Drug Monograph

Fludrocortisone

Brand name: Florinef · Generic: Fludrocortisone acetate
Synthetic mineralocorticoid · Oral
Pharmacokinetic Profile
Plasma Half-Life
~3.5 h (biological 18–36 h)
Metabolism
Hepatic; resistant to 11β-HSD2 inactivation (9α-fluorination)
Protein Binding
~70–80% (mainly albumin)
Bioavailability
Rapid & nearly complete oral absorption
Volume of Distribution
~0.4–0.6 L/kg
Clinical Information
Drug Class
Synthetic mineralocorticoid (9α-fluorinated cortisol analogue)
Available Form
Oral tablet 0.1 mg only (no parenteral form)
Mineralocorticoid Potency
~125–250× hydrocortisone
Glucocorticoid Potency
~10–15× hydrocortisone (clinically minor at replacement doses)
Renal Adjustment
Titrate to BP and electrolytes
Hepatic Adjustment
Use with caution; effects may be amplified
Pregnancy
Compatible at replacement doses
Lactation
Compatible at replacement doses
Schedule / Legal
Prescription only · Not controlled · WHO Essential Medicine
Generic Available
Yes
Rx

Indications

Fludrocortisone is the only mineralocorticoid available for clinical use. It is structurally cortisol with a fluorine atom at the 9α position, a small change that confers strong resistance to inactivation by 11β-hydroxysteroid dehydrogenase type 2 in mineralocorticoid target tissues. The result is a markedly amplified mineralocorticoid effect — roughly 125–250-fold more potent than hydrocortisone for sodium retention — at doses (0.05–0.4 mg/day) that produce only a small glucocorticoid contribution. It is therefore the standard agent for replacing aldosterone deficiency and for clinical situations that benefit from sustained sodium and water retention.

IndicationApproved PopulationTherapy TypeStatus
Primary adrenocortical insufficiency (Addison disease)Adults & childrenMineralocorticoid replacement (with glucocorticoid)FDA Approved
Salt-losing congenital adrenal hyperplasiaAll ages, lifelongReplacement (with glucocorticoid; +/- salt supplementation in infancy)FDA Approved

The label is narrow because fludrocortisone has been in clinical use since the early 1950s and its formal FDA indications were never updated to reflect the broad off-label uses that are now standard practice. In contemporary medicine the great majority of fludrocortisone prescriptions fall outside the formally approved list but are supported by guideline-level evidence.

Common Off-Label & Guideline-Endorsed Uses

Neurogenic orthostatic hypotension (high evidence): 0.1–0.4 mg PO once daily, titrated to symptoms and supine BP — recommended as a first-line pharmacologic option after adequate salt and water intake. Often paired with midodrine, droxidopa, or pyridostigmine. Supine hypertension is the chief dose-limiting concern (Fanciulli et al., AAS/EFAS consensus 2018).

Postural orthostatic tachycardia syndrome — POTS (moderate evidence): 0.1–0.2 mg/day; expert-consensus recommendation, especially in the hypovolaemic POTS subtype.

Septic shock with vasopressor dependence (moderate evidence): 50 µg PO/NG once daily for 7 days alongside hydrocortisone 50 mg IV q6h — reduced 90-day mortality in the APROCCHSS trial (Annane 2018 NEJM). The 2021 Surviving Sepsis Campaign guideline suggests low-dose corticosteroids for refractory septic shock, while acknowledging uncertainty about whether fludrocortisone adds benefit beyond hydrocortisone.

Cerebral salt wasting (moderate evidence): 0.1–0.4 mg/day to correct natriuresis and volume depletion; randomised data exist in tuberculous meningitis (Misra 2018 JAMA Neurology).

Hyperkalaemic type IV renal tubular acidosis (limited evidence): 0.1 mg/day in selected patients with hyporeninaemic hypoaldosteronism, including some on calcineurin inhibitors. Often impractical because of fluid retention and hypertension.

Dose

Dosing

Fludrocortisone dosing is titrated by clinical scenario, with adequacy judged on blood pressure, postural symptoms, serum potassium, and — in adrenal insufficiency — plasma renin activity. Doses are far smaller than for any glucocorticoid and the only available strength is the 0.1 mg tablet, which can be split or given on alternate days when half-tablet doses are needed.

Adult Dosing by Clinical Scenario

Clinical ScenarioStarting DoseMaintenance DoseMaximum DoseNotes
Primary adrenal insufficiency (Addison disease)0.1 mg PO once daily0.05–0.2 mg/day0.2 mg/dayAlways combined with glucocorticoid replacement (hydrocortisone preferred). Do not reduce salt intake
Endocrine Society 2016
Secondary adrenal insufficiencyNot routinely indicatedAldosterone production is preserved in secondary insufficiency (intact RAAS); fludrocortisone is generally unnecessary
Hydrocortisone alone is usually sufficient
Neurogenic orthostatic hypotension0.1 mg PO once dailyTitrate by 0.1 mg every 1–2 wk to 0.1–0.3 mg/day0.4 mg/dayCombine with high-salt diet (≥10 g/day) and 2–2.5 L fluid intake. Add midodrine, droxidopa, or pyridostigmine for inadequate response
Stop and reassess if supine BP >180/100 mmHg
Postural orthostatic tachycardia syndrome (POTS)0.05–0.1 mg PO once dailyTitrate to 0.1–0.2 mg/day0.2 mg/dayMost useful in hypovolaemic phenotype; less effective in hyperadrenergic POTS
Expert-consensus recommendation
Septic shock (APROCCHSS regimen)50 µg PO/NG once daily50 µg/day × 7 days, no taper50 µg/dayAlways given alongside hydrocortisone 50 mg IV q6h
Annane 2018 NEJM; absorption may be impaired in critical illness (Polito 2016)
Cerebral salt-wasting syndrome0.1 mg PO once daily0.1–0.4 mg/day0.4 mg/dayStudied in tuberculous meningitis (Misra 2018); also used after subarachnoid haemorrhage and TBI
Combine with adequate sodium intake
Hyperkalaemic type IV RTA / hyporeninaemic hypoaldosteronism0.1 mg PO once daily0.05–0.2 mg/day if tolerated0.2 mg/dayOften limited by fluid retention and hypertension; loop diuretic may be added
Patiromer or sodium zirconium are usually preferred
Adrenal crisis / acute illness in known adrenal insufficiencyContinue usual fludrocortisone dose; intensify glucocorticoidHigh-dose hydrocortisone (≥50 mg q6h IV) provides sufficient mineralocorticoid activity, so no fludrocortisone increase is needed during stress dosing
Resume oral fludrocortisone once oral intake returns

Pediatric Dosing

Clinical ScenarioStarting DoseMaintenance DoseMaximum DoseNotes
Salt-losing congenital adrenal hyperplasia (infants)0.05–0.2 mg PO daily, often divided BID0.05–0.3 mg/day in infancy0.3 mg/dayAdd sodium chloride 1–2 g/day (~17–34 mEq) for the first 8–12 months
Endocrine Society 2018
Salt-losing CAH (older children & adolescents)0.05–0.1 mg PO once daily0.05–0.2 mg/day0.2 mg/daySalt supplementation is usually not required after weaning
Titrate to plasma renin activity in upper-normal range
Primary adrenal insufficiency (children)0.05–0.1 mg PO once daily0.05–0.2 mg/day0.2 mg/dayAlways combined with hydrocortisone (do not use long-acting glucocorticoids in growing children)
Monitor growth, BP, plasma renin

Adjustment in Special Populations

PopulationStarting DoseMaintenance DoseMaximum DoseNotes
Older adults (≥65 y)0.05 mg PO once dailyLowest effective dose, often ≤0.1 mg/day0.2 mg/dayHigher risk of supine hypertension, fluid overload, and hypokalaemia. Monitor closely for heart failure
Avoid in established heart failure
Hypertension or heart failureUse only if essentialLowest dose tolerated; add diuretic for oedemaAs clinically requiredAdrenal insufficiency takes precedence — never withhold replacement
Hydrocortisone alone may sometimes suffice in mild cases
Hepatic impairment0.05 mg PO once dailyTitrate cautiouslyAs toleratedEffects may be amplified; monitor BP and electrolytes more frequently
PregnancyContinue pre-pregnancy doseOften need to increase by 25–50% in T2/T3As requiredProgesterone has antimineralocorticoid activity; renin/electrolytes guide adjustment
Stress-dose hydrocortisone during labour
Sodium Intake Pearl

Fludrocortisone cannot retain sodium that is not being eaten. Patients on the drug should not be on a salt-restricted diet — a normal-to-liberal salt intake is essential for the medicine to work. In adrenal insufficiency this is usually achieved by adding salt to food to taste; in orthostatic hypotension a deliberate target of ≥10 g/day (170 mmol Na+) is common. Conversely, an unexplained loss of efficacy on a stable dose is most often the result of new salt restriction, not loss of drug response.

Stress-Dose Pearl

During major stress, hydrocortisone at 100–300 mg/day provides ≈1–3 mg/day of mineralocorticoid effect (hydrocortisone has weak mineralocorticoid activity at high doses). This is more than enough to cover the patient’s mineralocorticoid needs, so fludrocortisone does not need to be increased during stress dosing — the glucocorticoid is doing the work. Resume the usual fludrocortisone dose once oral hydrocortisone returns to a maintenance level (<50 mg/day).

PK

Pharmacology

Mechanism of Action

Fludrocortisone activates the cytoplasmic mineralocorticoid receptor (MR) in epithelial cells of the distal nephron, distal colon, and salivary and sweat ducts. The activated receptor translocates to the nucleus and increases transcription of the epithelial sodium channel (ENaC), the basolateral Na+/K+-ATPase, and serum/glucocorticoid-regulated kinase 1, the net effect of which is reabsorption of sodium and water from tubular fluid in exchange for potassium and hydrogen ions. The resulting expansion of plasma volume raises blood pressure and corrects orthostatic symptoms; the increased K+ excretion accounts for the principal adverse effect. The 9α-fluorine substitution on the cortisol scaffold makes fludrocortisone resistant to inactivation by 11β-hydroxysteroid dehydrogenase type 2, the enzyme that normally protects the mineralocorticoid receptor from cortisol — a single chemical change that effectively converts cortisol into a selective mineralocorticoid.

ADME Profile

ParameterValueClinical Implication
AbsorptionRapid and nearly complete oral absorption; Tmax ~0.5–2 h; high-fat meals enhance absorption; antacids may modestly reduce itSingle morning dose adequate in most patients; absorption may be impaired in critical illness or severe enteropathy (Polito 2016)
DistributionVd ~0.4–0.6 L/kg; protein binding 70–80% (mainly albumin)Lower Vd than glucocorticoids; effect is concentrated at epithelial mineralocorticoid sites
MetabolismHepatic, with the active drug derived from hydrolysis of the acetate prodrug; metabolism by hydrolysis, reduction, and oxidation; resistant to 11β-HSD2 inactivationStrong CYP3A4 inducers (rifampin, phenytoin, carbamazepine) accelerate clearance and may require dose increase; 11β-HSD2 resistance accounts for the disproportionate mineralocorticoid potency
EliminationPlasma t½ ~1–3.5 h; biological t½ 18–36 h; metabolites and small amounts of unchanged drug excreted in urineOnce-daily morning dosing covers the day in most patients; renal impairment does not require dose adjustment

Comparative potency: fludrocortisone has roughly 10–15× the glucocorticoid potency and 125–250× the mineralocorticoid potency of hydrocortisone. A 0.1 mg dose therefore delivers approximately 1–1.5 mg of hydrocortisone-equivalent glucocorticoid effect — clinically negligible — alongside a substantial mineralocorticoid load. This is why patients with adrenal insufficiency still require a dedicated glucocorticoid replacement (typically hydrocortisone 15–25 mg/day) in addition to fludrocortisone.

SE

Side Effects

The adverse-effect profile of fludrocortisone reflects mineralocorticoid excess: sodium retention, oedema, hypertension, hypokalaemia, and the cardiovascular consequences of these. At typical replacement doses (0.05–0.2 mg/day) most patients tolerate the drug well; problems arise predominantly when dose, salt intake, or co-medications push the patient into volume overload. Glucocorticoid-class adverse effects (osteoporosis, hyperglycaemia, cushingoid features) are uncommon at replacement doses but emerge at 0.4 mg/day and above.

≥10% Very Common Adverse Effects
Adverse EffectIncidenceClinical Note
Mild peripheral oedema~10–25% on chronic therapyOften dose-dependent and self-limiting in the first weeks; persistent oedema requires dose review or addition of a loop diuretic
Hypokalaemia~10–30% (dose-dependent)More common at doses ≥0.2 mg/day or with concomitant loop/thiazide diuretics; supplement potassium proactively
Hypertension or rise in baseline BP~10–15%Clinically significant elevation usually responds to dose reduction; supine hypertension is the chief concern in orthostatic-hypotension patients
Headache~10–15%Often mild and self-limiting; worsening or thunderclap headache should prompt BP measurement
1–10% Common Adverse Effects
Adverse EffectIncidenceClinical Note
Weight gain~5–10%Predominantly fluid retention rather than glucocorticoid-mediated central adiposity at replacement doses
Hypomagnesaemia~5–10%Often parallels hypokalaemia; check Mg if K+ is hard to correct
Hypernatraemia~3–5%Mild rise of serum Na+ is common; usually does not need intervention
Insomnia & mood change~3–5%More likely if dose is given in the evening; switch to morning administration
Acne & cushingoid features (chronic high-dose use)~1–5% at >0.2 mg/dayReflects the glucocorticoid component; uncommon at replacement doses
Hyperglycaemia (chronic high-dose use)~2–5%Dose-related; check glucose if dose ≥0.3 mg/day or pre-diabetic
Serious Serious Adverse Effects (any frequency)
Adverse EffectEstimated FrequencyTypical OnsetRequired Action
Severe hypertension~1–3%; higher in older adultsWithin weeks of starting or dose escalationReduce or stop dose; treat with calcium channel blocker (avoid thiazide which worsens hypokalaemia); reassess salt intake
Decompensated heart failure / pulmonary oedemaRare at replacement doses; higher in older adults and those with structural heart diseaseDays to weeks of overdosingStop fludrocortisone; loop diuretic; address underlying cardiac disease; restart at lower dose if essential
Severe hypokalaemia (≤2.5 mmol/L) and arrhythmia~1% at doses ≥0.2 mg/dayDays to weeks; precipitated by diuretics or vomitingUrgent potassium replacement (oral or IV); ECG monitoring; review concurrent diuretics
Hypertensive encephalopathy or PRESVery rareDays–weeks after marked BP elevationDiscontinue, control BP, neuro-imaging
Adrenal crisis (after abrupt withdrawal in adrenal insufficiency)Variable; depends on glucocorticoid status more than fludrocortisone aloneHours to days after missed doses during illnessParenteral hydrocortisone 100 mg + IV fluids; resume oral fludrocortisone once stable
Glaucoma / posterior subcapsular cataract (long-term use)Rare at replacement doses; increases with high-dose chronic useMonths–yearsAnnual ophthalmology review for any patient on chronic glucocorticoid replacement
Glucocorticoid-mediated osteoporosisUncommon at replacement doses; increases with dose >0.2 mg/dayMonths–yearsCalcium and vitamin D, weight-bearing exercise; baseline DEXA in chronic high-dose users
AnaphylaxisVery rareMinutes–hours of administrationEmergency epinephrine; permanent discontinuation; document allergy
Discontinuation Discontinuation Patterns

Fludrocortisone is rarely stopped because of intolerance — patients with adrenal insufficiency depend on it lifelong, and most non-replacement uses are time-limited. Withdrawal occurs more often because of dose-limiting hypertension or oedema than because of true intolerance.

Replacement therapy
<5% discontinue or switch chronic therapy
Top reasons: persistent oedema, supine hypertension, refractory hypokalaemia, heart-failure decompensation
Orthostatic hypotension
~15–25% discontinue within 6 months
Top reasons: intolerable supine hypertension, lower-limb oedema, weight gain, hypokalaemia
Reason for DiscontinuationApproximate RateContext
Supine hypertension~5–10%Most common limiting factor in orthostatic-hypotension patients
Persistent oedema~3–5%Often manageable with loop diuretic + dose reduction
Heart failure decompensation~1–2%Mainly in older adults with structural heart disease
Refractory hypokalaemia~1–2%Higher with concomitant diuretic or vomiting
Management Priority — Supine Hypertension in Orthostatic Hypotension

Supine hypertension is the dose-limiting adverse effect in patients treated for neurogenic orthostatic hypotension. Counsel patients to sleep with the head of the bed elevated 30–45° and to avoid taking the dose within 4 hours of lying flat. Check supine BP at clinic visits, not just standing BP — it is common for patients to feel symptomatically improved while running supine BPs >180/100 mmHg, which carries cardiovascular and renal risk over time. A pragmatic ceiling is supine BP ≤160/90 mmHg.

Int

Drug Interactions

The clinically important interactions of fludrocortisone are dominated by pharmacodynamic effects on potassium handling and blood pressure rather than by hepatic enzyme interactions. Co-prescription with diuretics is so common that the patterns below should be anticipated as the rule rather than the exception.

Major Loop & thiazide diuretics
MechanismAdditive renal potassium wasting
EffectSevere hypokalaemia, especially at fludrocortisone ≥0.2 mg/day
ManagementCheck potassium before starting, at week 1, and with each dose change. Supplement potassium proactively. Consider potassium-sparing diuretic (amiloride) if ongoing fluid retention
FDA PI / Lexicomp
Major Live attenuated vaccines (MMR, varicella, yellow fever, BCG, oral typhoid, intranasal influenza)
MechanismAt physiologic replacement doses, fludrocortisone confers minimal immunosuppression — but cumulative glucocorticoid exposure (with concomitant hydrocortisone) may reach immunosuppressive thresholds
EffectRisk of disseminated vaccine-strain infection only when combined glucocorticoid dose exceeds the ACIP-defined immunosuppressive threshold
ManagementReplacement-dose fludrocortisone alone does not contraindicate live vaccines. Apply ACIP rules to the concomitant glucocorticoid (≥20 mg/day prednisone-equivalent for ≥14 days)
CDC ACIP
Major Strong CYP3A4 inducers (rifampin, phenytoin, carbamazepine, phenobarbital, St John’s wort)
MechanismAccelerated metabolism reduces fludrocortisone exposure
EffectLoss of mineralocorticoid effect; risk of salt-wasting crisis in adrenal insufficiency
ManagementIncrease fludrocortisone dose (often by 50–100%); monitor electrolytes and BP closely; rifampin is the worst offender
FDA PI / Lexicomp
Major Cardiac glycosides (digoxin)
MechanismFludrocortisone-induced hypokalaemia sensitises the myocardium to digoxin
EffectIncreased risk of digoxin toxicity and arrhythmia
ManagementMaintain potassium >4 mmol/L; check digoxin level if symptoms suggest toxicity
FDA PI
Moderate Potassium-sparing diuretics (spironolactone, eplerenone, amiloride, triamterene)
MechanismDirect antagonism at the mineralocorticoid receptor (spironolactone, eplerenone) or downstream ENaC blockade (amiloride, triamterene)
EffectLoss of fludrocortisone effect with risk of salt wasting and hyperkalaemia
ManagementAvoid combination in adrenal insufficiency; if needed for refractory oedema, use only under specialist supervision
Lexicomp
Moderate NSAIDs
MechanismInhibition of renal prostaglandin synthesis reduces ENaC-mediated sodium reabsorption and impairs renal blood flow
EffectPartial antagonism of mineralocorticoid effect; additive sodium retention may also occur, paradoxically worsening oedema
ManagementAvoid prolonged NSAID use; monitor BP, weight, and renal function
Lexicomp
Moderate ACE inhibitors, ARBs, direct renin inhibitors
MechanismSuppression of the renin–angiotensin axis reduces endogenous aldosterone but does not directly block exogenous fludrocortisone; potassium retention is additive
EffectHyperkalaemia is the main concern; renin will be artificially suppressed and is no longer a useful titration marker
ManagementMonitor potassium more closely; titrate fludrocortisone by BP and electrolytes rather than renin
Lexicomp
Moderate Warfarin & other VKAs
MechanismMineralocorticoids may increase or decrease vitamin K-dependent factor synthesis (case-report level)
EffectVariable INR change
ManagementCheck INR within 5–7 days of dose change
Lexicomp
Moderate High-dose salt restriction or salt-substitute use (KCl-based)
MechanismSodium-restricted diet limits fludrocortisone effect; KCl-based salt substitutes raise potassium load
EffectApparent loss of efficacy and/or unexpected hyperkalaemia
ManagementCounsel patients explicitly about salt intake and salt substitutes at every initiation visit
Lexicomp
Minor Antacids (high-dose, simultaneous administration)
MechanismModest reduction in absorption
EffectMild reduction in fludrocortisone bioavailability
ManagementSeparate administration by ≥2 hours
Lexicomp
Mon

Monitoring

Adequate fludrocortisone replacement is judged by clinical signs (postural symptoms, oedema, weight) and a small panel of laboratory measures. Plasma renin activity is the gold-standard pharmacodynamic marker — a renin in the upper-normal range usually indicates a correctly dosed patient.

  • Blood pressure (supine & standing) Every visit; weekly during titration
    Routine
    In adrenal insufficiency, target normotension without postural drop >20/10 mmHg. In orthostatic hypotension, target standing BP that prevents symptoms while keeping supine BP ≤160/90 mmHg.
  • Serum potassium Baseline, week 1–2, then every 3–6 months
    Routine
    Target potassium 3.8–5.0 mmol/L. Check more frequently with concurrent diuretic, ACEI/ARB, or NSAID; supplement proactively at doses ≥0.2 mg/day.
  • Serum sodium Baseline, then every 3–6 months
    Routine
    Should be normal-to-high in well-replaced patients. A falling sodium is an early sign of under-replacement, especially during illness or salt restriction.
  • Plasma renin activity (PRA) or direct renin concentration Baseline, then 3–6 months after dose change
    Routine
    Aim for upper-normal range. Markedly elevated renin suggests under-replacement; suppressed renin suggests over-replacement and predisposes to hypertension. Concomitant ACE inhibitor or ARB invalidates renin as a titration marker.
  • Body weight & oedema Every visit; daily home weight after dose change
    Routine
    Rapid weight gain (>2 kg in a week) signals fluid retention and warrants dose review; persistent ankle oedema usually settles with dose reduction or addition of a low-dose loop diuretic.
  • Linear growth (children) Every 3–6 months
    Routine
    Over-replacement (especially of the concomitant glucocorticoid) is a leading cause of growth failure in CAH. Plot height velocity and bone age annually.
  • ECG If unexplained palpitations or potassium <3 mmol/L
    Trigger-based
    Look for U waves, prolonged QT, and arrhythmia in the context of severe hypokalaemia.
  • DEXA bone densitometry Baseline if chronic high-dose use (≥0.2 mg/day) anticipated
    Trigger-based
    Replacement-dose fludrocortisone alone is not a major bone risk; concomitant glucocorticoid usually drives the indication for bone surveillance.
  • Ophthalmology review Annually if chronic high-dose use
    Trigger-based
    Posterior subcapsular cataract and steroid-induced glaucoma reflect the glucocorticoid component; routine review is more relevant for the concurrent hydrocortisone or prednisolone.
CI

Contraindications & Cautions

Absolute Contraindications

  • Documented hypersensitivity to fludrocortisone or any excipient.
  • Untreated systemic fungal infection. Even at replacement doses, the glucocorticoid component can permit dissemination.
  • Live attenuated vaccines in patients receiving combined glucocorticoid replacement that exceeds the ACIP-defined immunosuppressive threshold.

Relative Contraindications (Specialist Input Recommended)

  • Uncontrolled hypertension — fludrocortisone will worsen it; if essential for adrenal insufficiency, use the lowest effective dose with intensified antihypertensive therapy.
  • Decompensated heart failure — sodium and water retention can precipitate pulmonary oedema; consider whether high-dose hydrocortisone alone could provide enough mineralocorticoid cover.
  • Severe hypokalaemia — correct potassium before initiation.
  • Active or latent tuberculosis without concurrent antitubercular therapy, when fludrocortisone is being used in combination with high-dose glucocorticoid.
  • Severe renal impairment with overt fluid overload — may worsen volume status.
  • Concurrent strong potassium-sparing diuretic in adrenal insufficiency — antagonises the desired effect.

Use with Caution

  • Older adults — heightened risk of supine hypertension, fluid overload, and electrolyte disturbance.
  • Diabetes mellitus — at higher fludrocortisone doses (≥0.2 mg/day) glucocorticoid contribution may worsen glycaemia.
  • Pregnancy — replacement doses are compatible; doses often need to be increased in the second and third trimesters because of the antimineralocorticoid effect of progesterone.
  • Children — monitor growth velocity; over-replacement is the leading cause of growth failure in CAH.
  • Concurrent NSAID, diuretic, or RAAS inhibitor — pharmacodynamic interactions are common; monitor electrolytes more frequently.
  • Glaucoma or strong family history — baseline IOP and ophthalmology review.
FDA Class-Wide Regulatory Warning HPA-Axis Suppression and Adrenal Crisis

Fludrocortisone is a corticosteroid and shares the class-wide warning that abrupt withdrawal of corticosteroid therapy after extended use may precipitate adrenal crisis. Patients with adrenal insufficiency depend on fludrocortisone (and the concurrent glucocorticoid) lifelong; missed doses during illness, surgery, or vomiting can cause life-threatening salt wasting, hyponatraemia, hyperkalaemia, and circulatory collapse. All patients should carry a medical-alert card identifying steroid dependence and be educated in sick-day rules: continue fludrocortisone, double the glucocorticoid during minor illness, and seek urgent parenteral hydrocortisone if vomiting prevents oral therapy.

Additional class-level cautions include increased susceptibility to infection (with masking of signs at higher doses), risk of sodium retention and oedema, and risk of hypokalaemia and cardiac arrhythmia.

Pt

Patient Counselling

Purpose of Therapy

Explain that fludrocortisone replaces the salt-and-water-balance hormone (aldosterone) that the adrenal glands normally make, or — when used for orthostatic hypotension or POTS — boosts the body’s ability to retain salt and water in order to keep blood pressure up when standing. Set expectations: patients with adrenal insufficiency need this medicine for life, alongside their glucocorticoid (usually hydrocortisone). Patients using it for orthostatic problems may take it short-term or long-term depending on response.

How to Take

Take the dose once daily in the morning with or without food. If a dose is missed and remembered the same day, take it as soon as possible; if it is already evening, skip and resume the next morning rather than doubling up. Never stop the medicine suddenly without speaking to the prescriber, especially if it is being taken for adrenal insufficiency — abrupt stopping can cause a dangerous drop in blood pressure and salt levels. Tablets can be split if a half dose is needed.

Salt & Fluid Intake
Tell patient This medicine works by helping the body hold onto salt and water. Do not be on a low-salt diet — eat normally salted food and add salt to meals to taste. Avoid potassium-based salt substitutes (such as LoSalt or NoSalt). Drink 2–2.5 litres of fluid daily unless told otherwise.
Call prescriber If you start or are advised to start a low-salt diet for any other reason, before changing what you eat. Severe salt restriction can stop this medicine working and trigger illness in adrenal insufficiency.
Never Stop Suddenly & Sick-Day Rules
Tell patient If this medicine is being taken for adrenal insufficiency, it must be continued every day for life. During illness with fever or vomiting, continue the fludrocortisone and double the hydrocortisone dose for 2–3 days; if vomiting prevents tablets staying down, get urgent care for an injection. Carry a steroid-emergency card and a “sick-day kit” with injectable hydrocortisone if your team has provided one.
Call prescriber Vomiting that prevents tablets being absorbed, planned surgery, severe injury, or before taking any new long-term medicine. Severe weakness, dizziness on standing, or confusion needs emergency assessment.
Blood Pressure & Swelling
Tell patient The dose is balanced to give enough salt and water retention without causing high blood pressure. A home blood-pressure cuff is helpful — check sitting and lying down. Some swelling of the ankles, especially at the end of the day, can occur in the first few weeks; this often settles. If swelling persists or worsens, the dose may need adjusting.
Call prescriber Blood pressure consistently above 160/90 mmHg, breathlessness on lying flat, rapid weight gain (more than 2 kg in a week), or new shortness of breath when walking — possible signs of fluid overload or heart strain.
Potassium & Muscle Symptoms
Tell patient The medicine causes the body to lose potassium in the urine. Some people need a potassium supplement, especially if also taking water tablets (diuretics). Eat potassium-rich foods (bananas, oranges, tomatoes, potatoes) unless told otherwise. Do not take potassium supplements without talking to the prescriber.
Call prescriber Muscle weakness, cramps, or palpitations — these can be signs of low potassium and need a blood test.
Sleeping Position (for Orthostatic Hypotension)
Tell patient Sleeping with the head of the bed raised by 10–20 cm (using bed-risers, not just extra pillows) reduces overnight blood pressure spikes. Avoid taking the dose within 4 hours of lying flat for the night.
Call prescriber Severe morning headache, blurred vision, or chest pain on waking — possible severe overnight hypertension.
Vaccines, Pregnancy & New Medicines
Tell patient Replacement-dose fludrocortisone alone does not stop you from having the standard inactivated vaccines (such as flu and pneumococcal), and these are encouraged. Pregnancy is compatible with fludrocortisone, but the dose may need to be increased in later pregnancy. Check with the prescriber before starting any new long-term medicine, especially water tablets, anti-inflammatory painkillers, or rifampicin/anticonvulsants.
Call prescriber If you become pregnant, plan to become pregnant, or are starting a new long-term medicine. Adjustments may be needed.
Ref

Sources

Regulatory (PI / SmPC)
  1. U.S. Food and Drug Administration / DailyMed. Fludrocortisone acetate (Florinef) tablets — current full prescribing information. https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=fludrocortisone Authoritative source for FDA-approved indications (primary adrenocortical insufficiency, salt-losing CAH), dosing, contraindications, and adverse-reaction tables.
  2. Electronic Medicines Compendium (eMC). Fludrocortisone acetate — Summary of Product Characteristics. https://www.medicines.org.uk/emc/search?q=fludrocortisone UK regulatory equivalent of the FDA label, including paediatric dosing detail.
  3. World Health Organization. Model List of Essential Medicines — fludrocortisone. https://list.essentialmeds.org/ WHO designation of fludrocortisone as an essential medicine for adrenal insufficiency.
Key Clinical Trials & Cohort Studies
  1. Annane D, Renault A, Brun-Buisson C, et al; CRICS-TRIGGERSEP Network. Hydrocortisone plus fludrocortisone for adults with septic shock (APROCCHSS). N Engl J Med. 2018;378(9):809–818. doi:10.1056/NEJMoa1705716. PMID 29490185. https://pubmed.ncbi.nlm.nih.gov/29490185/ Pivotal RCT showing reduced 90-day mortality with hydrocortisone 50 mg q6h plus fludrocortisone 50 µg/day for 7 days in septic shock.
  2. Annane D, Sébille V, Charpentier C, et al. Effect of treatment with low doses of hydrocortisone and fludrocortisone on mortality in patients with septic shock. JAMA. 2002;288(7):862–871. doi:10.1001/jama.288.7.862. PMID 12186604. https://pubmed.ncbi.nlm.nih.gov/12186604/ Original 2002 trial that introduced the hydrocortisone–fludrocortisone combination to critical-care practice.
  3. Misra UK, Kalita J, Kumar M. Safety and efficacy of fludrocortisone in the treatment of cerebral salt wasting in patients with tuberculous meningitis: a randomized clinical trial. JAMA Neurol. 2018;75(11):1383–1391. doi:10.1001/jamaneurol.2018.2178. PMID 30105362. https://pubmed.ncbi.nlm.nih.gov/30105362/ RCT demonstrating that fludrocortisone normalised serum sodium and natriuresis more rapidly than saline alone in tuberculous meningitis-associated cerebral salt wasting.
  4. Bosch NA, Teja B, Law AC, Pang B, Jafarzadeh SR, Walkey AJ. Comparative effectiveness of fludrocortisone and hydrocortisone vs hydrocortisone alone among patients with septic shock. JAMA Intern Med. 2023;183(5):451–459. doi:10.1001/jamainternmed.2023.0258. PMID 36972033. https://pubmed.ncbi.nlm.nih.gov/36972033/ Large target-trial-emulation cohort study supporting incremental benefit of adding fludrocortisone to hydrocortisone in septic shock.
  5. Ekman B, Quinkler M, Zhang P, Isidori AM, Murray RD, Wahlberg J. Mineralocorticoid effects of fludrocortisone and hydrocortisone in primary adrenal insufficiency: EU-AIR patient data. J Endocrinol Invest. 2025. doi:10.1007/s40618-025-02657-7. PMID 40913682. https://pubmed.ncbi.nlm.nih.gov/40913682/ European Adrenal Insufficiency Registry analysis quantifying combined mineralocorticoid potency of typical fludrocortisone + hydrocortisone replacement combinations.
Guidelines
  1. Bornstein SR, Allolio B, Arlt W, et al. Diagnosis and treatment of primary adrenal insufficiency: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2016;101(2):364–389. doi:10.1210/jc.2015-1710. PMID 26760044. https://pubmed.ncbi.nlm.nih.gov/26760044/ Definitive guideline for replacement strategy in primary adrenal insufficiency, including target dose, monitoring, and pregnancy adjustment.
  2. Speiser PW, Arlt W, Auchus RJ, et al. Congenital adrenal hyperplasia due to steroid 21-hydroxylase deficiency: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2018;103(11):4043–4088. doi:10.1210/jc.2018-01865. PMID 30272171. https://pubmed.ncbi.nlm.nih.gov/30272171/ Anchor reference for fludrocortisone dosing and monitoring across the paediatric and adult salt-losing CAH lifespan, including the role of supplementary sodium chloride in infancy.
  3. Fanciulli A, Jordan J, Biaggioni I, et al. Consensus statement on the definition of neurogenic supine hypertension in cardiovascular autonomic failure by the American Autonomic Society (AAS) and the European Federation of Autonomic Societies (EFAS). Clin Auton Res. 2018;28(4):355–362. doi:10.1007/s10286-018-0529-8. PMID 29766366. https://pubmed.ncbi.nlm.nih.gov/29766366/ Multi-society consensus on the diagnosis and management of supine hypertension that complicates fludrocortisone therapy in neurogenic orthostatic hypotension.
  4. Arnold AC, Ng J, Raj SR. Postural tachycardia syndrome — diagnosis, physiology, and prognosis. Auton Neurosci. 2018;215:3–11. doi:10.1016/j.autneu.2018.02.005. PMID 29523389. https://pubmed.ncbi.nlm.nih.gov/29523389/ Clinical overview supporting fludrocortisone as a pharmacologic option in selected POTS phenotypes, particularly the hypovolaemic subtype.
  5. Evans L, Rhodes A, Alhazzani W, et al. Surviving Sepsis Campaign: international guidelines for management of sepsis and septic shock 2021. Crit Care Med. 2021;49(11):e1063–e1143. doi:10.1097/CCM.0000000000005337. PMID 34605781. https://pubmed.ncbi.nlm.nih.gov/34605781/ Surviving Sepsis recommendations on low-dose corticosteroid therapy in vasopressor-dependent septic shock.
  6. Centers for Disease Control and Prevention. ACIP General Best Practice Guidelines for Immunization — altered immunocompetence. https://www.cdc.gov/vaccines/hcp/acip-recs/general-recs/immunocompetence.html Defines the dose and duration thresholds for clinically significant glucocorticoid-induced immunosuppression and live-vaccine avoidance.
Mechanistic / Basic Science
  1. Cain DW, Cidlowski JA. Immune regulation by glucocorticoids. Nat Rev Immunol. 2017;17(4):233–247. doi:10.1038/nri.2017.1. PMID 28192415. https://pubmed.ncbi.nlm.nih.gov/28192415/ Review of glucocorticoid effects on innate and adaptive immunity, applicable to the smaller glucocorticoid component of fludrocortisone.
Pharmacokinetics / Special Populations
  1. Polito A, Hamitouche N, Ribot M, et al. Pharmacokinetics of oral fludrocortisone in septic shock. Br J Clin Pharmacol. 2016;82(6):1509–1516. doi:10.1111/bcp.13065. PMID 27411519. https://pubmed.ncbi.nlm.nih.gov/27411519/ Verified PK study of enteral fludrocortisone in critically ill patients; reports detectable plasma concentrations with terminal half-life ~2.5–3.5 h and underpins the variable-absorption observation in septic shock.
  2. U.S. National Library of Medicine. LactMed — Fludrocortisone. https://www.ncbi.nlm.nih.gov/books/NBK500960/ Lactation-safety reference confirming compatibility of replacement-dose fludrocortisone with breastfeeding.