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

Stem definitionDrug idCAS RN
steroids not used as glucocorticosteroids 1208 426-13-1

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • fluorometholone
  • fluormetholon
  • flumetholone
  • flumetholon
A glucocorticoid employed, usually as eye drops, in the treatment of allergic and inflammatory conditions of the eye. It has also been used topically in the treatment of various skin disorders. (From Martindale, The Extra Pharmacopoeia, 30th ed, p732)
  • Molecular weight: 376.47
  • Formula: C22H29FO4
  • CLOGP: 2.11
  • LIPINSKI: 0
  • HAC: 4
  • HDO: 2
  • TPSA: 74.60
  • ALOGS: -4.36
  • ROTB: 1

  • Status: OFP

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

Drug dosage:

None

ADMET properties:

None

Approvals:

DateAgencyCompanyOrphan
Jan. 12, 1972 FDA ALLERGAN

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
Eye irritation 73.76 22.18 27 1901 21944 63465150
Eye pain 72.45 22.18 30 1898 33824 63453270
Treatment failure 68.69 22.18 53 1875 198990 63288104
Ocular hyperaemia 42.92 22.18 19 1909 25125 63461969
Keratitis 40.42 22.18 11 1917 3411 63483683
Hypopyon 33.30 22.18 7 1921 725 63486369
Corneal opacity 33.20 22.18 7 1921 736 63486358
Intraocular pressure increased 30.13 22.18 10 1918 6068 63481026
Corneal perforation 29.35 22.18 6 1922 542 63486552
Vision blurred 28.40 22.18 23 1905 91901 63395193
Corneal disorder 26.98 22.18 7 1921 1807 63485287
Corneal erosion 26.51 22.18 5 1923 298 63486796
Ophthalmic herpes simplex 24.42 22.18 5 1923 455 63486639
Corneal neovascularisation 24.11 22.18 4 1924 113 63486981
Cataract 23.62 22.18 17 1911 57036 63430058
Keratitis fungal 22.69 22.18 4 1924 163 63486931

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
Corneal disorder 49.89 30.72 10 935 924 34955062
Treatment failure 48.22 30.72 24 921 46673 34909313
Intraocular pressure increased 45.63 30.72 13 932 5370 34950616
Ocular hyperaemia 39.77 30.72 14 931 11438 34944548
Keratitis 34.62 30.72 8 937 1443 34954543

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
Keratitis 69.22 20.49 18 2624 4304 79737442
Eye pain 66.86 20.49 30 2612 37548 79704198
Corneal disorder 64.41 20.49 15 2627 2276 79739470
Intraocular pressure increased 55.77 20.49 18 2624 9187 79732559
Ocular hyperaemia 48.51 20.49 22 2620 28184 79713562
Eye irritation 48.23 20.49 20 2622 20661 79721085
Cataract 44.68 20.49 27 2615 62093 79679653
Corneal opacity 41.31 20.49 9 2633 1011 79740735
Keratitis fungal 38.38 20.49 7 2635 317 79741429
Corneal erosion 37.27 20.49 7 2635 373 79741373
Hypopyon 34.88 20.49 8 2634 1134 79740612
Ophthalmic herpes simplex 32.71 20.49 7 2635 723 79741023
Corneal perforation 32.40 20.49 7 2635 756 79740990
Corneal neovascularisation 29.13 20.49 5 2637 159 79741587
Conjunctivitis 28.91 20.49 15 2627 25700 79716046
Corneal oedema 28.29 20.49 8 2634 2612 79739134
Vision blurred 27.69 20.49 25 2617 105873 79635873
Glaucoma 26.53 20.49 13 2629 19748 79721998
Corneal scar 25.99 20.49 5 2637 303 79741443
Foreign body sensation in eyes 25.17 20.49 7 2635 2150 79739596
Visual acuity reduced 24.29 20.49 14 2628 29455 79712291
Bladder cyst 24.08 20.49 4 2638 104 79741642
Corneal degeneration 23.02 20.49 4 2638 137 79741609
Blood urine present 22.73 20.49 12 2630 21285 79720461
Ulcerative keratitis 21.47 20.49 7 2635 3682 79738064
Eye inflammation 21.25 20.49 8 2634 6405 79735341

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC C05AA06 CARDIOVASCULAR SYSTEM
VASOPROTECTIVES
AGENTS FOR TREATMENT OF HEMORRHOIDS AND ANAL FISSURES FOR TOPICAL USE
Corticosteroids
ATC D07AB06 DERMATOLOGICALS
CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
CORTICOSTEROIDS, PLAIN
Corticosteroids, moderately potent (group II)
ATC D07CB03 DERMATOLOGICALS
CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
CORTICOSTEROIDS, COMBINATIONS WITH ANTIBIOTICS
Corticosteroids, moderately potent, combinations with antibiotics
ATC D07XB04 DERMATOLOGICALS
CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
CORTICOSTEROIDS, OTHER COMBINATIONS
Corticosteroids, moderately potent, other combinations
ATC D10AA01 DERMATOLOGICALS
ANTI-ACNE PREPARATIONS
ANTI-ACNE PREPARATIONS FOR TOPICAL USE
Corticosteroids, combinations for treatment of acne
ATC S01BA07 SENSORY ORGANS
OPHTHALMOLOGICALS
ANTIINFLAMMATORY AGENTS
Corticosteroids, plain
ATC S01BB03 SENSORY ORGANS
OPHTHALMOLOGICALS
ANTIINFLAMMATORY AGENTS
Corticosteroids and mydriatics in combination
ATC S01CA07 SENSORY ORGANS
OPHTHALMOLOGICALS
ANTIINFLAMMATORY AGENTS AND ANTIINFECTIVES IN COMBINATION
Corticosteroids and antiinfectives in combination
ATC S01CB05 SENSORY ORGANS
OPHTHALMOLOGICALS
ANTIINFLAMMATORY AGENTS AND ANTIINFECTIVES IN COMBINATION
Corticosteroids/antiinfectives/mydriatics in combination
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
CHEBI has role CHEBI:35472 anti-inflammatory drugs

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

DiseaseRelationSNOMED_IDDOID
Cyclitis indication 17657000
Iritis indication 65074000 DOID:1406
Iridocyclitis indication 77971008
Corneal abrasion indication 85848002
Corneal ulcer indication 91514001 DOID:8463
Uveitis indication 128473001 DOID:13141
Punctate keratopathy indication 246936005
Herpes zoster keratitis indication 397573005
Rosacea indication 398909004 DOID:8881
Allergic conjunctivitis indication 473460002 DOID:11204
Post-Op Ocular Inflammation indication
Otitis externa off-label use 3135009
Allergic otitis externa off-label use 405821001
Otitis Externa Eczema off-label use
Otitis Externa Seborrhea off-label use
Ocular hypertension contraindication 4210003 DOID:9282
Herpes simplex keratitis contraindication 9389005
Herpes simplex dendritic keratitis contraindication 29943008
Fungal infection of eye contraindication 31194008
Severe myopia contraindication 34187009
Tuberculosis of eye contraindication 49107007
Diabetes mellitus contraindication 73211009 DOID:9351
Open-angle glaucoma contraindication 84494001 DOID:1067
Krukenberg spindle contraindication 85430004
Anemia due to enzyme deficiency contraindication 111577008
Deficiency of glucose-6-phosphate dehydrogenase contraindication 124134002 DOID:2862
Eye infection contraindication 128351009
Bacterial infection of eye contraindication 128984004
Viral eye infection contraindication 312132001
Vaccinia keratitis contraindication 397552005
Porphyria contraindication 418470004




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 11.06 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 8.80 DRUG MATRIX CHEMBL
Androgen receptor Transcription factor Ki 6.07 DRUG MATRIX
Progesterone receptor Transcription factor Ki 6.98 DRUG MATRIX

External reference:

IDSource
4018212 VUID
N0000146545 NUI
D01367 KEGG_DRUG
4018212 VANDF
C0016351 UMLSCUI
CHEBI:31625 CHEBI
CHEMBL1200600 ChEMBL_ID
DB00324 DRUGBANK_ID
D005469 MESH_DESCRIPTOR_UI
9878 PUBCHEM_CID
7079 IUPHAR_LIGAND_ID
803 INN_ID
SV0CSG527L UNII
4491 RXNORM
4744 MMSL
6193 MMSL
7403 MMSL
002194 NDDF
108851006 SNOMEDCT_US
2925007 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
FML HUMAN PRESCRIPTION DRUG LABEL 1 0023-0316 OINTMENT 1 mg OPHTHALMIC NDA 18 sections
FML HUMAN PRESCRIPTION DRUG LABEL 1 11980-211 SUSPENSION/ DROPS 1 mg OPHTHALMIC NDA 17 sections
FML FORTE HUMAN PRESCRIPTION DRUG LABEL 1 11980-228 SUSPENSION/ DROPS 2.50 mg OPHTHALMIC NDA 17 sections
FML FORTE HUMAN PRESCRIPTION DRUG LABEL 1 11980-228 SUSPENSION/ DROPS 2.50 mg OPHTHALMIC NDA 17 sections
FLUOROMETHOLONE HUMAN PRESCRIPTION DRUG LABEL 1 60758-880 SOLUTION/ DROPS 1 mg OPHTHALMIC NDA AUTHORIZED GENERIC 19 sections
FLUOROMETHOLONE HUMAN PRESCRIPTION DRUG LABEL 1 60758-880 SOLUTION/ DROPS 1 mg OPHTHALMIC NDA AUTHORIZED GENERIC 19 sections