Is Budesonide registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 17 valid registrations of Budesonide, including BUDIAIR 200 MCG PRESSURISED INH SOLUTION (200 µg, Pressurised inhalation, solution, SAR 83.45); Budenoor (64 µg, Nasal spray, SAR 45.00); Budrelfa (3 mg, Gastro-resistant capsule, hard, SAR 363.35); CORTIMENT MMX 9 MG PROLONGED RELEASE TABLET (9 mg, Prolonged-release tablet, SAR 327.00); CORTRIEF NASAL SPRAY (64 µg, Nasal spray, suspension, SAR 45.00).

Is Budesonide approved by the US FDA?

Drugs@FDA lists 35 application product lines for Budesonide, including RHINOCORT (Prescription); RHINOCORT ALLERGY (Over-the-counter); PULMICORT RESPULES (Prescription); ENTOCORT EC (Prescription); PULMICORT FLEXHALER (Prescription).

Is Budesonide authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Budesonide: Jorveza.

Is Budesonide on the WHO Model List of Essential Medicines?

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

Are there safety signals or safety updates for Budesonide?

US FDA: 10 entries (latest 2026-04-27).

Active substance

Budesonide

SFDA 23
US FDA 35
EMA 1
Health Canada 21
US price lines 13
NHS prices 19
WHO EML 2
Safety 10

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
BUDIAIR 200 MCG PRESSURISED INH SOLUTION	200 µg	Pressurised inhalation, solution · Inhalation use	1 Pressurised container	SAR 83.45	Generic · Prescription	CHIESI FARMACEUTICIS	Valid
Budenoor	64 µg	Nasal spray · Nasal use	1 Bottle	SAR 45.00	Generic · Prescription	Unicare Pharma	Valid
Budrelfa	3 mg	Gastro-resistant capsule, hard · Oral use	100 Blister	SAR 363.35	NCE · Prescription	Dr Falk Pharma	Valid
CORTIMENT MMX 9 MG PROLONGED RELEASE TABLET	9 mg	Prolonged-release tablet · Oral use	30 Blister	SAR 327.00	NCE · Prescription	Ferring GmbH	Valid
CORTRIEF NASAL SPRAY	64 µg	Nasal spray, suspension · Nasal use	1 Spray Container	SAR 45.00	Generic · Prescription	Middle East Pharmaceutical Industries Co Ltd Avalon Pharma	Valid
ENEMACORT 0.02MG-ML TABLET FOR ENEMA	2.3 mg/ml	Enema · Rectal use	4 Bottle	SAR 20.95	Generic · Prescription	MEDICAL UNION PHARMACEUTICALS CO	Valid
PULMICORT 0.5MG-ML (S.DOSE FOR NUB) SUSP	0.5 mg/ml	Nebuliser suspension · Inhalation use	20 Ampoule	SAR 134.25	NCE · Prescription	AstraZeneca	Valid
PULMICORT TURBUHALER 100MCG-DOSE	0.1 mg	Inhalation powder · Inhalation use	1 Inhaler	SAR 67.15	NCE · Prescription	AstraZeneca	Valid
PULMICORT TURBUHALER 200MCG-DOSE	0.2 mg	Inhalation powder · Inhalation use	1 Inhaler	SAR 96.60	NCE · Prescription	AstraZeneca	Valid
PULMICORT0.25MG-ML SINGLE DOSE PLASTIC U	0.25 mg/ml	Nebuliser suspension · Inhalation use	20 Ampoule	SAR 94.40	NCE · Prescription	AstraZeneca	Valid
Polmena	0.5 mg/ml	Nebuliser suspension · Inhalation use	20 Ampoule	SAR 120.80	Prescription	Med City Pharma	Valid
Pulmirema 0.25 mg	0.125 mg/ml	Nebuliser suspension · Inhalation use	30 Vial	SAR 134.50	Generic · Prescription	SUDAIR PHARMA COMPANY	Valid
Pulmirema 0.5 mg	0.25 mg/ml	Nebuliser suspension · Inhalation use	30 Vial	SAR 134.50	Generic · Prescription	SUDAIR PHARMA COMPANY	Valid
Pulmirema 1 mg	0.5 mg/ml	Nebuliser suspension · Inhalation use	30 Vial	SAR 191.30	Generic · Prescription	SUDAIR PHARMA COMPANY	Valid
Pulmistad	0.5 mg/ml	Nebuliser suspension · Inhalation use	20 Ampoule	SAR 104.40	Generic · Prescription	STADA ARZNEIMITTEL GmbH	Valid
Pulmistad	0.25 mg/ml	Nebuliser suspension · Inhalation use	20 Ampoule	SAR 66.10	Generic · Prescription	STADA ARZNEIMITTEL GmbH	Valid
RHINOCORT AQUA 64MCG NASAL SPRAY	0.064 mg	Nasal spray, suspension · Nasal use	1 Spray Container	SAR 50.65	NCE · Prescription	McNeil Sweden AB	Valid
BUDINIDE	50 µg	Nasal spray · Nasal use	1 Spray Pump	SAR 30.80	Generic · Prescription	RIYADH PHARMA	Withdrawn by MAH · Not Marketed
ENTOCORT 20MCG-ML ENEMA AFTER RECONSTITU	20 µ/ml	Enema · Rectal use	7 Bottle	SAR 179.90	NCE · Prescription	AstraZeneca	Withdrawn by MAH · Not Marketed
PULMICORT METERED AEROSOL 200MCG-DOSE	0.2 mg	Aerosol · Inhalation use	1 Inhaler	SAR 78.05	NCE · Prescription	AstraZeneca	Withdrawn by MAH · Not Marketed
PULMICORT METERED AEROSOL 50MCG-DOSE	0.05 mg	Inhalation vapour · Inhalation use	1 Inhaler	SAR 44.00	NCE · Prescription	AstraZeneca	Withdrawn by MAH · Not Marketed
RHINOCORT AQUA NASAL SPRAY WITH PUMP	1 mg/ml	Nasal spray · Nasal use	1 Spray Container	SAR 47.60	NCE · Prescription	AstraZeneca	Withdrawn by MAH · Not Marketed
RHINOCORT NASAL AEROSOL 50MCG-DOSE	0.05 mg	Nasal spray · Nasal use	1 Spray Container	SAR 44.00	NCE · Prescription	AstraZeneca	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

ASTHMA; CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD); GRAFT VERSUS HOST DISEASE; SJOGREN'S SYNDROME

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

Product	Strength	Form · route	Applicant	Status	First approved
RHINOCORT	0.032MG/INH	spray, metered · nasal	KENVUE BRANDS	Prescription	1 Oct 1999
RHINOCORT ALLERGY	0.032MG/SPRAY	spray, metered · nasal	KENVUE BRANDS	Over-the-counter	1 Oct 1999
PULMICORT RESPULES	0.25MG/2ML; 0.5MG/2ML; 1MG/2ML	suspension · inhalation	ASTRAZENECA	Prescription	8 Aug 2000
ENTOCORT EC	3MG	capsule, delayed release · oral	PADAGIS US	Prescription	2 Oct 2001
PULMICORT FLEXHALER	0.08MG/INH; 0.16MG/INH	powder, metered · inhalation	CHEPLAPHARM	Prescription	12 Jul 2006
BUDESONIDE	0.25MG/2ML; 0.5MG/2ML	suspension · inhalation	TEVA PHARMS	Prescription	18 Nov 2008
BUDESONIDE	0.25MG/2ML; 0.5MG/2ML	suspension · inhalation	NEPHRON	Prescription	30 Mar 2009
BUDESONIDE	3MG	capsule, delayed release · oral	AUROBINDO PHARMA USA	Prescription	16 May 2011
BUDESONIDE	0.25MG/2ML; 0.5MG/2ML	suspension · inhalation	IMPAX LABS INC	Prescription	31 Jul 2012
UCERIS	9MG	tablet, extended release · oral	SALIX	Prescription	14 Jan 2013
BUDESONIDE	0.032MG/INH	spray, metered · nasal	APOTEX	Prescription	12 May 2014
BUDESONIDE	0.032MG/SPRAY	spray, metered · nasal	APOTEX	Over-the-counter	12 May 2014
UCERIS	2MG/ACTUATION	aerosol, foam · rectal	SALIX	Prescription	7 Oct 2014
BUDESONIDE	1MG/2ML	suspension · inhalation	TEVA PHARMS USA	Prescription	8 Mar 2016
BUDESONIDE	3MG	capsule, delayed release · oral	DR REDDYS LABS SA	Prescription	8 Apr 2016
BUDESONIDE	3MG	capsule, delayed release · oral	RISING	Prescription	7 Apr 2017
BUDESONIDE	3MG	capsule, delayed release · oral	ZYDUS PHARMS	Prescription	4 May 2017
BUDESONIDE	3MG	capsule, delayed release · oral	AMNEAL PHARMS	Prescription	31 Jul 2017
BUDESONIDE	0.25MG/2ML; 0.5MG/2ML; 1MG/2ML	suspension · inhalation	CIPLA	Prescription	16 Nov 2017
BUDESONIDE	9MG	tablet, extended release · oral	ACTAVIS LABS FL INC	Prescription	3 Jul 2018
BUDESONIDE	0.5MG/2ML	suspension · inhalation	LUPIN	Prescription	9 Nov 2018
BUDESONIDE	9MG	tablet, extended release · oral	MYLAN	Prescription	17 Sep 2020
BUDESONIDE	0.25MG/2ML; 0.5MG/2ML; 1MG/2ML	suspension · inhalation	SUN PHARM	Prescription	14 Apr 2021
TARPEYO	4MG	capsule, delayed release · oral	CALLIDITAS	Prescription	15 Dec 2021
BUDESONIDE	2MG/ACTUATION	aerosol, foam · rectal	PADAGIS ISRAEL	Prescription	12 Apr 2023

10 more — full table

EMA European Union — centrally authorised medicines

Jorveza Dr. Falk Pharma GmbH · Authorised · authorised 8 Jan 2018 · ATC A07EA06

Therapeutic indication (EMA)

Jorveza is indicated for the treatment of eosinophilic esophagitis (EoE) in adults (older than 18 years of age). Jorveza 0.2 mg/mL oral suspension is indicated for the treatment of eosinophilic esophagitis (EoE) in paediatric patients 2 to 17 years of age.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
CORTIMENT	02455889	9 MG	TABLET (DELAYED- AND EXTENDED-RELEASE) · ORAL	FERRING INC
ENTOCORT	02229293	3 MG	CAPSULE (SUSTAINED-RELEASE) · ORAL	TILLOTTS PHARMA GMBH
ENTOCORT ENEMA	02052431	2.3 MG	TABLET; ENEMA; KIT · RECTAL	TILLOTTS PHARMA GMBH
JORVEZA	02493675	1 MG	TABLET (ORALLY-DISINTEGRATING) · ORAL	AVIR PHARMA INC.
JORVEZA	02513854	0.5 MG	TABLET (ORALLY-DISINTEGRATING) · ORAL	AVIR PHARMA INC.
MYLAN-BUDESONIDE AQ	02230648	100 MCG / ACT	SPRAY (METERED-DOSE) · NASAL	MYLAN PHARMACEUTICALS ULC
MYLAN-BUDESONIDE AQ	02241003	64 MCG / ACT	SPRAY (METERED-DOSE) · NASAL	MYLAN PHARMACEUTICALS ULC
PULMICORT NEBUAMP 0.125 MG/ML	02229099	0.125 MG / ML	SUSPENSION · INHALATION	ASTRAZENECA CANADA INC
PULMICORT NEBUAMP 0.25 MG/ML	01978918	0.25 MG / ML	SUSPENSION · INHALATION	ASTRAZENECA CANADA INC
PULMICORT NEBUAMP 0.5 MG/ML	01978926	0.5 MG / ML	SUSPENSION · INHALATION	ASTRAZENECA CANADA INC
PULMICORT TURBUHALER	00851752	200 MCG / ACT	POWDER (METERED-DOSE) · INHALATION	ASTRAZENECA CANADA INC
PULMICORT TURBUHALER	00851760	400 MCG / ACT	POWDER (METERED-DOSE) · INHALATION	ASTRAZENECA CANADA INC
PULMICORT TURBUHALER	00852074	100 MCG / ACT	POWDER (METERED-DOSE) · INHALATION	ASTRAZENECA CANADA INC
RHINOCORT AQUA	02231923	64 MCG / ACT	SPRAY (METERED-DOSE) · NASAL	KENVUE CANADA INC.
TARO-BUDESONIDE	02494264	0.125 MG / ML	SUSPENSION · INHALATION	TARO PHARMACEUTICALS INC
TARO-BUDESONIDE	02494272	0.25 MG / ML	SUSPENSION · INHALATION	TARO PHARMACEUTICALS INC
TARO-BUDESONIDE	02494280	0.5 MG / ML	SUSPENSION · INHALATION	TARO PHARMACEUTICALS INC
TEVA-BUDESONIDE	02465949	0.125 MG / ML	SUSPENSION · INHALATION	TEVA CANADA LIMITED
TEVA-BUDESONIDE	02465957	0.5 MG / ML	SUSPENSION · INHALATION	TEVA CANADA LIMITED
TEVA-BUDESONIDE	02535416	0.25 MG / ML	SUSPENSION · INHALATION	TEVA CANADA LIMITED
UCERIS	02498057	2 MG / ACT	FOAM · RECTAL	BAUSCH HEALTH, CANADA INC.

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	BUDESONIDE 0.25 MG/2 ML SUSP	$0.6974	per ML	23 Sep 2026
US NADAC	BUDESONIDE 0.5 MG/2 ML SUSP	$0.67608	per ML	23 Sep 2026
US NADAC	BUDESONIDE 1 MG/2 ML INH SUSP	$3.42737	per ML	23 Sep 2026
US NADAC	BUDESONIDE 2 MG RECTAL FOAM	$9.56406	per GM	23 Sep 2026
US NADAC	BUDESONIDE 32 MCG NASAL SPRAY	$1.41168	per ML	23 Sep 2026
US NADAC	BUDESONIDE DR 3 MG CAPSULE	$0.49753	per EA	23 Sep 2026
US NADAC	BUDESONIDE EC 3 MG CAPSULE	$0.49753	per EA	23 Sep 2026
US NADAC	BUDESONIDE ER 9 MG TABLET	$15.54905	per EA	23 Sep 2026
US NADAC	EOHILIA 2 MG/10 ML PACKET	$3.28718	per ML	31 Jul 2026
US NADAC	PULMICORT 0.5 MG/2 ML RESPULE	$4.9112	per ML	23 Sep 2026
US NADAC	PULMICORT 1 MG/2 ML RESPULE	$9.8448	per ML	22 Apr 2026
US NADAC	PULMICORT 180 MCG FLEXHALER	$253.49738	per EA	21 Jan 2026
NHS Drug Tariff	Budesonide 100micrograms/dose dry powder inhaler	£14.25	200 dose	1 Oct 2026
NHS Drug Tariff	Budesonide 1mg orodispersible tablets sugar free	£323.00	90 tablet	1 Oct 2026
NHS Drug Tariff	Budesonide 1mg/2ml nebuliser liquid unit dose vials	£13.94	20 unit dose	1 Oct 2026
NHS Drug Tariff	Budesonide 1mg/2ml nebuliser suspension unit dose ampoules	£45.60	20 unit dose	1 Oct 2026
NHS Drug Tariff	Budesonide 200micrograms/dose dry powder inhalation cartridge	£9.59	100 dose	1 Oct 2026
NHS Drug Tariff	Budesonide 200micrograms/dose dry powder inhalation cartridge with device	£14.86	100 dose	1 Oct 2026
NHS Drug Tariff	Budesonide 200micrograms/dose dry powder inhaler	£14.25	100 dose	1 Oct 2026
NHS Drug Tariff	Budesonide 2mg/100ml enema	£33.66	7 enema	1 Oct 2026
NHS Drug Tariff	Budesonide 2mg/application foam enema	£57.11	14 dose	1 Oct 2026
NHS Drug Tariff	Budesonide 3mg gastro-resistant capsules	£75.05	100 capsule	1 Oct 2026
NHS Drug Tariff	Budesonide 3mg gastro-resistant modified-release capsules	£60.00	100 capsule	1 Oct 2026
NHS Drug Tariff	Budesonide 400micrograms/dose dry powder inhaler	£14.25	50 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
Asthma
Respiratory > Inhalation > powder: 100 µg per actuation in dry powder inhaler; 200 µg per actuation in dry powder inhaler | Respiratory > Inhalation > suspension: 100 µg per actuation in pressurized metered dose inhaler; 200 µg per actuation in pressurized metered dose inhaler
28. Ear, nose and throat medicines [c] · core
Allergic rhinitis
Local > Nasal > Spray: 32 µg per actuation (EMLc); 64 µg per actuation (EMLc)

Safety signals and safety-related labeling changes

US FDA 27 Apr 2026 BREZTRI AEROSPHERE — 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 27 Apr 2026 SYMBICORT AEROSPHERE — 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 5 Jun 2024 ENTOCORT EC — 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 5 Jun 2024 ORTIKOS — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Patient Counseling Information / Patient Information / Medication Guide
US FDA 5 Jun 2024 TARPEYO — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Patient Counseling Information / Patient Information / Medication Guide
US FDA 5 Jun 2024 UCERIS — 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 9 Apr 2020 UCERIS — safety-related labeling change
Labeling sections changed: Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 6 Sep 2019 PULMICORT RESPULES — safety-related labeling change
Labeling sections changed: Adverse Reactions; Use in Specific Populations
US FDA 6 Sep 2019 PULMICORT FLEXHALER — safety-related labeling change
Labeling sections changed: Use in Specific Populations
US FDA 20 Dec 2017 SYMBICORT — 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 budesonide →

Combinations containing Budesonide

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.