Evigrade

Desloratadine

AEMPS

Second-generation antihistamine

ATC code: R06AX27

Brand names: Aerius, Neoclarityn, Clarinex

Updated · Methodology

Indications

A

Allergic rhinitis

First line

First-line for seasonal and perennial allergic rhinitis under ARIA 2020 and 2022 alongside other second-generation antihistamines. Standard dose 5 mg once daily. Children 1–5 years: 1.25 mg (2.5 mL syrup) once daily. Tolerability and sedation comparable to bilastine and fexofenadine.

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

Desloratadine is a second-generation antihistamine and the active metabolite of loratadine. It is prescribed for seasonal and perennial allergic rhinitis and urticaria ( 2024, AEMPS Ficha Técnica). Desloratadine is recommended for viral runny nose and for general immunity, conflating the common cold with allergic rhinitis. The Cochrane review by De Sutter 2015 in people with ordinary colds did not confirm significant effect of antihistamines as monotherapy. If desloratadine 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

An active metabolite of loratadine. A selective peripheral H1-antagonist with a long half-life (27 hours). Minimal blood-brain barrier penetration – sedation is close to placebo. Metabolized primarily by 3-hydroxylation; data on specific CYP isoenzymes are limited and drug interactions are minimal.

Safety

Contraindications

  • Hypersensitivity to desloratadine, loratadine, or excipients
  • Age under 6 months

Serious adverse effects

  • Rare hypersensitivity reactions (angioedema, anaphylaxis)
  • Hepatotoxicity (very rare)

Common adverse effects

  • Fatigue
  • Dry mouth
  • Headache
  • Drowsiness (~2%, placebo-level)

Pregnancy: can you take Desloratadine?

AEMPS summary of product characteristics (section 4.6): a large amount of data in pregnant women (more than 1,000 pregnancies) indicates that desloratadine causes no malformations and no fetal or neonatal toxicity. Animal studies do not suggest direct or indirect harmful effects with respect to reproductive toxicity. As a precaution, it is preferable to avoid desloratadine during pregnancy.

Breastfeeding: can you take Desloratadine?

Hale L1 · Compatible

Fully compatible. Hale L1. RID 0.04%, same as loratadine. Drug of choice for nursing mothers with allergic rhinitis or chronic urticaria.

RID, infant dose via milk
0.04%
Maternal half-life
27.0 h
Maternal peak time
1.5 h
Peak milk concentration
0 mg/L
Milk-to-plasma ratio
1.2

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. The 27-hour half-life keeps levels steady even if a dose is missed. With moderate-to-severe renal or hepatic impairment, extend the interval to 48 hours or reduce the dose to 2.5 mg.
Label mentions7 mentions

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

From this drug’s label

  • «Inhibitors of Cytochrome P450 3A4: In controlled clinical studies co-administration of desloratadine with ketoconazole, erythromycin, or azithromycin resulted in increased plasma concentrations of…»

    FDA, section 7 · Open on DailyMed

  • «No se han observado interacciones clínicamente relevantes en ensayos clínicos con desloratadina comprimidos en los que se administraron conjuntamente eritromicina o ketoconazol (ver sección 5.1).»

    AEMPS, section 4.5 · Open on CIMA

  • «Inhibitors of Cytochrome P450 3A4: In controlled clinical studies co-administration of desloratadine with ketoconazole, erythromycin, or azithromycin resulted in increased plasma concentrations of…»

    FDA, section 7 · Open on DailyMed

  • «Fluoxetine: In controlled clinical studies co-administration of desloratadine with fluoxetine, a selective serotonin reuptake inhibitor (SSRI), resulted in increased plasma concentrations of…»

    FDA, section 7 · Open on DailyMed

  • «No se han observado interacciones clínicamente relevantes en ensayos clínicos con desloratadina comprimidos en los que se administraron conjuntamente eritromicina o ketoconazol (ver sección 5.1).»

    AEMPS, section 4.5 · Open on CIMA

  • «Inhibitors of Cytochrome P450 3A4: In controlled clinical studies co-administration of desloratadine with ketoconazole, erythromycin, or azithromycin resulted in increased plasma concentrations of…»

    FDA, section 7 · Open on DailyMed

  • SSRIs/SNRIsclass named in the label
    «Fluoxetine: In controlled clinical studies co-administration of desloratadine with fluoxetine, a selective serotonin reuptake inhibitor (SSRI), resulted in increased plasma concentrations of…»

    FDA, section 7 · Open on DailyMed

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Frequently asked

What is Desloratadine used for?

Desloratadine is evaluated for the following indications with varying evidence strength: Allergic rhinitis (evidence tier A), Chronic urticaria (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 Desloratadine?

Common side effects of Desloratadine (≥ 1 in 100): Fatigue, Dry mouth, Headache, Drowsiness (~2%, placebo-level). See the Safety section for uncommon and serious reactions.

Is Desloratadine safe during pregnancy?

AEMPS summary of product characteristics (section 4.6): a large amount of data in pregnant women (more than 1,000 pregnancies) indicates that desloratadine causes no malformations and no fetal or neonatal toxicity. Animal studies do not suggest direct or indirect harmful effects with respect to reproductive toxicity. As a precaution, it is preferable to avoid desloratadine during pregnancy.

Is Desloratadine compatible with breastfeeding?

Fully compatible. Hale L1. RID 0.04%, same as loratadine. Drug of choice for nursing mothers with allergic rhinitis or chronic urticaria.

Who should not take Desloratadine?

Desloratadine is contraindicated in: Hypersensitivity to desloratadine, loratadine, or excipients; Age under 6 months. Full list in the Safety section.

Official sources

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

Other drugs in this group

Dexchlorpheniramine, Dimenhydrinate, Diphenhydramine, Doxylamine/pyridoxine, Fexofenadine, Loratadine, Bilastine, Ebastine