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

Stem definitionDrug idCAS RN
steroids for topical use, acetal derivatives 1205 356-12-7

Description:

MoleculeDescription

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:

DateAgencyCompanyOrphan
June 30, 1971 FDA

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients 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 termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients 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 termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients 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:

SourceCodeDescription
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|

DiseaseRelationSNOMED_IDDOID
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 levelDissociation constantType (acidic/basic)
pKa1 11.08 acidic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent 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:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Glucocorticoid receptor Nuclear hormone receptor AGONIST Ki 8.62 DRUG MATRIX CHEMBL
Progesterone receptor Transcription factor Ki 8.54 DRUG MATRIX

External reference:

IDSource
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:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
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