Prescription medicine
Eplerenone Brand names: Inspra
Eplerenone (Inspra) is a prescription medicine with an FDA approval on record since 2002. FDA's NDC Directory lists it from 9 generic labelers, and pharmacies paid $0.308 per eplerenone 25 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the eplerenone FDA label on DailyMed (effective June 23, 2025, Viatris Specialty LLC); the NDA 21437 record on Drugs@FDA; every eplerenone label on DailyMed.
Highlights of the record
FDA label of June 23, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageINSPRA is an aldosterone antagonist indicated for:
Improving survival of stable adult patients with symptomatic heart failure with reduced ejection fraction (HFrEF) after an acute myocardial infarction.
Forms and strengths
- 25 mg
- 50 mg
Film-coated tablet; coated tablet; tablet.
On the market
- Earliest approval on file
- September 27, 2002 Inspra, Upjohn; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 9 first July 30, 2008; 8 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 11 of which 9 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.308 per tablet Eplerenone 25 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 12,729 through July 30, 2026
What is eplerenone used for?
From the label: indications and usageINSPRA is an aldosterone antagonist indicated for:
Improving survival of stable adult patients with symptomatic heart failure with reduced ejection fraction (HFrEF) after an acute myocardial infarction. ( 1.1 )
The treatment of hypertension in adults, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. […]
Conditions named in the indications of eplerenone's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Aldosterone Antagonist.
Source: FDA drug label (Inspra), NDA021437 (Upjohn), as published by Viatris Specialty LLC, effective June 23, 2025 (SPL set 1a52bedc-8e2c-4116-a296-a87770676b4a), via openFDA; the full label on DailyMed
Is there a generic for eplerenone (Inspra)?
The FDA approved the first generic eplerenone on July 30, 2008. 9 generic applications are approved; 8 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists eplerenone from 9 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 2002 earliest approval on file
- 2008 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for eplerenone (Inspra)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.308 per Eplerenone 25 mg tablet, down 31% from $0.446 on October 8, 2025. The survey records the price, not the reason for a change; large moves often follow a new generic or a list-price change. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Eplerenone 25 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Eplerenone 25 mg tablet | Generic | $0.308 per tablet | $9.24 | -31% |
| Eplerenone 50 mg tablet | Generic | $0.450 per tablet | $13.51 | -12% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the eplerenone label say about other medicines?
The eplerenone label names 13 other medicines in its interaction, contraindication or warning sections. The labels of 10 other medicines name eplerenone. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Amiloride | contraindications | concomitant administration of potassium supplements or potassium-sparing diuretics (e.g., amiloride, spironolactone, or triamterene) [see Warnings and Precautions (5.1), Adverse Reactions (6.2), Drug Interactions (7), and Clinical Pharmacology (12.3) ]. |
| Clarithromycin | contraindications | concomitant administration of strong CYP3A inhibitors (e.g., ketoconazole, itraconazole, nefazodone, troleandomycin, clarithromycin, ritonavir, and nelfinavir) [see Drug Interactions (7.1), Clinical Pharmacology (12.3) ]. |
| Erythromycin | drug interactions | CYP3A Inhibitors: In post-MI HFrEF patients, do not exceed 25 mg once daily when used with moderate CYP3A inhibitors (e.g., verapamil, erythromycin, saquinavir, fluconazole). |
| Fluconazole | drug interactions | CYP3A Inhibitors: In post-MI HFrEF patients, do not exceed 25 mg once daily when used with moderate CYP3A inhibitors (e.g., verapamil, erythromycin, saquinavir, fluconazole). |
| Itraconazole | contraindications | concomitant administration of strong CYP3A inhibitors (e.g., ketoconazole, itraconazole, nefazodone, troleandomycin, clarithromycin, ritonavir, and nelfinavir) [see Drug Interactions (7.1), Clinical Pharmacology (12.3) ]. |
| Ketoconazole | contraindications | concomitant administration of strong CYP3A inhibitors (e.g., ketoconazole, itraconazole, nefazodone, troleandomycin, clarithromycin, ritonavir, and nelfinavir) [see Drug Interactions (7.1), Clinical Pharmacology (12.3) ]. |
| Lithium | drug interactions | Lithium toxicity has been reported in patients receiving lithium concomitantly with diuretics and ACE inhibitors. |
| Nefazodone | contraindications | concomitant administration of strong CYP3A inhibitors (e.g., ketoconazole, itraconazole, nefazodone, troleandomycin, clarithromycin, ritonavir, and nelfinavir) [see Drug Interactions (7.1), Clinical Pharmacology (12.3) ]. |
| Nelfinavir | contraindications | concomitant administration of strong CYP3A inhibitors (e.g., ketoconazole, itraconazole, nefazodone, troleandomycin, clarithromycin, ritonavir, and nelfinavir) [see Drug Interactions (7.1), Clinical Pharmacology (12.3) ]. |
| Ritonavir | contraindications | concomitant administration of strong CYP3A inhibitors (e.g., ketoconazole, itraconazole, nefazodone, troleandomycin, clarithromycin, ritonavir, and nelfinavir) [see Drug Interactions (7.1), Clinical Pharmacology (12.3) ]. |
| Spironolactone | contraindications | concomitant administration of potassium supplements or potassium-sparing diuretics (e.g., amiloride, spironolactone, or triamterene) [see Warnings and Precautions (5.1), Adverse Reactions (6.2), Drug Interactions (7), and Clinical Pharmacology (12.3) ]. |
| Triamterene | contraindications | concomitant administration of potassium supplements or potassium-sparing diuretics (e.g., amiloride, spironolactone, or triamterene) [see Warnings and Precautions (5.1), Adverse Reactions (6.2), Drug Interactions (7), and Clinical Pharmacology (12.3) ]. |
| Verapamil | drug interactions | CYP3A Inhibitors: In post-MI HFrEF patients, do not exceed 25 mg once daily when used with moderate CYP3A inhibitors (e.g., verapamil, erythromycin, saquinavir, fluconazole). |
Other labels that name eplerenone
Source: FDA drug label (Inspra), NDA021437 (Upjohn), as published by Viatris Specialty LLC, effective June 23, 2025 (SPL set 1a52bedc-8e2c-4116-a296-a87770676b4a), via openFDA; the full label on DailyMed
What do FAERS reports show for eplerenone?
The FDA Adverse Event Reporting System holds 12,729 reports that list eplerenone among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1,237 are coded as a death and 6,664 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as eplerenone?
29 other medicines are given the same way (oral) and in the same FDA class as eplerenone or labeled mainly for the same use (heart failure), the same class first. Heart failure lists all 37 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Spironolactone | High blood pressure, Heart failure | 38 labelers | $0.0426 per tablet 25 mg tablet | A presentation being discontinued |
| Hydrochlorothiazide and spironolactone | High blood pressure, Heart failure | 6 labelers | $0.483 per tablet 25-25 tablet | No current entry |
| Metoprolol | High blood pressure, Heart failure | 64 labelers | $0.085 per tablet 100 mg tablet | A presentation being discontinued |
| Lisinopril | High blood pressure, Heart failure | 36 labelers | $0.0254 per tablet 20 mg tablet | No current entry |
| Carvedilol | High blood pressure, Heart failure | 41 labelers | $0.0179 per tablet 6.25 mg tablet | No current entry |
| Hydrochlorothiazide | High blood pressure, Heart failure | 44 labelers | $0.0115 per tablet 25 mg tablet | A presentation being discontinued |
| Valsartan | High blood pressure, Heart failure | 34 labelers | $0.0963 per tablet 40 mg tablet | A presentation being discontinued |
| Furosemide | High blood pressure, Heart failure | 33 labelers | $0.026 per tablet 20 mg tablet | In shortage |
Every medicine labeled for the same conditions as eplerenone
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does eplerenone compare with medicines for the same use?
4 side-by-side pages set eplerenone beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to eplerenone
- 29 medicines for the same use
- Other aldosterone antagonists
- the pharmacologic class, with prices and generics
- Eplerenone side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other