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Florinef (fludrocortisone)
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.
At a glance
| Generic name | fludrocortisone |
|---|---|
| Also known as | Florinef |
| Sponsor | Generic |
| Drug class | Mineralocorticoid |
| Target | Annexin A1, Glucocorticoid receptor, Mineralocorticoid receptor |
| Modality | Small molecule |
| Therapeutic area | Nephrology |
| Phase | FDA-approved |
| First approval | 1954-01-01 (United States) |
Approved indications
- Primary and Secondary Adrenocortical Insufficiency
- Salt-Losing Adrenogenital Syndrome
Common side effects
- Hypertension
- Edema
- Hypokalemic alkalosis
- Potassium loss
- Muscle weakness
- Menstrual irregularities
- Hyperglycemia
- Headache
- Increased sweating
- Acneiform eruptions
- Hirsutism
- Impaired wound healing
Serious adverse events
- Congestive heart failure
- Cardiac enlargement
- Peptic ulcer with perforation and hemorrhage
- Convulsions
- Increased intracranial pressure with papilledema
- Posterior subcapsular cataracts
- Pancreatitis
- Aseptic necrosis of femoral and humeral heads
- Anaphylactoid reactions
- Necrotizing angiitis
Drug interactions
- Amphotericin B or potassium-depleting diuretics (benzothiadiazines and related drugs, ethacrynic acid and furosemide)
- Digitalis glycosides
- Oral anticoagulants
- Antidiabetic drugs (oral agents and insulin)
- Aspirin
- Barbiturates, phenytoin, or rifampin
- Anabolic steroids (particularly C-17 alkylated androgens such as oxymetholone, methandrostenolone, norethandrolone, and similar compounds)
- Vaccines
- Estrogen
Key clinical trials
- A Multicenter, Open-label, Phase 2 Basket Study of MK-5684 in Participants With Selected Solid Tumors (OMAHA-015) (Phase 2)
- Mechanism-based Therapy of Hypotensive Syncope (N/A)
- 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 (Phase 1)
- Phase 3 Study of Corticotherapy (Hydrocortisone Alone Versus Hydrocortisone Plus Fludrocortisone) Versus Corticotherapy Plus Intensive Insulin Therapy for Septic Shock (Phase 3)
- Acupuncture for the Treatment of Medication-Dependent Hypotension in Heart Failure (Phase 1)
- An Open, Randomized, Long-Term Clinical Trial of Flutamide, Testolactone, and Reduced Hydrocortisone Dose vs. Conventional Treatment of Children With Congenital Adrenal Hyperplasia (Phase 3)
- Hydrocortisone and Fludrocortisone for Critical Illness-related Corticosteroid Insufficiency (Phase 3)
- 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 (Phase 1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Florinef CI brief — competitive landscape report
- Florinef updates RSS · CI watch RSS
- Generic portfolio CI