avoid driving or operating machinery until they know how the medication affects them. Alcohol consumption does not appear to potentiate the central nervous system effects of fexofenadine; moderate alcohol intake is generally acceptable, but heavy drinking may exacerbate allergy symptoms and should be avoided.

Dosage Instructions

• Seasonal allergic rhinitis – adults and children 12 years and older: 60 mg twice daily or 180 mg once daily. The 180 mg once‑daily dose is convenient and equally effective.
• Chronic idiopathic urticaria – adults and children 12 years and older: 180 mg once daily.
• Children 6‑11 years: 30 mg twice daily for both allergic rhinitis and urticaria. The 120 mg tablet is not typically used in this age group; if a 120 mg dose is prescribed, it would be for older children with specific needs.
• Renal impairment: For adults with creatinine clearance ≤30 mL/min, the dose should be reduced to 60 mg once daily. For children, a corresponding reduction based on weight should be made.
• Administration: Take the tablet with a full glass of water on an empty stomach, at least 1 hour before or 2 hours after a meal, for optimal absorption. Avoid taking with fruit juices (grapefruit, orange, apple) or within 2 hours of antacids containing aluminum or magnesium hydroxide.
• Missed dose: If a dose is missed, take it as soon as remembered. If it is nearly time for the next scheduled dose, skip the missed dose and resume the usual schedule. Do not double the dose.

Side Effects and Contraindications

Most common side effects (incidence >2% and more than placebo): Headache (4‑8%), dizziness (2%), nausea (2%), diarrhea (2‑4%), and fatigue. These are generally mild and temporary.
Other adverse reactions: Dyspepsia, myalgia, and upper respiratory tract infection have been reported.
Serious adverse reactions: Hypersensitivity reactions, including angioedema and anaphylaxis, are rare. No clinically significant cardiac arrhythmias or QTc prolongation have been observed even at supratherapeutic doses.
Absolute contraindications: Known hypersensitivity to fexofenadine hydrochloride or any of its excipients.

Drug Interactions

• Fruit juices (grapefruit, orange, apple): Reduce the oral bioavailability of fexofenadine by up to 50%. Separate administration by at least 2 hours.
• Antacids containing aluminum or magnesium hydroxide: Decrease fexofenadine absorption if taken simultaneously. Separate by at least 2 hours.
• P‑glycoprotein (P‑gp) inhibitors (e.g., ketoconazole, itraconazole, ritonavir, verapamil): May increase fexofenadine plasma levels by inhibiting its efflux, but no dose adjustment is required as increases are not considered clinically significant.
• P‑glycoprotein (P‑gp) inducers (e.g., rifampin, St. John's Wort): May reduce fexofenadine efficacy; monitor symptom control.
• Alcohol: No clinically significant interaction; moderate consumption is permitted.
• Fexofenadine does not inhibit or induce cytochrome P450 enzymes; interactions with CYP‑metabolized drugs are not expected.

Practical Advice

• Take fexofenadine exactly as directed on the package label or by your healthcare provider. Swallow the tablet whole with a full glass of water.
• For best results, take on an empty stomach with water; avoid taking with fruit juices or within 2 hours of an antacid.
• If you miss a dose, take it as soon as you remember, but do not take two doses at once.
• This medication is non‑sedating for most people; however, if you feel dizzy, avoid driving or operating machinery.
• Limit alcohol intake, as heavy drinking can worsen allergy symptoms.
• Store at room temperature (20‑25°C / 68‑77°F) in a dry place, protected from light. Keep out of reach of children.
• Do not use for more than 2 weeks for hives or 7 days for nasal symptoms without consulting a doctor. If symptoms do not improve or worsen, seek medical evaluation.
• Do not share your medication, even if others have similar symptoms.

Alternative Medications

• Cetirizine (Zyrtec®): Another second‑generation antihistamine with similar efficacy but slightly more sedation potential. Available OTC.
• Loratadine (Claritin®): A non‑sedating antihistamine that can be taken with or without food. Available OTC.
• Levocetirizine (Xyzal®): An isomer of cetirizine, effective with lower sedation. Available OTC.
• Desloratadine (Clarinex®): A non‑sedating, longer‑acting metabolite of loratadine. Available by prescription.
• Bilastine (Ilaxten®, not FDA‑approved in the US): A newer non‑sedating antihistamine available in other countries.
• Intranasal corticosteroids (fluticasone propionate Flonase®, triamcinolone Nasacort®): For long‑term control of allergic rhinitis without systemic side effects.

Clinical Efficacy

Fexofenadine has been extensively studied in placebo‑controlled trials for seasonal allergic rhinitis and chronic urticaria. In seasonal rhinitis, fexofenadine 180 mg once daily or 60 mg twice daily significantly reduced total symptom scores, including sneezing, rhinorrhea, nasal itching, and ocular symptoms, compared with placebo. The onset of relief is within 1‑2 hours and persists for 24 hours. In chronic idiopathic urticaria, fexofenadine 180 mg once daily significantly decreased pruritus severity and wheal counts over 4‑6 weeks of treatment. Fexofenadine has a well‑characterized safety profile; at therapeutic and even supratherapeutic doses (up to 690 mg twice daily for 28 days), it does not cause QTc prolongation, making it suitable for patients with cardiovascular risk. It is recommended as a first‑line non‑sedating antihistamine in national and international guidelines for allergic rhinitis and urticaria.

Important:

Fexofenadine is an over‑the‑counter antihistamine available without a prescription. It is generally well tolerated, but some individuals may experience dizziness. Do not exceed the recommended dose. If you have kidney disease, consult your healthcare provider before use, as a lower dose may be required. Take this medication on an empty stomach with water; avoid fruit juices and antacids within 2 hours of dosing to ensure full effectiveness. Pregnant or nursing women should consult a doctor before use. If symptoms do not improve after 7 days for allergies or 2 weeks for hives, or if they worsen, discontinue use and seek medical attention. Stop use and get immediate help if you develop signs of a serious allergic reaction, such as rash, swelling, or difficulty breathing. Keep out of reach of children. Store at room temperature. Do not share your medication with others. This product is not a substitute for emergency anaphylaxis treatment.

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