Fludrocortisone
Fludrocortisone (fludrocortisone) is a small molecule pharmaceutical. Fludrocortisone was first approved as Florinef on 1982-01-01. It is used to treat addison disease and adrenocortical hyperfunction in the USA. The pharmaceutical is active against mineralocorticoid receptor.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| endocrine system diseases | D004700 |
| immune system diseases | D007154 |
Trade Name
FDA
EMA
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Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Fludrocortisone acetate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| FLORINEF | Casper Pharma | N-010060 DISCN | 1982-01-01 | 1 products, RLD |
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| fludrocortisone acetate | ANDA | 2024-01-11 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| addison disease | — | D000224 | E27.1 |
| adrenocortical hyperfunction | EFO_1000797 | D000308 | — |
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
H: Systemic hormonal preparations, excl. sex hormones and insulins
— H02: Corticosteroids for systemic use
— H02A: Corticosteroids for systemic use, plain
— H02AA: Mineralocorticoids for systemic use, plain
— H02AA02: Fludrocortisone
S: Sensory organ drugs
— S01: Ophthalmologicals
— S01C: Antiinflammatory agents and antiinfectives in combination
— S01CA: Corticosteroids and antiinfectives in combination, opthalmologic
— S01CA06: Fludrocortisone and antiinfectives
— S02: Otologicals
— S02C: Corticosteroids and antiinfectives in combination, otologic
— S02CA: Corticosteroids and antiinfectives in combination
— S02CA07: Fludrocortisone and antiinfectives
— S03: Ophthalmological and otological preparations
— S03C: Corticosteroids and antiinfectives in combination, opthalmologic and otologic
— S03CA: Corticosteroids and antiinfectives in combination
— S03CA05: Fludrocortisone and antiinfectives
HCPCS
No data
Clinical
Clinical Trials
52 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Septic shock | D012772 | — | A48.3 | — | 3 | 4 | 1 | — | 7 |
| Orthostatic hypotension | D007024 | — | I95.1 | 1 | 1 | 1 | 1 | 3 | 6 |
| Congenital adrenal hyperplasia | D000312 | — | E25.0 | 1 | 1 | — | 1 | 1 | 4 |
| Sepsis | D018805 | HP_0100806 | A41.9 | — | — | — | 1 | 1 | 2 |
| Adrenal insufficiency | D000309 | — | — | — | — | 1 | 1 | — | 2 |
| Vasovagal syncope | D019462 | — | R55 | — | — | 1 | 1 | — | 2 |
| Hypertension | D006973 | EFO_0000537 | I10 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Prostatic neoplasms | D011471 | — | C61 | 3 | 1 | 1 | — | — | 4 |
| Critical illness | D016638 | — | — | — | 1 | 1 | — | — | 2 |
| Hypotension | D007022 | EFO_0005251 | I95 | 1 | 2 | 1 | — | — | 2 |
| Cardiogenic shock | D012770 | — | R57.0 | — | — | 1 | — | — | 1 |
| Wounds and injuries | D014947 | — | T14.8 | — | — | 1 | — | — | 1 |
| Traumatic brain injuries | D000070642 | — | S06 | — | — | 1 | — | — | 1 |
| Pneumonia | D011014 | EFO_0003106 | — | — | — | 1 | — | — | 1 |
| Blood pressure | D001794 | EFO_0004325 | — | — | 1 | 1 | — | — | 1 |
| Spinal cord injuries | D013119 | EFO_1001919 | — | — | 1 | 1 | — | — | 1 |
| Autonomic dysreflexia | D020211 | EFO_1001762 | G90.4 | — | 1 | 1 | — | — | 1 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 2 | 1 | — | — | — | 3 |
| Parkinson disease | D010300 | EFO_0002508 | G20 | 1 | 1 | — | — | — | 2 |
| Melanoma | D008545 | — | — | — | 1 | — | — | — | 1 |
| Ovarian hyperstimulation syndrome | D016471 | — | — | — | 1 | — | — | — | 1 |
| Heart failure | D006333 | HP_0001635 | I50 | 1 | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Sensorineural hearing loss | D006319 | HP_0000407 | H90.5 | 1 | — | — | — | — | 1 |
| Depression | D003863 | — | F33.9 | 1 | — | — | — | — | 1 |
| Multiple system atrophy | D019578 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Type 1 diabetes mellitus | D003922 | EFO_0001359 | E10 | — | — | — | — | 1 | 1 |
| Subarachnoid hemorrhage | D013345 | EFO_0000713 | I60 | — | — | — | — | 1 | 1 |
| Inappropriate adh syndrome | D007177 | EFO_1000982 | E22.2 | — | — | — | — | 1 | 1 |
| Hyponatremia | D007010 | HP_0002902 | E87.1 | — | — | — | — | 1 | 1 |
| Hyperaldosteronism | D006929 | HP_0011736 | E26 | — | — | — | — | 1 | 1 |
| Individuality | D007206 | — | — | — | — | — | — | 1 | 1 |
| Nephrolithiasis | D053040 | — | N20.0 | — | — | — | — | 1 | 1 |
| Renal tubular acidosis | D000141 | — | N25.89 | — | — | — | — | 1 | 1 |
| Borderline personality disorder | D001883 | HP_0012076 | F60.3 | — | — | — | — | 1 | 1 |
| Postural orthostatic tachycardia syndrome | D054972 | — | G90.A | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Fludrocortisone |
| INN | fludrocortisone |
| Description | Fludrocortisone is a C21-steroid, a 3-oxo-Delta(4) steroid, a 20-oxo steroid, a 21-hydroxy steroid, a fluorinated steroid, a mineralocorticoid, a 17alpha-hydroxy steroid and an 11beta-hydroxy steroid. It has a role as an adrenergic agent and an anti-inflammatory drug. It derives from a hydride of a pregnane. |
| Classification | Small molecule |
| Drug class | cortisone derivatives |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | C[C@]12C[C@H](O)[C@@]3(F)[C@@H](CCC4=CC(=O)CC[C@@]43C)[C@@H]1CC[C@]2(O)C(=O)CO |
Identifiers
| PDB | — |
| CAS-ID | 127-31-1 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1201388 |
| ChEBI ID | 50885 |
| PubChem CID | 31378 |
| DrugBank | DB00687 |
| UNII ID | U0476M545B (ChemIDplus, GSRS) |
Target
Agency Approved
NR3C2
NR3C2
Organism
Homo sapiens
Gene name
NR3C2
Gene synonyms
MCR, MLR
NCBI Gene ID
Protein name
mineralocorticoid receptor
Protein synonyms
aldosterone receptor, mineralocorticoid receptor 1, mineralocorticoid receptor 2, mineralocorticoid receptor delta, Nuclear receptor subfamily 3 group C member 2
Uniprot ID
Mouse ortholog
Nr3c2 (110784)
mineralocorticoid receptor (Q8VII9)
Alternate
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Variants
No data
Financial
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Estimated US medical usage
Fludrocortisone
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Safety
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Adverse Events
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1,074 adverse events reported
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