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)
Hypernatraemia14.05.04.001--
Hypersensitivity10.01.03.003--
Hypertension24.08.02.001--
Impaired healing08.03.02.001--Not Available
Increased insulin requirement14.06.01.006; 05.06.01.006--Not Available
Infection11.01.08.002--Not Available
Injury12.01.08.004--Not Available
Insomnia19.02.01.002; 17.15.03.002--
Intracranial pressure increased17.07.02.002--Not Available
Intraocular pressure increased13.07.04.002--Not Available
Lipoatrophy23.07.01.001; 14.08.04.006--
Menstruation irregular21.01.01.005; 05.05.01.008--
Mood swings19.04.03.001--Not Available
Multiple fractures12.04.02.009; 15.08.02.005--Not Available
Muscle atrophy17.05.03.004; 15.05.03.003--Not Available
Muscular weakness17.05.03.005; 15.05.06.001--
Myalgia15.05.02.001--
Myopathy15.05.05.001--Not Available
Neoplasm16.16.02.001--Not Available
Nitrogen balance negative13.13.01.010--Not Available
Oedema14.05.06.010; 08.01.07.006--Not Available
Oesophagitis07.08.05.001--
Optic neuritis06.04.08.002; 10.02.01.097; 17.04.05.001--Not Available
Osteonecrosis24.04.05.004; 15.02.04.007--
Osteoporosis15.02.03.002; 14.04.04.002--
Pancreatitis07.18.01.001--
Papilloedema24.03.07.001; 17.07.02.004; 06.09.02.002--
Peptic ulcer07.04.07.001--Not Available
Petechiae24.07.06.004; 23.06.01.003; 01.01.03.002--Not Available
Purpura24.07.06.005; 23.06.01.004; 01.01.04.003--
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ADReCS-Target
Drug Name ADR Term Target
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