Two medicines, side by side
Sacubitril/valsartan vs spironolactone
Sacubitril/valsartan and spironolactone are both labeled for heart failure. Drugs@FDA records approvals of sacubitril/valsartan since 2015 and of spironolactone since 1960. Pharmacies paid $0.533 per unit (Sacubitril-valsartan 49-51 mg) and $0.0426 per spironolactone 25 mg tablet (NADAC, October 7, 2026); the strengths differ, so the two prices are not like for like. Sacubitril/valsartan's other strengths are brand-only: $11.56 per Entresto 49 mg-51 mg tablet. In FDA's classes, sacubitril/valsartan is a neprilysin inhibitor and spironolactone an aldosterone antagonist.
Check it at the source: the sacubitril/valsartan FDA label on DailyMed (effective July 6, 2026); the spironolactone FDA label on DailyMed (effective November 28, 2025).
Highlights of the sacubitril and valsartan record
Sacubitril and valsartan (Entresto) · label of July 6, 2026
FETAL TOXICITY When pregnancy is detected, discontinue ENTRESTO as soon as possible (5.1) Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus (5.1) WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning. When pregnancy is detected, discontinue ENTRESTO as soon as possible. ( 5.1 ) Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.
Used for
From the label: indicationsENTRESTO is a combination of sacubitril, a neprilisin inhibitor, and valsartan, an angiotensin II receptor blocker, and is indicated: to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal. […]
On the market
- Earliest approval on file
- July 7, 2015
- Generic labelers
- 27 labelers
- Pharmacy cost
- $0.533 per unit
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 (Sacubitril/valsartan label of July 6, 2026, Spironolactone label of November 28, 2025); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do sacubitril/valsartan and spironolactone differ on the record?
In FDA's classes, sacubitril/valsartan is a neprilysin inhibitor and spironolactone an aldosterone antagonist.
How each works, in its label's words: Sacubitril/valsartan, “ENTRESTO contains a neprilysin inhibitor, sacubitril, and an angiotensin receptor blocker, valsartan.”; Spironolactone, “Spironolactone and its active metabolites are specific pharmacologic antagonists of aldosterone, acting primarily through competitive binding of receptors at the aldosterone-dependent …”
Half-life, in each label's words: Sacubitril/valsartan, “Sacubitril, LBQ657, and valsartan are eliminated from plasma with a mean elimination half-life (T 1/2 ) of …”; Spironolactone, “The mean half-life values of its metabolites including canrenone, 7-α-(thiomethyl) spirolactone (TMS), and …”
Only the sacubitril/valsartan label carries a boxed warning.
Generics: sacubitril/valsartan since 2024; spironolactone since 1980 (Drugs@FDA).
| Sacubitril/valsartan | Spironolactone | |
|---|---|---|
| Labeled for | Heart failure | Heart failure, Edema (fluid retention), High blood pressure |
| Pharmacologic class | Angiotensin 2 Receptor Blocker, Neprilysin Inhibitor | Aldosterone Antagonist |
| How it works (label) | ENTRESTO contains a neprilysin inhibitor, sacubitril, and an angiotensin receptor blocker, valsartan. ENTRESTO inhibits neprilysin (neutral endopeptidase; | 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) | Sacubitril, LBQ657, and valsartan are eliminated from plasma with a mean elimination half-life (T 1/2 ) of approximately 1.4 hours, 11.5 hours, and 9.9 hours, respectively. | 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) | July 7, 2015 | January 21, 1960 |
| First generic approved | May 28, 2024 | May 7, 1980 |
| Generic labelers (NDC) | 27 labelers | 38 labelers |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | $0.533 per unit (Sacubitril-valsartan 49-51 mg) | $0.0426 per tablet (Spironolactone 25 mg tablet) |
| 12-month price change | -54% | -14% |
| Boxed warning | Yes | 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) | 115,389 | 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)
What next?
- Alternatives to sacubitril/valsartan
- every medicine labeled for the same conditions