Two medicines, side by side
Eplerenone vs spironolactone
Eplerenone and spironolactone are both labeled for high blood pressure and heart failure. Drugs@FDA records approvals of eplerenone since 2002 and of spironolactone since 1960. Pharmacies paid $0.308 per eplerenone 25 mg tablet and $0.0426 per spironolactone 25 mg tablet (NADAC, October 7, 2026). How each works, in its label's words: Eplerenone, “Eplerenone binds to the mineralocorticoid receptor and blocks the binding of aldosterone, a component of the renin-angiotensin-aldosterone-system (RAAS).”; Spironolactone, “Spironolactone and its active metabolites are specific pharmacologic antagonists of aldosterone, acting primarily through competitive binding of receptors at the aldosterone-dependent …”
Check it at the source: the eplerenone FDA label on DailyMed (effective June 23, 2025); the spironolactone FDA label on DailyMed (effective November 28, 2025).
Highlights of the eplerenone record
Eplerenone (Inspra) · label of June 23, 2025
Used for
From the label: indicationsINSPRA 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. […]
On the market
- Earliest approval on file
- September 27, 2002
- Generic labelers
- 9 labelers
- Pharmacy cost
- $0.308 per tablet
Supply and safety
- Shortage
- No current entry
- Recalls
- 0
Highlights of the spironolactone record
Spironolactone (Aldactone) · label of November 28, 2025
Used for
From the label: indicationsALDACTONE is an aldosterone antagonist indicated for: • The treatment of NYHA Class III–IV heart failure and reduced ejection fraction to increase survival, manage edema, and to reduce the need for hospitalization for heart failure ( 1.1 ). • Use as an add-on therapy for the treatment of hypertension, to lower blood pressure. […]
On the market
- Earliest approval on file
- January 21, 1960
- Generic labelers
- 38 labelers
- Pharmacy cost
- $0.0426 per tablet
Supply and safety
- Shortage
- A presentation being discontinued
- Recalls
- 6
Source: FDA drug labels via openFDA (Eplerenone label of June 23, 2025, Spironolactone label of November 28, 2025); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do eplerenone and spironolactone differ on the record?
How each works, in its label's words: Eplerenone, “Eplerenone binds to the mineralocorticoid receptor and blocks the binding of aldosterone, a component of the renin-angiotensin-aldosterone-system (RAAS).”; Spironolactone, “Spironolactone and its active metabolites are specific pharmacologic antagonists of aldosterone, acting primarily through competitive binding of receptors at the aldosterone-dependent …”
Both are in FDA's class aldosterone antagonists.
Half-life, in each label's words: Eplerenone, “12.3 Pharmacokinetics Eplerenone is cleared predominantly by cytochrome P450 (CYP) 3A4 metabolism, with an elimination …”; Spironolactone, “The mean half-life values of its metabolites including canrenone, 7-α-(thiomethyl) spirolactone (TMS), and …”
Generics: eplerenone since 2008; spironolactone since 1980 (Drugs@FDA).
| Eplerenone | Spironolactone | |
|---|---|---|
| Labeled for | Heart failure, High blood pressure | Heart failure, Edema (fluid retention), High blood pressure |
| Pharmacologic class | Aldosterone Antagonist | Aldosterone Antagonist |
| How it works (label) | Eplerenone binds to the mineralocorticoid receptor and blocks the binding of aldosterone, a component of the renin-angiotensin-aldosterone-system (RAAS). | Spironolactone and its active metabolites are specific pharmacologic antagonists of aldosterone, acting primarily through competitive binding of receptors at the aldosterone-dependent sodium-potassium exchange site in the distal convoluted … |
| Half-life (label) | 12.3 Pharmacokinetics Eplerenone is cleared predominantly by cytochrome P450 (CYP) 3A4 metabolism, with an elimination half-life of 3 to 6 hours. | The mean half-life values of its metabolites including canrenone, 7-α-(thiomethyl) spirolactone (TMS), and 6-β-hydroxy-7-α-(thiomethyl) spirolactone (HTMS) are 16.5, 13.8, and 15 hours, respectively. |
| Earliest approval on file (Drugs@FDA) | September 27, 2002 | January 21, 1960 |
| First generic approved | July 30, 2008 | May 7, 1980 |
| Generic labelers (NDC) | 9 labelers | 38 labelers |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | $0.308 per tablet (Eplerenone 25 mg tablet) | $0.0426 per tablet (Spironolactone 25 mg tablet) |
| 12-month price change | -31% | -14% |
| Boxed warning | No | No |
| Shortage now | No current entry | A presentation being discontinued |
| Recalls recorded | 0 | 6 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 12,729 | 139,757 |
| DEA schedule | none | none |
Source: Drugs@FDA, FDA NDC Directory, CMS NADAC of October 7, 2026, FDA shortages and recalls, FAERS via openFDA (FDA files October 8, 2026)
Do their labels mention each other?
Spironolactone label, contraindicationsConcomitant use of eplerenone ALDACTONE is contraindicated in patients with ( 4 ): ▪ Hyperkalemia ▪ Addison's disease ▪ Concomitant use of eplerenone
Spironolactone label, contraindicationsHyperkalemia Addison’s disease Concomitant use of eplerenone Spironolactone oral suspension is contraindicated in patients with ( 4 ):
Source: FDA drug labels via openFDA
What next?
- Alternatives to eplerenone
- every medicine labeled for the same conditions