FDA-filed SPL labeling · retrieved through openFDA

Fludrocortisone Acetate

Fludrocortisone Acetate is a mineralocorticoid hormone used to treat adrenocortical insufficiency in Addison's disease and salt-losing adrenogenital syndrome.

Brand name Florinef
Rx Form 1 Route Oral
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 16 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

At a glance
Linked label effectiveMay 13, 2026
Clinical labels in scope ⓘ16
AvailabilityRx
Earliest approval/marketing year ⓘ1955
FDA-listed product records ⓘ41
Boxed warningNone found in compared labels
How we combine label and product data →
✓No current FDA shortage listed · checked Sep 21, 2026
⭐ Fludrocortisone Acetate at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Fludrocortisone Acetate is a hormone replacement tablet prescribed for Addison's disease and salt-losing adrenogenital syndrome, helping the body maintain the right balance of sodium and potassium. It requires careful monitoring of blood pressure, electrolytes, and salt intake throughout treatment. Take it exactly as your prescriber directs, and reach out to your care team any time you feel unwell or face a significant physical stressor like surgery or illness.
How we write & review this content — our editorial policy →

📖 Fludrocortisone Acetate: Patient Information Guide

A plain-language walkthrough of Fludrocortisone Acetate — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for▾

Fludrocortisone Acetate is a mineralocorticoid hormone used as replacement therapy when the adrenal glands cannot produce enough of their own hormones.

  • Addison's disease (primary and secondary adrenocortical insufficiency): Fludrocortisone Acetate tablets are used as part of hormone replacement, typically alongside a glucocorticoid like hydrocortisone or cortisone, to approximate normal adrenal function.
  • Salt-losing adrenogenital syndrome: Fludrocortisone Acetate tablets help the body retain the sodium it would otherwise lose in this condition.
⚙️How it works▾

Fludrocortisone acetate works similarly to the hormone hydrocortisone, but with a much stronger and longer-lasting effect on electrolyte balance. It acts on the kidneys — specifically the distal tubules — to increase sodium reabsorption back into the bloodstream, while promoting the excretion of potassium and hydrogen ions in the urine. This sodium retention also leads to water retention and a rise in blood pressure. In people with adrenal insufficiency, this replaces what the body can no longer make on its own.

At higher doses, fludrocortisone also affects other body systems — suppressing the adrenal cortex, influencing blood sugar regulation, and affecting protein metabolism — which is why careful dosing is essential.

💊How it's taken▾

Fludrocortisone Acetate is taken as an oral tablet, typically once daily, though frequency may range from a few times per week to twice daily depending on the condition being treated and the individual's response. For Addison's disease, it is usually given alongside a glucocorticoid (such as cortisone or hydrocortisone) in divided daily doses. Your prescriber will adjust your dose based on your symptoms, blood pressure, and electrolyte levels — particularly during illness, surgery, or other physical stressors. Never adjust the dose on your own; always follow your prescriber's instructions.

🤒Side effects — in detail▾

Most side effects from fludrocortisone acetate are related to its effect on sodium and water balance. Common ones include:

  • High blood pressure
  • Swelling (edema) from fluid retention
  • Low potassium (which can cause muscle weakness)
  • Weight gain
  • Headache and dizziness (vertigo)
  • Skin thinning, bruising, or increased sweating
  • Blood sugar changes, including worsening of diabetes
  • Menstrual irregularities

More serious reactions — including heart enlargement, congestive heart failure, eye problems (cataracts, glaucoma), severe mental disturbances, or signs of infection — require prompt medical attention. Contact your doctor right away if any of these occur.

⚠️Warnings & precautions▾
  • Sodium retention is powerful: This medication should only be used for its approved indications. Salt intake and blood pressure must be monitored throughout treatment to avoid hypertension and dangerous fluid buildup.
  • Potassium loss: Fludrocortisone causes the kidneys to excrete potassium. Low potassium can cause muscle weakness and heart rhythm problems. Regular blood tests and possible potassium supplementation may be needed.
  • Infection risk: Corticosteroids suppress the immune system and can mask signs of infection. Any new infection during treatment needs prompt treatment. Avoid live vaccines during therapy.
  • Eye problems: Prolonged use can lead to posterior subcapsular cataracts (a type of eye lens clouding) and glaucoma. Regular eye check-ups are advisable.
  • Children are especially vulnerable: Kids on corticosteroids are at higher risk from infections like chickenpox and measles, which can become severe or life-threatening. Avoid exposure and seek care immediately if exposure occurs.
  • Stress dosing: During surgery, serious illness, or injury, the body's steroid requirements can increase. Contact your prescriber before any planned procedure.
  • Tuberculosis (TB): Fludrocortisone can cause latent (dormant) TB to become active. People with a history of TB need close monitoring.
🔀What it interacts with▾

Several medications can interact with fludrocortisone acetate in clinically important ways:

  • Potassium-depleting diuretics or amphotericin B: Increase the risk of severely low potassium — frequent potassium monitoring is needed.
  • Digitalis glycosides (e.g., digoxin): Low potassium from fludrocortisone raises the risk of dangerous heart rhythm problems with these heart medications.
  • Oral anticoagulants (blood thinners): Fludrocortisone may reduce the blood-thinning effect; INR/prothrombin levels should be monitored and doses adjusted.
  • Diabetes medications (insulin or oral agents): Fludrocortisone can raise blood sugar, reducing the effectiveness of antidiabetic drugs — blood sugar monitoring and dose adjustment may be needed.
  • Aspirin: Increases the risk of stomach ulcers; stopping steroids abruptly after high-dose aspirin can also trigger salicylate toxicity.
  • Barbiturates, phenytoin, or rifampin: Speed up the body's breakdown of fludrocortisone, potentially making it less effective — a dose increase may be needed.
  • Anabolic steroids: Combining these with fludrocortisone increases the risk of fluid retention and swelling, especially if you have heart or liver problems.
  • Estrogen therapy: Can change how much active fludrocortisone circulates in the blood; dose adjustments may be needed when estrogen is started or stopped.

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

📋Before taking it▾
  • Do not take fludrocortisone acetate if you have a systemic (body-wide) fungal infection — it is contraindicated in this situation.
  • Tell your doctor if you have ever had an allergic reaction to corticosteroids.
  • Inform your prescriber if you have a history of tuberculosis or have tested positive on a TB skin test — close monitoring or preventive treatment may be needed.
  • Let your doctor know about all vaccines you need; certain immunizations should not be given during corticosteroid therapy.
  • Tell your doctor if you have diabetes — fludrocortisone can raise blood sugar and change your medication needs.
  • If you are pregnant or planning to become pregnant, discuss the risks and benefits with your prescriber before starting treatment.
  • Children taking this medication need special monitoring for growth suppression and are more susceptible to serious infections like chickenpox and measles.
  • Anyone with active tuberculosis should only use fludrocortisone under very specific circumstances and alongside appropriate anti-TB therapy.
🚑If you take too much▾

Signs of too much fludrocortisone acetate include high blood pressure, significant swelling, low potassium, excessive weight gain, and an enlarged heart. If overdose is suspected, the medication should be stopped and a doctor contacted — symptoms typically improve within several days after discontinuation. Muscle weakness from potassium loss can be treated with potassium supplementation, and regular blood pressure and electrolyte monitoring can help catch overdose early.

📡Pharmacodynamics — effects in the body▾

Fludrocortisone acetate acts on the kidneys to increase how much sodium is reabsorbed back into the blood, while causing more potassium and hydrogen ions to be lost in the urine. Even at small oral doses, it produces marked sodium retention and increased potassium excretion, which leads to a rise in blood pressure. These effects on electrolyte balance are considerably stronger and longer-lasting than those seen with hydrocortisone, making careful dosing essential.

🔬Pharmacokinetics — how your body processes it▾

After oral administration, fludrocortisone acetate has a plasma (blood) half-life of approximately 3.5 hours or more, meaning it takes that long for the blood concentration to reduce by half. However, its biological half-life — how long its effects actually last in the body — is much longer, ranging from 18 to 36 hours. This prolonged duration of action means that even once-daily dosing can provide sustained mineralocorticoid effects throughout the day.

📦How to store it▾

Store at controlled room temperature 15° to 30°C (59° to 86°F)(see USP). Avoid excessive heat. Keep out of the reach of children.

📄 Written from Fludrocortisone Acetate’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

🩺 Pharmacist Counseling Corner

Quick, plain-English answers to the questions patients ask most about Fludrocortisone Acetate — the kind of thing our pharmacy team would talk through with you at the counter.

What exactly is fludrocortisone acetate used for? ▾
Fludrocortisone acetate is a hormone replacement tablet. It's used for two specific conditions: Addison's disease, where your adrenal glands don't make enough hormones on their own, and salt-losing adrenogenital syndrome, where your body loses too much sodium. It's not a general-purpose steroid — it's approved only for these conditions.
How should I take this medication — does it matter when or if I eat first? ▾
You'll typically take fludrocortisone as a once-daily oral tablet. If you have Addison's disease, your doctor will likely have you take it alongside a separate glucocorticoid medication like hydrocortisone or cortisone. Always follow your prescriber's specific instructions. If you're ever unsure about the timing or whether to take it with food, your pharmacist or doctor can clarify based on your full regimen.
What side effects should I watch out for? ▾
The most common issues are related to sodium and water retention — things like swelling, weight gain, and rising blood pressure. Low potassium is also a concern and can cause muscle weakness. Call your doctor promptly if you notice significant swelling, unusual muscle weakness, a sudden jump in blood pressure, or signs of infection, since fludrocortisone can mask the usual warning signs that you're getting sick.
Can I get vaccines while taking this medication? ▾
You should talk to your doctor before getting any vaccines while on fludrocortisone. Corticosteroids can suppress your immune response, which means some vaccines may not work as well. Smallpox vaccination should be avoided entirely during treatment. Other vaccines — especially live vaccines — need to be discussed with your prescriber first.
Are there medications I should avoid while on fludrocortisone? ▾
Yes, a few important ones. Potassium-depleting water pills and certain antibiotics (like amphotericin B) can drive your potassium too low when combined with fludrocortisone. If you take digoxin for your heart, low potassium becomes a serious concern. Blood thinners, diabetes medications, aspirin, and some seizure or antibiotic medications can also interact. Make sure your entire care team knows everything you're taking.
What should I do if I get sick or need surgery while taking fludrocortisone? ▾
Contact your doctor before any planned surgery, and reach out right away if you develop a serious illness or injury. Your body's need for this medication can change significantly during physical stress, and your dose may need to be adjusted. Don't stop taking it on your own — sudden changes can be dangerous. Your prescriber needs to guide any dose changes.
Is Fludrocortisone Acetate available over the counter? ▾
Fludrocortisone Acetate is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.
When was Fludrocortisone Acetate first available? ▾
Fludrocortisone Acetate has been available in the United States since at least 1955, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Fludrocortisone Acetate? ▾
Fludrocortisone Acetate is supplied by 23 manufacturers listed in the FDA NDC Directory, including Bryant Ranch Prepack, AvKARE, Amneal Pharmaceuticals NY LLC.

💬 Answers drafted from Fludrocortisone Acetate’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

🧰 Keep exploring

🌿Drug & Supplement CheckerFludrocortisone Acetate vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Fludrocortisone Acetate NDCs & costs 🅰️Browse Drugs A–ZLook up any medication

💊 How Fludrocortisone Acetate comes

Fludrocortisone Acetate is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Tablet

By mouth
How this form is used
What it may be used for
  • Fludrocortisone Acetate tablets are used as partial replacement therapy for primary and secondary adrenocortical insufficiency in Addison's disease
  • Fludrocortisone Acetate tablets are used to treat salt-losing adrenogenital syndrome
Important instructions
  • Fludrocortisone Acetate tablets are taken by mouth, typically once daily
  • Fludrocortisone Acetate tablets for Addison's disease are preferably taken alongside a glucocorticoid such as cortisone or hydrocortisone, as directed by your prescriber
  • Fludrocortisone Acetate dose may need adjustment during times of stress such as surgery, infection, or injury — always follow your prescriber's guidance
  • Fludrocortisone Acetate tablets should be taken with attention to dietary salt intake, as too much sodium can worsen fluid retention and blood pressure
Available strengths 1 strength
0.1 mg
36 FDA-listed product records ⓘ

📊 Fludrocortisone Acetate across the U.S. market

How Fludrocortisone Acetate appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

1
Dose forms ⓘ
23
Manufacturers
1
Brand names
41
FDA-listed product records ⓘ
1955
First marketed ⓘ

Also listed with the FDA, not a patient dose form: Powder (5) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Bryant Ranch Prepack12%
AvKARE10%
Amneal Pharmaceuticals NY LLC7%
Amneal Pharmaceuticals of New York LLC7%
AvPAK7%
American Health Packaging7%
Other makers49%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

📈 How widely Fludrocortisone Acetate is used

A general measure of how commonly Fludrocortisone Acetate is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Fludrocortisone Acetate is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

163,820
Medicaid prescriptions filled (Q1–Q4 2025)
$3.7M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Fludrocortisone Acetate prescribed? Of the 1,596 medications we measure, Fludrocortisone Acetate ranks #424 by Medicaid prescriptions — more than 73% of them.

Where Fludrocortisone Acetate ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #424 of 1,596
#419 Diazepam Nasal Spray 167,844 Rx #420 Bupivacaine 166,102 Rx #421 Cefadroxil 165,523 Rx #422 Phenobarbital 164,240 Rx #423 Doxazosin 163,836 Rx #424 Fludrocortisone Acetat... 163,820 Rx #425 Ritonavir 162,610 Rx #426 Ursodiol 159,875 Rx #427 Tobramycin Ophthalmic 159,866 Rx #428 Nitrofurantoin 157,792 Rx #429 Glucagon Nasal Powder 154,534 Rx

Utilization by Fludrocortisone Acetate product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

fludrocortisone acetate 0.1 MG Oral Tablet

163,820 Medicaid prescriptions (Q1–Q4 2025) 100% of Fludrocortisone Acetate prescriptions shown $3.7M gross reimbursement (before rebates) ≈ $23 per prescription (gross)

Summed across the 9 of 35 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 313979

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Fludrocortisone Acetate, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 9 of 35 listed Fludrocortisone Acetate NDCs with Medicaid activity.

🔍 Compare Fludrocortisone Acetate products

A representative set of FDA-listed product records for Fludrocortisone Acetate — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 41 of 41 products — FDA National Drug Code Directory. See every product, package size and price: browse all 41 Fludrocortisone Acetate NDCs →

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Fludrocortisone Acetate RxCUI 4452 1 dose form · 1 strength
  1. Dose form (SCDF) Oral Tablet RxCUI 372213 In current FDA listings
    Clinical drug / strength (SCD) acetate 0.1 MG RxCUI 313979

Look up RxCUI 4452 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

🏷️ Sold under these brand names

Florinef

🏭 Manufacturers & labelers

Bryant Ranch Prepack 5 AvKARE 4 Amneal Pharmaceuticals NY LLC 3 Amneal Pharmaceuticals of New York LLC 3 AvPAK 3 American Health Packaging 3 Cardinal Health 107, LLC 3 Major Pharmaceuticals 2 Zydus Lifesciences Limited 1 Viona Pharmaceuticals Inc 1 Teva Pharmaceuticals USA, Inc. 1 Sicor S.r.l. 1 Nuray Chemicals Private Limited 1 Novitium Pharma LLC 1 NorthStar Rx LLC 1 NCS HealthCare of KY, LLC dba Vangard Labs 1 NCS HealthCare of KY, Inc dba Vangard Labs 1 Medisca Inc. 1 Golden State Medical Supply, Inc. 1 Farmabios S.p.A. 1 Eywa Pharma Inc 1 Curia Spain S.A.U. 1 Cardinal Health 1

RxNorm drug class

Fludrocortisone Acetate belongs to the Mineralocorticoids class.

Drug family (ATC) Mineralocorticoids

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

🔬 Where this comes from

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective May 13, 2026
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Fludrocortisone Acetate.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Fludrocortisone Acetate after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
16
NDC products indexed
41
Distinct labelers/manufacturers represented
23
Linked representative label ⓘ
Eywa Pharma Inc
Linked label effective
May 13, 2026
Composite sections available
17
Linked SPL Set ID
eff2eae8-94ce-46ca-a027-6b1d08e7b96b
Linked SPL Document ID
a521d1c2-f4c3-4b7c-ba34-13e06d8ef71b
Open the linked representative label on DailyMed ↗

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 16 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Eywa Pharma Inc is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.