Is Dexamethasone registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 6 valid registrations of Dexamethasone, including Adrixa (4 mg/ml, Solution for injection, SAR 27.00); DEXAMETHASONE SOD.PHOSPHATE 8MG-2ML AMP (4 mg/ml, Solution, SAR 10.85); Demsone (0.4 mg/ml, Oral solution, SAR 58.85); Demsone 10 mg per 5 ml (2 mg/ml, Oral solution, SAR 294.35); OZURDEX 700 mcg Intravitreal Implant In Applicator (700 µg, Intravitreal implant in applicator, SAR 3260.15).

Is Dexamethasone approved by the US FDA?

Drugs@FDA lists 126 application product lines for Dexamethasone, including MAXIDEX (Prescription); DEXAMETHASONE (Prescription); DEXAMETHASONE SODIUM PHOSPHATE (Prescription); DEXAMETHASONE (Prescription); DEXAMETHASONE SODIUM PHOSPHATE (Prescription).

Is Dexamethasone authorised in the European Union?

EMA lists 2 centrally authorised medicines containing Dexamethasone: Ozurdex, Neofordex.

Is Dexamethasone on the WHO Model List of Essential Medicines?

Yes — 22.6. Other medicines administered to the mother (core list): Respiratory distress syndrome of the newborn, altered by maternal corticosteroid therapy.

Are there safety signals or safety updates for Dexamethasone?

US FDA: 14 entries (latest 2026-03-17).

Active substance

Dexamethasone

SFDA 13
US FDA 126
EMA 4
Health Canada 17
US price lines 20
NHS prices 19
WHO EML 5
Safety 14

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Adrixa	4 mg/ml	Solution for injection · Intravenous use	5 Ampoule	SAR 27.00	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
DEXAMETHASONE SOD.PHOSPHATE 8MG-2ML AMP	4 mg/ml	Solution · Intravenous use	5 Ampoule	SAR 10.85	Generic · Prescription	EIPICO	Valid
DEXAMETHASONE SOD.PHOSPHATE 8MG-2ML AMP	4 mg/ml	Solution · Intravenous use	100 Ampoule	SAR 217.25	Generic · Prescription	EIPICO	Valid
Demsone	0.4 mg/ml	Oral solution · Oral use	1 Bottle	SAR 58.85	NCE · Prescription	Rosemont Pharmaceuticals Ltd	Valid
Demsone 10 mg per 5 ml	2 mg/ml	Oral solution · Oral use	1 Bottle	SAR 294.35	NCE · Prescription	Rosemont Pharmaceuticals Ltd	Valid
OZURDEX 700 mcg Intravitreal Implant In Applicator	700 µg	Intravitreal implant in applicator · Intravitreal use	1 Applicator	SAR 3260.15	NCE · Prescription	ABBVIE Deutschland GmbH	Valid
MILLICORTEN 1 MG	1 mg	Tablet · Oral use	20 Blister	SAR 22.75	Generic · Prescription	NOVARTIS	Withdrawn by MAH · Not Marketed
OFTALMOLOSA CUSI DEXAMETHASONE 0.05%	0.05 %	Eye ointment · Ocular use	1 Tube	SAR 3.85	Generic · Prescription	ALCON CUSI	Withdrawn by MAH · Not Marketed
ORADEXON 0.5 MG TABS	0.5 mg	Tablet · Oral use	20 Blister	SAR 6.30	NCE · Prescription	ORGANON	Withdrawn by MAH · Not Marketed
ORADEXON 1.5 MG TABS	1.5 mg	Tablet · Oral use	10 Blister	SAR 9.00	NCE · Prescription	ORGANON	Withdrawn by MAH · Not Marketed
ORADEXON AMPULES 5 MG.-ML.	5 mg/ml	Solution for injection · Intravenous use	1 Ampoule	SAR 14.15	NCE · Prescription	ORGANON	Withdrawn by MAH · Not Marketed
ZENOS AMP 4MG-ML	4 mg/ml	Injection · Intravenous use	1 Ampoule	SAR 3.80	Generic · Prescription	Hikma Pharmaceuticals PLC	Withdrawn by MAH · Not Marketed
ZENOS AMP 4MG-ML	4 mg/ml	Injection · Intravenous use	1 Ampoule	SAR 5.40	Generic · Prescription	Hikma Pharmaceuticals PLC	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

AMYLOIDOSIS - LIGHT CHAIN; ANAPHYLACTIC SHOCK; BACTERIAL MENINGITIS; CASTLEMAN DISEASE; HYPERTHYROIDISM; IMMUNE THROMBOCYPTOPENIC PUPURA; LYMPHOPLASMACYTIC LYMPHOMA; OTITIS EXTERNA; PEMPHIGUS; PROSTATE CANCER; Septic Shock; THROMBOTIC THROMBOCYTOPENIC PURPURA; TREATMENT OF ALTITUDE SICKNESS

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

Product	Strength	Form · route	Applicant	Status	First approved
MAXIDEX	0.1%	suspension/drops · ophthalmic	HARROW EYE	Prescription	20 Jun 1962
DEXAMETHASONE	4MG	tablet · oral	PRASCO	Prescription	20 Oct 1971
DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	injectable · injection	HIKMA PHARMS	Prescription	15 Jul 1975
DEXAMETHASONE	0.5MG/5ML	elixir · oral	KANCHAN HLTHCARE	Prescription	21 Sep 1976
DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	injectable · injection	FRESENIUS KABI USA	Prescription	6 Sep 1977
DEXAMETHASONE	4MG; 0.5MG; 0.75MG; 1MG; 1.5MG; 2MG; 6MG	tablet · oral	HIKMA PHARMS	Prescription	19 Jul 1978
DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	injectable · injection	HIKMA PHARMS	Prescription	7 Sep 1982
DEXAMETHASONE	0.25MG	tablet · oral	PANGEA	Prescription	28 Apr 1983
DEXAMETHASONE	0.5MG/5ML	solution · oral	HIKMA PHARMS	Prescription	1 Sep 1983
DEXAMETHASONE INTENSOL	1MG/ML	concentrate · oral	HIKMA PHARMS	Prescription	1 Sep 1983
DEXAMETHASONE	6MG	tablet · oral	HIKMA	Prescription	15 Sep 1983
DEXAMETHASONE	6MG; 0.5MG; 0.75MG; 4MG	tablet · oral	ALVOGEN	Prescription	15 Dec 1983
DEXAMETHASONE SODIUM PHOSPHATE	EQ 0.1% PHOSPHATE	solution/drops · ophthalmic, otic	BAUSCH AND LOMB INC	Prescription	26 Jul 1996
DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE	EQ 10MG PHOSPHATE/ML	injectable · injection	FRESENIUS KABI USA	Prescription	11 Apr 2003
DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	injectable · injection	FRESENIUS KABI USA	Prescription	22 Apr 2005
DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	injectable · injection	MYLAN LABS LTD	Prescription	29 Aug 2008
DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	injectable · injection	MYLAN LABS LTD	Prescription	29 Aug 2008
OZURDEX	0.7MG	implant · intravitreal	ABBVIE	Prescription	17 Jun 2009
DEXAMETHASONE	0.5MG/5ML	elixir · oral	CHARTWELL MOLECULAR	Prescription	11 May 2011
DEXAMETHASONE	0.5MG/5ML	elixir · oral	RISING	Prescription	12 Jul 2011
DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	injectable · injection	FRESENIUS KABI USA	Prescription	30 Sep 2015
DEXAMETHASONE	1.5MG	tablet · oral	PHARMOBEDIENT	Prescription	17 Jul 2017
DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE	EQ 10MG PHOSPHATE/ML	injectable · injection	SOMERSET THERAPS LLC	Prescription	19 Apr 2018
DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	injectable · injection	SOMERSET	Prescription	8 Jun 2018
DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	injectable · injection	FRESENIUS KABI USA	Prescription	6 Jul 2018

101 more — full table

EMA European Union — centrally authorised medicines

Ozurdex AbbVie Deutschland GmbH & Co. KG · Authorised · authorised 26 Jul 2010 · ATC S01BA01

Therapeutic indication (EMA)

Ozurdex is indicated for the treatment of adult patients with macular oedema following either branch retinal-vein occlusion (BRVO) or central retinal-vein occlusion (CRVO). Ozurdex is indicated for the treatment of adult patients with inflammation of the posterior segment of the eye presenting as noninfectious uveitis. Ozurdex is indicated for the treatment of adult patients with visual impairment due to diabetic macular oedema (DME) who are pseudophakic or who are considered insufficiently responsive to, or unsuitable for non-corticosteroid therapy.

Neofordex THERAVIA · Authorised · authorised 16 Mar 2016 · ATC H02AB02

Therapeutic indication (EMA)

Treatment of multiple myeloma.

Neofordex Laboratoires CTRS - Boulogne Billancourt · Application withdrawn · ATC H02AB02

Therapeutic indication (EMA)

Treatment of symptomatic multiple myeloma

Dexamethasone Taw Taw Pharma (Ireland) Ltd · Application withdrawn · ATC H02AB02

Therapeutic indication (EMA)

Indicated for cerebral oedema, post-traumatic shock-lung syndrome, asthma, skin diseases, autoimmune diseases, rheumatoid arthritis, prophylaxis and treatment of post-operative or cytostatic-induced vomiting, treatment of COVID-19, eye inflammation and infection.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
APO-DEXAMETHASONE	02250055	4 MG	TABLET · ORAL	APOTEX INC
APO-DEXAMETHASONE	02261081	0.5 MG	TABLET · ORAL	APOTEX INC
DEXAMETHASONE	02023865	0.1 %	SOLUTION · OPHTHALMIC; OTIC	PHARMA STULLN INC.
DEXAMETHASONE OMEGA UNIDOSE	02387743	10 MG / 1 ML	SOLUTION · INTRAVENOUS; INTRASYNOVIAL; INTRAMUSCULAR	OMEGA LABORATORIES LIMITED
DEXAMETHASONE SOD PHOSPH INJ 10MG/ML USP	00874582	10 MG / 1 ML	LIQUID · INTRASYNOVIAL; INTRAMUSCULAR; INTRAVENOUS	SANDOZ CANADA INCORPORATED
DEXAMETHASONE SODIUM PHOSPHATE INJ USP 4MG/ML	00664227	4 MG / ML	SOLUTION · INTRAMUSCULAR; INTRASYNOVIAL; INTRAVENOUS	SANDOZ CANADA INCORPORATED
DEXAMETHASONE SODIUM PHOSPHATE INJECTION, USP	01977547	4 MG / ML	SOLUTION · INTRA-ARTICULAR; INTRAMUSCULAR; INTRAVENOUS	STERIMAX INC
DEXAMETHASONE-OMEGA	02204266	4 MG / ML	LIQUID · INTRA-ARTICULAR; INTRAVENOUS; SOFT TISSUE INJECTION; INTRALESIONAL; INTRAMUSCULAR	OMEGA LABORATORIES LIMITED
DEXAMETHASONE-OMEGA	02204274	10 MG / ML	LIQUID · INTRAVENOUS; INTRAMUSCULAR	OMEGA LABORATORIES LIMITED
MAXIDEX	00042560	0.1 % / W/V	SUSPENSION · OPHTHALMIC	NOVARTIS PHARMACEUTICALS CANADA INC
MAXIDEX	00042579	0.1 % / W/W	OINTMENT · OPHTHALMIC	NOVARTIS PHARMACEUTICALS CANADA INC
ODAN-DEXAMETHASONE ELIXIR	02528584	0.5 MG / 5 ML	ELIXIR · ORAL	ODAN LABORATORIESLTD
OZURDEX	02363445	0.7 MG	IMPLANT · INTRAVITREAL	ABBVIE CORPORATION
PMS-DEXAMETHASONE	01964070	4 MG	TABLET · ORAL	PHARMASCIENCE INC
PMS-DEXAMETHASONE	01964976	0.5 MG	TABLET · ORAL	PHARMASCIENCE INC
PMS-DEXAMETHASONE	02279363	2 MG	TABLET · ORAL	PHARMASCIENCE INC
PMS-DEXAMETHASONE ELIXIR	01946897	0.5 MG / 5 ML	ELIXIR · ORAL	PHARMASCIENCE INC

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	DEXAMETHASONE 0.1% EYE DROP	$8.17447	per ML	23 Sep 2026
US NADAC	DEXAMETHASONE 0.5 MG TABLET	$0.07073	per EA	23 Sep 2026
US NADAC	DEXAMETHASONE 0.5 MG/5 ML ELX	$0.10498	per ML	23 Sep 2026
US NADAC	DEXAMETHASONE 0.5 MG/5 ML LIQ	$0.17177	per ML	23 Sep 2026
US NADAC	DEXAMETHASONE 0.5 MG/5 ML LIQ	$0.02943	per ML	23 Sep 2026
US NADAC	DEXAMETHASONE 0.75 MG TABLET	$0.08973	per EA	23 Sep 2026
US NADAC	DEXAMETHASONE 1 MG TABLET	$0.15533	per EA	23 Sep 2026
US NADAC	DEXAMETHASONE 1.5 MG TABLET	$0.1744	per EA	23 Sep 2026
US NADAC	DEXAMETHASONE 10 MG/ML VIAL	$1.23567	per ML	23 Sep 2026
US NADAC	DEXAMETHASONE 10 MG/ML VIAL	$1.1568	per ML	23 Sep 2026
US NADAC	DEXAMETHASONE 100 MG/10 ML VL	$0.5104	per ML	23 Sep 2026
US NADAC	DEXAMETHASONE 120 MG/30 ML VL	$0.69401	per ML	23 Sep 2026
NHS Drug Tariff	Dexamethasone (base) 3.3mg/1ml solution for injection ampoules	£7.90	10 ampoule	1 Oct 2026
NHS Drug Tariff	Dexamethasone (base) 3.8mg/1ml solution for injection vials	£19.99	10 vial	1 Oct 2026
NHS Drug Tariff	Dexamethasone (base) 6.6mg/2ml solution for injection vials	£24.00	5 vial	1 Oct 2026
NHS Drug Tariff	Dexamethasone 0.1% eye drops	£1.42	5 ml	1 Oct 2026
NHS Drug Tariff	Dexamethasone 0.1% eye drops 0.3ml unit dose preservative free	£5.53	20 unit dose	1 Oct 2026
NHS Drug Tariff	Dexamethasone 0.1% eye drops 0.4ml unit dose preservative free	£11.53	20 unit dose	1 Oct 2026
NHS Drug Tariff	Dexamethasone 0.1% eye drops 0.5ml unit dose preservative free	£12.22	20 unit dose	1 Oct 2026
NHS Drug Tariff	Dexamethasone 0.1% eye drops preservative free	£9.75	6 ml	1 Oct 2026
NHS Drug Tariff	Dexamethasone 10mg soluble tablets sugar free	£10.00	10 tablet	1 Oct 2026
NHS Drug Tariff	Dexamethasone 10mg/5ml oral solution sugar free	£167.47	150 ml	1 Oct 2026
NHS Drug Tariff	Dexamethasone 1mg tablets	£4.97	30 tablet	1 Oct 2026
NHS Drug Tariff	Dexamethasone 20mg soluble tablets sugar free	£20.00	10 tablet	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)

22.6. Other medicines administered to the mother · core
Respiratory distress syndrome of the newborn, altered by maternal corticosteroid therapy
Parenteral > General injections > unspecified: 4 mg per mL (dexamethasone phosphate (as sodium))
8.2.4. Hormones and antihormones · complementary
Anaplastic large cell lymphoma, ALK-negative; Lymphoid leukaemia, not elsewhere classified; Plasma cell myeloma; Burkitt lymphoma including Burkitt leukaemia; Anaplastic large cell lymphoma, ALK-positive
Oral > Liquid: 2 mg per 5 mL (EMLc) | Oral > Solid: 2 mg (EMLc); 4 mg | Parenteral > General injections > unspecified: 4 mg per mL in 1 mL ampoule (as disodium phosophate salt) | Oral > Liquid: 2 mg per 5 mL (as sodium phosphate) (EMLc) | Parenteral > General injections > unspecified: 4 mg per mL in 1 mL ampoule dexamethasone phosphate (as sodium phosphate, equivalent to 3.3 mg/mL dexamethasone base) | Oral > Solid > tablet: 2 mg (as dexamethasone base) (EMLc); 4 mg (as dexamethasone base) | Parenteral > General injections > unspecified: 4 mg per mL in 1 mL ampoule dexamethasone phosphate (as sodium phosphate, equivalent to 3.3 mg/mL dexamethasone base | Oral > Solid > tablet: 4 mg (as dexamethasone base)
3. Antiallergics and medicines used in anaphylaxis · core
Allergic or hypersensitivity conditions of unspecified type
Oral > Liquid: 0.5 mg per 5 mL (as sodium phosphate) (EMLc); 2 mg per 5 mL (as sodium phosphate) | Parenteral > General injections > unspecified: 4 mg per mL in 1 mL ampoule dexamethasone phosphate (as sodium phosphate, equivalent to 3.3 mg/mL dexamethasone base) | Oral > Solid > tablet: 0.5 mg (as dexamethasone base); 0.75 mg (as dexamethasone base); 1.5 mg (as dexamethasone base); 2 mg (as dexamethasone base); 4 mg (as dexamethasone base)
2.3. Medicines for other common symptoms in palliative care · core
Palliative care
Oral > Liquid: 2 mg per 5 mL (as sodium phosphate); 0.5 mg per 5 mL (as sodium phosphate) (EMLc) | Parenteral > General injections > unspecified: 4 mg per mL in 1 mL ampoule (dexamethasone phosphate (as sodium phosphate) equialent to 3.3 mg dexamethasone base) | Oral > Solid > tablet: 2 mg (as dexamethasone base); 4 mg (as dexamethasone base); 0.5 mg (as dexamethasone base); 0.75 mg (as dexamethasone base); 1.5 mg (as dexamethasone base)
17.2. Antiemetic medicines · core
Nausea or vomiting
Oral > Liquid: 0.5 mg per 5 mL (as sodium phosphate); 2 mg per 5 mL (as sodium phosphate) | Parenteral > General injections > unspecified: 4 mg per mL in 1 mL ampoule dexamethasone phosphate (as sodium phosphate, equivalent to 3.3 mg/mL dexamethasone base) | Oral > Solid > tablet: 0.5 mg (as dexamethasone base); 0.75 mg (as dexamethasone base); 1.5 mg (as dexamethasone base); 4 mg (as dexamethasone base); 2 mg (as dexamethasone base)

Safety signals and safety-related labeling changes

US FDA 17 Mar 2026 TOBRADEX ST — 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 11 Mar 2026 OZURDEX — safety-related labeling change
Labeling sections changed: Adverse Reactions; Use in Specific Populations
US FDA 7 Apr 2025 DEXTENZA — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations
US FDA 5 Jun 2024 HEMADY — safety-related labeling change
Labeling sections changed: Warnings and Precautions
US FDA 5 Jun 2024 HEXADROL — safety-related labeling change
Labeling sections changed: Warnings and Precautions
US FDA 5 Jun 2024 HEXADROL — safety-related labeling change
Labeling sections changed: Warnings and Precautions
US FDA 5 Jun 2024 HEXADROL — safety-related labeling change
Labeling sections changed: Warnings and Precautions
US FDA 10 Dec 2021 MAXIDEX — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions
US FDA 14 May 2021 TOBRADEX — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions
US FDA 14 May 2021 MAXITROL — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Patient Counseling Information / Patient Information / Medication Guide
US FDA 14 May 2021 MAXITROL — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Patient Counseling Information / Patient Information / Medication Guide
US FDA 14 May 2021 TOBRADEX — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions
US FDA 3 Nov 2020 CIPRODEX — safety-related labeling change
Labeling sections changed: Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 8 May 2019 DECADRON — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions

All safety entries for dexamethasone →

Combinations containing Dexamethasone

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.