Eplerenone

Pronunciation: eh-PLEH-reh-known.

Generic name
eplerenone
Drug class
Selective mineralocorticoid (aldosterone) receptor antagonist
Form
Tablet (25 mg, 50 mg)
Route
Oral
Legal status
Prescription-only

Availability and supply rules vary by country

Trade names by country: United States · United Kingdom · Canada · Australia · New Zealand

Australia: Inspra (5), INPLER / EPLERENONE-DWRN / EPLERENONE SP / EPLERENONE GXP (generics) (5) · Full directory

What eplerenone is and how it works

Eplerenone is a prescription medicine that selectively blocks the hormone aldosterone at its receptor in the kidney and heart. By blocking aldosterone, it helps the body get rid of excess sodium and fluid while holding on to potassium, which lowers blood pressure and reduces strain on the heart. (1) (2)

Eplerenone is used both for high blood pressure and, more specifically, to help people survive longer and stay out of hospital after a heart attack or with certain types of heart failure. Its most important real risk is a high blood potassium level (hyperkalaemia), so regular blood tests are a routine and necessary part of taking it -- never skip these tests.

Mechanism of action: how eplerenone works

Eplerenone is a selective aldosterone (mineralocorticoid) receptor antagonist. Blocking aldosterone's action at the mineralocorticoid receptor in the kidney, heart, and blood vessels reduces sodium and water retention, promotes potassium retention, and reduces the fibrotic and remodelling effects of aldosterone on the heart -- the basis for its cardiovascular-mortality benefit in heart failure. Its greater receptor selectivity compared with spironolactone (an older, non-selective aldosterone antagonist) is associated with a substantially lower rate of hormone-related side effects such as gynaecomastia. (1) (2)

What eplerenone is used for

After a heart attack, with reduced heart pumping function and heart failure

Used, in addition to standard treatments including beta-blockers, to improve survival in stable patients with reduced left ventricular function (ejection fraction 40% or less) and clinical heart failure after a recent heart attack. (1) (2)

Chronic heart failure with reduced pumping function (NYHA class II)

Used, in addition to standard optimal heart-failure therapy, to reduce the risk of cardiovascular death and hospitalisation in adults with mild (NYHA class II) chronic heart failure and reduced left ventricular systolic function (ejection fraction 30% or less). (2)

High blood pressure (hypertension)

Used alone or combined with other blood-pressure-lowering medicines to treat high blood pressure (an FDA-labelled use in the United States). (1)

Before taking eplerenone

Do not take / not appropriate for

  • Do not take eplerenone if you have a known allergy to it or any ingredient of the tablet. (all countries) (2)
  • Do not take eplerenone if your blood potassium level is already high (above the threshold your lab uses to flag hyperkalaemia) before you start. (all countries) (1) (2)
  • Do not take eplerenone if you have severe kidney impairment, or (for the UK/EU label) severe liver impairment (Child-Pugh Class C). (all countries) (1) (2)
  • Do not combine eplerenone with strong CYP3A4 inhibitor medicines (such as ketoconazole, itraconazole, clarithromycin, ritonavir, or nelfinavir). (all countries) (1) (2)
  • Do not combine eplerenone with a potassium-sparing diuretic, potassium supplements, or the combination of an ACE inhibitor together with an ARB (angiotensin receptor blocker). (all countries) (1) (2)

Tell your clinician about

  • Any kidney or liver problems, including how well your kidneys are currently working.
  • Whether you have diabetes, especially with protein in your urine (proteinuria/microalbuminuria).
  • All other medicines you take, especially ACE inhibitors, ARBs, NSAIDs, lithium, or anything affecting liver enzymes (CYP3A4).
  • Whether you are pregnant, planning pregnancy, or breastfeeding.
  • Your age, since older adults are at higher risk of hyperkalaemia and need closer monitoring.
(1) (2)

How to take eplerenone

  • Take eplerenone once daily, at about the same time each day, with or without food.
  • Attend every scheduled blood test for potassium and kidney function -- these are not optional extras, they are how your prescriber keeps this medicine safe for you.
  • Do not change your dose or stop taking eplerenone without your clinician's guidance.
  • Do not take potassium supplements or salt substitutes containing potassium unless your clinician has specifically told you to.
(1) (2)

Procedures and treatment changes

Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (1) (2) (3) (4) (5) (6)

Missed dose

If you miss a dose, take it as soon as you remember unless it is almost time for your next dose -- in that case, skip the missed dose and continue your normal schedule. Do not take a double dose. Contact your clinician or pharmacist if you are unsure.

Overdose

Seek urgent medical attention if you think you have taken too much eplerenone, or if you develop symptoms of a high potassium level such as muscle weakness, tingling, an irregular or slow heartbeat, or fainting. The most likely effects of overdose are hypotension (low blood pressure) or hyperkalaemia. (2)

Side effects

Side effects and their urgency vary; report severe, persistent, or concerning symptoms.

Raised blood potassium (hyperkalaemia) -- see Serious warnings below.

What to notice: Raised blood potassium (hyperkalaemia) -- see Serious warnings below.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1) (2)

Dizziness, headache, or fainting (syncope).

What to notice: Dizziness, headache, or fainting (syncope).

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (2)

Diarrhoea, nausea, constipation, or vomiting.

What to notice: Diarrhoea, nausea, constipation, or vomiting.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (2)

Cough.

What to notice: Cough.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1) (2)

Fatigue and flu-like symptoms.

What to notice: Fatigue and flu-like symptoms.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)

Breast tenderness or enlargement in men (gynaecomastia) -- reported at a low rate, less common than with spironolactone because eplerenone is more selective for the aldosterone receptor.

What to notice: Breast tenderness or enlargement in men (gynaecomastia) -- reported at a low rate, less common than with spironolactone because eplerenone is more selective for the aldosterone receptor.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (2)

Serious warnings

Signs of a high blood potassium level (hyperkalaemia) — high caution

Symptoms: Muscle weakness or cramps, tingling or numbness, an irregular, slow, or pounding heartbeat, or fainting. Hyperkalaemia can sometimes have no symptoms at all, which is why scheduled blood tests matter even when you feel fine.

Action: Contact your clinician promptly, or seek emergency care for a fast or irregular heartbeat, fainting, or severe weakness. Never skip a scheduled potassium blood test. Your prescriber may reduce your dose or pause treatment based on your results -- do not adjust your own dose. (1) (2)

Signs of worsening kidney function — high caution

Symptoms: A marked drop in how much urine you pass, swelling, or unusual tiredness.

Action: Contact your clinician promptly -- kidney function and potassium are closely linked with this medicine, and both are checked together. (2)

Signs of a serious allergic reaction (angioedema) — emergency

Symptoms: Swelling of the face, lips, tongue, or throat; difficulty breathing or swallowing; widespread rash or hives.

Action: Seek emergency medical help immediately. (2)

Interactions

  • Strong CYP3A4 inhibitor medicines (such as ketoconazole, itraconazole, clarithromycin, ritonavir, and nelfinavir) significantly raise eplerenone levels and must not be combined with it. (1) (2)
  • Moderate CYP3A4 inhibitors (such as erythromycin, amiodarone, diltiazem, verapamil, and fluconazole) raise eplerenone levels; your dose may need to be capped at 25 mg daily if these are needed together. (2)
  • ACE inhibitors and ARBs (angiotensin receptor blockers) increase the risk of high potassium when combined with eplerenone; combining all three (ACE inhibitor + ARB + eplerenone) is not allowed. (1) (2)
  • Potassium supplements and potassium-sparing diuretics are not recommended once you have started eplerenone, because of the increased risk of high potassium. (2)
  • Lithium levels should be monitored frequently if taken together with eplerenone. (1)
  • NSAIDs (common pain relievers like ibuprofen) may reduce eplerenone's blood-pressure-lowering effect and raise the risk of kidney problems, especially if you are dehydrated or have existing kidney disease. (2)
  • Strong CYP3A4 inducers (such as rifampicin, carbamazepine, phenytoin, and St John's wort) can reduce how well eplerenone works and are not recommended together with it. (2)

Pregnancy, breastfeeding, kidney/liver function, age

Pregnancy

Data in pregnant women are limited. Discuss the balance of benefits and risks with your clinician before starting or continuing eplerenone if you are pregnant or planning pregnancy. (1) (2) (3) (4) (5) (6)

Breastfeeding

It is not known whether eplerenone passes into human breast milk. Discuss with your clinician whether to continue breastfeeding or continue treatment. (1) (2) (3) (4) (5) (6)

Children

Safety and effectiveness in children have not been established in the sources reviewed for this dossier. (1) (2) (3) (4) (5) (6)

Elderly

Older adults are at higher risk of hyperkalaemia and are specifically named as a group needing closer, more frequent potassium monitoring. (1) (2) (3) (4) (5) (6)

Hepatic_impairment

Not recommended, or contraindicated (severe impairment, Child-Pugh Class C, per the UK/EU label), in significant liver disease; use with caution and closer monitoring in mild-to-moderate impairment. (1) (2) (3) (4) (5) (6)

Renal_impairment

Contraindicated in severe renal impairment (creatinine clearance 30 mL/min or less, or eGFR below 30 mL/min/1.73m2 per the UK/EU label); moderate impairment requires a reduced starting dose and closer potassium monitoring. (1) (2) (3) (4) (5) (6)

Monitoring

Before starting

  • Baseline serum potassium
  • Baseline kidney function (creatinine/eGFR or creatinine clearance)
  • Review of other medicines for CYP3A4 and RAAS-blocking interactions
  • Liver function, if there is known or suspected liver disease

During treatment

  • Serum potassium: before starting, within the first week, and about one month after starting or after any dose change, then periodically thereafter -- more frequently in elderly patients, people with reduced kidney function, and people with diabetes.
  • Kidney function alongside potassium monitoring.
  • Blood pressure response and heart-failure symptoms, according to the reason eplerenone was started.
(1) (2)

Storage

Store tablets at room temperature in their original packaging, out of reach of children.

Study the drug class: Mineralocorticoid receptor antagonists · Potassium-sparing diuretics

Professional information

Clinician-facing context only, sourced from the current US FDA prescribing information and UK SmPC; verify against the current full label before prescribing.

United States

Indication: Post-MI heart failure with LV dysfunction; hypertension

Dose summary: Post-MI HF: 25 mg OD titrated to 50 mg OD within 4 weeks per potassium/tolerance. Hypertension: 50 mg OD, may increase to 50 mg BID; not recommended above 100 mg/day total (no added antihypertensive benefit, increased hyperkalaemia risk).

Renal context: Contraindicated at CrCl <=30 mL/min; hypertension indication also contraindicated at CrCl <50 mL/min or elevated serum creatinine thresholds specified in the label. (1)

United Kingdom / European Union

Indication: Post-MI LV dysfunction with heart failure; NYHA class II chronic heart failure with LV systolic dysfunction (LVEF <=30%)

Dose summary: 25 mg OD titrated to target 50 mg OD within 4 weeks based on potassium. Moderate renal impairment (CrCl 30-60 mL/min): start 25 mg every other day. Mild-moderate CYP3A4 inhibitor co-therapy: cap at 25 mg OD.

Renal context: Contraindicated at eGFR <30 mL/min/1.73m2; moderate impairment requires reduced starting dose and closer monitoring. (2)

Mechanism of action

Hepatic guidance

Contraindicated in severe hepatic impairment (Child-Pugh Class C) per UK/EU labelling; no dose adjustment required for mild-to-moderate impairment per the US label, but caution and monitoring are still advised.

Overdose note

No specific antidote. Manage supportively: if hyperkalaemia develops, standard measures to lower potassium; if hypotension develops, standard supportive care. Eplerenone is not expected to be removed effectively by haemodialysis. (1) (2)

Frequently asked questions

Is eplerenone available in the US, UK, Europe, Canada, Australia, and New Zealand?

Yes. It is authorised in all of these regions, sold as Inspra (with generic eplerenone also widely available in the US, UK, EU, and Australia). (1) (2) (3) (4) (5) (6)

Does eplerenone have a boxed warning like some other heart medicines?

No. Directly checking the current FDA prescribing information confirms eplerenone does not carry a formal boxed warning. It does have an important, clearly flagged hyperkalaemia (high potassium) risk, managed with a real blood-test schedule and dose-adjustment rules. (1)

Why do I need regular blood tests while taking eplerenone?

Eplerenone can raise your blood potassium level, which can be dangerous if it climbs too high, sometimes without obvious symptoms. Regular blood tests -- before starting, within the first week, about a month later, and periodically after that -- let your prescriber catch and manage this early, including reducing your dose or pausing treatment if needed. (1) (2)

Is eplerenone the same as spironolactone?

They are related -- both are aldosterone (mineralocorticoid) receptor antagonists -- but eplerenone is more selective for the aldosterone receptor, which is associated with a lower rate of hormone-related side effects such as breast tenderness or enlargement compared with spironolactone. (2)

What is the mechanism of action of eplerenone?

Eplerenone is a selective aldosterone (mineralocorticoid) receptor antagonist. Blocking aldosterone's action at the mineralocorticoid receptor in the kidney, heart, and blood vessels reduces sodium and water retention, promotes potassium retention, and reduces the fibrotic and remodelling effects of aldosterone on the heart -- the basis for its cardiovascular-mortality benefit in heart failure. Its greater receptor selectivity compared with spironolactone (an older, non-selective aldosterone antagonist) is associated with a substantially lower rate of hormone-related side effects such as gynaecomastia. (1) (2)

What is the generic name of Eplerenone?

The generic name is eplerenone. (1) (2)

What class of drug is eplerenone?

Eplerenone is classed as: Selective mineralocorticoid (aldosterone) receptor antagonist. (1) (2)

References

  1. INSPRA (eplerenone) tablets, for oral use -- full prescribing informationU.S. Food and Drug Administration / DailyMed (NIH), full prescribing information, Pfizer/Viatris · United States · accessed 2026-07-30 · source 1
  2. Inspra 25 mg Film-coated Tablets -- Summary of Product Characteristicselectronic medicines compendium (emc), United Kingdom -- Pfizer/Viatris · United Kingdom · accessed 2026-07-30 · source 2
  3. Eplerenone (Inspra and generics) -- EU marketing authorisation via mutual recognition procedureEuropean Medicines Agency (EMA) / national mutual-recognition-procedure registrations · European Union · accessed 2026-07-30 · source 3
  4. PrINSPRA (eplerenone tablets) Tablets 25 mg and 50 mg -- Product MonographHealth Canada product monograph, Viatris Canada · Canada · accessed 2026-07-30 · source 4
  5. INSPRA eplerenone 25 mg and 50 mg tablet blister pack -- ARTG entry 100162, plus AusPAR (2013)Therapeutic Goods Administration (TGA), Australia · Australia · accessed 2026-07-30 · source 5
  6. INSPRA New Zealand Data Sheet and Consumer Medicine InformationMedsafe (New Zealand regulator) · New Zealand · accessed 2026-07-30 · source 6

Brand names by country

Single-ingredient eplerenone names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.

Priority countries

United States

  • Inspra25 mg, 50 mg · viatris specialty llc

United Kingdom

  • Inspra (2)MHRA licensed emc smpc confirmed · 25 mg, 50 mg · Pfizer / Viatris
  • Eplerenone (generic, e.g. Eplerenone Accord) (2)MHRA licensed generic confirmed · 25 mg, 50 mg · Accord Healthcare and other generic manufacturers

Canada

  • INSPRA

Australia

  • Inspra (5)TGA ARTG registered 2005-06-22 confirmed · 25 mg, 50 mg · Viatris Pty Ltd
  • INPLER / EPLERENONE-DWRN / EPLERENONE SP / EPLERENONE GXP (generics) (5)TGA ARTG registered generic confirmed · 25 mg, 50 mg · Arrotex Pharmaceuticals and other generic sponsors

New Zealand

  • Inspra (6)Medsafe registered confirmed · 25 mg, 50 mg · Viatris Ltd, Auckland
View brands in additional countries.

European Union

Inspra (3), Eplerenone (generic) (3)

This page provides general reference information about eplerenone and is not a substitute for advice from the prescriber managing your treatment. All dosing and treatment decisions, and interpretation of your blood test results, should be made with your prescriber.

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