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dexamethasone 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
prednisone and prednisolone derivatives	824	50-02-2

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: dexamethasone dexasone dexmethsone	An anti-inflammatory 9-fluoro-glucocorticoid. The NIH COVID-19 Treatment Guidelines Panel recommends the use of dexamethasone in patients with COVID-19 who are receiving mechanical ventilation or in those who require supplemental oxygen but are not on me-chanical ventilation. It is not recommended the use of dexamethasone or other corticosteroids in nonhospitalized patients with mild to moderate COVID-19 or in hospitalized patients with COVID-19 who do not require supplemental oxygen. Molecular weight: 392.47 Formula: C22H29FO5 CLOGP: 1.78 LIPINSKI: 0 HAC: 5 HDO: 3 TPSA: 94.83 ALOGS: -3.89 ROTB: 2 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

dexamethasone
dexasone
dexmethsone

An anti-inflammatory 9-fluoro-glucocorticoid. The NIH COVID-19 Treatment Guidelines Panel recommends the use of dexamethasone in patients with COVID-19 who are receiving mechanical ventilation or in those who require supplemental oxygen but are not on me-chanical ventilation. It is not recommended the use of dexamethasone or other corticosteroids in nonhospitalized patients with mild to moderate COVID-19 or in hospitalized patients with COVID-19 who do not require supplemental oxygen.

Molecular weight: 392.47
Formula: C22H29FO5
CLOGP: 1.78
LIPINSKI: 0
HAC: 5
HDO: 3
TPSA: 94.83
ALOGS: -3.89
ROTB: 2

Status: OFP

Legend:
OFP - off patent
OFM - off market
ONP - on patent

Drug dosage:

Dose	Unit	Route
1.50	mg	O
1.50	mg	P

ADMET properties:

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Property	Value	Reference
t_half (Half-life)	3.70 hours	Lombardo F, Berellini G, Obach RS
CL (Clearance)	3.30 mL/min/kg	Lombardo F, Berellini G, Obach RS
EoM (Fraction excreted unchanged in urine)	2.60 %	Benet LZ, Broccatelli F, Oprea TI
BDDCS (Biopharmaceutical Drug Disposition Classification System)	1	Benet LZ, Broccatelli F, Oprea TI
Vd (Volume of distribution)	0.94 L/kg	Lombardo F, Berellini G, Obach RS
MRTD (Maximum Recommended Therapeutic Daily Dose)	0.33 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
fu (Fraction unbound in plasma)	0.32 %	Lombardo F, Berellini G, Obach RS
S (Water solubility)	0.08 mg/mL	Bocci G, Oprea TI, Benet LZ

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Approvals:

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Date	Agency	Company
Aug. 25, 2021	PMDA	NICHI - IKO PHARMACEUTICAL Co., Ltd.
July 26, 2010	EMA	AbbVie Deutschland GmbH & Co. KG
Oct. 30, 1958	FDA

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FDA Adverse Event Reporting System (Female)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Plasma cell myeloma	2646.05	10.38	1867	323768	34038	63129349
Neutropenia	2135.34	10.38	3474	322161	171531	62991856
Neuropathy peripheral	2047.03	10.38	2712	322923	110955	63052432
Febrile neutropenia	1748.64	10.38	2569	323066	115880	63047507
Thrombocytopenia	1671.05	10.38	2872	322763	148285	63015102
Disease progression	989.69	10.38	2039	323596	120719	63042668
Diarrhoea	948.56	10.38	6585	319050	708781	62454606
Rheumatoid arthritis	808.43	10.38	160	325475	253659	62909728
Death	737.43	10.38	3826	321809	370555	62792832
Pneumonia	677.29	10.38	4328	321307	452439	62710948

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FDA Adverse Event Reporting System (Male)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Plasma cell myeloma	2377.25	11.57	2337	300629	39700	34614265
Neuropathy peripheral	1403.75	11.57	2556	300410	80707	34573258
Neutropenia	1154.29	11.57	3475	299491	153303	34500662
Thrombocytopenia	988.25	11.57	3287	299679	152960	34501005
Febrile neutropenia	940.22	11.57	2962	300004	133887	34520078
Pneumonia	928.48	11.57	5832	297134	356795	34297170
Completed suicide	718.24	11.57	31	302935	98137	34555828
Drug abuse	653.76	11.57	55	302911	99041	34554924
Plasma cell myeloma recurrent	641.99	11.57	429	302537	4036	34649929
Off label use	575.29	11.57	5848	297118	413676	34240289

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FDA Adverse Event Reporting System (Geriatric)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Plasma cell myeloma	3858.21	10.09	2971	498056	50288	79193073
Neutropenia	2971.88	10.09	5957	495070	281753	78961608
Febrile neutropenia	2699.89	10.09	5041	495986	225958	79017403
Thrombocytopenia	2529.02	10.09	5315	495712	259944	78983417
Neuropathy peripheral	2290.11	10.09	3568	497459	137737	79105624
Pneumonia	1640.54	10.09	8326	492701	651920	78591441
Completed suicide	1338.75	10.09	46	500981	245721	78997640
Disease progression	1212.21	10.09	3198	497829	181164	79062197
Plasma cell myeloma recurrent	1087.64	10.09	561	500466	4440	79238921
Off label use	1069.56	10.09	9504	491523	897711	78345650

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	A01AC02	ALIMENTARY TRACT AND METABOLISM STOMATOLOGICAL PREPARATIONS STOMATOLOGICAL PREPARATIONS Corticosteroids for local oral treatment
ATC	C05AA09	CARDIOVASCULAR SYSTEM VASOPROTECTIVES AGENTS FOR TREATMENT OF HEMORRHOIDS AND ANAL FISSURES FOR TOPICAL USE Corticosteroids
ATC	D07AB19	DERMATOLOGICALS CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS CORTICOSTEROIDS, PLAIN Corticosteroids, moderately potent (group II)
ATC	D07CB04	DERMATOLOGICALS CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS CORTICOSTEROIDS, COMBINATIONS WITH ANTIBIOTICS Corticosteroids, moderately potent, combinations with antibiotics
ATC	D07XB05	DERMATOLOGICALS CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS CORTICOSTEROIDS, OTHER COMBINATIONS Corticosteroids, moderately potent, other combinations
ATC	D10AA03	DERMATOLOGICALS ANTI-ACNE PREPARATIONS ANTI-ACNE PREPARATIONS FOR TOPICAL USE Corticosteroids, combinations for treatment of acne
ATC	H02AB02	SYSTEMIC HORMONAL PREPARATIONS, EXCL. SEX HORMONES AND INSULINS CORTICOSTEROIDS FOR SYSTEMIC USE CORTICOSTEROIDS FOR SYSTEMIC USE, PLAIN Glucocorticoids
ATC	R01AD03	RESPIRATORY SYSTEM NASAL PREPARATIONS DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE Corticosteroids
ATC	R01AD53	RESPIRATORY SYSTEM NASAL PREPARATIONS DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE Corticosteroids
ATC	S01BA01	SENSORY ORGANS OPHTHALMOLOGICALS ANTIINFLAMMATORY AGENTS Corticosteroids, plain

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Drug Use | Suggest Off label Use Form| |View source of the data|

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Disease	Relation	SNOMED_ID	DOID
Disorder of musculoskeletal system	indication	928000	DOID:17
Cerebral edema	indication	2032001
Otitis externa	indication	3135009
Keratitis	indication	5888003	DOID:4677
Berylliosis	indication	8247009	DOID:10322
Psoriasis	indication	9014002	DOID:8893
Ankylosing spondylitis	indication	9631008	DOID:7147
Cyclitis	indication	17657000
Systemic AL amyloidosis	indication	23132008
Rheumatic heart disease	indication	23685000

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🐶 Veterinary Drug Use

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Species	Use	Relation
Cats	Inflammation	Indication
Cattle	Primary bovine ketosis	Indication
Cattle	Inflammation	Indication
Dogs	Inflammation	Indication
Horses	Inflammation	Indication

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🐶 Veterinary products

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Product	Applicant	Ingredients
Azium Aqueous Suspension Veterinary	Intervet Inc.	1
Azium Boluses 10 mg	Intervet Inc.	1
Azium Oral Solution 2 mg	Intervet Inc.	1
Azium Powder	Intervet Inc.	1
Azium Solution	Intervet Inc.	1
Azium Tablets 0.25 mg	Intervet Inc.	1
Dexachel	Zoetis Inc.	1
Dexameth-A-Vet	Bimeda Animal Health Limited	1
Dexameth-A-Vet Injection	Bimeda Animal Health Limited	1
Dexamethasone Injection	Sparhawk Laboratories Inc.	1

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Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	11.06	acidic
pKa2	12.45	acidic

Orange Book patent data (new drug applications)

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Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
0.05%;0.3%	TOBRADEX ST	EYEVANCE	N050818	Feb. 13, 2009	RX	SUSPENSION/DROPS	OPHTHALMIC	8101582	Dec. 19, 2027	USE OF A COMBINATION OF TOBRAMYCIN AND DEXAMETHASONE TO TREAT OCULAR INFLAMMATION WHERE AN INFECTION OR RISK OF INFECTION EXISTS
0.05%;0.3%	TOBRADEX ST	EYEVANCE	N050818	Feb. 13, 2009	RX	SUSPENSION/DROPS	OPHTHALMIC	7795316	Aug. 3, 2028	USE OF A COMBINATION OF TOBRAMYCIN AND DEXAMETHASONE TO TREAT OCULAR INFLAMMATION WHERE AN INFECTION OR RISK OF INFECTION EXISTS
0.3%;0.1%	CIPRODEX	NOVARTIS	N021537	July 18, 2003	RX	SUSPENSION/DROPS	OTIC	8846650	June 4, 2025	TREATMENT OF ACUTE OTITIS MEDIA
0.4MG	DEXTENZA	OCULAR THERAPEUTIX	N208742	Nov. 30, 2018	RX	INSERT	OPHTHALMIC	8563027	Feb. 12, 2030	DEXTENZA IS APPROVED FOR THE TREATMENT OF OCULAR PAIN FOLLOWING OPHTHALMIC SURGERY
0.4MG	DEXTENZA	OCULAR THERAPEUTIX	N208742	Nov. 30, 2018	RX	INSERT	OPHTHALMIC	11458041	Nov. 16, 2037	TREATMENT OF OCULAR INFLAMMATION AND PAIN FOLLOWING OPHTHALMIC SURGERY
0.4MG	DEXTENZA	OCULAR THERAPEUTIX	N208742	Nov. 30, 2018	RX	INSERT	OPHTHALMIC	11458041	Nov. 16, 2037	TREATMENT OF OCULAR ITCHING ASSOCIATED WITH ALLERGIC CONJUNCTIVITIS
0.7MG	OZURDEX	ABBVIE	N022315	June 17, 2009	RX	IMPLANT	INTRAVITREAL	10702539	Jan. 9, 2023	TREATMENT OF DIABETIC MACULAR EDEMA
0.7MG	OZURDEX	ABBVIE	N022315	June 17, 2009	RX	IMPLANT	INTRAVITREAL	10702539	Jan. 9, 2023	TREATMENT OF MACULAR EDEMA FOLLOWING BRANCH RETINAL VEIN OCCLUSION (BRVO) OR CENTRAL RETINAL VEIN OCCLUSION (CRVO)
0.7MG	OZURDEX	ABBVIE	N022315	June 17, 2009	RX	IMPLANT	INTRAVITREAL	10702539	Jan. 9, 2023	TREATMENT OF NON-INFECTIOUS UVEITIS AFFECTING THE POSTERIOR SEGMENT OF THE EYE
0.7MG	OZURDEX	ABBVIE	N022315	June 17, 2009	RX	IMPLANT	INTRAVITREAL	8034366	Jan. 9, 2023	TREATMENT OF MACULAR EDEMA

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Orange Book exclusivity data (new drug applications)

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Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
0.4MG	DEXTENZA	OCULAR THERAPEUTIX	N208742	Nov. 30, 2018	RX	INSERT	OPHTHALMIC	Oct. 7, 2024	TREATMENT OF OCULAR ITCHING ASSOCIATED WITH ALLERGIC CONJUNCTIVITIS
20MG	HEMADY	DEXCEL	N211379	Oct. 3, 2019	RX	TABLET	ORAL	Oct. 3, 2026	INDICATED IN COMBINATION WITH OTHER ANTI-MYELOMA PRODUCTS FOR THE TREATMENT OF ADULTS WITH MULTIPLE MYELOMA (MM)
2MG	DEXAMETHASONE	AMNEAL	A216295	Sept. 8, 2022	RX	TABLET	ORAL	March 8, 2023	COMPETITIVE GENERIC THERAPY

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Bioactivity Summary:

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Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Glucocorticoid receptor	Nuclear hormone receptor	P04150	GCR_HUMAN	AGONIST	EC50	8.88	WOMBAT-PK	CHEMBL
Annexin A1	Cytosolic other	P04083	ANXA1_HUMAN				WOMBAT-PK
Interleukin-5	Cytokine	P05113	IL5_HUMAN		IC50	8.46	WOMBAT-PK
Mineralocorticoid receptor	Nuclear hormone receptor	P08235	MCR_HUMAN		EC50	9	WOMBAT-PK
Interleukin-4	Cytokine	P05112	IL4_HUMAN		IC50	8.33	WOMBAT-PK
Androgen receptor	Nuclear hormone receptor	P10275	ANDR_HUMAN		Ki	5.85	CHEMBL
Progesterone receptor	Nuclear hormone receptor	P06401	PRGR_HUMAN		Ki	6.25	CHEMBL
Prostaglandin G/H synthase 2	Enzyme	P35354	PGH2_HUMAN		Ki	6.89	PDSP
Androgen receptor	Transcription factor		ANDR_RAT		Ki	4.79	DRUG MATRIX
Fatty acid-binding protein, liver	Unclassified		FABPL_RAT		Ki	4.66	CHEMBL

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External reference:

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ID	Source
DEX	PDB_CHEM_ID
002174	NDDF
203704	RXNORM
2768	IUPHAR_LIGAND_ID
372584003	SNOMEDCT_US
4017922	VUID
4017922	VANDF
4552	MMSL
5743	PUBCHEM_CID
6848	MMSL

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Dexamethasone	HUMAN PRESCRIPTION DRUG LABEL	1	0054-3177	SOLUTION	0.50 mg	ORAL	ANDA	20 sections
Dexamethasone	HUMAN PRESCRIPTION DRUG LABEL	1	0054-3177	SOLUTION	0.50 mg	ORAL	ANDA	20 sections
Dexamethasone	HUMAN PRESCRIPTION DRUG LABEL	1	0054-4179	TABLET	0.50 mg	ORAL	ANDA	20 sections
Dexamethasone	HUMAN PRESCRIPTION DRUG LABEL	1	0054-4179	TABLET	0.50 mg	ORAL	ANDA	20 sections
Dexamethasone	HUMAN PRESCRIPTION DRUG LABEL	1	0054-4180	TABLET	0.75 mg	ORAL	ANDA	20 sections
Dexamethasone	HUMAN PRESCRIPTION DRUG LABEL	1	0054-4180	TABLET	0.75 mg	ORAL	ANDA	20 sections
Dexamethasone	HUMAN PRESCRIPTION DRUG LABEL	1	0054-4181	TABLET	1 mg	ORAL	ANDA	20 sections
Dexamethasone	HUMAN PRESCRIPTION DRUG LABEL	1	0054-4181	TABLET	1 mg	ORAL	ANDA	20 sections
Dexamethasone	HUMAN PRESCRIPTION DRUG LABEL	1	0054-4182	TABLET	1.50 mg	ORAL	ANDA	20 sections
Dexamethasone	HUMAN PRESCRIPTION DRUG LABEL	1	0054-4182	TABLET	1.50 mg	ORAL	ANDA	20 sections

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