Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Fludrocortisone acetate
Drug ID BADD_D00918
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 For partial replacement therapy for primary and secondary adrenocortical insufficiency in Addison's disease and for the treatment of salt-losing adrenogenital syndrome.
Marketing Status Prescription; Discontinued
ATC Code H02AA02
DrugBank ID DB00687
KEGG ID D00986
MeSH ID C034635
PubChem ID 225609
TTD Drug ID Not Available
NDC Product Code 69238-7033; 68084-288; 58159-074; 0115-7033; 55154-6645; 42291-764; 49452-3155; 51927-2408; 50268-330; 63629-8806; 71335-0976; 63629-7780; 14096-127; 42291-529; 46439-8721; 0615-6562; 38779-0129; 65089-0015; 62991-2773; 0555-0997
Synonyms fludrocortisone acetate | fluorocortisol acetate | fludrocortisone 21-acetate | 9 alpha-fluorocortisol acetate | Florinef | Cortineff
Chemical Information
Molecular Formula C23H31FO6
CAS Registry Number 514-36-3
SMILES CC(=O)OCC(=O)C1(CCC2C1(CC(C3(C2CCC4=CC(=O)CCC43C)F)O)C)O
Chemical Structure
ADRs Induced by Drug
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--Not Available
Anaphylactic shock10.01.07.002; 24.06.02.004--Not Available
Anaphylactoid reaction10.01.07.003; 24.06.03.007--Not Available
Benign intracranial hypertension17.07.02.001--Not Available
Blood potassium decreased13.11.01.010--Not Available
Carbohydrate tolerance decreased13.02.02.003--Not Available
Cardiac failure congestive02.05.01.002--Not Available
Cardiomegaly02.04.02.001--Not Available
Cataract subcapsular06.06.01.002--Not Available
Cushingoid05.01.01.002; 14.11.01.006; 19.07.03.001; 24.08.02.004--
Dermatitis acneiform23.02.01.004--
Dermatitis allergic10.01.03.014; 23.03.04.003--Not Available
Diabetes mellitus05.06.01.001; 14.06.01.001--Not Available
Diarrhoea07.02.01.001--
Dysgeusia07.14.03.001; 17.02.07.003--
Ecchymosis01.01.03.001; 23.06.01.001; 24.07.06.002--Not Available
Erythema23.03.06.001--Not Available
Exophthalmos05.02.02.002; 06.09.04.001--Not Available
Fluid retention14.05.06.002; 20.01.02.003--Not Available
Glaucoma06.03.01.002--
Glucose tolerance impaired05.06.02.001; 14.06.02.001--
Glycosuria20.02.01.005--
Haemoglobin13.01.05.018--Not Available
Hallucination19.10.02.002--
Headache17.14.01.001--
Hirsutism05.05.01.005; 23.02.04.001--
Hyperchlorhydria07.11.03.001--Not Available
Hyperglycaemia05.06.02.002; 14.06.02.002--
Hyperhidrosis08.01.03.028; 23.02.03.004--
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