fluocinonide 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | 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:

PropertyValueReference
BA (Bioavailability) 5 %

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
kinase-safety-class ACVR2B,AXL,BRAF,CAMK2D,CDK5,CDK9,EIF2AK3,ERBB2,GRK2,ITK,MAPK10,MAPK7,NTRK2,PDK1,PDK2,PDK4,PRKDC,TEK 18
kinase-selectivity-class GRK2 1
pfas-class PFAS structural alert (1 = True, 0 = False) 0

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 242.58 18.40 149 7056 147605 90473637
Dermatitis atopic 219.19 18.40 79 7126 23393 90597849
Drug ineffective 159.66 18.40 342 6863 1383956 89237286
Pruritus 113.28 18.40 174 7031 541351 90079891
Eczema 112.00 18.40 63 7142 52807 90568435
Skin exfoliation 109.94 18.40 68 7137 67845 90553397
Rash 88.94 18.40 195 7010 795905 89825337
Dry skin 78.25 18.40 61 7144 88012 90533230
Product dose omission issue 77.24 18.40 105 7100 291582 90329660
Papule 63.80 18.40 24 7181 7978 90613264
Product use in unapproved indication 61.72 18.40 102 7103 336134 90285108
Seborrhoeic keratosis 59.05 18.40 18 7187 3162 90618080
Sleep disorder due to a general medical condition 55.65 18.40 38 7167 44700 90576542
Skin plaque 51.93 18.40 22 7183 9953 90611289
Therapeutic product effect incomplete 39.86 18.40 62 7143 193834 90427408
Hypothalamic pituitary adrenal axis suppression 37.60 18.40 8 7197 330 90620912
Pustule 35.74 18.40 12 7193 2871 90618371
Macule 32.65 18.40 11 7194 2658 90618584
Lentigo 32.42 18.40 8 7197 640 90620602
Erythema 32.27 18.40 62 7143 229184 90392058
Seborrhoeic dermatitis 28.82 18.40 9 7196 1711 90619531
Skin irritation 28.21 18.40 16 7189 13587 90607655
Illness 27.10 18.40 33 7172 81936 90539306
Skin discomfort 23.83 18.40 8 7197 1913 90619329
Infusion related reaction 22.99 18.40 3 7202 416777 90204465
Haemangioma of skin 22.40 18.40 6 7199 664 90620578
Therapeutic product ineffective 22.04 18.40 8 7197 2406 90618836
Psoriatic arthropathy 22.03 18.40 53 7152 228282 90392960
Spinal synovial cyst 21.73 18.40 4 7201 77 90621165
Xerosis 21.58 18.40 7 7198 1504 90619738
Hidradenitis 20.69 18.40 9 7196 4338 90616904
Skin burning sensation 20.53 18.40 15 7190 19596 90601646
Product dose omission in error 19.93 18.40 15 7190 20488 90600754
Post inflammatory pigmentation change 19.35 18.40 5 7200 482 90620760
Skin lesion 19.25 18.40 19 7186 37346 90583896
Discomfort 18.70 18.40 56 7149 274279 90346963
Dry eye 18.62 18.40 23 7182 57908 90563334
Injection site pain 18.58 18.40 42 7163 173657 90447585

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 140.23 20.51 75 3922 48529 42568809
Dermatitis atopic 135.74 20.51 49 3948 12355 42604983
Drug ineffective 118.28 20.51 210 3787 629987 41987351
Skin exfoliation 113.87 20.51 62 3935 41491 42575847
Pruritus 93.46 20.51 101 3896 188670 42428668
Skin plaque 82.69 20.51 28 3969 5835 42611503
Rash 69.86 20.51 106 3891 276848 42340490
Discomfort 53.83 20.51 32 3965 25187 42592151
Sleep disorder due to a general medical condition 47.61 20.51 26 3971 17427 42599911
Psoriatic arthropathy 46.41 20.51 29 3968 24938 42592400
Papule 42.02 20.51 17 3980 5809 42611529
Skin fissures 39.74 20.51 19 3978 9657 42607681
Treatment failure 38.96 20.51 38 3959 62586 42554752
Therapeutic product effect incomplete 38.55 20.51 40 3957 70899 42546439
Erythema 36.71 20.51 48 3949 108745 42508593
Product use in unapproved indication 35.99 20.51 63 3934 184393 42432945
Product dose omission issue 35.83 20.51 57 3940 154308 42463030
Dry skin 29.43 20.51 29 3968 48309 42569029
Skin lesion 28.02 20.51 22 3975 27152 42590186
Sleep disorder 27.70 20.51 28 3969 48067 42569271
Chronic spontaneous urticaria 26.37 20.51 6 3991 286 42617052
Skin discomfort 25.41 20.51 7 3990 729 42616609
Skin haemorrhage 25.03 20.51 13 3984 7872 42609466
Nail dystrophy 24.17 20.51 6 3991 416 42616922
Tinea versicolour 23.01 20.51 6 3991 507 42616831
Skin irritation 22.65 20.51 12 3985 7562 42609776
Transient acantholytic dermatosis 21.55 20.51 5 3992 260 42617078
Eye irritation 20.65 20.51 13 3984 11305 42606033

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
Dermatitis atopic 286.44 17.34 96 7837 25445 110555921
Psoriasis 219.02 17.34 132 7801 139861 110441505
Pruritus 124.63 17.34 179 7754 581381 109999985
Rash 108.43 17.34 203 7730 820761 109760605
Skin exfoliation 100.43 17.34 68 7865 87583 110493783
Product dose omission issue 93.29 17.34 115 7818 321667 110259699
Dry skin 90.07 17.34 69 7864 107584 110473782
Eczema 87.40 17.34 58 7875 72235 110509131
Sleep disorder due to a general medical condition 86.15 17.34 51 7882 52061 110529305
Skin plaque 55.56 17.34 24 7909 12621 110568745
Discomfort 42.71 17.34 64 7869 214643 110366723
Papule 40.51 17.34 18 7915 10115 110571251
Skin fissures 37.97 17.34 23 7910 24435 110556931
Drug ineffective 34.02 17.34 205 7728 1520335 109061031
Hidradenitis 33.60 17.34 13 7920 5167 110576199
Hypothalamic pituitary adrenal axis suppression 32.83 17.34 8 7925 674 110580692
Erythema 32.07 17.34 67 7866 291380 110289986
Skin discomfort 32.06 17.34 10 7923 2100 110579266
Skin irritation 27.03 17.34 16 7917 16303 110565063
Psoriatic arthropathy 24.94 17.34 48 7885 196713 110384653
Product use in unapproved indication 24.40 17.34 79 7854 447298 110134068
Tinea versicolour 23.77 17.34 6 7927 584 110580782
Illness 23.13 17.34 29 7904 82142 110499224
Eye pruritus 23.07 17.34 19 7914 32756 110548610
Post inflammatory pigmentation change 22.13 17.34 6 7927 771 110580595
Toxicity to various agents 21.92 17.34 4 7929 480551 110100815
Transient acantholytic dermatosis 21.81 17.34 5 7928 324 110581042
Injection site pain 19.66 17.34 41 7892 177881 110403485
Dry eye 19.52 17.34 22 7911 55771 110525595
Product dose omission in error 19.48 17.34 15 7918 23497 110557869
Intertrigo 19.37 17.34 6 7927 1232 110580134
Skin haemorrhage 18.76 17.34 15 7918 24812 110556554
Eye irritation 18.70 17.34 17 7916 33435 110547931
General physical health deterioration 18.43 17.34 4 7929 425291 110156075
Diarrhoea 18.40 17.34 142 7791 1139363 109442003
Impaired quality of life 18.26 17.34 16 7917 30001 110551365
Inappropriate schedule of product administration 18.08 17.34 43 7890 203594 110377772
Sleep disorder 17.70 17.34 42 7891 198602 110382764

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 D000893 Anti-Inflammatory Agents
MeSH PA D005938 Glucocorticoids
MeSH PA D006728 Hormones
MeSH PA D018926 Anti-Allergic Agents

Related Drugs by ATC class:

C05AA Corticosteroids 8 drugs
betamethasonedexamethasonefluocinolone acetonidefluocortolonefluorometholonehydrocortisoneprednisolonetriamcinolone
D07AC Corticosteroids, potent (group III) 20 drugs
amcinonidebeclometasone dipropionatebetamethasonebudesonidedesoximetasonediflorasone diacetatediflucortolonedifluprednatefluclorolonefludroxycortidefluocinolone acetonidefluocortolone show all 20 →
D07CC Corticosteroids, potent, combinations with antibiotics 5 drugs
beclometasone dipropionatebetamethasonefludroxycortidefluocinolone acetonidefluocortolone

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)

None

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
CHEMBL1501 ChEMBL_ID
D005447 MESH_DESCRIPTOR_UI
DB01047 DRUGBANK_ID
7078 IUPHAR_LIGAND_ID
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
C035394 MESH_SUPPLEMENTAL_RECORD_UI
CT1IX58L9S UNII
CHEBI:5108 CHEBI
2W4A77YPAN INXIGHT DRUGS

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Fluocinonide HUMAN PRESCRIPTION DRUG LABEL 1 0093-0262 CREAM 0.50 mg TOPICAL ANDA 18 sections
Fluocinonide HUMAN PRESCRIPTION DRUG LABEL 1 0093-0263 CREAM 0.50 mg TOPICAL ANDA 18 sections
Fluocinonide HUMAN PRESCRIPTION DRUG LABEL 1 0093-0264 OINTMENT 0.50 mg TOPICAL ANDA 18 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 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 16590-368 CREAM 0.50 mg TOPICAL ANDA 19 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 21922-064 CREAM 0.50 mg TOPICAL ANDA 17 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 18 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 45802-761 GEL 0.50 mg TOPICAL ANDA 18 sections
Fluocinonide HUMAN PRESCRIPTION DRUG LABEL 1 50090-1671 CREAM 0.50 mg TOPICAL ANDA 21 sections
Fluocinonide HUMAN PRESCRIPTION DRUG LABEL 1 50090-1784 CREAM 0.50 mg TOPICAL ANDA 20 sections
Fluocinonide HUMAN PRESCRIPTION DRUG LABEL 1 50090-3277 CREAM 0.50 mg TOPICAL ANDA 21 sections
Fluocinonide HUMAN PRESCRIPTION DRUG LABEL 1 50090-6309 CREAM 0.50 mg TOPICAL ANDA 17 sections
Fluocinonide HUMAN PRESCRIPTION DRUG LABEL 1 50090-7923 CREAM 0.50 mg TOPICAL ANDA 17 sections
Fluocinonide HUMAN PRESCRIPTION DRUG LABEL 1 51672-1253 CREAM 0.50 mg TOPICAL NDA 21 sections
Fluocinonide HUMAN PRESCRIPTION DRUG LABEL 1 51672-1254 CREAM 0.50 mg TOPICAL ANDA 21 sections
Fluocinonide HUMAN PRESCRIPTION DRUG LABEL 1 51672-1264 OINTMENT 0.50 mg TOPICAL ANDA 21 sections
Fluocinonide HUMAN PRESCRIPTION DRUG LABEL 1 51672-1273 SOLUTION 0.50 mg TOPICAL ANDA 20 sections