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Fluticasone

AEMPS

Inhaled and intranasal corticosteroid

ATC code: R03BA05

Updated · Methodology

Indications

A

Allergic rhinitis

First line

Seasonal and perennial allergic rhinitis in adults and children from 4–6 years (depending on formulation). Per ARIA 2020 and SEAIC 2023, intranasal corticosteroids are first-line for moderate-to-severe and persistent symptoms. Fluticasone propionate dose: 100–200 µg (2 sprays per nostril) once daily; fluticasone furoate (Avamys): 27.5–55 µg once daily. Effect at 6–12 hours, full effect at 3–7 days. Long-term safety on childhood growth confirmed at standard doses (Skoner 2018).

Sources

  1. AEMPS: Ficha técnica de Fluticasona (2024)
  2. EAACI: ARIA guideline 2019 update on allergic rhinitis (2020)
  3. J Allergy Clin Immunol Pract: Intranasal Versus Oral Treatments for Allergic Rhinitis: A Systematic Review With Meta-Analysis. (2024)
  4. J Allergy Clin Immunol Pract: Growth velocity reduced with once-daily fluticasone furoate nasal spray in prepubescent children with perennial allergic rhinitis. (2014)

ICD-10: J30.9 · ICD-11: CA08.0

A

Asthma

First line

Bronchial asthma in adults and children. Per 2024, an inhaled corticosteroid is the backbone of controller therapy across all steps (1–5). Fluticasone propionate dose: 100–1000 µg/day in two doses for adults; 50–200 µg/day for children 4-16. Fluticasone furoate dose: 100–200 µg once daily. From GINA step 3 onward, use a fixed-dose ICS-LABA combination. Reassess symptoms and spirometry at 4–12 weeks; step down every 3–6 months when stable.

Sources

  1. AEMPS: Ficha técnica de Fluticasona (2024)
  2. GEMA: GEMA 5.4 – manejo de la exacerbación de asma (2024)

ICD-10: J45 · ICD-11: CA23

B

Chronic obstructive pulmonary disease

Second line

COPD with frequent exacerbations (≥2/year or ≥1 with hospitalization) and eosinophils ≥300 cells/µL. Per 2024, an inhaled corticosteroid is added to LABA or LABA + LAMA – monotherapy is not indicated. Fluticasone propionate dose: 500 µg twice daily. Increased pneumonia risk in COPD – discuss with the patient and reassess at 12 months.

Sources

  1. AEMPS: Ficha técnica de Fluticasona (2024)
  2. GOLD: Global Strategy for Diagnosis, Management and Prevention of COPD (2024)

ICD-10: J44 · ICD-11: CA22

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

Fluticasone is a synthetic glucocorticoid with high affinity for glucocorticoid receptors in bronchial and nasal mucosa. Suppresses pro-inflammatory cytokines (IL-4, IL-5, IL-13) and reduces eosinophil and mast cell trafficking. Inhaled systemic bioavailability <1% (fluticasone propionate) or ~7% (fluticasone furoate) – minimizing systemic effects at standard doses. Local effect peaks at 1–2 weeks.

Safety

Contraindications

  • Hypersensitivity
  • Active respiratory tuberculosis (without concurrent antitubercular therapy)
  • Untreated bacterial nasopharyngeal infection (for nasal form)

Serious adverse effects

  • Pneumonia in COPD patients
  • Nasal septal perforation (rare, with long-term nasal use)
  • Systemic glucocorticoid effects at high doses: adrenal suppression, decreased BMD, cataract, glaucoma

Common adverse effects

  • Oral candidiasis
  • Hoarseness
  • Throat irritation
  • Epistaxis (nasal form)
  • Nasal dryness
  • Headache

Pregnancy: can you take Fluticasone?

Compatible at standard doses when clearly needed. Per ACOG 2020, asthma and rhinitis control outweighs the theoretical risk of inhaled corticosteroid. Beclomethasone and budesonide have more pregnancy data.

Breastfeeding: can you take Fluticasone?

Compatible. Hale L1-L2. Inhaled systemic absorption <1% – minimal milk transfer.

Calculate RIDFull 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

Rinse and spit after each inhalation – prevents oral candidiasis and hoarseness. Monitor childhood growth every 6–12 months on long-term therapy.
Label mentions19 mentions

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

From this drug’s label

  • MajorAtazanavir
    «Inhibitors of Cytochrome P450 3A4: Fluticasone propionate is a substrate of CYP3A4. The use of strong CYP3A4 inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole…»

    FDA, section 7 · Open on DailyMed

  • MajorClarithromycin
    «Inhibitors of Cytochrome P450 3A4: Fluticasone propionate is a substrate of CYP3A4. The use of strong CYP3A4 inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole…»

    FDA, section 7 · Open on DailyMed

  • MajorCobicistat
    «Se espera que el tratamiento concomitante con inhibidores de CYP3A, incluyendo medicamentos que contienen cobicistat, aumente el riesgo de reacciones adversas sistémicas . Se debe evitar esa…»

    AEMPS, section 4.5 · Open on CIMA

  • Majorinhibidores del CYP3A4class named in the label
    «Se espera que el tratamiento concomitante con inhibidores de CYP3A, incluyendo medicamentos que contienen cobicistat, aumente el riesgo de reacciones adversas sistémicas . Se debe evitar esa…»

    AEMPS, section 4.5 · Open on CIMA

  • MajorItraconazole
    «Inhibitors of Cytochrome P450 3A4: Fluticasone propionate is a substrate of CYP3A4. The use of strong CYP3A4 inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole…»

    FDA, section 7 · Open on DailyMed

  • MajorKetoconazole
    «DRUG INTERACTIONS: Strong cytochrome P450 3A4 inhibitors (e.g., ritonavir, ketoconazole): Use not recommended. May increase risk of systemic corticosteroid effects. ( 7.1 )»

    FDA, section 7 · Open on DailyMed

  • MajorRitonavir
    «En un estudio sobre la interacción del fármaco llevado a cabo en sujetos sanos, se ha demostrado que ritonavir (potente inhibidor del citocromo P450 3A4) puede aumentar de manera considerable las…»

    AEMPS, section 4.5 · Open on CIMA

  • MajorRitonavir
    «DRUG INTERACTIONS: Strong cytochrome P450 3A4 inhibitors (e.g., ritonavir, ketoconazole): Use not recommended. May increase risk of systemic corticosteroid effects. ( 7.1 )»

    FDA, section 7 · Open on DailyMed

  • MajorVoriconazole
    «Inhibitors of Cytochrome P450 3A4: Fluticasone propionate is a substrate of CYP3A4. The use of strong CYP3A4 inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole…»

    FDA, section 7 · Open on DailyMed

  • ModerateCYP3A4 inhibitorsclass named in the label
    «Inhibitors of Cytochrome P450 3A4: Fluticasone propionate is a substrate of CYP3A4. The use of strong CYP3A4 inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole…»

    FDA, section 7 · Open on DailyMed

  • ModerateKetoconazole
    «En varios estudios realizados se ha demostrado que otros inhibidores del citocromo P450 3A4 producen incrementos insignificantes (eritromicina) y menores (ketoconazol) de la exposición sistémica al…»

    AEMPS, section 4.5 · Open on CIMA

  • MinorErythromycin
    «En varios estudios realizados se ha demostrado que otros inhibidores del citocromo P450 3A4 producen incrementos insignificantes (eritromicina) y menores (ketoconazol) de la exposición sistémica al…»

    AEMPS, section 4.5 · Open on CIMA

From other drugs’ labels

  • MajorAtazanavir
    «Established and Other Potentially Significant Drug Interactions: Atazanavir with ritonavir ↑ fluticasone With concomitant use of fluticasone propionate and atazanavir with ritonavir systemic…»

    FDA, section 7 · Open on DailyMed

  • MajorCobicistat
    «Established and Other Potentially Significant Interactions: Corticosteroids: e.g., betamethasone budesonide ciclesonide dexamethasone fluticasone methylprednisolone mometasone triamcinolone ↓…»

    FDA, section 7 · Open on DailyMed

  • MajorDarunavir
    «Darunavir y cobicistat se metabolizan a través de CYP3A, y la administración de forma conjunta con inductores del CYP3A puede por tanto resultar en una exposición plasmática subterapéutica a…»

    AEMPS, section 4.5 · Open on CIMA

  • MajorDarunavir
    «Established and Other Potentially Significant Drug Interactions: Corticosteroids: dexamethasone (systemic) Corticosteroids primarily metabolized by CYP3A: eg. betamethasone budesonide ciclesonide…»

    FDA, section 7 · Open on DailyMed

  • MajorRitonavir
    «Esteroides: En pacientes que recibieron ritonavir con propionato de fluticasona inhalado o intranasal Se han notificado efectos sistémicos de los corticoesteroides que incluyeron síndrome de Cushing…»

    AEMPS, section 4.5 · Open on CIMA

  • ModerateRitonavir
    «Established and Other Potentially Significant Drug Interactions: Systemic/Inhaled/Nasal/Ophthalmic Corticosteroids: e.g., betamethasone budesonide ciclesonide dexamethasone fluticasone…»

    FDA, section 7 · Open on DailyMed

  • Itraconazole
    «Antivirales para uso sistémico: Fluticasona INH 1 mg 2 veces/ día»

    AEMPS, section 4.5 · Open on CIMA

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Frequently asked

What is Fluticasone used for?

Fluticasone is evaluated for the following indications with varying evidence strength: Allergic rhinitis (evidence tier A), Asthma (evidence tier A), Chronic obstructive pulmonary disease (evidence tier B). See the full indication matrix with dosing and citations above on this page.

What are the side effects of Fluticasone?

Common side effects of Fluticasone (≥ 1 in 100): Oral candidiasis, Hoarseness, Throat irritation, Epistaxis (nasal form), Nasal dryness, Headache. See the Safety section for uncommon and serious reactions.

Is Fluticasone safe during pregnancy?

Compatible at standard doses when clearly needed. Per ACOG 2020, asthma and rhinitis control outweighs the theoretical risk of inhaled corticosteroid. Beclomethasone and budesonide have more pregnancy data.

Is Fluticasone compatible with breastfeeding?

Compatible. Hale L1-L2. Inhaled systemic absorption <1% – minimal milk transfer.

Who should not take Fluticasone?

Fluticasone is contraindicated in: Hypersensitivity; Active respiratory tuberculosis (without concurrent antitubercular therapy); Untreated bacterial nasopharyngeal infection (for nasal form). Full list in the Safety section.

Official sources

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

Other drugs in this group

Fluticasone propionate, Formoterol, Ipratropium bromide, Mometasone, Roflumilast, Salmeterol + Fluticasone, Aclidinium, Montelukast