Is Fluticasone registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 16 valid registrations of Fluticasone, including AVAMYS SUSPENSION FOR NASAL SPRAY (27.5 µg, Nasal spray, suspension, SAR 44.30); CUTIVATE 0.005% ointment (0.005 %, Ointment, SAR 18.05); CUTIVATE 0.05% cream (0.05 %, Cream, SAR 18.05); FLIXOTIDE 0.5MG-2ML NEBULE (0.25 mg/ml, Nebuliser suspension, SAR 45.00); FLIXOTIDE 125 MCG EVOHALER (125 µg, Nebuliser suspension, SAR 85.45).

Is Fluticasone approved by the US FDA?

Drugs@FDA lists 41 application product lines for Fluticasone, including FLOVENT DISKUS 50 (Prescription); FLOVENT DISKUS 100 (Prescription); FLOVENT DISKUS 250 (Prescription); FLUTICASONE PROPIONATE (Prescription); FLUTICASONE PROPIONATE (Prescription).

Is Fluticasone authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Fluticasone: Avamys.

Is Fluticasone on the WHO Model List of Essential Medicines?

Yes — 25.1. Antiasthmatic and medicines for chronic obstructive pulmonary disease (core list): Therapeutic equivalent to budesonide for Asthma.

Are there safety signals or safety updates for Fluticasone?

EMA PRAC: 2 entries; US FDA: 15 entries (latest 2024-12-17).

Active substance

Fluticasone

SFDA 29
US FDA 41
EMA 2
Health Canada 19
US price lines 26
NHS prices 12
WHO EML 1
Safety 17

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
AVAMYS SUSPENSION FOR NASAL SPRAY	27.5 µg	Nasal spray, suspension · Nasal use	1 Applicator	SAR 44.30	NCE · Prescription	GLAXO SAUDI ARABIA	Valid
CUTIVATE 0.005% ointment	0.005 %	Ointment · Topical	1 Tube	SAR 18.05	NCE · Prescription	Glaxo Saudi Arabia Ltd	Valid
CUTIVATE 0.05% cream	0.05 %	Cream · Topical	1 Tube	SAR 18.05	NCE · Prescription	Glaxo Saudi Arabia Ltd	Valid
FLIXOTIDE 0.5MG-2ML NEBULE	0.25 mg/ml	Nebuliser suspension · Inhalation use	10 Ampoule	SAR 45.00	NCE · Prescription	Glaxo Saudi Arabia Ltd	Valid
FLIXOTIDE 125 MCG EVOHALER	125 µg	Nebuliser suspension · Inhalation use	1 Pressurised container	SAR 85.45	Generic · Prescription	GLAXO SAUDI ARABIA	Valid
FLIXOTIDE 2MG-2ML NEBULE	1 mg/ml	Nebuliser suspension · Inhalation use	10 Ampoule	SAR 118.05	NCE · Prescription	Glaxo Saudi Arabia Ltd	Valid
FLIXOTIDE 50 MCG EVOHALER	50 µg	Nebuliser suspension · Inhalation use	1 Pressurised container	SAR 51.20	Generic · Prescription	GLAXO SAUDI ARABIA	Valid
FLIXOTIDE EVOHALER 250MCG	250 µg	Nebuliser suspension · Inhalation use	1 Pressurised container	SAR 125.60	Generic · Prescription	GLAXO SAUDI ARABIA	Valid
FLUSORT 0.05% NASAL SPRAY	0.05 %	Nasal spray · Nasal use	1 Bottle	SAR 18.00	Generic · OTC	Glenmark Pharmaceuticals Limited	Valid
Flohale	125 µg	Pressurised inhalation · Inhalation use	1 Inhaler	SAR 79.75	Generic · Prescription	SUDAIR PHARMA COMPANY	Valid
Flohale	250 µg	Pressurised inhalation · Inhalation use	1 Inhaler	SAR 117.25	Generic · Prescription	SUDAIR PHARMA COMPANY	Valid
Otri Allergy Nasal Spray	0.05 %	Nasal spray · Nasal use	1 Pressurised container	SAR 26.00	NCE · OTC	HALEON UK TRADING LIMITED	Valid
POTENCORT 0.005% OINTMENT	0.005 %	Ointment · Topical	1 Tube	SAR 5.15	Generic · Prescription	Gulf Pharmaceutical Industries (Julphar)	Valid
POTENCORT 0.05% CREAM	0.05 %	Cream · Topical	1 Tube	SAR 5.15	Generic · Prescription	Gulf Pharmaceutical Industries (Julphar)	Valid
RHINASE 0.05% AQUEOUS NASAL SPRAY	0.05 %	Nasal spray · Nasal use	1 Spray Container	SAR 24.70	Generic · OTC	Middle East Pharmaceutical Industries Co Ltd Avalon Pharma	Valid
TICANASE 0.05% NASAL SPRAY	0.05 %	Nasal drops, suspension · Nasal use	1 Nasal Applicator	SAR 24.70	Generic · OTC	EUROPEAN EGYPTIAN PHARMACEUTICAL IND. CO	Valid
AVAMYS SUSPENSION FOR NASAL SPRAY		Nasal spray, suspension · Nasal use	1 Applicator	SAR 52.10	NCE · Prescription	GLAXO OPERATION	Withdrawn by MAH · Not Marketed
CUTIVATE 0.005% OINT	0.005 %	Ointment · Topical	1 Tube	SAR 20.80	NCE · Prescription	GLAXO	Withdrawn by MAH · Not Marketed
CUTIVATE 0.05% CREAM	0.05 %	Cream · Topical	1 Tube	SAR 20.80	NCE · Prescription	GLAXO	Withdrawn by MAH · Not Marketed
FLIXONASE NASULE DROPS 400 MCG -0.4 ML	1000 µ/ml	Nasal drops · Inhalation use	1 Inhaler	SAR 65.90	NCE · Prescription	GLAXOSMITHKLINE (GSK)	Withdrawn by MAH · Not Marketed
FLIXOTIDE 125MCG EVOHALER	125 µg	Solution for injection · Inhalation use	1 Pressurised container	SAR 126.60	NCE · Prescription	GLAXOWELLCOME	Withdrawn by MAH · Not Marketed
FLIXOTIDE 250MCG INHALER	250 µg	Nebuliser suspension · Inhalation use	1 Inhaler	SAR 203.45	NCE · Prescription	GLAXO	Withdrawn by MAH · Not Marketed
FLIXOTIDE 25MCG INHALER	25 µg	Nebuliser suspension · Inhalation use	1 Inhaler	SAR 41.25	NCE · Prescription	GLAXO	Withdrawn by MAH · Not Marketed
FLIXOTIDE 50 MCG EVOHALER	50 µg	inhalation solution · Inhalation use	1 Pressurised container	SAR 56.85	Generic · Prescription	GLAXOWELLCOME	Withdrawn by MAH · Not Marketed
FLIXOTIDE DISKUS 100MCG BLISTER POWDER	100 µg	Inhalation powder · Inhalation use	1 Inhaler	SAR 59.70	NCE · Prescription	GLAXO	Withdrawn by MAH · Not Marketed

4 more — full table

Indications — CHI Daman Drug Formulary

ALLERGIC RHINITIS; SINUSITIS

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
FLOVENT DISKUS 50	0.05MG/INH	powder · inhalation	GLAXO GRP LTD	Prescription	29 Sep 2000
FLOVENT DISKUS 100	0.1MG/INH	powder · inhalation	GLAXO GRP LTD	Prescription	29 Sep 2000
FLOVENT DISKUS 250	0.25MG/INH	powder · inhalation	GLAXO GRP LTD	Prescription	29 Sep 2000
FLUTICASONE PROPIONATE	0.05%	cream · topical	FOUGERA PHARMS	Prescription	14 May 2004
FLUTICASONE PROPIONATE	0.05%	cream · topical	ENCUBE	Prescription	14 May 2004
FLUTICASONE PROPIONATE	0.005%	ointment · topical	PADAGIS ISRAEL	Prescription	14 May 2004
FLUTICASONE PROPIONATE	0.05%	cream · topical	PADAGIS ISRAEL	Prescription	14 May 2004
FLOVENT HFA	0.22MG/INH; 0.11MG/INH; 0.044MG/INH	aerosol, metered · inhalation	GLAXO GRP LTD	Prescription	14 May 2004
FLUTICASONE PROPIONATE	0.05MG/SPRAY	spray, metered · nasal	HIKMA PHARMS	Prescription	22 Feb 2006
FLUTICASONE PROPIONATE	0.005%	ointment · topical	COSETTE PHARMS NC	Prescription	3 Mar 2006
FLUTICASONE PROPIONATE	0.05%	cream · topical	COSETTE PHARMS NC	Prescription	30 Jun 2006
FLONASE SENSIMIST ALLERGY RELIEF	0.0275MG/SPRAY	spray, metered · nasal	HALEON US HOLDINGS	Over-the-counter	27 Apr 2007
FLUTICASONE PROPIONATE	0.05MG/SPRAY	spray, metered · nasal	APOTEX	Prescription	12 Sep 2007
FLUTICASONE PROPIONATE	0.05MG/SPRAY	spray, metered · nasal	CHARTWELL RX	Prescription	9 Jan 2012
FLUTICASONE PROPIONATE	0.05%	lotion · topical	PADAGIS ISRAEL	Prescription	30 Jul 2013
FLONASE ALLERGY RELIEF	0.05MG/SPRAY	spray, metered · nasal	HALEON US HOLDINGS	Over-the-counter	23 Jul 2014
ARNUITY ELLIPTA	0.1MG/INH; 0.2MG/INH; 0.05MG/INH	powder · inhalation	GLAXOSMITHKLINE	Prescription	20 Aug 2014
FLUTICASONE PROPIONATE	0.05MG/SPRAY	spray, metered · nasal	APOTEX	Over-the-counter	29 Feb 2016
FLUTICASONE PROPIONATE	0.05MG/SPRAY	spray, metered · nasal	HIKMA PHARMS	Over-the-counter	26 May 2016
XHANCE	0.093MG/SPRAY	spray, metered · nasal	PARATEK PHARMS	Prescription	18 Sep 2017
FLUTICASONE PROPIONATE	0.05MG/SPRAY	spray, metered · nasal	AUROBINDO PHARMA LTD	Over-the-counter	10 May 2024
FLUTICASONE PROPIONATE	0.05MG/SPRAY	spray, metered · nasal	RUBICON RESEARCH	Prescription	5 Jun 2025
FLUTICASONE PROPIONATE	0.05MG/SPRAY	spray, metered · nasal	RUBICON RESEARCH	Over-the-counter	15 Aug 2025
FLUTICASONE PROPIONATE	0.044MG/INH	aerosol, metered · inhalation	GLENMARK SPECLT	Prescription	3 Mar 2026
FLUTICASONE PROPIONATE	0.05MG/SPRAY	spray, metered · nasal	GLENMARK SPECLT	Over-the-counter	16 Mar 2026

16 more — full table

EMA European Union — centrally authorised medicines

Avamys GlaxoSmithKline Trading Services Limited · Authorised · authorised 11 Jan 2008 · ATC R01AD12

Therapeutic indication (EMA)

Adults, adolescents (12 years and over) and children (6-11 years). Avamys is indicated for the treatment of the symptoms of allergic rhinitis.

Alisade Glaxo Group Ltd. · Lapsed · authorised 6 Oct 2008 · ATC R01AD12

Therapeutic indication (EMA)

Adults, adolescents (12 years and over) and children (6 - 11 years). Alisade is indicated for the treatment of the symptoms of allergic rhinitis.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
24HR NASAL ALLERGY RELIEF	02460513	50 MCG / ACT	SPRAY (METERED-DOSE) · NASAL	APOTEX INC
APO-FLUTICASONE	02294745	50 MCG / ACT	SPRAY (METERED-DOSE) · NASAL	APOTEX INC
APO-FLUTICASONE HFA	02510987	250 MCG / ACT	AEROSOL (METERED-DOSE) · INHALATION; ORAL	APOTEX INC
APO-FLUTICASONE HFA	02526557	125 MCG / ACT	AEROSOL (METERED-DOSE) · INHALATION; ORAL	APOTEX INC
APO-FLUTICASONE HFA	02528428	50 MCG / ACT	AEROSOL (METERED-DOSE) · ORAL; INHALATION	APOTEX INC
ARNUITY ELLIPTA	02446561	100 MCG / ACT	POWDER · INHALATION; ORAL	GLAXOSMITHKLINE INC
ARNUITY ELLIPTA	02446588	200 MCG / ACT	POWDER · ORAL; INHALATION	GLAXOSMITHKLINE INC
AVAMYS	02298589	27.5 MCG / ACT	SPRAY (METERED-DOSE) · NASAL	GLAXOSMITHKLINE INC
FLONASE ALLERGY RELIEF	02248307	50 MCG / ACT	SPRAY (METERED-DOSE) · NASAL	HALEON CANADA ULC
FLOVENT DISKUS	02237245	100 MCG / ACT	POWDER · INHALATION	GLAXOSMITHKLINE INC
FLOVENT DISKUS	02237246	250 MCG / ACT	POWDER · INHALATION	GLAXOSMITHKLINE INC
FLOVENT DISKUS	02237247	500 MCG / ACT	POWDER · INHALATION	GLAXOSMITHKLINE INC
FLOVENT HFA	02244291	50 MCG / ACT	AEROSOL (METERED-DOSE) · INHALATION; ORAL	GLAXOSMITHKLINE INC
FLOVENT HFA	02244292	125 MCG / ACT	AEROSOL (METERED-DOSE) · ORAL; INHALATION	GLAXOSMITHKLINE INC
FLOVENT HFA	02244293	250 MCG / ACT	AEROSOL (METERED-DOSE) · ORAL; INHALATION	GLAXOSMITHKLINE INC
PMS-FLUTICASONE HFA	02503115	50 MCG / ACT	AEROSOL (METERED-DOSE) · ORAL; INHALATION	PHARMASCIENCE INC
PMS-FLUTICASONE HFA	02503123	125 MCG / ACT	AEROSOL (METERED-DOSE) · ORAL; INHALATION	PHARMASCIENCE INC
PMS-FLUTICASONE HFA	02503131	250 MCG / ACT	AEROSOL (METERED-DOSE) · ORAL; INHALATION	PHARMASCIENCE INC
TEVA-FLUTICASONE	02453738	50 MCG / ACT	METERED-DOSE PUMP · NASAL	TEVA CANADA LIMITED

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	ARNUITY ELLIPTA 100 MCG INH	$6.64675	per EA	23 Sep 2026
US NADAC	ARNUITY ELLIPTA 100 MCG INH	$6.64902	per EA	23 Sep 2026
US NADAC	ARNUITY ELLIPTA 200 MCG INH	$8.90364	per EA	23 Sep 2026
US NADAC	ARNUITY ELLIPTA 200 MCG INH	$8.90107	per EA	23 Sep 2026
US NADAC	ARNUITY ELLIPTA 50 MCG INH	$6.646	per EA	23 Sep 2026
US NADAC	FLUTICASONE PROP 0.005% OINT	$0.54147	per GM	23 Sep 2026
US NADAC	FLUTICASONE PROP 0.005% OINT	$0.43253	per GM	23 Sep 2026
US NADAC	FLUTICASONE PROP 0.005% OINT	$0.36476	per GM	23 Sep 2026
US NADAC	FLUTICASONE PROP 0.05% CREAM	$0.35643	per GM	23 Sep 2026
US NADAC	FLUTICASONE PROP 0.05% CREAM	$0.24346	per GM	23 Sep 2026
US NADAC	FLUTICASONE PROP 0.05% CREAM	$0.22386	per GM	23 Sep 2026
US NADAC	FLUTICASONE PROP 0.05% LOTION	$2.96333	per ML	23 Sep 2026
NHS Drug Tariff	Fluticasone 0.005% ointment	£4.24	30 gram	1 Oct 2026
NHS Drug Tariff	Fluticasone 0.05% cream	£4.24	30 gram	1 Oct 2026
NHS Drug Tariff	Fluticasone 125micrograms/dose inhaler CFC free	£21.26	120 dose	1 Oct 2026
NHS Drug Tariff	Fluticasone 250micrograms/dose inhaler CFC free	£36.14	120 dose	1 Oct 2026
NHS Drug Tariff	Fluticasone 400microgram/unit dose nasal drops	£21.99	30 unit dose	1 Oct 2026
NHS Drug Tariff	Fluticasone 50micrograms/dose inhaler CFC free	£6.53	120 dose	1 Oct 2026
NHS Drug Tariff	Fluticasone furoate 27.5micrograms/dose nasal spray	£7.98	120 dose	1 Oct 2026
NHS Drug Tariff	Fluticasone propionate 100micrograms/dose dry powder inhaler	£8.00	60 dose	1 Oct 2026
NHS Drug Tariff	Fluticasone propionate 250micrograms/dose dry powder inhaler	£25.51	60 dose	1 Oct 2026
NHS Drug Tariff	Fluticasone propionate 500micrograms/dose dry powder inhaler	£43.37	60 dose	1 Oct 2026
NHS Drug Tariff	Fluticasone propionate 50micrograms/dose dry powder inhaler	£4.00	60 dose	1 Oct 2026
NHS Drug Tariff	Fluticasone propionate 50micrograms/dose nasal spray	£11.01	150 dose	1 Oct 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

WHO WHO Model List of Essential Medicines (2025)

25.1. Antiasthmatic and medicines for chronic obstructive pulmonary disease · core
Therapeutic equivalent to budesonide for Asthma

Safety signals and safety-related labeling changes

US FDA 17 Dec 2024 DYMISTA — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 15 Mar 2024 XHANCE — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 18 Oct 2023 ARNUITY ELLIPTA — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 2 Jun 2023 TRELEGY ELLIPTA — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 12 May 2023 BREO ELLIPTA — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 8 Apr 2022 ARMONAIR RESPICLICK — safety-related labeling change
Labeling sections changed: Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 9 Jul 2021 AIRDUO RESPICLICK — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 19 Mar 2021 CUTIVATE — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 7 Jan 2019 ADVAIR DISKUS 100/50 — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 7 Jan 2019 ADVAIR DISKUS 250/50 — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 7 Jan 2019 ADVAIR DISKUS 500/50 — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 7 Jan 2019 FLOVENT DISKUS 100 — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 7 Jan 2019 ADVAIR HFA — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 7 Jan 2019 FLONASE — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 7 Jan 2019 FLOVENT HFA — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for fluticasone →

Combinations containing Fluticasone

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.