Prescription medication · Mineralocorticoid
fludrocortisone
Also sold as Florinef. This medicine is used to treat Addison's disease and salt-losing adrenogenital syndrome.
Data updated 2026-05-15
- 1,195
- FDA reports
- 6
- InteractionsFew interactions
- $0.35
- Generic price (NADAC)
What the data shows
fludrocortisone (Florinef) is a prescription Mineralocorticoid, with 1,195 FDA adverse-event reports on file, with 6 documented drug interactions.
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
fludrocortisone (Florinef) is a prescription Mineralocorticoid. This medicine is used to treat Addison's disease and salt-losing adrenogenital syndrome.
Fludrocortisone is a medicine that helps your body balance salt and fluids. It is used when your adrenal glands don't make enough of certain hormones.
Verify with FDA → · CMS NADAC pricing →
Drug Pricing (NADAC)
Generic Price
$0.35/unit
Generic Available
Yes (3 manufacturers)
Pricing data from NADAC (CMS), effective December 25, 2024. Compare all drug costs →
What it does
This medicine is used to treat Addison's disease and salt-losing adrenogenital syndrome.
Common side effects
High blood pressure, Swelling in your hands, feet, or ankles, Enlarged heart
Key warnings
This medicine may cause you to retain too much sodium and water, leading to high blood pressure, swelling, and heart problems.
The sections below are summarized in plain English from fludrocortisone's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
Fludrocortisone is a mineralocorticoid. It works by helping your body to retain sodium and water. This helps to increase blood volume and blood pressure.
How to Take It
Take this medicine exactly as your doctor tells you. The usual dose is 0.1 mg daily, but it can range from 0.1 mg three times a week to 0.2 mg daily. Your doctor may also prescribe cortisone or hydrocortisone to take with fludrocortisone. If you develop high blood pressure, your doctor may lower your dose to 0.05 mg daily.
This is a plain-language summary of fludrocortisone's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.
Pregnancy & Breastfeeding
Talk to your doctor if you are pregnant or breastfeeding before taking this medicine. It is not known if this medicine will harm your unborn baby. It is also not known if this medicine passes into breast milk.
This is a plain-language summary of fludrocortisone's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.
Missed Dose
If you miss a dose, take it as soon as you remember. If it is close to your next dose, skip the missed dose and continue with your regular schedule.
This is a plain-language summary of fludrocortisone's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.
Storage
Store at room temperature (68° to 77°F) and keep away from excessive heat.
Side Effects (from patient reports)
Based on 1,195 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for fludrocortisone, by number of reports
- Feeling tired
Feeling tired
146 reports
- Falling down
Falling down
144 reports
- Feeling lightheaded
Feeling lightheaded
135 reports
- Feeling sick to your stomach
Feeling sick to your stomach
129 reports
- Death
Death
126 reports
- Loose stools
Loose stools
123 reports
- Head pain
Head pain
108 reports
- Lung infection
Lung infection
96 reports
- Low blood pressure
Low blood pressure
95 reports
- Weakness
Weakness
93 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Serious Warnings
This medicine may cause you to retain too much sodium and water, leading to high blood pressure, swelling, and heart problems. Tell your doctor right away if you have any of these symptoms. This medicine can also interact with other medicines, so be sure to tell your doctor about all the medicines you are taking.
Known Drug Interactions
Amphotericin B or potassium-depleting diuretics (benzothiadiazines and related drugs, ethacrynic acid and furosemide) – enhanced hypokalemia.
Mechanism: Both drugs cause your body to lose potassium through your urine, which can lead to dangerously low levels of this important mineral.
What to do: Your doctor should monitor your potassium levels closely and may need to give you a potassium supplement.
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 ).
Mechanism: Taking these together increases the risk of stomach ulcers and can make aspirin less effective. If you stop the steroid suddenly, aspirin levels in your blood could rise to unsafe levels.
What to do: Your doctor should monitor your aspirin levels and may need to adjust your dose. Do not stop taking the steroid without talking to your doctor first.
Barbiturates, phenytoin, or rifampin – increased metabolic clearance of fludrocortisone acetate because of the induction of hepatic enzymes.
Mechanism: Rifampin causes your liver to break down fludrocortisone much faster than normal. This makes the fludrocortisone less effective in your body.
What to do: Your doctor may need to increase your dose of fludrocortisone to make sure it still works properly.
Amphotericin B or potassium-depleting diuretics (benzothiadiazines and related drugs, ethacrynic acid and furosemide) – enhanced hypokalemia.
Mechanism: Both of these medications can cause your body to lose potassium. Taking them together increases the risk of your potassium levels becoming dangerously low.
What to do: Your doctor should monitor your potassium levels closely while you are taking both medications.
Amphotericin B or potassium-depleting diuretics (benzothiadiazines and related drugs, ethacrynic acid and furosemide) – enhanced hypokalemia.
Mechanism: Both drugs cause the body to get rid of potassium through the urine. This can lead to very low potassium levels in your blood.
What to do: Your doctor should check your blood potassium levels often and may suggest a supplement if needed.
This is a plain-language summary of interactions documented in FDA labeling, not individualized advice. Ask a pharmacist or prescriber before combining medications.
Common Questions
What should I do if I experience side effects?
Can I take this medicine with other medications?
How often will I see the doctor while taking this medicine?
What are the symptoms of low potassium?
Can this medicine affect my blood sugar?
Will this medicine affect my bones?
Can I stop taking this medicine suddenly?
What should I do if I am going to have surgery?
Does this medicine interact with alcohol?
What if the blister pack is broken?
What are the common side effects of fludrocortisone?
Does fludrocortisone interact with other medications?
What drug class is fludrocortisone?
Is fludrocortisone safe during pregnancy?
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What the FDA Data Shows for fludrocortisone
The FDA label for fludrocortisone (sold under brand names such as Florinef) classifies it as a prescription-only medication in the Mineralocorticoid class. This medicine is used to treat Addison's disease and salt-losing adrenogenital syndrome. Official labeling lists 6 commonly reported side effects, including High blood pressure, Swelling in your hands, feet, or ankles, Enlarged heart.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 1,195 voluntary reports. The database also lists 6 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated minor severity. NADAC pricing from CMS shows a generic unit cost of $0.35.
Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice, always consult a licensed healthcare provider before starting, stopping, or changing any medication.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.
Last updated: May 19, 2025
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages