fluorometholone 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| steroids not used as glucocorticosteroids | 1208 | 426-13-1 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
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)
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
None
ADMET properties:
None
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Jan. 12, 1972 | FDA | ALLERGAN |
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 |
|---|---|---|---|---|---|---|
| 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 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 |
|---|---|---|---|---|---|---|
| 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 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 |
|---|---|---|---|---|---|---|
| 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:
| Source | Code | Description |
|---|---|---|
| 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|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| 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 level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 11.06 | acidic |
Orange Book patent data (new drug applications)
None
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 | 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:
| ID | Source |
|---|---|
| 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:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| 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 |