Prescription medicine
Hydrochlorothiazide and spironolactone First approved as Aldactazide
Hydrochlorothiazide and spironolactone (Aldactazide) is a prescription medicine with an FDA approval on record since 1961. FDA's NDC Directory lists it from 6 generic labelers, and pharmacies paid $0.483 per spironolactone-hydrochlorothiazide 25-25 tablet in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the hydrochlorothiazide and spironolactone FDA label on DailyMed (effective March 11, 2026, Mylan Pharmaceuticals Inc.); the NDA 12616 record on Drugs@FDA; every hydrochlorothiazide and spironolactone label on DailyMed.
Highlights of the record
FDA label of March 11, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageSpironolactone, an ingredient of spironolactone and hydrochlorothiazide tablets, has been shown to be a tumorigen in chronic toxicity studies in rats (see Precautions section).
Forms and strengths
- 25 mg / 25 mg
Tablet; film-coated tablet.
On the market
- Earliest approval on file
- January 27, 1961 Aldactazide, Pfizer; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 10 first August 3, 1979; 3 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 7 of which 6 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.483 per tablet Spironolactone-hydrochlorothiazide 25-25 tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 751 through July 30, 2026
What is hydrochlorothiazide and spironolactone used for?
From the label: indications and usageSpironolactone, an ingredient of spironolactone and hydrochlorothiazide tablets, has been shown to be a tumorigen in chronic toxicity studies in rats (see Precautions section). Spironolactone and hydrochlorothiazide tablets should be used only in those conditions described below. Unnecessary use of this drug should be avoided. Spironolactone and hydrochlorothiazide tablets are indicated for: Edematous conditions for patients with: Congestive heart failure:
For the management of edema and sodium retention when the patient is only partially responsive to, or is intolerant of, other therapeutic measures; […]
Conditions named in the indications of hydrochlorothiazide and spironolactone's FDA labels, with every medicine labeled for each:
From other hydrochlorothiazide and spironolactone labelsHigh blood pressure: Essential hypertension:
FDA pharmacologic class: Aldosterone Antagonist and Thiazide Diuretic.
Source: FDA drug label (Spironolactone and Hydrochlorothiazide), Mylan Pharmaceuticals Inc., effective March 11, 2026 (SPL set 0c8c973f-13a2-4883-8316-4006398e2931), via openFDA; the full label on DailyMed
Is there a generic for hydrochlorothiazide and spironolactone (Aldactazide)?
The FDA approved the first generic hydrochlorothiazide and spironolactone on August 3, 1979. 10 generic applications are approved; 3 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 hydrochlorothiazide and spironolactone from 6 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1961 earliest approval on file
- 1979 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for hydrochlorothiazide and spironolactone (Aldactazide)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.483 per Spironolactone-hydrochlorothiazide 25-25 tablet, down 14% from $0.560 on October 8, 2025. 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-hydrochlorothiazide 25-25 tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Spironolactone-hydrochlorothiazide 25-25 tablet | Generic | $0.483 per tablet | $14.50 | -14% |
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 hydrochlorothiazide and spironolactone label say about other medicines?
The hydrochlorothiazide and spironolactone label names 7 other medicines in its interaction, contraindication or warning sections. 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 | Abiraterone Spironolactone binds to the androgen receptor and may increase prostate-specific antigen (PSA) levels in abiraterone-treated prostate cancer patients. |
| Cholestyramine | drug interactions | Thiazide-induced electrolyte disturbances, i.e. hypokalemia, hypomagnesemia, increase the risk of digoxin toxicity, which may lead to fatal arrhythmic events (see Precautions ) Cholestyramine Hyperkalemic metabolic acidosis has been reported in patients given spironolactone concurrently with cholestyramine. |
| Digoxin | drug interactions | Digoxin Spironolactone has been shown to increase the half-life of digoxin. |
| Heparin | drug interactions | Drug interactions ACE inhibitors, Angiotensin II receptor antagonists, aldosterone blockers, potassium supplements, heparin, low molecular weight heparin, and other drugs known to cause hyperkalemia Concomitant administration may lead to severe hyperkalemia. |
| Indomethacin | drug interactions | Combination of NSAIDs, e.g., indomethacin, with potassium-sparing diuretics has been associated with severe hyperkalemia. |
| Lithium | drug interactions | Lithium Lithium generally should not be given with diuretics. |
| Mitotane | drug interactions | Mitotane Avoid concomitant use of spironolactone and hydrochlorothiazide tablets and mitotane. |
Check hydrochlorothiazide and spironolactone against other medicines
Source: FDA drug label (Spironolactone and Hydrochlorothiazide), Mylan Pharmaceuticals Inc., effective March 11, 2026 (SPL set 0c8c973f-13a2-4883-8316-4006398e2931), via openFDA; the full label on DailyMed
What do FAERS reports show for hydrochlorothiazide and spironolactone?
The FDA Adverse Event Reporting System holds 751 reports that list hydrochlorothiazide and spironolactone among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 45 are coded as a death and 264 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 hydrochlorothiazide and spironolactone?
27 other medicines are given the same way (oral) and in the same FDA class as hydrochlorothiazide and 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 |
| Chlorothiazide | High blood pressure, Heart failure, Edema (fluid retention) | none listed | n/a | A presentation being discontinued |
| 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 |
| 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 hydrochlorothiazide and spironolactone
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to hydrochlorothiazide and spironolactone
- 27 medicines for the same use
- Other aldosterone antagonists
- the pharmacologic class, with prices and generics
- Hydrochlorothiazide and spironolactone side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other