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Fexofenadine

AEMPS

Second-generation antihistamine

ATC code: R06AX26

Updated · Methodology

Indications

A

Allergic rhinitis

First line

First-line for seasonal and perennial allergic rhinitis under ARIA 2020. Adult dose 120 mg once daily for rhinitis; children 6–11 years take 30 mg twice daily. Efficacy and tolerability match cetirizine and loratadine; near-zero sedation makes it convenient for working patients and drivers.

Sources

  1. AEMPS: Ficha técnica de Fexofenadina (2024)
  2. EAACI: ARIA guideline 2019 update on allergic rhinitis (2020)
  3. International Archives of Allergy and Immunology: Systematic Review on the Efficacy of Fexofenadine in Seasonal Allergic Rhinitis: A Meta-Analysis of Randomized, Double-Blind, Placebo-Controlled Clinical Trials (2011)

ICD-10: J30.9 · ICD-11: CA08.0

Marketing claims without evidence base

The drug is promoted for these uses outside international guidelines. Each entry below is analyzed against AEMPS, FDA, EMA, Cochrane and major RCTs.

F

Immune support and respiratory infection care

Not recommended

Fexofenadine is a second-generation antihistamine. It is prescribed for seasonal and perennial allergic rhinitis and urticaria ( 2024). Fexofenadine is taken at the first signs of a cold and for immunity, expecting a systemic anti-allergic effect. The Cochrane review by De Sutter 2015 did not confirm significant benefit of antihistamines in the common cold. If fexofenadine was prescribed for a cold without confirmed allergic rhinitis, consider seeking a second opinion.

Sources

  1. AEMPS: Ficha técnica de Fexofenadina (2024)
  2. Cochrane (Hemila and Chalker): Vitamin C for preventing and treating the common cold (2013)
How to read tiers A–F
  • AStrong evidence – first or second line in international guidelines
  • BRecommended in selected cases
  • CStudy data contradict each other
  • DBenefit not proven, no documented harm
  • FDocumented harm, or risk without benefit

Mechanism of action

An active metabolite of terfenadine. A selective peripheral H1-antagonist without significant anticholinergic activity. P-glycoprotein keeps it out of the brain – sedation is near zero. Not CYP-metabolized; mostly excreted unchanged via bile and urine, so CYP-mediated interactions are minimal.

Safety

Contraindications

  • Fexofenadine hypersensitivity
  • Age under 6 months (liquid forms)

Serious adverse effects

  • Rare hypersensitivity reactions (angioedema, anaphylaxis) reported post-marketing

Common adverse effects

  • Headache
  • Drowsiness (1–2%, placebo-level)
  • Nausea

Pregnancy: can you take Fexofenadine?

AEMPS summary of product characteristics (section 4.6): there are no data on the use of fexofenadine in pregnant women. Limited animal studies do not indicate direct or indirect harmful effects on pregnancy, embryo-fetal development, parturition or postnatal development. Fexofenadine should not be used during pregnancy unless clearly necessary.

Breastfeeding: can you take Fexofenadine?

Hale L2 · Probably compatible

Compatible. Hale L2. RID 0.7%. Active metabolite of terfenadine without cardiotoxicity. Non-sedating.

RID, infant dose via milk
0.7%
Maternal half-life
14.0 h
Maternal peak time
2.5 h
Peak milk concentration
0.04 mg/L
Milk-to-plasma ratio
0.2
Calculate RIDSafe feeding windowFull profile on NIH LactMed ↗

Reference information, not a clinical decision. Discuss feeding pauses or changes with your physician or an IBCLC.

Practical notes

Timing and administration

Take on an empty stomach or 1 hour before food. Fruit juices (apple, orange, grapefruit) reduce absorption by 30–40% via OATP inhibition – allow at least 4 hours between fexofenadine and juice. Aluminum- or magnesium-containing antacids reduce absorption – separate by at least 2 hours.
Label mentions8 mentions

Verbatim lines from the interaction sections, in the language of the label

From this drug’s label

  • antiácidosclass named in the label
    «No se ha observado interacción entre fexofenadina y omeprazol. Sin embargo la administración de un antiácido que contenga geles de hidróxidos de aluminio y magnesio 15 minutos antes de la toma de…»

    AEMPS, section 4.5 · Open on CIMA

  • Erythromycin
    «La fexofenadina no se biotransforma por vía hepática, y por lo tanto no interacciona con otros medicamentos que se metabolizan a través de mecanismos hepáticos. La fexofenadina es una P-glicoproteína…»

    AEMPS, section 4.5 · Open on CIMA

  • Ketoconazole
    «La fexofenadina no se biotransforma por vía hepática, y por lo tanto no interacciona con otros medicamentos que se metabolizan a través de mecanismos hepáticos. La fexofenadina es una P-glicoproteína…»

    AEMPS, section 4.5 · Open on CIMA

  • Omeprazole
    «No se ha observado interacción entre fexofenadina y omeprazol. Sin embargo la administración de un antiácido que contenga geles de hidróxidos de aluminio y magnesio 15 minutos antes de la toma de…»

    AEMPS, section 4.5 · Open on CIMA

From other drugs’ labels

  • Erythromycin
    «Fexofenadina: Cuando se administra un tratamiento simultáneo con eritromicina y fexofenadina, las concentraciones plasmáticas de fexofenadina aumentan de 2 a 3 veces, debido probablemente al aumento…»

    AEMPS, section 4.5 · Open on CIMA

  • Montelukast
    «DRUG INTERACTIONS: No dose adjustment is needed when montelukast sodium is co-administered with theophylline, prednisone, prednisolone, oral contraceptives, fexofenadine, digoxin, warfarin…»

    FDA, section 7 · Open on DailyMed

  • Ritonavir
    «Ritonavir dosificado como potenciador farmacocinético o agente antirretroviral: Ritonavir posee una afinidad elevada por diversas formas isoméricas del citocromo P450 (CYP) y puede inhibir la…»

    AEMPS, section 4.5 · Open on CIMA

  • Ulipristal acetate
    «Sustratos de la glucoproteína P (P­gp): Los datos in vitro indican que el acetato de ulipristal puede ser un inhibidor de P­gp en concentraciones clínicamente relevantes. Los resultados in vivo con…»

    AEMPS, section 4.5 · Open on CIMA

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Frequently asked

What is Fexofenadine used for?

Fexofenadine is evaluated for the following indications with varying evidence strength: Chronic urticaria (evidence tier A), Allergic rhinitis (evidence tier A), Immune support and respiratory infection care (evidence tier F). See the full indication matrix with dosing and citations above on this page.

What are the side effects of Fexofenadine?

Common side effects of Fexofenadine (≥ 1 in 100): Headache, Drowsiness (1–2%, placebo-level), Nausea. See the Safety section for uncommon and serious reactions.

Is Fexofenadine safe during pregnancy?

AEMPS summary of product characteristics (section 4.6): there are no data on the use of fexofenadine in pregnant women. Limited animal studies do not indicate direct or indirect harmful effects on pregnancy, embryo-fetal development, parturition or postnatal development. Fexofenadine should not be used during pregnancy unless clearly necessary.

Is Fexofenadine compatible with breastfeeding?

Compatible. Hale L2. RID 0.7%. Active metabolite of terfenadine without cardiotoxicity. Non-sedating.

Who should not take Fexofenadine?

Fexofenadine is contraindicated in: Fexofenadine hypersensitivity; Age under 6 months (liquid forms). Full list in the Safety section.

Official sources

Direct links to regulator labels. Open in a new tab.

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