Prescription medicine
Spironolactone Brand names: Aldactone, Carospir
Spironolactone (Aldactone) is a prescription medicine with an FDA approval on record since 1960. FDA's NDC Directory lists it from 38 generic labelers, and pharmacies paid $0.0426 per spironolactone 25 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- A presentation discontinued
Check it at the source: the spironolactone FDA label on DailyMed (effective November 28, 2025, Pfizer Laboratories Div Pfizer Inc); the NDA 12151 record on Drugs@FDA; every spironolactone label on DailyMed.
Highlights of the record
FDA label of November 28, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageALDACTONE 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 ).
Forms and strengths
- 25 mg
- 50 mg
- 100 mg
- 25 mg/5ml
Film-coated tablet; tablet; coated tablet; suspension.
On the market
- Earliest approval on file
- January 21, 1960 Aldactone, Pfizer; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 19 first May 7, 1980; 12 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 42 of which 38 under generic applications, 2 under brand applications, repackagers included
- Last listed patent
- October 28, 2036 Carospir oral suspension; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.0426 per tablet Spironolactone 25 mg tablet
- Shortage (FDA)
- None current 2 past records
- Recalls by its makers (FDA)
- 6 since 2013 1 Class I among all firms' recalls; latest August 5, 2025; 2 more by firms not listed as its makers
- FAERS reports
- 139,757 through July 30, 2026
What is spironolactone used for?
From the label: indications and usageALDACTONE 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. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions ( 1.2 ). […]
Conditions named in the indications of spironolactone's FDA labels, with every medicine labeled for each:
From other spironolactone labelsHigh blood pressure: Essential hypertension Spironolactone tablets are indicated for the treatment of hypertension, to lower blood pressure.
FDA pharmacologic class: Aldosterone Antagonist.
Source: FDA drug label (Aldactone), Pfizer Laboratories Div Pfizer Inc, effective November 28, 2025 (SPL set 0fed2822-3a03-4b64-9857-c682fcd462bc), via openFDA; the full label on DailyMed
Is there a generic for spironolactone (Aldactone)?
The FDA approved the first generic spironolactone on May 7, 1980. 19 generic applications are approved; 12 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 spironolactone from 38 labelers under a generic (ANDA) application and from 2 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists no patent for Aldactone tablets; a patent listed only for Carospir oral suspension runs to October 28, 2036. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1960 earliest approval on file
- 1980 first generic approved
- 2036 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for spironolactone (Aldactone)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.0426 per Spironolactone 25 mg tablet, down 14% from $0.0498 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. 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.
- Spironolactone 25 mg tablet (generic)
- Carospir 25 mg/5 mL suspension (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Spironolactone 100 mg tablet | Generic | $0.168 per tablet | $5.03 | -12% |
| Spironolactone 25 mg tablet | Generic | $0.0426 per tablet | $1.28 | -14% |
| Spironolactone 25 mg/5 mL suspension | Generic | $1.72 per mL | n/a | -19% |
| Spironolactone 50 mg tablet | Generic | $0.0832 per tablet | $2.50 | -14% |
| Carospir 25 mg/5 mL suspension | Brand | $3.45 per mL | n/a | -3% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Is spironolactone in shortage?
No spironolactone presentation is listed as in shortage in the FDA Drug Shortage Database (read October 8, 2026); its 2 records are all marked to be discontinued, the latest updated December 10, 2025. ASHP keeps a separate shortage list, which can differ.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| Aldactone, Tablet, 100 mg (NDC 0025-1031-31) | Pfizer Inc. | To Be Discontinued | December 10, 2025 |
| Aldactone, Tablet, 25 mg (NDC 0025-1001-31) | Pfizer Inc. | To Be Discontinued | December 10, 2025 |
Every spironolactone presentation in the FDA shortage database
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
Has spironolactone been recalled?
The FDA's Enforcement Report lists 8 recalls naming spironolactone since 2013: 1 Class I (the most serious), 7 Class II, 0 Class III; 3 still ongoing. 2 of them are by firms that FDA's NDC Directory does not list as a maker of spironolactone and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| August 5, 2025 | Class II | SUN PHARMACEUTICAL INDUSTRIES INC | Presence of foreign substance: identified as aluminum. |
| August 18, 2021 | Class II | Prescription Labs Inc dba Greenpark not a listed maker | Lack of Assurance of Sterility |
| January 27, 2021 | Class I | Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals | Labeling: Label Mix-Up - Prepackaged bottles labeled spironolactone 25 mg may contain spironolactone 50 mg tablets. |
| January 27, 2021 | Class II | Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals | Labeling: Label Mix-Up - Prepackaged bottles labeled spironolactone 50 mg may contain spironolactone 25 mg tablets. |
| February 12, 2015 | Class II | Health Innovations Pharmacy, Inc not a listed maker | Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures … |
| September 4, 2013 | Class II | Greenstone Llc | Marketed without an Approved NDA/ANDA: This recall is being initiated because of changes to the dissolution profile in distributed lots resulting from a … |
| September 4, 2013 | Class II | Pfizer Us Pharmaceutical Group | Marketed without an Approved NDA/ANDA: This recall is being initiated because of changes to the dissolution profile in distributed lots resulting from a … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the spironolactone label say about other medicines?
The spironolactone label names 13 other medicines in its interaction, contraindication or warning sections. The labels of 40 other medicines name spironolactone. 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 |
|---|---|---|
| Abiraterone | drug interactions | Spironolactone binds to the androgen receptor and may increase prostate-specific antigen (PSA) levels in abiraterone-treated prostate cancer patients. Concomitant use of spironolactone and abiraterone is not recommended. |
| Cholestyramine | drug interactions | Cholestyramine: Hyperkalemic metabolic acidosis has been reported with concomitant use ( 7.5 ). |
| Cisplatin | warnings and precautions | Worsening of renal function can also occur with concomitant use of nephrotoxic drugs (e.g., aminoglycosides, cisplatin, and NSAIDs). Monitor volume status and renal function periodically. |
| Digoxin | drug interactions | ALDACTONE can interfere with radioimmunologic assays of digoxin exposure ( 7.4 ). |
| Eplerenone | contraindications | Concomitant use of eplerenone ALDACTONE is contraindicated in patients with ( 4 ): ▪ Hyperkalemia ▪ Addison's disease ▪ Concomitant use of eplerenone |
| Heparin | drug interactions | heparin and low molecular weight heparin |
| Lithium | drug interactions | Increased risk of lithium toxicity ( 7.2 ). |
| Midazolam | drug interactions | Dosage adjustments of the drugs metabolized by CYP2C8 (e.g., repaglinide) and CYP3A4/5 (e.g., midazolam, sirolimus and tacrolimus) may be necessary if they are given concurrently with spironolactone. |
| Mitotane | drug interactions | Avoid concomitant use of ALDACTONE and mitotane ( 7.8 ). |
| Repaglinide | drug interactions | Dosage adjustments of the drugs metabolized by CYP2C8 (e.g., repaglinide) and CYP3A4/5 (e.g., midazolam, sirolimus and tacrolimus) may be necessary if they are given concurrently with spironolactone. |
| Sirolimus | drug interactions | Dosage adjustments of the drugs metabolized by CYP2C8 (e.g., repaglinide) and CYP3A4/5 (e.g., midazolam, sirolimus and tacrolimus) may be necessary if they are given concurrently with spironolactone. |
| Tacrolimus | drug interactions | Dosage adjustments of the drugs metabolized by CYP2C8 (e.g., repaglinide) and CYP3A4/5 (e.g., midazolam, sirolimus and tacrolimus) may be necessary if they are given concurrently with spironolactone. |
| Trimethoprim | drug interactions | … aldosterone blockers non-steroidal anti-inflammatory drugs (NSAIDs) heparin and low molecular weight heparin trimethoprim |
Other labels that name spironolactone
Source: FDA drug label (Aldactone), Pfizer Laboratories Div Pfizer Inc, effective November 28, 2025 (SPL set 0fed2822-3a03-4b64-9857-c682fcd462bc), via openFDA; the full label on DailyMed
What do FAERS reports show for spironolactone?
The FDA Adverse Event Reporting System holds 139,757 reports that list spironolactone among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 18,069 are coded as a death and 66,281 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 spironolactone?
29 other medicines are given the same way (oral) and in the same FDA class as spironolactone 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 |
|---|---|---|---|---|
| Eplerenone | High blood pressure, Heart failure | 9 labelers | $0.308 per tablet 25 mg 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, Edema (fluid retention) | 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 |
| Enalapril | High blood pressure, Heart failure | 29 labelers | $0.0664 per tablet 10 mg tablet | No current entry |
Every medicine labeled for the same conditions as spironolactone
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does spironolactone compare with medicines for the same use?
15 side-by-side pages set spironolactone beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to spironolactone
- 29 medicines for the same use
- Other aldosterone antagonists
- the pharmacologic class, with prices and generics
- Spironolactone side effects
- the label's list beside FAERS reports
- Spironolactone shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other