{"id":"fludrocortisone","rwe":[],"_fda":{"id":"35818f71-8d18-1daa-e063-6394a90aeb9f","set_id":"001e72ea-2c9e-468c-90cc-6c347234e2a9","openfda":{"unii":["V47IF0PVH4"],"route":["ORAL"],"rxcui":["313979"],"spl_id":["35818f71-8d18-1daa-e063-6394a90aeb9f"],"brand_name":["Fludrocortisone Acetate"],"spl_set_id":["001e72ea-2c9e-468c-90cc-6c347234e2a9"],"package_ndc":["68084-288-11","68084-288-01","68084-288-65"],"product_ndc":["68084-288"],"generic_name":["FLUDROCORTISONE ACETATE"],"product_type":["HUMAN PRESCRIPTION DRUG"],"substance_name":["FLUDROCORTISONE ACETATE"],"manufacturer_name":["American Health Packaging"],"application_number":["ANDA040431"],"original_packager_product_ndc":["0115-7033"]},"version":"9","warnings":["WARNINGS BECAUSE OF ITS MARKED EFFECT ON SODIUM RETENTION THE USE OF FLUDROCORTISONE ACETATE IN THE TREATMENT OF CONDITIONS OTHER THAN THOSE INDICATED HEREIN IS NOT ADVISED. Corticosteroids may mask some signs of infection, and new infections may appear during their use. There may be decreased resistance and inability to localize infection when corticosteroids are used. If an infection occurs during fludrocortisone acetate therapy, it should be promptly controlled by suitable antimicrobial therapy. Prolonged use of corticosteroids may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves, and may enhance the establishment of secondary ocular infections due to fungi or viruses. Average and large doses of hydrocortisone or cortisone can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium. These effects are less likely to occur with the synthetic derivatives except when used in large doses. However, since fludrocortisone acetate is a potent mineralocorticoid, both the dosage and salt intake should be carefully monitored in order to avoid the development of hypertension, edema or weight gain. Periodic checking of serum electrolyte levels is advisable during prolonged therapy; dietary salt restriction and potassium supplementation may be necessary. All corticosteroids increase calcium excretion. Patients should not be vaccinated against smallpox while on corticosteroid therapy. Other immunization procedures should not be undertaken in patients who are on corticosteroids, especially on high dose, because of possible hazards of neurological complications and a lack of antibody response. The use of fludrocortisone acetate in patients with active tuberculosis should be restricted to those cases of fulminating or disseminated tuberculosis in which the corticosteroid is used for the management of the disease in conjunction with an appropriate antituberculous regimen. If corticosteroids are indicated in patients with latent tuberculosis or tuberculin reactivity, close observation is necessary since reactivation of the disease may occur. During prolonged corticosteroid therapy these patients should receive chemoprophylaxis. Children who are on immunosuppressant drugs are more susceptible to infections than healthy children. Chicken pox and measles, for example, can have a more serious or even fatal course in children on immunosuppressant corticosteroids. In such children, or in adults who have not had these diseases, particular care should be taken to avoid exposure. If exposed, therapy with variicella zoster immune globulin (VZIG) or pooled intravenous immunoglobulin (IVIG), as appropriate, may be indicated. If chicken pox develops, treatment with antiviral agents may be considered."],"pregnancy":["Pregnancy: Teratogenic Effects: Category C Adequate animal reproduction studies have not been conducted with fludrocortisone acetate. However, many corticosteroids have been shown to be teratogenic in laboratory animals at low doses. Teratogenicity of these agents in man has not been demonstrated. It is not known whether fludrocortisone acetate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Fludrocortisone acetate should be given to a pregnant woman only if clearly needed.","Pregnancy: Nonteratogenic Effects Infants born of mothers who have received substantial doses of fludrocortisone acetate during pregnancy should be carefully observed for signs of hypoadrenalism. Maternal treatment with corticosteroids should be carefully documented in the infant's medical records to assist in follow up."],"overdosage":["OVERDOSAGE Development of hypertension, edema, hypokalemia, excessive increase in weight, and increase in heart size are signs of overdosage of fludrocortisone acetate. When these are noted, administration of drugs should be discontinued, after which the symptoms will usually subside within several days; subsequent treatment with fludrocortisone acetate should be with a reduced dose. Muscular weakness may develop due to excessive potassium loss and can be treated by administering a potassium supplement. Regular monitoring of blood pressure and serum electrolytes can help to prevent overdosage (see WARNINGS )."],"description":["DESCRIPTION Fludrocortisone acetate tablets USP, 0.1 mg contain fludrocortisone acetate, USP a synthetic adrenocortical steroid possessing very potent mineralocorticoid properties and high glucocorticoid activity; it is used only for its mineralocorticoid effects. The chemical name for fludrocortisone acetate is 9-fluoro-11β, 17, 21-trihydroxypregn-4-ene-3, 20-dione 21-acetate; its structural formula is: Fludrocortisone acetate tablets USP, 0.1 mg are available for oral administration as scored tablets providing 0.1 mg fludrocortisone acetate, USP per tablet. Inactive ingredients: croscarmellose sodium NF, lactose monohydrate NF, magnesium stearate NF, and microcrystalline cellulose NF. Structural Formula"],"precautions":["PRECAUTIONS General Adverse reactions to corticosteroids may be produced by too rapid withdrawal or by continued use of large doses. To avoid drug-induced adrenal insufficiency, supportive dosage may be required in times of stress (such as trauma, surgery, or severe illness) both during treatment with fludrocortisone acetate and for a year afterwards. There is an enhanced corticosteroid effect in patients with hypothyroidism and in those with cirrhosis. Corticosteroids should be used cautiously in patients with ocular herpes simplex because of possible corneal perforation. The lowest possible dose of corticosteroid should be used to control the condition being treated. A gradual reduction in dosage should be made when possible. Psychic derangements may appear when corticosteroids are used. These may range from euphoria, insomnia, mood swings, personality changes, and severe depression to frank psychotic manifestations. Existing emotional instability or psychotic tendencies may also be aggravated by corticosteroids. Aspirin should be used cautiously in conjunction with corticosteroids in patients with hypoprothrombinemia. Corticosteroids should be used with caution in patients with nonspecific ulcerative colitis if there is a probability of impending perforation, abscess, or other pyogenic infection. Corticosteroids should also be used cautiously in patients with diverticulitis, fresh intestinal anastomoses, active or latent peptic ulcer, renal insufficiency, hypertension, osteoporosis, and myasthenia gravis. Information for Patients The physician should advise the patient to report any medical history of heart disease, high blood pressure, or kidney or liver disease and to report current use of any medicines to determine if these medicines might interact adversely with fludrocortisone acetate (see Drug Interactions ). Patients who are on immunosuppressant doses of corticosteroids should be warned to avoid exposure to chicken pox or measles and, if exposed, to obtain medical advice. The patient's understanding of his steroid-dependent status and increased dosage requirement under widely variable conditions of stress is vital. Advise the patient to carry medical identification indicating his dependence on steroid medication and, if necessary, instruct him to carry an adequate supply of medication for use in emergencies. Stress to the patient the importance of regular follow-up visits to check his progress and the need to promptly notify the physician of dizziness, severe or continuing headaches, swelling of feet or lower legs, or unusual weight gain. Advise the patient to use the medicine only as directed, to take a missed dose as soon as possible, unless it is almost time for the next dose, and not to double the next dose. Inform the patient to keep this medication and all drugs out of the reach of children. Laboratory Tests Patients should be monitored regularly for blood pressure determinations and serum electrolyte determinations (see WARNINGS ). Drug Interactions When administered concurrently, the following drugs may interact with adrenal corticosteroids. Amphotericin B or potassium-depleting diuretics (benzothiadiazines and related drugs, ethacrynic acid and furosemide) – enhanced hypokalemia. Check serum potassium levels at frequent intervals; use potassium supplements if necessary (see WARNINGS ). Digitalis glycosides – enhanced possibility of arrhythmias or digitalis toxicity associated with hypokalemia. Monitor serum potassium levels; use potassium supplements if necessary. Oral anticoagulants – decreased prothrombin time response. Monitor prothrombin levels and adjust anticoagulant dosage accordingly. Antidiabetic drugs (oral agents and insulin) – diminished antidiabetic effect. Monitor for symptoms of hyperglycemia; adjust dosage of antidiabetic drug upward if necessary. Aspirin – increased ulcerogenic effect; decreased pharmacologic effect of aspirin. Rarely salicylate toxicity may occur in patients who discontinue steroids after concurrent high-dose aspirin therapy. Monitor salicylate levels or the therapeutic effect for which aspirin is given; adjust salicylate dosage accordingly if effect is altered (see PRECAUTIONS, General ). Barbiturates, phenytoin, or rifampin – increased metabolic clearance of fludrocortisone acetate because of the induction of hepatic enzymes. Observe the patient for possible diminished effect of steroid and increase the steroid dosage accordingly. Anabolic steroids (particularly C-17 alkylated androgens such as oxymetholone, methandrostenolone, norethandrolone, and similar compounds) – enhanced tendency toward edema. Use caution when giving these drugs together, especially in patients with hepatic or cardiac disease. Vaccines – neurological complications and lack of antibody response (see WARNINGS ). Estrogen – increased levels of corticosteroid-binding globulin thereby increasing the bound (inactive) fraction; this effect is at least balanced by decreased metabolism of corticosteroids. When estrogen therapy is initiated, a reduction in corticosteroid dosage may be required, and increased amounts may be required when estrogen is terminated. Drug/Laboratory Test Interactions Corticosteroids may affect the nitrobluetetrazolium test for bacterial infection and produce false-negative results. Carcinogenesis, Mutagenesis, Impairment of Fertility Adequate studies have not been performed in animals to determine whether fludrocortisone acetate has carcinogenic or mutagenic activity or whether it affects fertility in males or females. Pregnancy: Teratogenic Effects: Category C Adequate animal reproduction studies have not been conducted with fludrocortisone acetate. However, many corticosteroids have been shown to be teratogenic in laboratory animals at low doses. Teratogenicity of these agents in man has not been demonstrated. It is not known whether fludrocortisone acetate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Fludrocortisone acetate should be given to a pregnant woman only if clearly needed. Pregnancy: Nonteratogenic Effects Infants born of mothers who have received substantial doses of fludrocortisone acetate during pregnancy should be carefully observed for signs of hypoadrenalism. Maternal treatment with corticosteroids should be carefully documented in the infant's medical records to assist in follow up. Nursing Mothers Corticosteroids are found in the breast milk of lactating women receiving systemic therapy with these agents. Caution should be exercised when fludrocortisone acetate is administered to a nursing woman. Pediatric Use Safety and effectiveness in children have not been established. Growth and development of infants and children on prolonged corticosteroid therapy should be carefully observed."],"how_supplied":["HOW SUPPLIED Fludrocortisone Acetate Tablets USP, 0.1 mg – Each white to off-white, round, convex tablet debossed with a \"7033\" on one side and with a bisect on the other side. Unit dose packages of 50 (5 x 10) NDC 68084-288-65 Unit dose packages of 100 (10 x 10) NDC 68084-288-01 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Avoid excessive heat. FOR YOUR PROTECTION: Do not use if blister is torn or broken."],"pediatric_use":["Pediatric Use Safety and effectiveness in children have not been established. Growth and development of infants and children on prolonged corticosteroid therapy should be carefully observed."],"effective_time":"20250519","nursing_mothers":["Nursing Mothers Corticosteroids are found in the breast milk of lactating women receiving systemic therapy with these agents. Caution should be exercised when fludrocortisone acetate is administered to a nursing woman."],"laboratory_tests":["Laboratory Tests Patients should be monitored regularly for blood pressure determinations and serum electrolyte determinations (see WARNINGS )."],"adverse_reactions":["ADVERSE REACTIONS Most adverse reactions are caused by the drug's mineralocorticoid activity (retention of sodium and water) and include hypertension, edema, cardiac enlargement, congestive heart failure, potassium loss, and hypokalemic alkalosis. When fludrocortisone is used in the small dosages recommended, the glucocorticoid side effects often seen with cortisone and its derivatives are not usually a problem; however the following untoward effects should be kept in mind, particularly when fludrocortisone is used over a prolonged period of time or in conjunction with cortisone or a similar glucocorticoid. Musculoskeletal – muscle weakness, steroid myopathy, loss of muscle mass, osteoporosis, vertebral compression fractures, aseptic necrosis of femoral and humeral heads, pathologic fracture of long bones, and spontaneous fractures. Gastrointestinal – peptic ulcer with possible perforation and hemorrhage, pancreatitis, abdominal distention, and ulcerative esophagitis. Dermatologic – impaired wound healing, thin fragile skin, bruising, petechiae and ecchymoses, facial erythema, increased sweating, subcutaneous fat atrophy, purpura, striae, hyperpigmentation of the skin and nails, hirsutism, acneiform eruptions and hives; reactions to skin tests may be suppressed. Neurological – convulsions, increased intracranial pressure with papilledema (psuedo-tumor cerebri) usually after treatment, vertigo, headache, and severe mental disturbances. Endocrine – menstrual irregularities; development of the cushingoid state; suppression of growth in children; secondary adrenocortical and pituitary unresponsiveness, particularly in times of stress (e.g., trauma, surgery, or illness); decreased carbohydrate tolerance; manifestations of latent diabetes mellitus; and increased requirements for insulin or oral hypoglycemic agents in diabetics. Ophthalmic – posterior subcapsular cataracts, increased intraocular pressure, glaucoma, and exophthalmos. Metabolic – hyperglycemia, glycosuria, and negative nitrogen balance due to protein catabolism. Allergic Reactions – allergic skin rash, maculopapular rash, and urticaria. Other adverse reactions that may occur following the administration of a corticosteroid are necrotizing angiitis, thrombophlebitis, aggravation or masking of infections, insomnia, syncopal episodes, and anaphylactoid reactions. To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch ."],"contraindications":["CONTRAINDICATIONS Corticosteroids are contraindicated in patients with systemic fungal infections and in those with a history of possible or known hypersensitivity to these agents."],"drug_interactions":["Drug Interactions When administered concurrently, the following drugs may interact with adrenal corticosteroids. Amphotericin B or potassium-depleting diuretics (benzothiadiazines and related drugs, ethacrynic acid and furosemide) – enhanced hypokalemia. Check serum potassium levels at frequent intervals; use potassium supplements if necessary (see WARNINGS ). Digitalis glycosides – enhanced possibility of arrhythmias or digitalis toxicity associated with hypokalemia. Monitor serum potassium levels; use potassium supplements if necessary. Oral anticoagulants – decreased prothrombin time response. Monitor prothrombin levels and adjust anticoagulant dosage accordingly. Antidiabetic drugs (oral agents and insulin) – diminished antidiabetic effect. Monitor for symptoms of hyperglycemia; adjust dosage of antidiabetic drug upward if necessary. Aspirin – increased ulcerogenic effect; decreased pharmacologic effect of aspirin. Rarely salicylate toxicity may occur in patients who discontinue steroids after concurrent high-dose aspirin therapy. Monitor salicylate levels or the therapeutic effect for which aspirin is given; adjust salicylate dosage accordingly if effect is altered (see PRECAUTIONS, General ). Barbiturates, phenytoin, or rifampin – increased metabolic clearance of fludrocortisone acetate because of the induction of hepatic enzymes. Observe the patient for possible diminished effect of steroid and increase the steroid dosage accordingly. Anabolic steroids (particularly C-17 alkylated androgens such as oxymetholone, methandrostenolone, norethandrolone, and similar compounds) – enhanced tendency toward edema. Use caution when giving these drugs together, especially in patients with hepatic or cardiac disease. Vaccines – neurological complications and lack of antibody response (see WARNINGS ). Estrogen – increased levels of corticosteroid-binding globulin thereby increasing the bound (inactive) fraction; this effect is at least balanced by decreased metabolism of corticosteroids. When estrogen therapy is initiated, a reduction in corticosteroid dosage may be required, and increased amounts may be required when estrogen is terminated."],"general_precautions":["General Adverse reactions to corticosteroids may be produced by too rapid withdrawal or by continued use of large doses. To avoid drug-induced adrenal insufficiency, supportive dosage may be required in times of stress (such as trauma, surgery, or severe illness) both during treatment with fludrocortisone acetate and for a year afterwards. There is an enhanced corticosteroid effect in patients with hypothyroidism and in those with cirrhosis. Corticosteroids should be used cautiously in patients with ocular herpes simplex because of possible corneal perforation. The lowest possible dose of corticosteroid should be used to control the condition being treated. A gradual reduction in dosage should be made when possible. Psychic derangements may appear when corticosteroids are used. These may range from euphoria, insomnia, mood swings, personality changes, and severe depression to frank psychotic manifestations. Existing emotional instability or psychotic tendencies may also be aggravated by corticosteroids. Aspirin should be used cautiously in conjunction with corticosteroids in patients with hypoprothrombinemia. Corticosteroids should be used with caution in patients with nonspecific ulcerative colitis if there is a probability of impending perforation, abscess, or other pyogenic infection. Corticosteroids should also be used cautiously in patients with diverticulitis, fresh intestinal anastomoses, active or latent peptic ulcer, renal insufficiency, hypertension, osteoporosis, and myasthenia gravis."],"storage_and_handling":["Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Avoid excessive heat. FOR YOUR PROTECTION: Do not use if blister is torn or broken."],"clinical_pharmacology":["CLINICAL PHARMACOLOGY Corticosteroids are thought to act at least in part, by controlling the rate of synthesis of proteins. Although there are a number of instances in which the synthesis of specific proteins is known to be induced by corticosteroids, the links between the initial actions of the hormones and the final metabolic effects have not been completely elucidated. The physiologic action of fludrocortisone acetate is similar to that of hydrocortisone. However, the effects of fludrocortisone acetate, particularly on electrolyte balance, but also on carbohydrate metabolism, are considerably heightened and prolonged. Mineralocorticoids act on the distal tubules of the kidney to enhance the reabsorption of sodium ions from the tubular fluid into the plasma; they increase the urinary excretion of both potassium and hydrogen ions. The consequence of these three primary effects together with similar actions on cation transport in other tissues appear to account for the entire spectrum of physiological activities that are characteristic of mineralocorticoids. In small oral doses, fludrocortisone acetate produces marked sodium retention and increased urinary potassium excretion. It also causes a rise in blood pressure, apparently because of these effects on electrolyte levels. In larger doses, fludrocortisone acetate inhibits endogenous adrenal cortical secretion, thymic activity, and pituitary corticotropin excretion; promotes the deposition of liver glycogen; and, unless protein intake is adequate, induces negative nitrogen balance. The approximate plasma half-life of fludrocortisone (fluorohydrocortisone) is 3.5 hours or more and the biological half-life is 18 to 36 hours."],"indications_and_usage":["INDICATIONS AND USAGE Fludrocortisone acetate tablets, 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."],"information_for_patients":["Information for Patients The physician should advise the patient to report any medical history of heart disease, high blood pressure, or kidney or liver disease and to report current use of any medicines to determine if these medicines might interact adversely with fludrocortisone acetate (see Drug Interactions ). Patients who are on immunosuppressant doses of corticosteroids should be warned to avoid exposure to chicken pox or measles and, if exposed, to obtain medical advice. The patient's understanding of his steroid-dependent status and increased dosage requirement under widely variable conditions of stress is vital. Advise the patient to carry medical identification indicating his dependence on steroid medication and, if necessary, instruct him to carry an adequate supply of medication for use in emergencies. Stress to the patient the importance of regular follow-up visits to check his progress and the need to promptly notify the physician of dizziness, severe or continuing headaches, swelling of feet or lower legs, or unusual weight gain. Advise the patient to use the medicine only as directed, to take a missed dose as soon as possible, unless it is almost time for the next dose, and not to double the next dose. Inform the patient to keep this medication and all drugs out of the reach of children."],"spl_unclassified_section":["PACKAGING INFORMATION American Health Packaging unit dose blisters (see How Supplied section) contain drug product from Amneal Pharmaceuticals LLC as follows: (0.1 mg / 50 UD) NDC 68084-288-65 packaged from NDC 0115-7033 (0.1 mg / 100 UD) NDC 68084-288-01 packaged from NDC 0115-7033 Distributed by: American Health Packaging Columbus, OH 43217 8228801/0525F"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Dosage depends on the severity of the disease and the response of the patient. Patients should be continually monitored for signs that indicate dosage adjustment is necessary, such as remission or exacerbations of the disease and stress (surgery, infection, trauma) (see WARNINGS and PRECAUTIONS, General ). Addison's Disease In Addison's disease, the combination of fludrocortisone acetate tablets with a glucocorticoid such as hydrocortisone or cortisone provides substitution therapy approximating normal adrenal activity with minimal risks of unwanted effects. The usual dose is 0.1 mg of fludrocortisone acetate tablets daily, although dosage ranging from 0.1 mg three times a week to 0.2 mg daily has been employed. In the event transient hypertension develops as a consequence of therapy, the dose should be reduced to 0.05 mg daily. Fludrocortisone acetate tablets are preferably administered in conjunction with cortisone (10 mg to 37.5 mg daily in divided doses) or hydrocortisone (10 mg to 30 mg daily in divided doses). Salt-Losing Adrenogenital Syndrome The recommended dosage for treating the salt-losing adrenogenital syndrome is 0.1 mg to 0.2 mg of fludrocortisone acetate tablets daily."],"spl_product_data_elements":["Fludrocortisone Acetate Fludrocortisone Acetate CROSCARMELLOSE SODIUM CROSCARMELLOSE LACTOSE MONOHYDRATE ANHYDROUS LACTOSE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE FLUDROCORTISONE ACETATE FLUDROCORTISONE white to off-white round, convex tablets 7033"],"package_label_principal_display_panel":["Package/Label Display Panel — Carton — 0.1 mg – 100 UD NDC 68084- 288 -01 Fludrocortisone Acetate Tablets, USP 0.1 mg 100 Tablets (10 x 10) Rx Only Each Tablet Contains: Fludrocortisone acetate, USP ..................................................0.1 mg Usual Dosage: See full prescribing information. Warning: Potent drug Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Avoid excess heat. FOR YOUR PROTECTION: Do not use if blister is torn or broken. The drug product contained in this package is from NDC # 0115-7033, Amneal Pharmaceuticals LLC. Distributed by: American Health Packaging, Columbus, Ohio 43217 428801 0228801/0625 0.1 mg Fludrocortisone Acetate Tablets Carton 10x10","Package/Label Display Panel— Carton — 0.1 mg – 50 UD NDC 68084- 288 -65 Fludrocortisone Acetate Tablets, USP 0.1 mg 50 Tablets (5 x 10) Rx Only Each Tablet Contains: Fludrocortisone acetate, USP ..............................................0.1 mg Usual Dosage: See full prescribing information. Warning: Potent drug Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Avoid excess heat. FOR YOUR PROTECTION: Do not use if blister is torn or broken. The drug product contained in this package is from NDC # 0115-7033, Amneal Pharmaceuticals LLC. Distributed by: American Health Packaging, Columbus, Ohio 43217 028865 0228865/0525 0.1 mg Fludrocortisone Acetate Tablets Carton 5x10","Package/Label Display Panel — Blister — 0.1 mg Fludrocortisone Acetate Tablet, USP 0.1 mg 0.1 mg Fludrocortisone Acetate Tablet Blister"],"drug_and_or_laboratory_test_interactions":["Drug/Laboratory Test Interactions Corticosteroids may affect the nitrobluetetrazolium test for bacterial infection and produce false-negative results."],"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["Carcinogenesis, Mutagenesis, Impairment of Fertility Adequate studies have not been performed in animals to determine whether fludrocortisone acetate has carcinogenic or mutagenic activity or whether it affects fertility in males or females."]},"tags":[],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[{"date":"","signal":"FATIGUE","source":"FDA FAERS","actionTaken":"146 reports"},{"date":"","signal":"FALL","source":"FDA FAERS","actionTaken":"144 reports"},{"date":"","signal":"DIZZINESS","source":"FDA FAERS","actionTaken":"135 reports"},{"date":"","signal":"NAUSEA","source":"FDA FAERS","actionTaken":"129 reports"},{"date":"","signal":"DEATH","source":"FDA FAERS","actionTaken":"126 reports"},{"date":"","signal":"DIARRHOEA","source":"FDA FAERS","actionTaken":"123 reports"},{"date":"","signal":"HEADACHE","source":"FDA FAERS","actionTaken":"108 reports"},{"date":"","signal":"OFF LABEL USE","source":"FDA FAERS","actionTaken":"103 reports"},{"date":"","signal":"PNEUMONIA","source":"FDA FAERS","actionTaken":"96 reports"},{"date":"","signal":"HYPOTENSION","source":"FDA FAERS","actionTaken":"95 reports"}],"drugInteractions":[{"drug":"Amphotericin B or potassium-depleting diuretics (benzothiadiazines and related drugs, ethacrynic acid and furosemide)","severity":"major","mechanism":"Enhanced hypokalemia","management":"Check serum potassium levels at frequent intervals; use potassium supplements if necessary","clinicalEffect":"Increased risk of hypokalemia"},{"drug":"Digitalis glycosides","severity":"major","mechanism":"Enhanced possibility of arrhythmias or digitalis toxicity associated with hypokalemia","management":"Monitor serum potassium levels; use potassium supplements if necessary","clinicalEffect":"Increased risk of arrhythmias or digitalis toxicity"},{"drug":"Oral anticoagulants","severity":"moderate","mechanism":"Decreased prothrombin time response","management":"Monitor prothrombin levels and adjust anticoagulant dosage accordingly","clinicalEffect":"Reduced anticoagulant effect"},{"drug":"Antidiabetic drugs (oral agents and insulin)","severity":"moderate","mechanism":"Diminished antidiabetic effect","management":"Monitor for symptoms of hyperglycemia; adjust dosage of antidiabetic drug upward if necessary","clinicalEffect":"Increased risk of hyperglycemia"},{"drug":"Aspirin","severity":"moderate","mechanism":"Increased ulcerogenic effect; decreased pharmacologic effect of aspirin","management":"Monitor salicylate levels or the therapeutic effect for which aspirin is given; adjust salicylate dosage accordingly if effect is altered","clinicalEffect":"Increased risk of ulcers; reduced aspirin effect"},{"drug":"Barbiturates, phenytoin, or rifampin","severity":"moderate","mechanism":"Increased metabolic clearance of fludrocortisone acetate because of the induction of hepatic enzymes","management":"Observe the patient for possible diminished effect of steroid and increase the steroid dosage accordingly","clinicalEffect":"Reduced effectiveness of steroid"},{"drug":"Anabolic steroids (particularly C-17 alkylated androgens such as oxymetholone, methandrostenolone, norethandrolone, and similar compounds)","severity":"moderate","mechanism":"Enhanced tendency toward edema","management":"Use caution when giving these drugs together, especially in patients with hepatic or cardiac disease","clinicalEffect":"Increased risk of edema"},{"drug":"Vaccines","severity":"major","mechanism":"Neurological complications and lack of antibody response","management":"Refer to WARNINGS section for specific management","clinicalEffect":"Increased risk of neurological complications; reduced vaccine efficacy"},{"drug":"Estrogen","severity":"moderate","mechanism":"Increased levels of corticosteroid-binding globulin thereby increasing the bound (inactive) fraction; this effect is at least balanced by decreased metabolism of corticosteroids","management":"When estrogen therapy is initiated, a reduction in corticosteroid dosage may be required, and increased amounts may be required when estrogen is terminated","clinicalEffect":"Potential need for dose adjustment of corticosteroids"}],"commonSideEffects":[{"effect":"Hypertension","drugRate":"","severity":"common","organSystem":""},{"effect":"Edema","drugRate":"","severity":"common","organSystem":""},{"effect":"Hypokalemic alkalosis","drugRate":"","severity":"common","organSystem":""},{"effect":"Potassium loss","drugRate":"","severity":"common","organSystem":""},{"effect":"Muscle weakness","drugRate":"","severity":"common","organSystem":""},{"effect":"Menstrual irregularities","drugRate":"","severity":"common","organSystem":""},{"effect":"Hyperglycemia","drugRate":"","severity":"common","organSystem":""},{"effect":"Headache","drugRate":"","severity":"common","organSystem":""},{"effect":"Increased sweating","drugRate":"","severity":"common","organSystem":""},{"effect":"Acneiform eruptions","drugRate":"","severity":"common","organSystem":""},{"effect":"Hirsutism","drugRate":"","severity":"common","organSystem":""},{"effect":"Impaired wound healing","drugRate":"","severity":"common","organSystem":""},{"effect":"Thin fragile skin","drugRate":"","severity":"common","organSystem":""},{"effect":"Bruising","drugRate":"","severity":"common","organSystem":""},{"effect":"Petechiae","drugRate":"","severity":"common","organSystem":""},{"effect":"Facial erythema","drugRate":"","severity":"common","organSystem":""},{"effect":"Insomnia","drugRate":"","severity":"common","organSystem":""},{"effect":"Vertigo","drugRate":"","severity":"common","organSystem":""},{"effect":"Glycosuria","drugRate":"","severity":"common","organSystem":""},{"effect":"Cushingoid state","drugRate":"","severity":"common","organSystem":""}],"contraindications":["Corticosteroids are contraindicated in patients with systemic fungal infections.","Corticosteroids are contraindicated in patients with a history of possible or known hypersensitivity to these agents."],"specialPopulations":{},"discontinuationRates":[],"seriousAdverseEvents":[{"effect":"Congestive heart failure","drugRate":"","severity":"serious"},{"effect":"Cardiac enlargement","drugRate":"","severity":"serious"},{"effect":"Peptic ulcer with perforation and hemorrhage","drugRate":"","severity":"serious"},{"effect":"Convulsions","drugRate":"","severity":"serious"},{"effect":"Increased intracranial pressure with papilledema","drugRate":"","severity":"serious"},{"effect":"Posterior subcapsular cataracts","drugRate":"","severity":"serious"},{"effect":"Pancreatitis","drugRate":"","severity":"serious"},{"effect":"Aseptic necrosis of femoral and humeral heads","drugRate":"","severity":"serious"},{"effect":"Anaphylactoid reactions","drugRate":"","severity":"serious"},{"effect":"Necrotizing angiitis","drugRate":"","severity":"serious"}]},"status":"approved","trials":["NCT06979596","NCT06513650","NCT06633419","NCT00320099","NCT04952935","NCT00001521","NCT04404400","NCT06649409","NCT02140918","NCT02919917","NCT04280497","NCT00673270","NCT05555771","NCT05453214","NCT01648998","NCT02574910","NCT02532998","NCT01453959","NCT03001089","NCT07007910","NCT06381661","NCT06409364","NCT04351126","NCT01030874","NCT02478034","NCT00295347","NCT03773822","NCT06814132","NCT02871648","NCT01473108","NCT03062150","NCT03500120","NCT06832566","NCT04128137","NCT04552873","NCT03436485","NCT01993680","NCT01093261","NCT05440851","NCT04494789","NCT00368381","NCT07037043","NCT06136650","NCT00118482","NCT07383103","NCT04492280","NCT06104449","NCT05729724","NCT06136598","NCT06801236"],"aliases":["Florinef"],"patents":[],"pricing":[{"market":"United States","source":"CMS National Average Drug Acquisition Cost (NADAC)","asOfDate":"2024-01-03","unitCost":"$0.4300/EA","priceType":"NADAC","sourceUrl":"https://data.medicaid.gov/dataset/4j6z-xnwq","annualCost":"$157","description":"FLUDROCORTISONE 0.1 MG TABLET","retrievedDate":"2026-04-07"}],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=fludrocortisone","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T01:15:28.952737+00:00"},"aiSummary":{"url":"","method":"ai_extraction","source":"AI Strategic Summary","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"ai_extraction","retrievedAt":"2026-04-20T01:16:46.773915+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T01:15:34.791954+00:00"},"regulatory.us":{"url":"","method":"api_direct","source":"FDA Drugs@FDA","rawText":"","confidence":1,"sourceType":"fda_drugsfda","retrievedAt":"2026-04-20T01:15:28.078827+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=fludrocortisone","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T01:15:35.089059+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T01:15:27.426611+00:00"},"indications.approved":{"url":"","method":"ai_extraction","source":"FDA Label + AI","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"fda_label","retrievedAt":"2026-04-20T01:16:40.604098+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T01:15:27.426641+00:00"},"safety.safetySignals":{"url":"https://api.fda.gov/drug/event.json","method":"api_direct","source":"FDA FAERS","rawText":"","confidence":1,"sourceType":"fda_faers","retrievedAt":"2026-04-20T01:15:36.564395+00:00"},"safety.drugInteractions":{"url":"","method":"ai_extraction","source":"FDA Label + AI","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"fda_label","retrievedAt":"2026-04-20T01:16:32.404173+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL4303446/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T01:15:35.799284+00:00"},"safety.commonSideEffects":{"url":"","method":"ai_extraction","source":"FDA Label + AI","aiModel":"featherless","rawText":"ADVERSE REACTIONS Most adverse reactions are caused by the drug's mineralocorticoid activity (retention of sodium and water) and include hypertension, edema, cardiac enlargement, congestive heart failure, potassium loss, and hypokalemic alkalosis. When fludrocortisone is used in the small dosages recommended, the glucocorticoid side effects often seen with cortisone and its derivatives are not usually a problem; however the following untoward effects should be kept in mind, particularly when flu","confidence":0.95,"sourceType":"fda_label","retrievedAt":"2026-04-20T01:15:43.358836+00:00"},"safety.contraindications":{"url":"","method":"ai_extraction","source":"FDA Label + AI","aiModel":"featherless","rawText":"","confidence":0.95,"sourceType":"fda_label","retrievedAt":"2026-04-20T01:15:46.778907+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"ANDA040431","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T01:15:27.426646+00:00"}},"allNames":"florinef","offLabel":[],"timeline":[],"aiSummary":"Fludrocortisone (Florinef) is a marketed synthetic mineralocorticoid used primarily for adrenal insufficiency replacement, holding a significant position in the generic drug market. Its key strength lies in its well-established mechanism of promoting sodium retention and potassium excretion, which is crucial for managing both primary and secondary adrenocortical insufficiency. The primary risk is the key composition patent expiry in 2028, which could lead to increased competition from other generics.","brandName":"Florinef","companyId":"unknown","ecosystem":[],"mechanism":{"target":"Annexin A1, Glucocorticoid receptor, Mineralocorticoid receptor","novelty":"","modality":"Small molecule","drugClass":"Mineralocorticoid","explanation":"","oneSentence":"","technicalDetail":""},"commercial":null,"references":[],"_validation":{"fieldsValidated":3,"lastValidatedAt":"2026-04-20T01:16:46.774023+00:00","fieldsConflicting":1,"overallConfidence":0.8},"biosimilars":[],"companyName":"Generic","competitors":[],"dataSources":[{"url":"https://data.medicaid.gov/dataset/4j6z-xnwq","name":"CMS National Average Drug Acquisition Cost (NADAC)","fields":["pricing"],"retrievedDate":"2026-04-07"}],"genericName":"fludrocortisone","indications":{"approved":[{"id":"fludrocortisone-primary-and-secondary-adrenoco","name":"Primary and Secondary Adrenocortical Insufficiency","dosing":null,"approvals":[],"diseaseId":"","eligibility":"Patients with Addison's disease","pivotalTrial":null,"restrictions":[],"patientPopulation":"Patients with Addison's disease","diagnosticRequired":null,"brandNameForIndication":"Florinef"},{"id":"fludrocortisone-salt-losing-adrenogenital-synd","name":"Salt-Losing Adrenogenital Syndrome","dosing":null,"approvals":[],"diseaseId":"","eligibility":"Patients with salt-losing adrenogenital syndrome","pivotalTrial":null,"restrictions":[],"patientPopulation":"Patients with salt-losing adrenogenital syndrome","diagnosticRequired":null,"brandNameForIndication":"Florinef"}],"offLabel":[],"pipeline":[]},"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT06979596","phase":"Phase 2","title":"A Multicenter, Open-label, Phase 2 Basket Study of MK-5684 in Participants With Selected Solid Tumors (OMAHA-015)","status":"RECRUITING","sponsor":"Merck Sharp & Dohme LLC","isPivotal":false,"enrollment":250,"indication":"Malignant Neoplasm","completionDate":"2027-11-04"},{"nctId":"NCT06513650","phase":"N/A","title":"Mechanism-based Therapy of Hypotensive Syncope","status":"RECRUITING","sponsor":"Istituto Auxologico Italiano","isPivotal":false,"enrollment":140,"indication":"Syncope, Vasovagal, Neurally-Mediated","completionDate":"2026-05-31"},{"nctId":"NCT06633419","phase":"Phase 1","title":"A Phase 1, Open-Label, Fixed-Sequence Study to Evaluate the Effects of Multiple Doses of Carbamazepine on the Single-Dose Pharmacokinetics of MK-5684 in Healthy Adult Male Participants","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","isPivotal":false,"enrollment":14,"indication":"Healthy","completionDate":"2025-05-13"},{"nctId":"NCT00320099","phase":"Phase 3","title":"Phase 3 Study of Corticotherapy (Hydrocortisone Alone Versus Hydrocortisone Plus Fludrocortisone) Versus Corticotherapy Plus Intensive Insulin Therapy for Septic Shock","status":"COMPLETED","sponsor":"University of Versailles","isPivotal":true,"enrollment":508,"indication":"Septic Shock","completionDate":"2009-02"},{"nctId":"NCT04952935","phase":"Phase 1","title":"Acupuncture for the Treatment of Medication-Dependent Hypotension in Heart Failure","status":"UNKNOWN","sponsor":"Scripps Health","isPivotal":false,"enrollment":40,"indication":"Congestive Heart Failure, Hypotension","completionDate":"2022-07-01"},{"nctId":"NCT00001521","phase":"Phase 3","title":"An Open, Randomized, Long-Term Clinical Trial of Flutamide, Testolactone, and Reduced Hydrocortisone Dose vs. Conventional Treatment of Children With Congenital Adrenal Hyperplasia","status":"COMPLETED","sponsor":"Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)","isPivotal":true,"enrollment":66,"indication":"Congenital Adrenal Hyperplasia (CAH)","completionDate":"2024-04-01"},{"nctId":"NCT04404400","phase":"Phase 3","title":"Hydrocortisone and Fludrocortisone for Critical Illness-related Corticosteroid Insufficiency","status":"RECRUITING","sponsor":"Assistance Publique - Hôpitaux de Paris","isPivotal":true,"enrollment":1092,"indication":"Critical Illness Related Corticosteroids Insufficiency","completionDate":"2026-02"},{"nctId":"NCT06649409","phase":"Phase 1","title":"An Open-label, Randomized, 3-arm, Parallel-group, Positive- and Negative-arm Controlled Study to Evaluate the Mineralocorticoid Receptor Antagonism Effect of Vamorolone in Healthy Subjects","status":"COMPLETED","sponsor":"Santhera Pharmaceuticals","isPivotal":false,"enrollment":30,"indication":"Pharmacodynamic","completionDate":"2024-07-06"},{"nctId":"NCT02140918","phase":"Phase 2","title":"Hemodynamic and Biological Effects of 3 Increasing Doses of Fludrocortisone in Healthy Volunteers","status":"COMPLETED","sponsor":"Rennes University Hospital","isPivotal":false,"enrollment":16,"indication":"Healthy Volunteers","completionDate":"2016-04-20"},{"nctId":"NCT02919917","phase":"Phase 2","title":"Treatment of Post-SCI Hypotension: A Randomized Controlled Study of Usual Care Versus Anti Hypotension Therapy","status":"COMPLETED","sponsor":"James J. Peters Veterans Affairs Medical Center","isPivotal":true,"enrollment":66,"indication":"Spinal Cord Injury, Autonomic Dysreflexia","completionDate":"2021-09-01"},{"nctId":"NCT04280497","phase":"NA","title":"A Multicentre Concealed-Allocation Multi-arms Blinded Randomized Controlled Trial to Identify the Best Sepsis Population for Corticotherapy","status":"RECRUITING","sponsor":"Assistance Publique - Hôpitaux de Paris","isPivotal":false,"enrollment":1800,"indication":"Sepsis","completionDate":"2025-12"},{"nctId":"NCT00673270","phase":"Phase 1","title":"Hemodynamic and Biological Effects of Fludrocortisone and Hydrocortisone, in Healthy Volunteers With Aldosterone Induced Suppression","status":"TERMINATED","sponsor":"Rennes University Hospital","isPivotal":false,"enrollment":13,"indication":"Renin Angiotensin","completionDate":"2009-03"},{"nctId":"NCT05555771","phase":"NA","title":"Determining the Effectiveness of Counterpressure Maneuvers in Pediatric Patients Presenting With Syncope to the Emergency Department","status":"RECRUITING","sponsor":"Dr. Victoria Claydon","isPivotal":false,"enrollment":300,"indication":"Syncope, Vasovagal, Postural Orthostatic Tachycardia Syndrome","completionDate":"2026-09-30"},{"nctId":"NCT05453214","phase":"Phase 3","title":"Safety and Efficacy of Fludrocortisone Addition to Dexamethasone in the Management of Hospitalised COVID-19 Patients","status":"COMPLETED","sponsor":"Ain Shams University","isPivotal":true,"enrollment":10,"indication":"COVID-19, ARDS","completionDate":"2022-06-20"},{"nctId":"NCT01648998","phase":"Phase 1","title":"The Effects of Fludrocortisone on Information Processing in Healthy Female Volunteers","status":"COMPLETED","sponsor":"Leiden University Medical Center","isPivotal":false,"enrollment":40,"indication":"Depression","completionDate":"2013-12"},{"nctId":"NCT02574910","phase":"Phase 1","title":"A Phase 1 Multi-Center Study to Assess the Efficacy and Safety of Abiraterone Acetate as Adjunctive Therapy in Pre-Pubescent Children With Classic 21-Hydroxylase Deficiency","status":"TERMINATED","sponsor":"University of Texas Southwestern Medical Center","isPivotal":false,"enrollment":4,"indication":"Congenital Adrenal Hyperplasia","completionDate":"2023-06-03"},{"nctId":"NCT02532998","phase":"Phase 1","title":"A Phase I, Randomized, Single-Blind, Crossover Study to Assess the Pharmacodynamics of AZD9977 Following Single-Dose Administration to Healthy Male Subjects","status":"COMPLETED","sponsor":"AstraZeneca","isPivotal":false,"enrollment":40,"indication":"Pharmacodynamics, Healthy Subjects","completionDate":"2015-12"},{"nctId":"NCT01453959","phase":"Phase 4","title":"Fludrocortisone's Test in the Identification of Salt Sensitivity","status":"UNKNOWN","sponsor":"Fundação de Amparo à Pesquisa do Estado de São Paulo","isPivotal":false,"enrollment":40,"indication":"Hypertension","completionDate":"2013-06"},{"nctId":"NCT03001089","phase":"Phase 2","title":"Impact of the Administration of Fludrocortisone on Fluid and Electrolyte Balance in Very Premature Infants: Pilot Study","status":"COMPLETED","sponsor":"Assistance Publique - Hôpitaux de Paris","isPivotal":false,"enrollment":66,"indication":"Partial Mineralocorticoid Deficiency","completionDate":"2020-09-08"},{"nctId":"NCT07007910","phase":"Phase 1","title":"A Phase I Clinical Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of HSK46575 Tablets in Patients With Metastatic Castration-Resistant Prostate Cancer","status":"RECRUITING","sponsor":"Haisco Pharmaceutical Group Co., Ltd.","isPivotal":false,"enrollment":90,"indication":"m CRPC","completionDate":"2026-12"},{"nctId":"NCT06381661","phase":"Phase 2","title":"PALETTE- Adaptive Platform Trial for Personnalisation of Sepsis Treatment in Children and Adults: a Multi-national, Treatable Traits-guided, Adaptive, Exploratory, Bayesian Basket Trial","status":"NOT_YET_RECRUITING","sponsor":"Assistance Publique - Hôpitaux de Paris","isPivotal":false,"enrollment":2000,"indication":"Sepsis","completionDate":"2031-05-01"},{"nctId":"NCT06409364","phase":"Phase 2","title":"A Prospective, Blinded, Randomised Clinical Trial of Fludrocortisone Compared With Placebo in Critically Ill Patients Presenting With Aneurysmal Subarachnoid Haemorrhage","status":"RECRUITING","sponsor":"The George Institute","isPivotal":false,"enrollment":524,"indication":"Aneurysmal Subarachnoid Hemorrhage","completionDate":"2030-07-31"},{"nctId":"NCT04351126","phase":"Phase 2","title":"Pathophysiology and Nature of Ovarian Hyperstimulation Syndrome (OHSS) as a Clinical Entity Could be Fully Explained and Effectively Managed as a State of Defective Mineralocorticoid Response","status":"COMPLETED","sponsor":"Ganin Fertility Center","isPivotal":false,"enrollment":107,"indication":"Ovarian Hyperstimulation Syndrome","completionDate":"2020-02-29"},{"nctId":"NCT01030874","phase":"NA","title":"Effect of Treatment of Orthostatic Hypotension on a Rehabilitation Unit","status":"COMPLETED","sponsor":"VA Office of Research and Development","isPivotal":false,"enrollment":356,"indication":"Orthostatic Hypotension, Falls","completionDate":"2016-05"},{"nctId":"NCT02478034","phase":"NA","title":"Effekte Von Fludrocortison Auf Soziale Kognition Und Gedächtnis Unter Berücksichtigung Von Geschlechtereffekten","status":"COMPLETED","sponsor":"Charite University, Berlin, Germany","isPivotal":false,"enrollment":80,"indication":"Individuality","completionDate":"2016-03"},{"nctId":"NCT00295347","phase":"NA","title":"Mineralocorticoid Receptor in the Treatment of Severe Depression: A Randomized, Double Blind, and Placebo Controlled Trial","status":"COMPLETED","sponsor":"Universitätsklinikum Hamburg-Eppendorf","isPivotal":false,"enrollment":65,"indication":"Major Depression","completionDate":"2008-06"},{"nctId":"NCT03773822","phase":"Phase 3","title":"Low Dose of Hydrocortisone and Fludrocortisone in Adult Cardiogenic Shock. A Multicenter, Prospective, Double-blind, Randomized, Placebo-controlled Study","status":"COMPLETED","sponsor":"CMC Ambroise Paré","isPivotal":true,"enrollment":380,"indication":"Cardiogenic Shock","completionDate":"2023-04-05"},{"nctId":"NCT06814132","phase":"Phase 1","title":"An Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics of MK-5684 in Male Participants With Severe Renal Impairment and With End-stage Renal Disease","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","isPivotal":false,"enrollment":24,"indication":"Kidney Failure, Chronic, End-Stage Kidney Disease","completionDate":"2025-10-14"},{"nctId":"NCT02871648","phase":"Phase 1","title":"The Role of Minerelocorticoid Receptor on Modulating Aldosterone Production","status":"COMPLETED","sponsor":"Brigham and Women's Hospital","isPivotal":false,"enrollment":23,"indication":"Healthy Volunteers","completionDate":"2019-12"},{"nctId":"NCT01473108","phase":"Phase 1","title":"Study to Investigate the Effectiveness of Different Single Oral Doses of BAY94-8862 on Natriuresis After Administration of 0.5 mg Fludrocortisone (Astonin H®) With 50 mg Eplerenone (Inspra®) as Active","status":"COMPLETED","sponsor":"Bayer","isPivotal":false,"enrollment":67,"indication":"Clinical Pharmacology","completionDate":"2011-05-17"},{"nctId":"NCT03062150","phase":"NA","title":"Effects of Mineralocorticoid Receptor Stimulation on Cognitive Bias and Social Cognition in Patients With Major Depression and Healthy Controls: What's the Role of NMDA Receptors?","status":"COMPLETED","sponsor":"Charite University, Berlin, Germany","isPivotal":false,"enrollment":232,"indication":"Major Depression","completionDate":"2019-02-11"},{"nctId":"NCT03500120","phase":"N/A","title":"Case Detection and Confirmation, Subtype Classification of Patients With Primary Aldosteronism","status":"COMPLETED","sponsor":"Chongqing Medical University","isPivotal":false,"enrollment":200,"indication":"Primary Aldosteronism","completionDate":"2019-12-31"},{"nctId":"NCT06832566","phase":"Phase 4","title":"Ramadan Fasting Outcomes in Patients With Secondary Adrenal Insufficiency Before and After the Treatment of Hypotension.","status":"NOT_YET_RECRUITING","sponsor":"Hopital La Rabta","isPivotal":false,"enrollment":20,"indication":"Secondary Adrenal Insufficiency, Hypotension","completionDate":"2025-04-15"},{"nctId":"NCT04128137","phase":"Phase 4","title":"Evaluation of Efficacy and Tolerance of Fludrocortisone (Flucortac) in the Treatment of Orthostatic Neurogenic Hypotension","status":"UNKNOWN","sponsor":"H.A.C. PHARMA","isPivotal":false,"enrollment":90,"indication":"Neurogenic Orthostatic Hypotension","completionDate":"2024-06"},{"nctId":"NCT04552873","phase":"NA","title":"Urea Therapy for Hyponatremia in Subarachnoid Hemorrhage","status":"ACTIVE_NOT_RECRUITING","sponsor":"University Hospital, Grenoble","isPivotal":false,"enrollment":52,"indication":"Hyponatremia, Subarachnoid Hemorrhage","completionDate":"2025-08-01"},{"nctId":"NCT03436485","phase":"Phase 1","title":"Safety and Pharmacokinetics of ODM-208 in Patients With Metastatic Castration-resistant Prostate Cancer","status":"ACTIVE_NOT_RECRUITING","sponsor":"Orion Corporation, Orion Pharma","isPivotal":false,"enrollment":204,"indication":"Prostate Cancer Metastatic","completionDate":"2026-07-31"},{"nctId":"NCT01993680","phase":"Phase 2","title":"A Monocentric Randomized, Controlled, Double Blind, Crossover Phase II Trial to Show Non-inferiority of the Effect of Pyridostigmine Bromide vs. Fludrocortisone on Symptoms of Autonomic Dysregulation ","status":"COMPLETED","sponsor":"Christian Baumann","isPivotal":false,"enrollment":18,"indication":"Autonomic Disturbances in Parkinson's Disease","completionDate":"2016-04-01"},{"nctId":"NCT01093261","phase":"Phase 3","title":"Phase 3 Study of Hydrocortisone and Fludrocortisone in Glucocorticoid Insufficiency Related to Traumatic Brain Injury","status":"COMPLETED","sponsor":"Nantes University Hospital","isPivotal":true,"enrollment":336,"indication":"Traumatic Brain Injury, Trauma","completionDate":"2012-12"},{"nctId":"NCT05440851","phase":"NA","title":"Platform of Randomized Adaptive Clinical Trials in Critical Illness","status":"RECRUITING","sponsor":"University Health Network, Toronto","isPivotal":false,"enrollment":6250,"indication":"Respiratory Insufficiency, Extracorporeal Membrane Oxygenation Complication","completionDate":"2027-03-31"},{"nctId":"NCT04494789","phase":"Phase 2","title":"A Phase II Open Label Randomised Controlled Clinical Trial of Different Dosing Regimens of Fludrocortisone in Septic Shock With Assessment of Temporal Changes in Hormonal, Inflammatory, and Genetic Ma","status":"COMPLETED","sponsor":"The George Institute","isPivotal":false,"enrollment":155,"indication":"Critically Ill, Septic Shock","completionDate":"2023-06-30"},{"nctId":"NCT00368381","phase":"Phase 4","title":"A Blinded, Placebo Controlled Trial of Hydrocortisone Versus Hydrocortisone Plus Fludrocortisone for the Treatment of Adrenal Insufficiency in Severe Sepsis","status":"WITHDRAWN","sponsor":"CAMC Health System","isPivotal":false,"enrollment":0,"indication":"Sepsis, Adrenal Insufficiency","completionDate":"2009-09"},{"nctId":"NCT07037043","phase":"Phase 3","title":"Hydrocortisone Plus Fludrocortisone in High-risk Patients Undergoing for Cardiac Surgery","status":"NOT_YET_RECRUITING","sponsor":"Centre Hospitalier Universitaire, Amiens","isPivotal":true,"enrollment":196,"indication":"Inflammation in Cardiac Surgery","completionDate":"2028-06"},{"nctId":"NCT06136650","phase":"Phase 3","title":"MK-5684-004: A Phase 3, Randomized, Open-label Study of Opevesostat Versus Alternative Abiraterone Acetate or Enzalutamide in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) ","status":"RECRUITING","sponsor":"Merck Sharp & Dohme LLC","isPivotal":true,"enrollment":1314,"indication":"Metastatic Castration-resistant Prostate Cancer (mCRPC), Prostatic Neoplasms","completionDate":"2030-12-02"},{"nctId":"NCT00118482","phase":"Phase 4","title":"A Randomized Clinical Trial of Fludrocortisone for Vasovagal Syncope: The Second Prevention of Syncope Trial (POST II)","status":"COMPLETED","sponsor":"University of Calgary","isPivotal":false,"enrollment":213,"indication":"Syncope, Vasovagal, Neurally-Mediated","completionDate":"2011-07"},{"nctId":"NCT07383103","phase":"Phase 4","title":"Initiation of Hydrocortisone and Fludrocortisone in Adult Patients With Septic Shock：A Prospective Randomized Controlled Clinical Trial","status":"RECRUITING","sponsor":"Northern Jiangsu People's Hospital","isPivotal":false,"enrollment":336,"indication":"Septic Shock","completionDate":"2028-12-31"},{"nctId":"NCT04492280","phase":"Phase 4","title":"Evaluation of the Role of Hydrocortisone Either Alone or Combined With Fludrocortisone in the Outcome of Septic Shock in Adults","status":"COMPLETED","sponsor":"Ain Shams University","isPivotal":false,"enrollment":66,"indication":"Septic Shock","completionDate":"2019-09-01"},{"nctId":"NCT06104449","phase":"Phase 1","title":"A Phase 1 Clinical Study to Investigate the Safety and Pharmacokinetics of MK-5684 in Japanese Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC)","status":"ACTIVE_NOT_RECRUITING","sponsor":"Merck Sharp & Dohme LLC","isPivotal":false,"enrollment":6,"indication":"Prostatic Neoplasms, Metastatic Castration-Resistant Prostate Cancer","completionDate":"2026-04-20"},{"nctId":"NCT05729724","phase":"N/A","title":"Effect of Pharmacological Interventions Aimed to Increase Arterial Blood Pressure on Systolic Blood Pressure Drops Evidenced by 24-hour Ambulatory Blood Pressure Monitoring in Patients With Reflex Syn","status":"COMPLETED","sponsor":"Istituto Auxologico Italiano","isPivotal":false,"enrollment":111,"indication":"Syncope, Syncope, Vasovagal","completionDate":"2023-07-31"},{"nctId":"NCT06136598","phase":"Phase 1","title":"A Phase 1 Clinical Study to Investigate the Safety and Pharmacokinetics of MK-5684 in China Participants With Metastatic Castration-Resistant Prostate Cancer","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","isPivotal":false,"enrollment":14,"indication":"Prostatic Neoplasms, Metastatic Castration-Resistant Prostate Cancer","completionDate":"2026-03-09"},{"nctId":"NCT06801236","phase":"Phase 1","title":"A Phase 1 Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of ACE-232 in Patients With Metastatic Castration-Resistant Prostate Cancer (CRPC)","status":"RECRUITING","sponsor":"Acerand Therapeutics (Hong Kong) Limited","isPivotal":false,"enrollment":67,"indication":"Prostate Cancer (Adenocarcinoma), mCRPC (Metastatic Castration-resistant Prostate Cancer)","completionDate":"2028-08-01"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{"icon":"","route":"Oral","frequency":"Once daily","formulation":"Tablet"},"crossReferences":{"chemblId":"CHEMBL4303446"},"formularyStatus":[],"apiManufacturers":[],"developmentCodes":[],"ownershipHistory":[],"publicationCount":1855,"therapeuticAreas":["Nephrology"],"biosimilarFilings":[],"firstApprovalDate":"1954-01-01","companionDiagnostics":[],"firstApprovalCountry":"United States","genericManufacturerList":[],"modality":"Small molecule","enrichmentLevel":3,"visitCount":1,"regulatoryByCountry":[{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2002-03-18T00:00:00.000Z","mah":"IMPAX LABS","brand_name_local":null,"application_number":"ANDA040431"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2022-05-31T00:00:00.000Z","mah":"NOVITIUM PHARMA","brand_name_local":null,"application_number":"ANDA215279"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2024-10-16T00:00:00.000Z","mah":"ZYDUS LIFESCIENCES","brand_name_local":null,"application_number":"ANDA219251"},{"country_code":"AR","regulator":"ANMAT","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"TR","regulator":"TITCK","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"IN","regulator":"CDSCO","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"TH","regulator":"FDA-TH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"MY","regulator":"NPRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"PH","regulator":"FDA-PH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"CO","regulator":"INVIMA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"ZA","regulator":"SAHPRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"TW","regulator":"TFDA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"HK","regulator":"DH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"IL","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"IL","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"IL","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"SG","regulator":"HSA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"SG","regulator":"HSA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"SG","regulator":"HSA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AE","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AE","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AE","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"KR","regulator":"MFDS","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"KR","regulator":"MFDS","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"KR","regulator":"MFDS","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AU","regulator":"TGA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AU","regulator":"TGA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AU","regulator":"TGA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"GB","regulator":"MHRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"GB","regulator":"MHRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"CA","regulator":"Health Canada","status":"approved","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"GB","regulator":"MHRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"BR","regulator":"ANVISA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"MX","regulator":"COFEPRIS","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"trialStats":{"total":6,"withResults":1},"validation":{"fieldsValidated":3,"lastValidatedAt":"2026-04-20T01:16:46.774023+00:00","fieldsConflicting":1,"overallConfidence":0.8},"verificationStatus":"verified","dataCompleteness":{"mechanism":false,"indications":true,"safety":true,"trials":true,"score":3}}