Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Fludrocortisone
Drug ID BADD_D00917
Description Fludrocortisone is a synthetic mineralocorticoid used in conjunction with [hydrocortisone] to replace missing endogenous corticosteroids in patients with adrenal insufficiency.[A187169,A187187] It is functionally similar to [aldosterone], the body's primary endogenous mineralocorticoid, and is structurally analogous to [cortisol], differing only by a fluorine atom at the 9-position of the steroid structure - this fluorination is thought to be crucial to fludrocortisone's significant mineralocorticoid potency.[A5423]
Indications and Usage Fludrocortisone is indicated as partial replacement therapy for primary or secondary adrenocortical insufficiency in Addison's disease. It is also indicated for the treatment of salt-losing androgenital syndrome.[L8971]
Marketing Status approved; investigational
ATC Code H02AA02
DrugBank ID DB00687
KEGG ID D07967
MeSH ID D005438
PubChem ID 31378
TTD Drug ID D0R7JT
NDC Product Code Not Available
UNII U0476M545B
Synonyms Fludrocortisone | 9-Fluorocortisol | 9 Fluorocortisol | 9 alpha Fludrohydrocortisone | 9 alpha-Fluoro-17-Hydroxycorticosterone | 9 alpha Fluoro 17 Hydroxycorticosterone | 9-Fluoro-17-Hydroxycortisone | 9 Fluoro 17 Hydroxycortisone | 9-Fluorohydrocortisone | 9 Fluorohydrocortisone | 9 alpha-Fluorohydrocortisone | 9 alpha Fluorohydrocortisone | Astonin | Astonin-H | Astonin H | Astonin Merck | Merck, Astonin | FCOL
Chemical Information
Molecular Formula C21H29FO5
CAS Registry Number 127-31-1
SMILES CC12CCC(=O)C=C1CCC3C2(C(CC4(C3CCC4(C(=O)CO)O)C)O)F
Chemical Structure
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice.
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Abdominal distension07.01.04.001--
Alkalosis hypokalaemic14.01.02.002---
Amenorrhoea05.05.01.002; 21.01.02.001--
Anaphylactic shock10.01.07.002; 24.06.02.004---
Anaphylactoid reaction10.01.07.003; 24.06.03.007---
Asthenia08.01.01.001---
Atrophy08.03.04.001---
Carbohydrate tolerance decreased13.02.02.003---
Cardiac failure congestive02.05.01.002---
Cardiomegaly02.04.02.001---
Cataract06.06.01.001--
Cataract subcapsular06.06.01.002---
Dermatitis acneiform23.02.01.004--
Dermatitis allergic10.01.03.014; 23.03.04.003---
Dermatitis atopic10.01.04.004; 23.03.04.016---
Diabetes mellitus05.06.01.001; 14.06.01.001---
Ecchymosis01.01.03.001; 23.06.01.001; 24.07.06.002---
Erythema23.03.06.001---
Exophthalmos05.02.02.002; 06.09.04.001---
Fluid retention14.05.06.002; 20.01.02.003---
Fracture12.04.02.001; 15.08.02.001--
Glaucoma06.03.01.002--
Glucose tolerance decreased13.02.02.004---
Glucose tolerance impaired05.06.02.001; 14.06.02.001--
Glycosuria20.02.01.005--
Haemoglobin13.01.05.018---
Headache17.14.01.001--
Hirsutism05.05.01.005; 23.02.04.001--
Hyperglycaemia05.06.02.002; 14.06.02.002--
Hyperhidrosis08.01.03.028; 23.02.03.004--
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ADReCS-Target
Drug Name ADR Term Target
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