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

Stem definition	Drug id	CAS RN
steroids for topical use, acetal derivatives	1205	356-12-7

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: fluocinonide flucetonide fluocinolide fluocinolide acetate fluocinolone acetonide acetate	A topical glucocorticoid used in the treatment of ECZEMA. Molecular weight: 494.53 Formula: C26H32F2O7 CLOGP: 2.79 LIPINSKI: 0 HAC: 7 HDO: 1 TPSA: 99.13 ALOGS: -4.47 ROTB: 4 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

fluocinonide
flucetonide
fluocinolide
fluocinolide acetate
fluocinolone acetonide acetate

A topical glucocorticoid used in the treatment of ECZEMA.

Molecular weight: 494.53
Formula: C26H32F2O7
CLOGP: 2.79
LIPINSKI: 0
HAC: 7
HDO: 1
TPSA: 99.13
ALOGS: -4.47
ROTB: 4

Status: OFP

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

Drug dosage:

None

ADMET properties:

None

Approvals:

Date	Agency	Company	Orphan
June 30, 1971	FDA

FDA Adverse Event Reporting System (Female)

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
Psoriasis	201.66	17.05	107	4575	86850	63397490
Dermatitis atopic	86.58	17.05	31	4651	9693	63474647
Pruritus	47.84	17.05	91	4591	361362	63122978
Hypothalamic pituitary adrenal axis suppression	43.23	17.05	8	4674	172	63484168
Product dose omission issue	42.72	17.05	68	4614	234245	63250095
Eczema	41.01	17.05	27	4655	32264	63452076
Rash	34.62	17.05	105	4577	560766	62923574
Skin exfoliation	34.00	17.05	27	4655	43075	63441265
Dry skin	31.33	17.05	29	4653	56858	63427482
Illness	28.95	17.05	26	4656	49033	63435307
Product use in unapproved indication	25.99	17.05	47	4635	179033	63305307
Psoriatic arthropathy	24.62	17.05	32	4650	91488	63392852
Seborrhoeic keratosis	19.09	17.05	7	4675	2335	63482005

FDA Adverse Event Reporting System (Male)

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
Psoriasis	113.78	21.75	56	2530	38756	34915589
Dermatitis atopic	66.89	21.75	22	2564	5325	34949020
Skin exfoliation	50.30	21.75	29	2557	27403	34926942
Skin plaque	42.13	21.75	15	2571	4599	34949746
Pruritus	42.02	21.75	52	2534	141929	34812416
Rash	41.14	21.75	65	2521	222687	34731658
Drug ineffective	39.87	21.75	97	2489	456654	34497691
Psoriatic arthropathy	39.16	21.75	22	2564	19776	34934569
Papule	32.35	21.75	12	2574	4127	34950218
Product dose omission issue	29.36	21.75	40	2546	119671	34834674
Treatment failure	28.03	21.75	25	2561	46672	34907673
Sleep disorder	23.16	21.75	19	2567	31669	34922676
Product use in unapproved indication	22.58	21.75	35	2551	117464	34836881

FDA Adverse Event Reporting System (Geriatric)

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
Psoriasis	202.58	17.89	105	5229	89482	79649572
Dermatitis atopic	112.07	17.89	37	5297	10019	79729035
Pruritus	58.76	17.89	99	5235	394549	79344505
Product dose omission issue	53.66	17.89	74	5260	247463	79491591
Rash	43.07	17.89	109	5225	578249	79160805
Skin exfoliation	40.92	17.89	32	5302	55068	79683986
Psoriatic arthropathy	40.79	17.89	37	5297	77962	79661092
Hypothalamic pituitary adrenal axis suppression	39.05	17.89	8	5326	327	79738727
Dry skin	39.03	17.89	34	5300	67961	79671093
Papule	26.75	17.89	12	5322	7395	79731659
Eczema	26.67	17.89	22	5312	40796	79698258
Illness	26.16	17.89	23	5311	46488	79692566
Skin plaque	25.37	17.89	13	5321	10732	79728322
Diarrhoea	22.53	17.89	117	5217	880372	78858682

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	C05AA11	CARDIOVASCULAR SYSTEM VASOPROTECTIVES AGENTS FOR TREATMENT OF HEMORRHOIDS AND ANAL FISSURES FOR TOPICAL USE Corticosteroids
ATC	D07AC08	DERMATOLOGICALS CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS CORTICOSTEROIDS, PLAIN Corticosteroids, potent (group III)
ATC	D07CC05	DERMATOLOGICALS CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS CORTICOSTEROIDS, COMBINATIONS WITH ANTIBIOTICS Corticosteroids, potent, combinations with antibiotics
FDA MoA	N0000175450	Corticosteroid Hormone Receptor Agonists
FDA EPC	N0000175576	Corticosteroid
MeSH PA	D018926	Anti-Allergic Agents
MeSH PA	D000893	Anti-Inflammatory Agents
MeSH PA	D005938	Glucocorticoids
MeSH PA	D006728	Hormones

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

Disease	Relation	SNOMED_ID	DOID
Atopic dermatitis	indication	24079001	DOID:3310
Contact dermatitis	indication	40275004	DOID:2773
Seborrheic dermatitis	indication	50563003	DOID:8741
Lichen simplex chronicus	indication	53891004
Granuloma annulare	indication	65508009	DOID:3777
Pruritus ani	indication	90446007
Discoid lupus erythematosus	indication	200938002
Plaque psoriasis	indication	200965009
Scalp psoriasis	indication	238608008
Pruritus of genital organs	indication	267802000
Eruption of skin	indication	271807003	DOID:0050486
Primary cutaneous T-cell lymphoma	indication	400122007
Inflammatory dermatosis	indication	703938007
Infection of skin AND/OR subcutaneous tissue	contraindication	19824006
Hypercortisolism	contraindication	47270006
Diabetes mellitus	contraindication	73211009	DOID:9351
Hypopituitarism	contraindication	74728003	DOID:9406
Hyperglycemia	contraindication	80394007	DOID:4195

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	11.08	acidic

Orange Book patent data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
0.1%	VANOS	BAUSCH	N021758	Feb. 11, 2005	RX	CREAM	TOPICAL	7220424	Jan. 7, 2023	RELIEF OF THE INFLAMMATORY AND PRURITIC MANIFESTATIONS OF CORTICOSTEROID RESPONSIVE DERMATOSES IN PATIENTS 12 YEARS OF AGE OR OLDER

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Glucocorticoid receptor	Nuclear hormone receptor	P04150	GCR_HUMAN	AGONIST	Ki	8.62		DRUG MATRIX	CHEMBL
Progesterone receptor	Transcription factor		Q690N0_BOVIN		Ki	8.54		DRUG MATRIX

External reference:

ID	Source
4018429	VUID
N0000146755	NUI
D00325	KEGG_DRUG
4018429	VANDF
4019759	VANDF
C0016299	UMLSCUI
CHEBI:5109	CHEBI
CHEBI:5108	CHEBI
CHEMBL1501	ChEMBL_ID
D005447	MESH_DESCRIPTOR_UI
DB01047	DRUGBANK_ID
7078	IUPHAR_LIGAND_ID
C035394	MESH_SUPPLEMENTAL_RECORD_UI
2578	INN_ID
2W4A77YPAN	UNII
9642	PUBCHEM_CID
DB12553	DRUGBANK_ID
25126	RXNORM
4739	MMSL
6968	MMSL
002197	NDDF
18125000	SNOMEDCT_US
28426008	SNOMEDCT_US
395977002	SNOMEDCT_US
396060009	SNOMEDCT_US
C0060507	UMLSCUI
CHEMBL1201390	ChEMBL_ID
807-38-5	SECONDARY_CAS_RN
91488	PUBCHEM_CID
CT1IX58L9S	UNII

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Fluocinonide	HUMAN PRESCRIPTION DRUG LABEL	1	0093-0262	CREAM	0.50 mg	TOPICAL	ANDA	20 sections
Fluocinonide	HUMAN PRESCRIPTION DRUG LABEL	1	0093-0262	CREAM	0.50 mg	TOPICAL	ANDA	20 sections
Fluocinonide	HUMAN PRESCRIPTION DRUG LABEL	1	0093-0263	CREAM	0.50 mg	TOPICAL	ANDA	20 sections
Fluocinonide	HUMAN PRESCRIPTION DRUG LABEL	1	0093-0263	CREAM	0.50 mg	TOPICAL	ANDA	20 sections
Fluocinonide	HUMAN PRESCRIPTION DRUG LABEL	1	0093-0264	OINTMENT	0.50 mg	TOPICAL	ANDA	20 sections
Fluocinonide	HUMAN PRESCRIPTION DRUG LABEL	1	0093-0264	OINTMENT	0.50 mg	TOPICAL	ANDA	20 sections
Fluocinonide	HUMAN PRESCRIPTION DRUG LABEL	1	0115-1705	CREAM	0.50 mg	TOPICAL	ANDA	18 sections
Fluocinonide	HUMAN PRESCRIPTION DRUG LABEL	1	0115-1706	CREAM	0.50 mg	TOPICAL	ANDA	18 sections
Fluocinonide	HUMAN PRESCRIPTION DRUG LABEL	1	0115-1707	CREAM	0.50 mg	TOPICAL	ANDA	18 sections
fluocinonide	HUMAN PRESCRIPTION DRUG LABEL	1	0168-0134	SOLUTION	0.50 mg	TOPICAL	ANDA	18 sections
Fluocinonide	HUMAN PRESCRIPTION DRUG LABEL	1	0168-0135	GEL	0.50 mg	TOPICAL	ANDA	17 sections
fluocinonide	HUMAN PRESCRIPTION DRUG LABEL	1	0168-0457	CREAM	1 mg	TOPICAL	ANDA	26 sections
Fluocinonide	Human Prescription Drug Label	1	0472-0829	SOLUTION	0.50 mg	TOPICAL	ANDA	10 sections
Fluocinonide	HUMAN PRESCRIPTION DRUG LABEL	1	0713-0663	CREAM	0.50 mg	TOPICAL	ANDA	10 sections
Fluocinonide	HUMAN PRESCRIPTION DRUG LABEL	1	0713-0664	CREAM	0.50 mg	TOPICAL	ANDA	18 sections
Fluocinonide	HUMAN PRESCRIPTION DRUG LABEL	1	0713-0803	GEL	0.50 mg	TOPICAL	ANDA	17 sections
FLUOCINONIDE	HUMAN PRESCRIPTION DRUG LABEL	1	16590-368	CREAM	0.50 mg	TOPICAL	ANDA	19 sections
Fluocinonide	HUMAN PRESCRIPTION DRUG LABEL	1	16714-502	OINTMENT	0.50 mg	TOPICAL	ANDA	21 sections
Fluocinonide	HUMAN PRESCRIPTION DRUG LABEL	1	21695-207	CREAM	0.50 mg	TOPICAL	ANDA	19 sections
Fluocinonide	HUMAN PRESCRIPTION DRUG LABEL	1	21695-979	OINTMENT	0.50 mg	TOPICAL	ANDA	20 sections
Fluocinonide	HUMAN PRESCRIPTION DRUG LABEL	1	21922-001	SOLUTION	0.50 mg	TOPICAL	ANDA	19 sections
Fluocinonide	HUMAN PRESCRIPTION DRUG LABEL	1	33261-560	CREAM	0.50 mg	TOPICAL	ANDA	10 sections
Fluocinonide	Human Prescription Drug Label	1	33342-320	SOLUTION	0.50 mg	TOPICAL	ANDA	17 sections
fluocinonide	HUMAN PRESCRIPTION DRUG LABEL	1	40032-026	SOLUTION	0.50 mg	TOPICAL	ANDA	14 sections
Fluocinonide	HUMAN PRESCRIPTION DRUG LABEL	1	40032-095	OINTMENT	0.50 mg	TOPICAL	ANDA	10 sections
Fluocinonide	HUMAN PRESCRIPTION DRUG LABEL	1	43386-026	SOLUTION	0.50 mg	TOPICAL	ANDA	14 sections
Fluocinonide	HUMAN PRESCRIPTION DRUG LABEL	1	43386-095	OINTMENT	0.50 mg	TOPICAL	ANDA	10 sections
Fluocinonide	HUMAN PRESCRIPTION DRUG LABEL	1	45802-151	CREAM	1 mg	TOPICAL	ANDA	26 sections
Fluocinonide	HUMAN PRESCRIPTION DRUG LABEL	1	45861-064	CREAM	1 mg	TOPICAL	ANDA	27 sections
Fluocinonide Gel	HUMAN PRESCRIPTION DRUG LABEL	1	47781-533	GEL	0.50 mg	TOPICAL	NDA	20 sections