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

Stem definition	Drug id	CAS RN
steroids for topical use, acetal derivatives	1204	67-73-2

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: fluocinolone acetonide fluocinolonacetonid fluocinolone acetonide dihydrate fluocinolone acetonide oil	A glucocorticoid derivative used topically in the treatment of various skin disorders. It is usually employed as a cream, gel, lotion, or ointment. It has also been used topically in the treatment of inflammatory eye, ear, and nose disorders. (From Martindale, The Extra Pharmacopoeia, 30th ed, p732) Molecular weight: 452.50 Formula: C24H30F2O6 CLOGP: 2.25 LIPINSKI: 0 HAC: 6 HDO: 2 TPSA: 93.06 ALOGS: -3.92 ROTB: 2 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

fluocinolone acetonide
fluocinolonacetonid
fluocinolone acetonide dihydrate
fluocinolone acetonide oil

A glucocorticoid derivative used topically in the treatment of various skin disorders. It is usually employed as a cream, gel, lotion, or ointment. It has also been used topically in the treatment of inflammatory eye, ear, and nose disorders. (From Martindale, The Extra Pharmacopoeia, 30th ed, p732)

Molecular weight: 452.50
Formula: C24H30F2O6
CLOGP: 2.25
LIPINSKI: 0
HAC: 6
HDO: 2
TPSA: 93.06
ALOGS: -3.92
ROTB: 2

Status: OFP

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

Drug dosage:

None

ADMET properties:

None

Approvals:

Date	Agency	Company	Orphan
Feb. 15, 1963	FDA	MEDIMETRIKS PHARMS

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
Intraocular pressure increased	140.15	27.10	34	2114	6044	63480830
Psoriasis	95.11	27.10	50	2098	86907	63399967
Device dislocation	91.77	27.10	34	2114	25671	63461203
Hypotony of eye	80.79	27.10	12	2136	144	63486730
Product dose omission issue	80.46	27.10	65	2083	234248	63252626
Medical device removal	78.73	27.10	16	2132	1261	63485613
Corneal oedema	59.25	27.10	13	2135	1480	63485394
Implantation complication	57.38	27.10	7	2141	14	63486860
No adverse event	51.49	27.10	26	2122	41379	63445495
Dermatitis atopic	50.46	27.10	17	2131	9707	63477167
Off label use	43.95	27.10	80	2068	674382	62812492
Vitrectomy	42.31	27.10	7	2141	174	63486700
Endophthalmitis	38.71	27.10	11	2137	3581	63483293
Product quality issue	37.34	27.10	20	2128	35845	63451029
Drug delivery system issue	36.71	27.10	6	2142	138	63486736
Skin discolouration	36.34	27.10	20	2128	37808	63449066
Pruritus	31.56	27.10	49	2099	361404	63125470

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
Intraocular pressure increased	175.42	38.94	38	882	5345	34950666
Medical device removal	118.75	38.94	16	904	119	34955892
Device dislocation	91.08	38.94	23	897	6226	34949785
No adverse event	88.27	38.94	30	890	22897	34933114
Vitrectomy	69.05	38.94	10	910	131	34955880
Corneal oedema	57.97	38.94	12	908	1339	34954672
Trabeculectomy	57.66	38.94	7	913	19	34955992
Glaucoma drainage device placement	57.29	38.94	6	914	0	34956011
Cataract operation	52.67	38.94	11	909	1281	34954730
Implantation complication	51.79	38.94	6	914	9	34956002
Product dose omission issue	48.16	38.94	33	887	119678	34836333
Glaucoma	42.77	38.94	13	907	6899	34949112
Dermatitis atopic	41.57	38.94	12	908	5335	34950676
Complication of device insertion	40.12	38.94	6	914	99	34955912
Hypotony of eye	39.73	38.94	6	914	106	34955905
Drug delivery system issue	39.13	38.94	5	915	23	34955988

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
Intraocular pressure increased	207.42	26.93	48	2018	9157	79733165
Medical device removal	141.66	26.93	23	2043	672	79741650
Device dislocation	116.30	26.93	38	2028	25932	79716390
No adverse event	99.26	26.93	37	2029	37155	79705167
Vitrectomy	94.54	26.93	14	2052	219	79742103
Product dose omission issue	85.84	26.93	62	2004	247475	79494847
Hypotony of eye	85.50	26.93	13	2053	245	79742077
Corneal oedema	82.59	26.93	18	2048	2602	79739720
Dermatitis atopic	71.55	26.93	21	2045	10035	79732287
Glaucoma	61.36	26.93	22	2044	19739	79722583
Glaucoma drainage device placement	57.38	26.93	6	2060	0	79742322
Drug delivery system issue	56.30	26.93	8	2058	92	79742230
Trabeculectomy	52.02	26.93	7	2059	52	79742270
Implantation complication	50.15	26.93	6	2060	14	79742308
Retinal degeneration	47.26	26.93	10	2056	1256	79741066
Psoriasis	46.73	26.93	29	2037	89558	79652764
Product quality issue	46.61	26.93	21	2045	33919	79708403
Visual acuity reduced	46.17	26.93	20	2046	29449	79712873
Cataract operation	42.08	26.93	12	2054	5173	79737149
Drug delivery system malfunction	40.56	26.93	8	2058	709	79741613
Endophthalmitis	39.53	26.93	12	2054	6416	79735906
Ciliary body operation	38.25	26.93	4	2062	0	79742322
Ocular hypertension	29.31	26.93	7	2059	1513	79740809
Trabeculoplasty	28.69	26.93	3	2063	0	79742322
Aphakia	28.69	26.93	3	2063	0	79742322
Eye pain	27.04	26.93	15	2051	37563	79704759
Corneal decompensation	27.04	26.93	4	2062	62	79742260

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	C05AA10	CARDIOVASCULAR SYSTEM VASOPROTECTIVES AGENTS FOR TREATMENT OF HEMORRHOIDS AND ANAL FISSURES FOR TOPICAL USE Corticosteroids
ATC	D07AC04	DERMATOLOGICALS CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS CORTICOSTEROIDS, PLAIN Corticosteroids, potent (group III)
ATC	D07BC02	DERMATOLOGICALS CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS CORTICOSTEROIDS, COMBINATIONS WITH ANTISEPTICS Corticosteroids, potent, combinations with antiseptics
ATC	D07CC02	DERMATOLOGICALS CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS CORTICOSTEROIDS, COMBINATIONS WITH ANTIBIOTICS Corticosteroids, potent, combinations with antibiotics
ATC	S01BA15	SENSORY ORGANS OPHTHALMOLOGICALS ANTIINFLAMMATORY AGENTS Corticosteroids, plain
ATC	S01CA10	SENSORY ORGANS OPHTHALMOLOGICALS ANTIINFLAMMATORY AGENTS AND ANTIINFECTIVES IN COMBINATION Corticosteroids and antiinfectives in combination
ATC	S02BA08	SENSORY ORGANS OTOLOGICALS CORTICOSTEROIDS Corticosteroids
ATC	S02CA05	SENSORY ORGANS OTOLOGICALS CORTICOSTEROIDS AND ANTIINFECTIVES IN COMBINATION Corticosteroids and antiinfectives in combination
FDA MoA	N0000175450	Corticosteroid Hormone Receptor Agonists
FDA EPC	N0000175576	Corticosteroid
MeSH PA	D000893	Anti-Inflammatory Agents
MeSH PA	D005938	Glucocorticoids
MeSH PA	D006728	Hormones
CHEBI has role	CHEBI:35472	anti-inflammatory drugs
CHEBI has role	CHEBI:59683	antipruritic drugs

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

Disease	Relation	SNOMED_ID	DOID
Choroiditis	indication	16553002	DOID:11406
Atopic dermatitis	indication	24079001	DOID:3310
Chloasma	indication	36209000
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
Pityriasis simplex	indication	200767005
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
Otitis Externa Eczema	indication
Herpes simplex keratitis	contraindication	9389005
Herpes zoster auricularis	contraindication	21954000	DOID:9210
Sunburn	contraindication	23346002
Glaucoma	contraindication	23986001	DOID:1686
Fungal infection of eye	contraindication	31194008
Herpes zoster keratoconjunctivitis	contraindication	42448002
Eczema	contraindication	43116000
Tuberculosis of eye	contraindication	49107007
Herpes simplex keratoconjunctivitis	contraindication	72321008
Third degree burn injury	contraindication	80247002
Herpes simplex	contraindication	88594005	DOID:8566
Open wound	contraindication	125643001
Tuberculosis of ear	contraindication	186269001
Telangiectasia disorder	contraindication	247479008
Pregnancy, function	contraindication	289908002
Viral ear infection	contraindication	312137007
Fungal ear infection	contraindication	312148000
Fungal keratitis	contraindication	314558005
Adrenal cortical hypofunction	contraindication	386584007	DOID:10493
Vaccinia keratitis	contraindication	397552005
Herpes zoster keratitis	contraindication	397573005
Atrophoderma	contraindication	399979006
Peripheral vascular disease	contraindication	400047006
Breastfeeding (mother)	contraindication	413712001
Denuded skin	contraindication	418242004

🐶 Veterinary Drug Use

Species	Use	Relation
Cats	Pruritus and inflammation associated with acute otitis externa	Indication
Cats	Pruritus and inflammation associated with acute and chronic dermatoses	Indication
Dogs	Pruritus and inflammation associated with superficial acute and chronic dermatoses	Indication
Dogs	Allergic and acute moist dermatoses	Indication
Dogs	Nonspecific dermatoses	Indication
Dogs	Wound infections	Indication

🐶 Veterinary products

Product	Applicant	Ingredients
Neo-synalar Cream	Bausch Health US LLC	2
Synalar Cream Veterinary	Bausch Health US LLC	1
Synalar Solution Veterinary	Bausch Health US LLC	1
Synotic Otic Solution	Zoetis Inc.	2
Synsac Solution	Zoetis Inc.	2

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	11.08	acidic
pKa2	11.78	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
0.18MG	YUTIQ	ALIMERA SCIENCES INC	N210331	Oct. 12, 2018	RX	IMPLANT	INTRAVITREAL	7998108	Jan. 12, 2028	A METHOD OF INJECTING AN IMPLANT
EQ 0.3% BASE;0.025%	OTOVEL	LABORATORIOS SALVAT	N208251	April 29, 2016	RX	SOLUTION/DROPS	OTIC	8932610	March 24, 2030	TREATMENT OF ACUTE OTITIS MEDIA

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	8.85		DRUG MATRIX	CHEMBL
Progesterone receptor	Transcription factor		Q690N0_BOVIN		Ki	8.48		DRUG MATRIX

External reference:

ID	Source
4018222	VUID
N0000146554	NUI
D01825	KEGG_DRUG
4018222	VANDF
4019759	VANDF
C0016298	UMLSCUI
CHEBI:31623	CHEBI
CHEBI:5108	CHEBI
CHEMBL989	ChEMBL_ID
D005446	MESH_DESCRIPTOR_UI
DB00591	DRUGBANK_ID
7077	IUPHAR_LIGAND_ID
C035394	MESH_SUPPLEMENTAL_RECORD_UI
1046	INN_ID
0CD5FD6S2M	UNII
6215	PUBCHEM_CID
DB12553	DRUGBANK_ID
25126	RXNORM
4738	MMSL
002193	NDDF
011117	NDDF
28426008	SNOMEDCT_US
395977002	SNOMEDCT_US
396059004	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
Fluocinolone Acetonide	HUMAN PRESCRIPTION DRUG LABEL	1	0168-0058	CREAM	0.10 mg	TOPICAL	ANDA	18 sections
Fluocinolone Acetonide	HUMAN PRESCRIPTION DRUG LABEL	1	0168-0059	SOLUTION	0.10 mg	TOPICAL	ANDA	18 sections
Fluocinolone Acetonide	HUMAN PRESCRIPTION DRUG LABEL	1	0168-0060	CREAM	0.25 mg	TOPICAL	ANDA	18 sections
Fluocinolone Acetonide	HUMAN PRESCRIPTION DRUG LABEL	1	0168-0064	OINTMENT	0.25 mg	TOPICAL	ANDA	18 sections
TRI-LUMA	HUMAN PRESCRIPTION DRUG LABEL	3	0299-5950	CREAM	0.10 mg	TOPICAL	NDA	24 sections
TRI-LUMA	HUMAN PRESCRIPTION DRUG LABEL	3	0299-5950	CREAM	0.10 mg	TOPICAL	NDA	24 sections
TRI-LUMA	HUMAN PRESCRIPTION DRUG LABEL	3	0299-5950	CREAM	0.10 mg	TOPICAL	NDA	24 sections
Fluocinolone Acetonide Topical	HUMAN PRESCRIPTION DRUG LABEL	1	0591-2990	SOLUTION	0.10 mg	TOPICAL	ANDA	17 sections
Fluocinolone Acetonide	HUMAN PRESCRIPTION DRUG LABEL	1	0713-0222	CREAM	0.25 mg	TOPICAL	ANDA	10 sections
Fluocinolone Acetonide	HUMAN PRESCRIPTION DRUG LABEL	1	0713-0222	CREAM	0.25 mg	TOPICAL	ANDA	10 sections
Fluocinolone Acetonide	HUMAN PRESCRIPTION DRUG LABEL	1	0713-0223	CREAM	0.10 mg	TOPICAL	ANDA	10 sections
Fluocinolone Acetonide	HUMAN PRESCRIPTION DRUG LABEL	1	0713-0223	CREAM	0.10 mg	TOPICAL	ANDA	10 sections
Fluocinolone Acetonide	HUMAN PRESCRIPTION DRUG LABEL	1	0713-0224	OINTMENT	0.25 mg	TOPICAL	ANDA	10 sections
Fluocinolone Acetonide	HUMAN PRESCRIPTION DRUG LABEL	1	0713-0224	OINTMENT	0.25 mg	TOPICAL	ANDA	10 sections
FLUOCINOLONE ACETONIDE	HUMAN PRESCRIPTION DRUG LABEL	1	0713-0709	CREAM	0.25 mg	TOPICAL	ANDA	11 sections
FLUOCINOLONE ACETONIDE	HUMAN PRESCRIPTION DRUG LABEL	1	0713-0709	CREAM	0.25 mg	TOPICAL	ANDA	11 sections
fluocinolone acetonide	HUMAN PRESCRIPTION DRUG LABEL	1	10135-670	SOLUTION	0.10 mg	TOPICAL	ANDA	18 sections
fluocinolone acetonide	HUMAN PRESCRIPTION DRUG LABEL	1	10135-670	SOLUTION	0.10 mg	TOPICAL	ANDA	18 sections
Fluocinolone Acetonide	HUMAN PRESCRIPTION DRUG LABEL	1	13925-506	OIL	0.11 mg	TOPICAL	NDA authorized generic	24 sections
Fluocinolone Acetonide	HUMAN PRESCRIPTION DRUG LABEL	1	13925-507	OIL	0.11 mg	TOPICAL	NDA authorized generic	22 sections
Fluocinolone acetonide 0.01%	HUMAN PRESCRIPTION DRUG LABEL	1	13925-508	OIL	0.11 mg	AURICULAR (OTIC)	NDA authorized generic	22 sections
Fluocinolone Acetonide	HUMAN PRESCRIPTION DRUG LABEL	1	16590-097	CREAM	0.10 mg	TOPICAL	ANDA	11 sections
Fluocinolone Acetonide Topical Solution USP, 0.01%	HUMAN PRESCRIPTION DRUG LABEL	1	21922-003	SOLUTION	0.10 mg	TOPICAL	ANDA	17 sections
Retisert	HUMAN PRESCRIPTION DRUG LABEL	1	24208-416	IMPLANT	0.59 mg	INTRAVITREAL	NDA	22 sections
OTOVEL	HUMAN PRESCRIPTION DRUG LABEL	2	24338-080	SOLUTION	0.06 mg	AURICULAR (OTIC)	NDA	26 sections
Flac Otic Oil	HUMAN PRESCRIPTION DRUG LABEL	1	39328-079	OIL	0.11 mg	AURICULAR (OTIC)	ANDA	21 sections
Ciprofloxacin and Fluocinolone Acetonide	HUMAN PRESCRIPTION DRUG LABEL	2	42195-128	SOLUTION	0.06 mg	AURICULAR (OTIC)	NDA	26 sections
Ciprofloxacin and Fluocinolone Acetonide	HUMAN PRESCRIPTION DRUG LABEL	2	42195-128	SOLUTION	0.06 mg	AURICULAR (OTIC)	NDA	26 sections
Fluocinolone Acetonide	HUMAN PRESCRIPTION DRUG LABEL	1	43386-069	SOLUTION	0.10 mg	TOPICAL	ANDA	15 sections
Synalar	HUMAN PRESCRIPTION DRUG LABEL	1	43538-900	CREAM	0.25 mg	TOPICAL	NDA	21 sections