Evigrade

Ebastine

AEMPS

Second-generation antihistamine

ATC code: R06AX22

Updated · Methodology

Indications

A

Allergic rhinitis

First line

First-line for allergic rhinitis under ARIA 2020 alongside other second-generation antihistamines. Standard dose 10 mg once daily; 20 mg is acceptable for severe symptoms. Onset 1–3 hours after intake, with effect lasting at least 24 hours.

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

Ebastine is a second-generation antihistamine. It is prescribed for seasonal and perennial allergic rhinitis and urticaria ( 2024, AEMPS Ficha Técnica). Ebastine is used in seasonal colds and viral congestion as a universal anti-allergic agent. 2024 and the Cochrane review by De Sutter 2015 did not confirm significant benefit of antihistamines in the common cold. If ebastine was prescribed for a cold without confirmed allergic rhinitis, consider seeking a second opinion.

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

Selective peripheral H1-antagonist. CYP3A4 metabolizes it in the liver to the active metabolite carebastine (half-life 15–19 hours), allowing once-daily dosing. Minimal blood-brain barrier penetration. Developed by Spain's Almirall and widely used in Spain under the brand Ebastel.

Safety

Contraindications

  • Ebastine hypersensitivity
  • Age under 12 (for 20 mg dose)
  • Severe hepatic impairment

Serious adverse effects

  • QT prolongation when co-administered with CYP3A4 inhibitors
  • Rare hypersensitivity reactions

Common adverse effects

  • Headache
  • Drowsiness (~3%, placebo-level)
  • Dry mouth

Pregnancy: can you take Ebastine?

Limited data. The manufacturer advises against use in T1. Loratadine or cetirizine are preferred when antihistamine therapy is needed in pregnancy.

Breastfeeding: can you take Ebastine?

Hale L3 · Probably compatible, limited data

Compatible. Hale L3 (limited data). RID about 1.4%. Widely used in EU for allergic rhinitis and urticaria.

RID, infant dose via milk
1.4%
Maternal half-life
15.0 h
Maternal peak time
4 h
Peak milk concentration
0.05 mg/L

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

Practical notes

Timing and administration

Take once daily, with or without food. Concurrent strong CYP3A4 inhibitors (ketoconazole, itraconazole, clarithromycin, erythromycin) increase ebastine exposure and QT-prolongation risk – avoid up-dosing in these combinations. No dose adjustment is needed in mild-to-moderate hepatic impairment.
Label mentions10 mentions

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

From this drug’s label

  • Moderateantifúngicos azólicosclass named in the label
    «Administrar con precaución en pacientes con riesgo cardíaco conocido tales como pacientes con prolongación del intervalo QT, hipocaliemia, tratamiento concomitante con fármacos que incrementen el…»

    AEMPS, section 4.4 · Open on CIMA

  • ModerateErythromycin
    «Se ha estudiado la interacción de ebastina en combinación con ketoconazol o eritromicina (ambos compuestos producen un incremento del intervalo QTc). Con ambas combinaciones se ha observado una…»

    AEMPS, section 4.5 · Open on CIMA

  • ModerateItraconazole
    «Se ha estudiado la interacción de ebastina en combinación con ketoconazol o eritromicina (ambos compuestos producen un incremento del intervalo QTc). Con ambas combinaciones se ha observado una…»

    AEMPS, section 4.5 · Open on CIMA

  • ModerateKetoconazole
    «Se ha estudiado la interacción de ebastina en combinación con ketoconazol o eritromicina (ambos compuestos producen un incremento del intervalo QTc). Con ambas combinaciones se ha observado una…»

    AEMPS, section 4.5 · Open on CIMA

  • Moderatemacrólidosclass named in the label
    «Se ha estudiado la interacción de ebastina en combinación con ketoconazol o eritromicina (ambos compuestos producen un incremento del intervalo QTc). Con ambas combinaciones se ha observado una…»

    AEMPS, section 4.5 · Open on CIMA

  • «No se han descrito interacciones entre ebastina y teofilina, warfarina, cimetidina, diazepam y alcohol.»

    AEMPS, section 4.5 · Open on CIMA

  • «Se han observado interacciones farmacocinéticas al administrar ebastina con rifampicina. Estas interacciones pueden dar luegar a una disminución de las concentraciones plasmáticas y a una reducción…»

    AEMPS, section 4.5 · Open on CIMA

  • «No se han descrito interacciones entre ebastina y teofilina, warfarina, cimetidina, diazepam y alcohol.»

    AEMPS, section 4.5 · Open on CIMA

  • «No se han descrito interacciones entre ebastina y teofilina, warfarina, cimetidina, diazepam y alcohol.»

    AEMPS, section 4.5 · Open on CIMA

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Frequently asked

What is Ebastine used for?

Ebastine 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 Ebastine?

Common side effects of Ebastine (≥ 1 in 100): Headache, Drowsiness (~3%, placebo-level), Dry mouth. See the Safety section for uncommon and serious reactions.

Is Ebastine safe during pregnancy?

Limited data. The manufacturer advises against use in T1. Loratadine or cetirizine are preferred when antihistamine therapy is needed in pregnancy.

Is Ebastine compatible with breastfeeding?

Compatible. Hale L3 (limited data). RID about 1.4%. Widely used in EU for allergic rhinitis and urticaria.

Who should not take Ebastine?

Ebastine is contraindicated in: Ebastine hypersensitivity; Age under 12 (for 20 mg dose); Severe hepatic impairment. Full list in the Safety section.

Official sources

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

Other drugs in this group

Fexofenadine, Ketotifen, Levocetirizine, Loratadine, Rupatadine, Chloropyramine, Dexchlorpheniramine, Promethazine