U.S. Department of Health & Human Services Divider Arrow National Institutes of Health Divider Arrow NCATS

Details

Stereochemistry ABSOLUTE
Molecular Formula C23H31FO6
Molecular Weight 422.487
Optical Activity UNSPECIFIED
Defined Stereocenters 7 / 7
E/Z Centers 0
Charge 0

SHOW SMILES / InChI
Structure of FLUDROCORTISONE ACETATE

SMILES

CC(=O)OCC(=O)[C@@]1(O)CC[C@H]2[C@@H]3CCC4=CC(=O)CC[C@]4(C)[C@@]3(F)[C@@H](O)C[C@]12C

InChI

InChIKey=SYWHXTATXSMDSB-GSLJADNHSA-N
InChI=1S/C23H31FO6/c1-13(25)30-12-19(28)22(29)9-7-16-17-5-4-14-10-15(26)6-8-20(14,2)23(17,24)18(27)11-21(16,22)3/h10,16-18,27,29H,4-9,11-12H2,1-3H3/t16-,17-,18-,20-,21-,22-,23-/m0/s1

HIDE SMILES / InChI

Molecular Formula C23H31FO6
Molecular Weight 422.487
Charge 0
Count
Stereochemistry ABSOLUTE
Additional Stereochemistry No
Defined Stereocenters 7 / 7
E/Z Centers 0
Optical Activity UNSPECIFIED

Description
Curator's Comment: description was created based on several sources, including http://www.2ndchance.info/addison's-florinef.pdf

Fludrocortisone acetate (approved as Florinef) is a synthetic adrenocortical steroid possessing very potent mineralcorticoid properties and high glucocorticoid activity. Main indications are Partial replacement therapy for primary and secondary adrenocortical insufficiency in Addison's disease and for the treatment of salt losing adrenogenital syndrome.

Originator

Curator's Comment: refernce was retrived from https://www.researchgate.net/publication/284208027_Fludrocortisone_Acetate

Approval Year

Targets

Targets

Primary TargetPharmacologyConditionPotency
Target ID: P22199
Gene ID: 25672.0
Gene Symbol: Nr3c2
Target Organism: Rattus norvegicus (Rat)
1.07 nM [Kd]
Target ID: P08235
Gene ID: 4306.0
Gene Symbol: NR3C2
Target Organism: Homo sapiens (Human)
Target ID: P06536
Gene ID: 24413.0
Gene Symbol: Nr3c1
Target Organism: Rattus norvegicus (Rat)
Target ID: P04150
Gene ID: 2908.0
Gene Symbol: NR3C1
Target Organism: Homo sapiens (Human)
Conditions

Conditions

ConditionModalityTargetsHighest PhaseProduct
Primary
FLORINEF

Approved Use

Fludrocortisone acetate tablets USP, 0.1 mg are indicated as partial replacement therapy for primary and secondary adrenocortical insufficiency in Addison's disease and for the treatment of salt-losing adrenogenital syndrome.

Launch Date

1955
Primary
FLORINEF

Approved Use

Fludrocortisone acetate tablets USP, 0.1 mg are indicated as partial replacement therapy for primary and secondary adrenocortical insufficiency in Addison's disease and for the treatment of salt-losing adrenogenital syndrome.

Launch Date

1955
Cmax

Cmax

ValueDoseCo-administeredAnalytePopulation
1241.1 pg/mL
0.1 mg single, oral
dose: 0.1 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
FLUDROCORTISONE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: MALE
food status: FASTED
0.19 μg/L
50 μg single, oral
dose: 50 μg
route of administration: Oral
experiment type: SINGLE
co-administered:
FLUDROCORTISONE plasma
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: UNKNOWN
food status: UNKNOWN
AUC

AUC

ValueDoseCo-administeredAnalytePopulation
3275.8 pg × h/mL
0.1 mg single, oral
dose: 0.1 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
FLUDROCORTISONE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: MALE
food status: FASTED
1.25 μg × h/L
50 μg single, oral
dose: 50 μg
route of administration: Oral
experiment type: SINGLE
co-administered:
FLUDROCORTISONE plasma
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: UNKNOWN
food status: UNKNOWN
T1/2

T1/2

ValueDoseCo-administeredAnalytePopulation
2.57 h
0.1 mg single, oral
dose: 0.1 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
FLUDROCORTISONE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: MALE
food status: FASTED
1.35 h
50 μg single, oral
dose: 50 μg
route of administration: Oral
experiment type: SINGLE
co-administered:
FLUDROCORTISONE plasma
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: UNKNOWN
food status: UNKNOWN
Funbound

Funbound

ValueDoseCo-administeredAnalytePopulation
30%
0.1 mg single, oral
dose: 0.1 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
FLUDROCORTISONE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: MALE
food status: FASTED
Doses

Doses

DosePopulationAdverse events​
0.3 mg 1 times / day multiple, oral
Highest studied dose
Dose: 0.3 mg, 1 times / day
Route: oral
Route: multiple
Dose: 0.3 mg, 1 times / day
Sources:
unhealthy
Health Status: unhealthy
Sources:
Other AEs: Serum potassium decreased, Rise in blood pressure...
Other AEs:
Serum potassium decreased (5 patients)
Rise in blood pressure (5 patients)
Sources:
AEs

AEs

AESignificanceDosePopulation
Rise in blood pressure 5 patients
0.3 mg 1 times / day multiple, oral
Highest studied dose
Dose: 0.3 mg, 1 times / day
Route: oral
Route: multiple
Dose: 0.3 mg, 1 times / day
Sources:
unhealthy
Health Status: unhealthy
Sources:
Serum potassium decreased 5 patients
0.3 mg 1 times / day multiple, oral
Highest studied dose
Dose: 0.3 mg, 1 times / day
Route: oral
Route: multiple
Dose: 0.3 mg, 1 times / day
Sources:
unhealthy
Health Status: unhealthy
Sources:
Overview

Overview

CYP3A4CYP2C9CYP2D6hERG

OverviewOther

Other InhibitorOther SubstrateOther Inducer

Drug as victim

Drug as victim

PubMed

PubMed

TitleDatePubMed
Association between supine hypertension and orthostatic hypotension in autonomic failure.
2003-08
Primary aldosteronism and hypertensive disease.
2003-08
Automated coupling of capillary-HPLC to matrix-assisted laser desorption/ionization mass spectrometry for the analysis of small molecules utilizing a reactive matrix.
2003-07
Combination therapy with hydrocortisone and fludrocortisone does not improve symptoms in chronic fatigue syndrome: a randomized, placebo-controlled, double-blind, crossover study.
2003-06-15
[A 47-year-old man with "pure autonomic failure" and pernicious anemia].
2003-06-13
Monozygotic twins with congenital adrenal hyperplasia: long-term endocrine evaluation and gene analysis.
2003-06-10
Neurologic complications following treatment of canine hypoadrenocorticism.
2003-06
Impact of smoking on the response to treatment of thyroid associated ophthalmopathy.
2003-06
Corticosteroid insufficiency in acutely ill patients.
2003-05-22
Hyperpigmentation mimicking Laugier syndrome, levodopa therapy and Addison's disease.
2003-05
Blood pressure in children and adolescents with congenital adrenal hyperplasia (21-hydroxylase deficiency): a preliminary report.
2003-05
Serum leptin levels in patients with 21-hydroxylase deficiency before and after treatment.
2003-04-30
Simultaneous quantification of budesonide and its two metabolites, 6beta-hydroxybudesonide and 16alpha-hydroxyprednisolone, in human plasma by liquid chromatography negative electrospray ionization tandem mass spectrometry.
2003-04-30
Sepsis clinical knowledge: a role of steroid treatment.
2003-04
Bench-to-bedside review: endothelial cell dysfunction in severe sepsis: a role in organ dysfunction?
2003-04
Diminished renal kallikrein responses to mineralocorticoid stimulation in African Americans: determinants of an intermediate phenotype for hypertension.
2003-04
Hydrocortisone and fludrocortisone improved 28-day survival in septic shock and adrenal insufficiency.
2003-03-05
Stability of fludrocortisone acetate solutions prepared from tablets and powder.
2003-03
Parkinsonism associated with Addison's disease.
2003-03
Granulomatous interstitial nephritis.
2003-03
Congenital adrenal hypoplasia presenting as a chronic respiratory condition.
2003-03
Recently published papers: a number of treatment controversies.
2003-02
Chronic fatigue syndrome and Addison's disease.
2003-02
Drug treatment of orthostatic hypotension and vasovagal syncope.
2003-01-29
Treating interdialytic hyperkalemia with fludrocortisone.
2003-01-22
Successful treatment of severe orthostatic hypotension with erythropoietin.
2003-01
[Investigation of hyperaldosteronism in the hypertensive patient. Why? When? How?].
2003-01
A pilot randomized trial of induced blood pressure elevation: effects on function and focal perfusion in acute and subacute stroke.
2003
Neurocardiogenic syncope in children : current concepts in diagnosis and management.
2003
Reducing mortality in sepsis: new directions.
2002-12
Chronic unexplained fatigue.
2002-12
Treatment of orthostatic hypotension.
2002-12
Dysautonomias: clinical disorders of the autonomic nervous system.
2002-11-05
[Generic carbamazepine-induced subacute adrenal insufficiency?].
2002-11
Screening and diagnosis of primary aldosteronism.
2002-10-22
[Diabetic neuropathy--concept, staging, diagnosis, treatment].
2002-10
Recently published papers: new evidence for old debates, new drugs and some timely reminders.
2002-10
Autonomic failure mimicing dopamine agonist induced vertigo in a patient with macroprolactinoma.
2002-10
Hyperaldosteronism: the internist's hypertensive disease.
2002-10
The mineralocorticoid receptor may compensate for the loss of the glucocorticoid receptor at specific stages of mammary gland development.
2002-09
Effect of treatment with low doses of hydrocortisone and fludrocortisone on mortality in patients with septic shock.
2002-08-21
[Primary adrenal insufficiency due to autoimmune adrenalitis].
2002-08
Outcomes for laparoscopic bilateral adrenalectomy.
2002-08
Longitudinal analysis of growth and puberty in 21-hydroxylase deficiency patients.
2002-08
Salt losing nephropathy simulating congenital adrenal hyperplasia in an infant.
2002-07
A footnote on the origin of fluorosteroids.
2002-07
Yoghurt biotherapy: contraindicated in immunosuppressed patients?
2002-06
Cortisol replacement for severe sepsis and septic shock: what should I do?
2002-06
Orthostatic hypotension.
2002-05
Potassium-lowering effect of mineralocorticoid therapy in patients undergoing hemodialysis.
2002
Patents

Sample Use Guides

0.05mg to 0.3mg FLORINEF (Fludrocortisone acetate) daily (depends on indication)
Route of Administration: Oral
In Vitro Use Guide
Unknown
Substance Class Chemical
Created
by admin
on Mon Mar 31 17:53:17 GMT 2025
Edited
by admin
on Mon Mar 31 17:53:17 GMT 2025
Record UNII
V47IF0PVH4
Record Status Validated (UNII)
Record Version
  • Download
Name Type Language
FLUDROCORTISONE ACETATE
EP   JAN   MART.   ORANGE BOOK   USP   USP-RS   VANDF   WHO-DD   WHO-IP  
Common Name English
FLUDROCORTISONE 21-ACETATE
MI  
Preferred Name English
FLORINEF
Brand Name English
FLUDROCORTISONE ACETATE [JAN]
Common Name English
FLUDROCORTISONI ACETAS [WHO-IP LATIN]
Common Name English
FLUDROCORTISONE ACETATE [USP-RS]
Common Name English
FLUDROCORTISONE 21-ACETATE [MI]
Common Name English
FLUDROCORTISONE ACETATE [EP MONOGRAPH]
Common Name English
SCHEROFLURON
Common Name English
NSC-15186
Code English
FLUDROCORTISONE ACETATE [WHO-IP]
Common Name English
9-Fluoro-11?,17,21-trihydroxypregn-4-ene-3,20-dione 21-acetate
Systematic Name English
FLUOROCORTISOL ACETATE
Common Name English
FLUDROCORTISONE ACETATE [USP MONOGRAPH]
Common Name English
Fludrocortisone acetate [WHO-DD]
Common Name English
FLUDROCORTISONE ACETATE [VANDF]
Common Name English
FLUDROCORTISONE ACETATE [ORANGE BOOK]
Common Name English
FLUDROCORTISONE ACETATE [MART.]
Common Name English
PREGN-4-ENE-3,20-DIONE, 21-(ACETYLOXY)-9-FLUORO-11,17-DIHYDROXY-, (11.BETA.)-
Systematic Name English
Classification Tree Code System Code
NCI_THESAURUS C521
Created by admin on Mon Mar 31 17:53:17 GMT 2025 , Edited by admin on Mon Mar 31 17:53:17 GMT 2025
Code System Code Type Description
NCI_THESAURUS
C1103
Created by admin on Mon Mar 31 17:53:17 GMT 2025 , Edited by admin on Mon Mar 31 17:53:17 GMT 2025
PRIMARY
DAILYMED
V47IF0PVH4
Created by admin on Mon Mar 31 17:53:17 GMT 2025 , Edited by admin on Mon Mar 31 17:53:17 GMT 2025
PRIMARY
WHO INTERNATIONAL PHARMACOPEIA
FLUDROCORTISONE ACETATE
Created by admin on Mon Mar 31 17:53:17 GMT 2025 , Edited by admin on Mon Mar 31 17:53:17 GMT 2025
PRIMARY Description: A white or almost white, crystalline powder; odourless or almost odourless. Solubility: Practically insoluble in water; sparingly soluble in ethanol (~750 g/l) TS; slightly soluble in ether R. Category: Adrenal hormone. Storage: Fludrocortisone acetate should be kept in a well-closed container, protected from light. Additional information: Fludrocortisone acetate is hygroscopic. Definition: Fludrocortisone acetate contains not less than 96.0% and not more than 104.0% of C23H31FO6, calculated with reference to the dried substance.
FDA UNII
V47IF0PVH4
Created by admin on Mon Mar 31 17:53:17 GMT 2025 , Edited by admin on Mon Mar 31 17:53:17 GMT 2025
PRIMARY
NSC
15186
Created by admin on Mon Mar 31 17:53:17 GMT 2025 , Edited by admin on Mon Mar 31 17:53:17 GMT 2025
PRIMARY
DRUG CENTRAL
1191
Created by admin on Mon Mar 31 17:53:17 GMT 2025 , Edited by admin on Mon Mar 31 17:53:17 GMT 2025
PRIMARY
EPA CompTox
DTXSID2023062
Created by admin on Mon Mar 31 17:53:17 GMT 2025 , Edited by admin on Mon Mar 31 17:53:17 GMT 2025
PRIMARY
ECHA (EC/EINECS)
208-180-4
Created by admin on Mon Mar 31 17:53:17 GMT 2025 , Edited by admin on Mon Mar 31 17:53:17 GMT 2025
PRIMARY
PUBCHEM
225609
Created by admin on Mon Mar 31 17:53:17 GMT 2025 , Edited by admin on Mon Mar 31 17:53:17 GMT 2025
PRIMARY
CAS
514-36-3
Created by admin on Mon Mar 31 17:53:17 GMT 2025 , Edited by admin on Mon Mar 31 17:53:17 GMT 2025
PRIMARY
ChEMBL
CHEMBL1201010
Created by admin on Mon Mar 31 17:53:17 GMT 2025 , Edited by admin on Mon Mar 31 17:53:17 GMT 2025
PRIMARY
CHEBI
5102
Created by admin on Mon Mar 31 17:53:17 GMT 2025 , Edited by admin on Mon Mar 31 17:53:17 GMT 2025
PRIMARY
RS_ITEM_NUM
1273003
Created by admin on Mon Mar 31 17:53:17 GMT 2025 , Edited by admin on Mon Mar 31 17:53:17 GMT 2025
PRIMARY
MERCK INDEX
m5431
Created by admin on Mon Mar 31 17:53:17 GMT 2025 , Edited by admin on Mon Mar 31 17:53:17 GMT 2025
PRIMARY Merck Index
EVMPD
SUB02209MIG
Created by admin on Mon Mar 31 17:53:17 GMT 2025 , Edited by admin on Mon Mar 31 17:53:17 GMT 2025
PRIMARY
DRUG BANK
DBSALT000659
Created by admin on Mon Mar 31 17:53:17 GMT 2025 , Edited by admin on Mon Mar 31 17:53:17 GMT 2025
PRIMARY
SMS_ID
100000092613
Created by admin on Mon Mar 31 17:53:17 GMT 2025 , Edited by admin on Mon Mar 31 17:53:17 GMT 2025
PRIMARY
RXCUI
165516
Created by admin on Mon Mar 31 17:53:17 GMT 2025 , Edited by admin on Mon Mar 31 17:53:17 GMT 2025
PRIMARY RxNorm
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