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

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
kinase-safety-class ACVR2B,CAMK2D,CDK5,EIF2AK3,GRK2,ITK,MAPK10,PDK1,PDK2,PDK4,PRKDC 11
kinase-selectivity-class GRK2 1
pfas-class PFAS structural alert (1 = True, 0 = False) 0

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
Grip strength 168.19 21.35 58 12088 8907 90607394
Swollen joint count 102.85 21.35 40 12106 8613 90607688
Autoimmune disorder 100.82 21.35 83 12063 76661 90539640
Bone erosion 97.40 21.35 70 12076 52951 90563350
Porphyria acute 92.16 21.35 46 12100 17929 90598372
Adjustment disorder with depressed mood 80.05 21.35 64 12082 56689 90559612
Exostosis 79.42 21.35 62 12084 53072 90563229
Colitis ulcerative 78.76 21.35 65 12081 60201 90556100
Dislocation of vertebra 78.70 21.35 63 12083 55905 90560396
Frequent bowel movements 77.75 21.35 63 12083 56872 90559429
Foot deformity 75.18 21.35 63 12083 59588 90556713
Maternal exposure timing unspecified 74.38 21.35 43 12103 22440 90593861
Hepatic cirrhosis 73.98 21.35 64 12082 63189 90553112
Sleep disorder due to a general medical condition 72.99 21.35 55 12091 44683 90571618
Ear infection 70.51 21.35 65 12081 69710 90546591
Breast cancer stage III 69.01 21.35 70 12076 84377 90531924
Retinitis 68.85 21.35 50 12096 38408 90577893
Lupus vulgaris 66.08 21.35 52 12094 45007 90571294
Laryngitis 62.70 21.35 53 12093 50700 90565601
X-ray abnormal 61.46 21.35 50 12096 45374 90570927
Feeling hot 57.15 21.35 61 12085 77947 90538354
Deep vein thrombosis postoperative 56.58 21.35 58 12088 70751 90545550
Laboratory test abnormal 54.37 21.35 45 12101 41809 90574492
Drug ineffective 54.02 21.35 64 12082 1384234 89232067
Delirium 53.64 21.35 68 12078 104291 90512010
Bursitis 51.31 21.35 75 12071 131579 90484722
Grip strength decreased 50.26 21.35 62 12084 92514 90523787
White blood cell count increased 50.00 21.35 53 12093 67188 90549113
Facet joint syndrome 48.82 21.35 63 12083 98326 90517975
Walking aid user 47.85 21.35 39 12107 35467 90580834
Amnesia 46.98 21.35 65 12081 108440 90507861
Pancreatitis 46.61 21.35 52 12094 69774 90546527
C-reactive protein abnormal 45.94 21.35 70 12076 127359 90488942
Rectal haemorrhage 45.86 21.35 56 12090 82688 90533613
Weight fluctuation 45.51 21.35 30 12116 19719 90596582
Eye irritation 45.11 21.35 37 12109 33941 90582360
Hypercholesterolaemia 44.52 21.35 61 12085 100831 90515470
Eye pain 40.49 21.35 39 12107 44129 90572172
Visual impairment 39.88 21.35 67 12079 132298 90484003
Ill-defined disorder 39.85 21.35 81 12065 184810 90431491
Asthma 39.65 21.35 95 12051 242065 90374236
Lupus-like syndrome 38.99 21.35 40 12106 48806 90567495
Peripheral venous disease 37.41 21.35 51 12095 83870 90532431
Arthritis 36.89 21.35 74 12072 167241 90449060
Dry mouth 36.58 21.35 78 12068 183981 90432320
Road traffic accident 34.46 21.35 56 12090 107570 90508731
Folliculitis 33.26 21.35 80 12066 204273 90412028
Sciatica 32.79 21.35 53 12093 101329 90514972
Fall 32.49 21.35 12 12134 481798 90134503
Duodenal ulcer perforation 32.19 21.35 83 12063 221205 90395096
Impaired healing 31.19 21.35 85 12061 234114 90382187
Corneal opacity 29.83 21.35 9 12137 902 90615399
Blood cholesterol increased 29.21 21.35 77 12069 207935 90408366
Lip dry 28.94 21.35 50 12096 100905 90515396
Helicobacter infection 28.88 21.35 81 12065 226769 90389532
Sleep disorder due to general medical condition, insomnia type 28.45 21.35 57 12089 128637 90487664
Wound infection 28.31 21.35 51 12095 106351 90509950
Toxicity to various agents 27.97 21.35 3 12143 287843 90328458
Pulmonary fibrosis 27.93 21.35 51 12095 107452 90508849
Hypotension 27.84 21.35 5 12141 325392 90290909
Swollen joint count increased 26.70 21.35 51 12095 111155 90505146
Drug tolerance decreased 25.08 21.35 26 12120 32104 90584197
Gastrointestinal disorder 24.60 21.35 83 12063 256604 90359697
Liver disorder 23.63 21.35 51 12095 121218 90495083
Contusion 23.00 21.35 80 12066 251136 90365165
Anxiety 22.83 21.35 92 12054 309680 90306621
Keratitis 22.76 21.35 11 12135 3995 90612306
Lung disorder 22.59 21.35 57 12089 149826 90466475
Blister 22.31 21.35 80 12066 254918 90361383
Cough 21.98 21.35 11 12135 368951 90247350
Osteoporosis 21.62 21.35 43 12103 96488 90519813
Hypopyon 21.44 21.35 7 12139 907 90615394
Anti-cyclic citrullinated peptide antibody positive 21.38 21.35 75 12071 236358 90379943

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
Eye pain 53.61 27.53 20 1285 17010 42603020
Conjunctival scar 52.85 27.53 9 1296 297 42619733
Ocular hyperaemia 47.52 27.53 18 1287 15945 42604085
Keratitis 47.42 27.53 11 1294 1780 42618250
Corneal disorder 47.39 27.53 10 1295 1049 42618981
Intraocular pressure increased 45.96 27.53 14 1291 6419 42613611
Treatment failure 38.76 27.53 24 1281 62600 42557430
Madarosis 35.83 27.53 7 1298 499 42619531
Conjunctival hyperaemia 31.88 27.53 9 1296 3167 42616863
Conjunctivitis 29.38 27.53 12 1293 12927 42607103

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
Grip strength 180.93 22.73 60 13302 9081 110566856
Autoimmune disorder 127.33 22.73 86 13276 65397 110510540
Bone erosion 117.61 22.73 72 13290 46299 110529638
Swollen joint count 106.78 22.73 40 13322 8634 110567303
Adjustment disorder with depressed mood 105.86 22.73 66 13296 43817 110532120
Dislocation of vertebra 103.56 22.73 65 13297 43656 110532281
Porphyria acute 100.84 22.73 48 13314 18732 110557205
Exostosis 98.14 22.73 64 13298 45892 110530045
Foot deformity 97.42 22.73 65 13297 48415 110527522
Lupus vulgaris 89.48 22.73 54 13308 33829 110542108
Retinitis 86.61 22.73 52 13310 32275 110543662
Ear infection 84.54 22.73 66 13296 62666 110513271
Maternal exposure timing unspecified 84.11 22.73 44 13318 20969 110554968
Breast cancer stage III 83.08 22.73 72 13290 79045 110496892
Laryngitis 80.75 22.73 55 13307 42356 110533581
Hepatic cirrhosis 78.09 22.73 65 13297 67561 110508376
X-ray abnormal 76.32 22.73 51 13311 38066 110537871
Frequent bowel movements 75.02 22.73 65 13297 71325 110504612
Deep vein thrombosis postoperative 74.79 22.73 60 13302 59231 110516706
Colitis ulcerative 74.44 22.73 67 13295 77296 110498641
Sleep disorder due to a general medical condition 72.77 22.73 56 13306 52056 110523881
Grip strength decreased 66.64 22.73 64 13298 80110 110495827
Walking aid user 63.73 22.73 39 13323 25036 110550901
Ill-defined disorder 60.18 22.73 84 13278 156769 110419168
Bursitis 59.70 22.73 76 13286 129842 110446095
Amnesia 58.76 22.73 68 13294 105340 110470597
Laboratory test abnormal 58.57 22.73 46 13316 44033 110531904
Facet joint syndrome 58.27 22.73 65 13297 96763 110479174
Feeling hot 58.01 22.73 63 13299 91043 110484894
Hypercholesterolaemia 56.43 22.73 62 13300 90775 110485162
Folliculitis 55.89 22.73 84 13278 167569 110408368
Impaired healing 55.11 22.73 91 13271 196626 110379311
Duodenal ulcer perforation 54.97 22.73 86 13276 177614 110398323
C-reactive protein abnormal 53.58 22.73 72 13290 129623 110446314
Keratitis 53.56 22.73 21 13341 5123 110570814
Lupus-like syndrome 52.97 22.73 42 13320 40750 110535187
Visual impairment 51.57 22.73 72 13290 134356 110441581
Eye pain 51.38 22.73 45 13317 50054 110525883
Delirium 51.32 22.73 72 13290 134953 110440984
Helicobacter infection 50.76 22.73 84 13278 181793 110394144
Asthma 50.02 22.73 100 13262 250191 110325746
Corneal disorder 47.23 22.73 16 13346 2581 110573356
Drug ineffective 46.67 22.73 70 13292 1520470 109055467
Weight fluctuation 45.21 22.73 30 13332 22115 110553822
Pancreatitis 45.00 22.73 56 13306 93477 110482460
Peripheral venous disease 44.76 22.73 53 13309 84064 110491873
Glossodynia 44.71 22.73 89 13273 221915 110354022
Sleep disorder due to general medical condition, insomnia type 44.17 22.73 59 13303 105584 110470353
Road traffic accident 43.41 22.73 59 13303 107339 110468598
Swollen joint count increased 43.34 22.73 52 13310 83609 110492328
Hypotension 43.28 22.73 6 13356 523843 110052094
Blood cholesterol increased 43.28 22.73 79 13283 184706 110391231
Discomfort 43.15 22.73 86 13276 214621 110361316
Anti-cyclic citrullinated peptide antibody positive 42.87 22.73 78 13284 181906 110394031
Sciatica 42.35 22.73 54 13308 92345 110483592
Arthritis 42.26 22.73 74 13288 167512 110408425
White blood cell count increased 41.89 22.73 55 13307 96787 110479150
Toxicity to various agents 40.91 22.73 5 13357 480550 110095387
Wound infection 38.99 22.73 53 13309 96412 110479525
Dry mouth 38.87 22.73 79 13283 199869 110376068
Intraocular pressure increased 38.53 22.73 21 13341 10855 110565082
Contusion 38.23 22.73 86 13276 233275 110342662
Acute kidney injury 37.43 22.73 15 13347 635415 109940522
Gastrointestinal disorder 37.24 22.73 87 13275 241865 110334072
Rectal haemorrhage 37.04 22.73 58 13304 119775 110456162
Blister 36.36 22.73 83 13279 227293 110348644
Corneal opacity 36.32 22.73 11 13351 1240 110574697
Lip dry 36.00 22.73 52 13310 100031 110475906
Pulmonary fibrosis 35.23 22.73 52 13310 101990 110473947
Hand deformity 35.20 22.73 80 13282 218426 110357511
Arthropathy 34.44 22.73 94 13268 287428 110288509
Eye irritation 34.20 22.73 30 13332 33422 110542515
Conjunctival scar 33.94 22.73 8 13354 344 110575593
Drug tolerance decreased 32.88 22.73 27 13335 27513 110548424
Fibromyalgia 32.59 22.73 67 13295 170842 110405095
Corneal erosion 31.49 22.73 8 13354 471 110575466
Muscle injury 30.21 22.73 58 13304 140749 110435188
Rheumatic fever 29.44 22.73 53 13309 122526 110453411
Corneal scar 28.97 22.73 7 13355 335 110575602
Off label use 28.56 22.73 90 13272 1500095 109075842
Joint range of motion decreased 28.40 22.73 52 13310 121780 110454157
Maternal exposure during pregnancy 28.22 22.73 81 13281 254802 110321135
Osteoporosis 28.07 22.73 43 13319 87109 110488828
Drug interaction 27.54 22.73 13 13349 500170 110075767
Keratitis fungal 27.23 22.73 7 13355 432 110575505
Lower limb fracture 26.88 22.73 39 13323 75309 110500628
Anxiety 26.71 22.73 97 13265 344981 110230956
Dyspepsia 26.51 22.73 66 13296 190899 110385038
Ocular hyperaemia 26.46 22.73 28 13334 39258 110536679
Injury 26.45 22.73 63 13299 177202 110398735
Ophthalmic herpes simplex 26.38 22.73 8 13354 906 110575031
Corneal perforation 26.02 22.73 8 13354 948 110574989
Conjunctival hyperaemia 25.61 22.73 13 13349 5818 110570119
Rheumatoid factor positive 25.55 22.73 52 13310 131588 110444349
Liver disorder 25.06 22.73 54 13308 142189 110433748
Anaemia 24.77 22.73 18 13344 547068 110028869
Irritable bowel syndrome 24.11 22.73 58 13304 164157 110411780
Death 23.51 22.73 30 13332 698839 109877098
Hypopyon 22.80 22.73 8 13354 1432 110574505

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 D005938 Glucocorticoids
MeSH PA D006728 Hormones
MeSH PA D000893 Anti-Inflammatory Agents
MeSH PA D018926 Anti-Allergic Agents
CHEBI has role CHEBI:35472 anti-inflammatory drug
CHEBI has role CHEBI:66981 ophthalmology drug
CHEBI has role CHEBI:67079 anti-inflammatory agent

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D07CB Corticosteroids, moderately potent, combinations with antibiotics 4 drugs
dexamethasoneflumetasonefluprednidenetriamcinolone
D07XB Corticosteroids, moderately potent, other combinations 4 drugs
dexamethasoneflumetasonefluprednidenetriamcinolone
D10AA Corticosteroids, combinations for treatment of acne 2 drugs
dexamethasonemethylprednisolone
S01BA Corticosteroids, plain 15 drugs
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S01CB Corticosteroids/antiinfectives/mydriatics in combination 4 drugs
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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
SV0CSG527L INXIGHT DRUGS

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
fluorometholone HUMAN PRESCRIPTION DRUG LABEL 1 0781-6187 SUSPENSION/ DROPS 1 mg OPHTHALMIC ANDA 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
fluorometholone ophthalmic suspension HUMAN PRESCRIPTION DRUG LABEL 1 60219-1585 SUSPENSION/ DROPS 1 mg OPHTHALMIC ANDA 17 sections
fluorometholone ophthalmic suspension HUMAN PRESCRIPTION DRUG LABEL 1 60219-1586 SUSPENSION/ DROPS 1 mg OPHTHALMIC ANDA 17 sections
FLUOROMETHOLONE HUMAN PRESCRIPTION DRUG LABEL 1 60758-880 SOLUTION/ DROPS 1 mg OPHTHALMIC NDA authorized generic 18 sections