Home › NDC Lookup › Ingredients › Spironolactone › 00904-6927-61

⚪image loading
(from DailyMed)

spironolactone 25 mg Tablet, Film Coated, 100-count

by Major Pharmaceuticals · 100 BLISTER PACK in 1 CARTON (0904-6927-61) / 1 TABLET in 1 BLISTER PACK

NDC 00904-6927-61

🏷️ FDA NDC (as labeled) 0904-6927-61 billing pads the labeler segment with a zero

Rx only Generic On market Non-controlled

🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm

📋 All sources & update times →

This page is curated, coded, and maintained by Dr. Brian Staiger, PharmD

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️

Other active recalls for Spironolactone (different manufacturers) — 1 · tap to view

These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.

Class II · Aug 5, 2025 — Presence of foreign substance: identified as aluminum. (SUN PHARMACEUTICAL INDUSTRIES INC) · FDA recall D-0574-2025

Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 0904-6927-61

Product NDC 0904-6927

11-digit billing NDC 00904692761

NCPDP billing unit EA — each (per item)

RxCUI 313096

UNII 27O7W4T232

Application # ANDA205936

SPL Set ID 0c45d793-6f2f-4622-b5ed-6875acfbc02b

Established class (EPC) Aldosterone Antagonist

Mechanism of action Aldosterone Antagonists

DEA schedule Non-controlled

Marketing category ANDA

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2018-08-15

Route ORAL

Dosage form TABLET, FILM COATED

Substance SPIRONOLACTONE

GPI-14 37500020000305

GPI class Spironolactone

GCN Seq No 006817

GCN 27691

HICL code 002901

Ingredient (HICL) Spironolactone

HIC1 code R

Therapeutic class — broad (HIC1) Kidney/Urinary Tract

HIC2 code R1

Therapeutic class — intermediate (HIC2) Affect Primarily Kidneys/Urinary Tract

HIC3 code R1H

Therapeutic class — specific (HIC3) Potassium Sparing Diuretics

AHFS code 24:32.20.08

AHFS class Steroidal Mineralocorticoid Receptor Ant

FDB label name SPIRONOLACTONE 25 MG TABLET

FDB brand name Spironolactone

Legend status F — Federal legend — prescription drug or device

TE code (Orange Book) AB · RLD · RS

Why two NDCs? The FDA registers this code as 0904-6927-61 — a 4-4-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the labeler segment → 00904-6927-61. Same drug, same package — only the format differs.

Where does this data come from?

Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Aldosterone Antagonist class.

Pharmacologic class Aldosterone Antagonist

Drug family (ATC) Aldosterone antagonists

How it works Aldosterone Antagonists

Where does this data come from?

Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerMajor Pharmaceuticals

Application holderZYDUS PHARMACEUTICALS USA INC

FDA applicationANDA205936 (ANDA)

Labeler code00904

First marketedAug 2018

Product typeHuman Prescription Drug

Portfolio629 products on file

🔎 All NDCs from Major Pharmaceuticals

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).

Where does this data come from?

Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name SPIRONOLACTONE 25 MG TABLET Ingredient Spironolactone

📗 Our plain-language guide HelloPharmacist

Spironolactone has a few different uses depending on your situation. Most commonly, it's prescribed to treat moderate-to-severe heart failure, high blood pressure, or fluid buildup...
What exactly is spironolactone used for?
Yes, it actually matters quite a bit. Food can nearly double the amount of spironolactone your body absorbs. That doesn't mean you must always take it with food — but you should pi...
Does it matter if I take it with food or not?

📖 Read our full Spironolactone guide →

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

Some supplements/herbs that may interact with Spironolactone — tap one for details:

Activated CharcoalMajor Coffee CharcoalModerate European MandrakeModerate GlucomannanModerate Guar GumModerate Gum ArabicModerate Slippery ElmModerate TragacanthModerate

🌿 Every supplement checked against Spironolactone (206 interactions) — ranked by severity →

Nutrient depletion considerations

Spironolactone may be associated with lower levels of 7 nutrients — worth a chat with your pharmacist, not a cause for alarm.

POTASSIUM Major Depletion VITAMIN C Insignificant Depletion MAGNESIUM Moderate Depletion THIAMINE Moderate Depletion COENZYME Q10 Insufficient Evidence +2 more

🧪 Full Spironolactone nutrient depletion report →

An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.

Where does this data come from?

Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

UNII 4846Q921YM
Calcium sulfate dihydrate is a white, crystalline mineral salt. It works as a filler and binder in tablets and capsules, helping give them structure and hold ingredients together.
UNII M28OL1HH48
Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
UNII 3NXW29V3WO
Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
UNII EWQ57Q8I5X
Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
UNII OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
UNII 30IQX730WE
Polyethylene glycol 6000 is a synthetic polymer made from ethylene glycol units. It acts as a binder, filler, and solubilizer in medicines to help hold ingredients together, add bulk, and improve how well active drugs dissolve and absorb.
UNII U725QWY32X
Povidone K30 is a synthetic polymer made from petroleum. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in the stomach so the medicine can be absorbed.
UNII ETJ7Z6XBU4
Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
UNII 368GB5141J
A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
UNII O8232NY3SJ
A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
UNII 7SEV7J4R1U
A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

13 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?

Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?

No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.

Why might an inactive ingredient be missing?

Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.

Can inactive ingredients matter?

Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price system	Per ea	Per package
Retail pharmacies payNADAC · weekly	$0.043	$4.30 / 100 tablet
Medicaid paysCMS SDUD · 12 mo	$0.4060	$40.60 / 100 tablet
Medicare drug plans payPart D · Q2 2026	$0.1319	$13.19 / 100 tablet

NADAC price history (per ea) — tap or hover for the price & month

▼ Down 15% over the last 24 months.

Where does this data come from?

NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Spironolactone 25 mg 00378-2146-01	Mylan	100 tablets	$0.043	AB	Availability likely	—
spironolactone 25 mgthis 00904-6927-61	Major	100 tablets	$0.043	AB	Availability likely	—
spironolactone 25 mg 31722-0094-01	Camber	100 tablets	$0.043	AB	Availability likely	—
Spironolactone 25 mg 51079-0103-20	Mylan	1 tablet	$0.043	AB	Availability likely	—
Spironolactone 25 mg 53489-0143-01	Sun	100 tablets	$0.043	AB	Availability likely	—
Spironolactone 25 mg 53746-0511-01	Amneal	100 tablets	$0.043	AB	Availability likely	—
Spironolactone 25 mg 59651-0426-01	Aurobindo	100 tablets	$0.043	AB	Availability likely	—
Spironolactone 25 mg 60687-0465-01	American	100 tablets	$0.043	AB	Availability likely	—
Spironolactone 25 mg 64980-0706-01	Rising	100 tablets	$0.043	AB	Availability likely	—
spironolactone 25 mg 68382-0660-01	Zydus	100 tablets	$0.043	AB	Availability likely	—
Spironolactone 25 mg 69584-0852-10	Oxford	100 tablets	$0.043	AB	Availability likely	—
Spironolactone 25 mg 72603-0134-01	NorthStar	100 tablets	$0.043	AB	Availability likely	—
Spironolactone 25 mg 16729-0225-01	Accord	100 tablets	$0.045	AB	Availability likely	+4%
Spironolactone 25 mg 59746-0216-01	Jubilant	100 tablets	$0.052	AB	FDA listed	+21%
Aldactone 25 mg 00025-1001-31	Pfizer	100 tablets	—	AB	FDA listed	—
Spironolactone 25 mg 00615-8451-05	NCS	15 tablets	—	AB	FDA listed	—
Spironolactone 25 mg 42708-0101-30	QPharma,	30 tablets	—	AB	FDA listed	—
Spironolactone 25 mg 42708-0126-30	QPharma,	30 tablets	—	AB	FDA listed	—
Spironolactone 25 mg 43063-0832-01	PD-Rx	100 tablets	—	AB	FDA listed	—
Spironolactone 25 mg 48433-0087-20	Safecor	1 tablet	—	AB	FDA listed	—
Spironolactone 25 mg 50090-0136-00	A-S	100 tablets	—	AB	FDA listed	—
Spironolactone 25 mg 50090-3747-00	A-S	100 tablets	—	AB	FDA listed	—
Spironolactone 25 mg 50090-6369-00	A-S	100 tablets	—	AB	FDA listed	—
Spironolactone 25 mg 50090-6908-00	A-S	100 tablets	—	AB	FDA listed	—
Spironolactone 25 mg 50090-6909-00	A-S	90 tablets	—	AB	FDA listed	—
Spironolactone 25 mg 50090-7797-00	A-S	90 tablets	—	AB	FDA listed	—
spironolactone 25 mg 55154-3556-00	Cardinal	10 tablets	—	AB	FDA listed	—
Spironolactone 25 mg 55154-5517-00	Cardinal	1 tablet	—	AB	FDA listed	—
Spironolactone 25 mg 63187-0841-03	Proficient	3 tablets	—	AB	FDA listed	—
Spironolactone 25 mg 63629-1061-01	Bryant	100 tablets	—	AB	FDA listed	—
Spironolactone 25 mg 63629-1062-01	Bryant	500 tablets	—	AB	FDA listed	—
Spironolactone 25 mg 63629-1064-01	Bryant	30 tablets	—	AB	FDA listed	—
Spironolactone 25 mg 63629-1830-01	Bryant	30 tablets	—	AB	FDA listed	—
Spironolactone 25 mg 63629-2437-01	Bryant	500 tablets	—	AB	FDA listed	—
Spironolactone 25 mg 63629-8539-01	Bryant	1000 tablets	—	AB	FDA listed	—
Spironolactone 25 mg 65162-0511-03	Amneal	30 tablets	—	AB	FDA listed	—
Spironolactone 25 mg 67046-0744-03	Coupler	30 tablets	—	AB	FDA listed	—
Spironolactone 25 mg 67544-0310-30	Aphena	30 tablets	—	AB	FDA listed	—
Spironolactone 25 mg 68071-2989-03	NuCare	30 tablets	—	AB	FDA listed	—
Spironolactone 25 mg 68071-3375-01	NuCare	120 tablets	—	AB	FDA listed	—
Spironolactone 25 mg 68071-3967-03	NuCare	30 tablets	—	AB	FDA listed	—
Spironolactone 25 mg 68071-3969-01	NuCare	100 tablets	—	AB	FDA listed	—
Spironolactone 25 mg 68788-8545-03	Preferred	30 tablets	—	AB	FDA listed	—
Spironolactone 25 mg 70518-3625-00	REMEDYREPACK	30 tablets	—	AB	FDA listed	—
Spironolactone 25 mg 70518-4350-00	REMEDYREPACK	100 tablets	—	AB	FDA listed	—
spironolactone 25 mg 70518-4470-00	REMEDYREPACK	1 tablet	—	AB	FDA listed	—
spironolactone 25 mg 70771-1027-00	Zydus	1000 tablets	—	AB	FDA listed	—
Spironolactone 25 mg 71205-0146-30	Proficient	30 tablets	—	AB	FDA listed	—
Spironolactone 25 mg 71205-0772-30	Proficient	30 tablets	—	AB	FDA listed	—
Spironolactone 25 mg 71335-0053-01	Bryant	30 tablets	—	AB	FDA listed	—
Spironolactone 25 mg 71335-2205-01	Bryant	500 tablets	—	AB	FDA listed	—
Spironolactone 25 mg 71335-2217-01	Bryant	1000 tablets	—	AB	FDA listed	—
Spironolactone 25 mg 71335-2301-01	Bryant	1000 tablets	—	AB	FDA listed	—
Spironolactone 25 mg 71335-2366-01	Bryant	30 tablets	—	AB	FDA listed	—
Spironolactone 25 mg 71335-2846-01	Bryant	100 tablets	—	AB	FDA listed	—
Spironolactone 25 mg 71610-0102-60	Aphena	90 tablets	—	AB	FDA listed	—
Spironolactone 25 mg 71610-0742-30	Aphena	30 tablets	—	AB	FDA listed	—
Spironolactone 25 mg 71610-0970-30	Aphena	30 tablets	—	AB	FDA listed	—
Spironolactone 25 mg 72162-1624-01	Bryant	100 tablets	—	AB	FDA listed	—
Spironolactone 25 mg 72162-1693-05	Bryant	500 tablets	—	AB	FDA listed	—
Spironolactone 25 mg 72162-2150-05	Bryant	500 tablets	—	AB	FDA listed	—
Spironolactone 25 mg 72189-0497-90	Direct_Rx	90 tablets	—	AB	FDA listed	—
Spironolactone 25 mg 72789-0290-30	PD-Rx	30 tablets	—	AB	FDA listed	—
Spironolactone 25 mg 76420-0062-30	Asclemed	30 tablets	—	AB	FDA listed	—
Spironolactone 25 mg 76420-0556-01	Asclemed	100 tablets	—	AB	FDA listed	—
Spironolactone 25 mg 76420-0925-00	Asclemed	1000 tablets	—	AB	FDA listed	—
Spironolactone 25 mg 82804-0255-30	Proficient	30 tablets	—	AB	FDA listed	—
Spironolactone 25 mg 82804-0975-00	Proficient	100 tablets	—	AB	FDA listed	—
spironolactone 25 mg 51655-0636-26	Northwind	90 tablets	—	AB	FDA listed	—
Spironolactone 25 mg 67296-2319-09	Redpharm	90 tablets	—	AB	FDA listed	—

About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.

Where does this data come from?

Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️

2018

On the market since

Aug 2018

📍

2026

Currently FDA-listed

8 years listed

🔓

Generic on the market

this product is a generic

✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?

Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 00904-6927-61, not the drug overall. Other pack sizes report separately.

💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.

📅 Q1 2025 – Q4 2025 · 4 quarters of data

ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.

Prescriptions last 4 qtrs

1.9K

Units reimbursed last 4 qtrs

9.3K

Gross reimbursed last 4 qtrs

$3.8K

Avg / prescription

$2.04

Avg / unit

$0.4060

Latest quarter Q4 2025

394Rx

Medicaid pays / ea

$0.4060

gross reimbursed

NADAC / ea

$0.0430

acquisition cost

Spread

+$0.3630

+844% vs cost

What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.

Fee-for-service vs managed care ⓘ

33% FFS 67% MCO

Fee-for-service · 621 Rx Managed care · 1,239 Rx

State Medicaid map

Units reimbursed · per 100k residents

0.221.0

gray = no data reported ⓘ

Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.

Tap or hover a state

…for its Medicaid breakdown

🏆 Top states by units · per 100k residents

1 New York 21.0 /100k

2 New Hampshire 12.8 /100k

3 Kentucky 12.8 /100k

4 Missouri 8.5 /100k

5 Massachusetts 7.0 /100k

6 North Dakota 5.6 /100k

7 South Dakota 5.1 /100k

8 California 2.5 /100k

National units — by quarter

💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Spironolactone — the program that covers self-administered drugs. 15 manufacturers.

⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Spironolactone. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.

Period

Total Part D spend

$23.96M

Claims incl. refills

2.6M

Beneficiaries

1.9M

Spend / beneficiary

$12.45

Spend / claim

$9.09

Trend by period

💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

📦 Packaging — all sizes for this product

Package NDC	Description	Marketing start	Status
00904-6927-61 You're viewing this	100 BLISTER PACK in 1 CARTON (0904-6927-61) / 1 TABLET in 1 BLISTER PACK	2018-08-15	Active

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.

🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients

🎯 Indications and Usage ~3 min read ▾

1 INDICATIONS AND USAGE Spironolactone 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 ). • The management of edema in adult patients who are cirrhotic when edema is not responsive to fluid and sodium restrictions and in the setting of nephrotic syndrome when treatment of the underlying disease, restriction of fluid and sodium intake, and the use of other diuretics produce an inadequate response ( 1.3 ). • Treatment of primary hyperaldosternism for: ( 1.4 ) o Short-term preoperative treatment o Long-term maintenance for patients with discrete aldosterone-producing adrenal adenomas who are not candidates for surgery and patients with bilateral micro or macronodular adrenal hyperplasia

1.1Heart Failure Spironolactone tablets are indicated for treatment of NYHA Class III-IV heart failure and reduced ejection fraction to increase survival, manage edema, and reduce the need for hospitalization for heart failure. Spironolactone tablets are usually administered in conjunction with other heart failure therapies.

1.2Hypertension Spironolactone tablets are indicated as add-on therapy for the treatment of hypertension, to lower blood pressure in patients who are not adequately controlled on other agents. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes.

Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC).

Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly.

Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.

Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.

1.3 Edema Associated with Hepatic Cirrhosis or Nephr…

⏱️ Dosage and Administration ~2 min read ▾

2 DOSAGE AND ADMINISTRATION • Heart Failure: Initiate treatment at 25 mg once daily ( 2.2 ). • Hypertension: Initiate treatment at 25 mg to 100 mg daily in either single or divided doses ( 2.3 ). • Edema: Initiate therapy in a hospital setting and titrate slowly. The recommended initial daily dose is 100 mg in single or divided doses ( 2.4 ). • Primary hyperaldosteronism: Initiate treatment at 100 mg to 400 mg in preparation for surgery. In patients unsuitable for surgery use the lowest effective dosage determined for the individual patient ( 2.5 ).

2.1General Considerations Spironolactone can be taken with or without food, but should be taken consistently with respect to food [see Clinical Pharmacology ( 12.3 )] .

2.2Treatment of Heart Failure In patients with serum potassium ≤5.0 mEq/L and eGFR >50 mL/min/1.73 m 2 , initiate treatment at 25 mg once daily. Patients who tolerate 25 mg once daily may have their dosage increased to 50 mg once daily as clinically indicated. Patients who develop hyperkalemia on 25 mg once daily may have their dosage reduced to 25 mg every other day [see Warnings and Precautions ( 5.1 )] .

In patients with an eGFR between 30 and 50 mL/min/1.73 m 2 , consider initiating therapy at 25 mg every other day because of the risk of hyperkalemia [see Use in Specific Populations ( 8.6 )].

2.3Treatment of Essential Hypertension The recommended initial daily dose is 25 mg to 100 mg of spironolactone administered in either single or divided doses is recommended. Dosage can be titrated at two-week intervals. Doses greater than 100 mg/day generally do not provide additional reductions in blood pressure.

2.4Treatment of Edema In patients with cirrhosis, initiate therapy in a hospital setting and titrate slowly [see Use in Specific Populations ( 8.7 )] . The recommended initial daily dosage is 100 mg of spironolactone administered in either single or divided doses, but may range from 25 mg to 200 mg daily. When given as the sole agent for diuresis, administer for at least five days before increasing dose to obtain desired effect.

2.5Treatment of Primary Hyperaldosteronism Administer spironolactone in doses of 100 mg to 400 mg daily in preparation for surgery. For patients who are considered unsuitable for surgery, spironolactone can be used as long-term maintenance therapy at the lowest effective dosage determined for the individual patient.

💊 Dosage Forms and Strengths 87 words ▾

3 DOSAGE FORMS AND STRENGTHS Tablets: 25 mg are white to off-white, round, biconvex, film-coated tablets debossed with '660' on one side and plain on the other side. Tablets: 50 mg are white to off-white, oval shaped, biconvex, film-coated tablets debossed with '661' on the scored side and plain on the other side. Tablets: 100 mg are white to off-white, round, biconvex, film-coated tablets debossed with '662' on one side and scored on the other side.

Tablets: 25 mg, 50 mg, and 100 mg ( 3 )

⛔ Contraindications 40 words ▾

4 CONTRAINDICATIONS Spironolactone tablets are contraindicated in the patients with: • Hyperkalemia • Addison's disease • Concomitant use of eplerenone Spironolactone tablets are contraindicated in patients with ( 4 ): • Hyperkalemia • Addison's disease • Concomitant use of eplerenone

⚠️ Warnings and Cautions ~1 min read ▾

5 WARNINGS AND PRECAUTIONS • Hyperkalemia: Monitor serum potassium within one week of initiation and regularly thereafter ( 5.1 ). • Hypotension and Worsening Renal Function: Monitor volume status and renal function periodically ( 5.2 ). • Electrolyte and Metabolic Abnormalities: Monitor serum electrolytes, uric acid and blood glucose periodically ( 5.3 ). • Gynecomastia: Spironolactone can cause gynecomastia ( 5.4 ).

5.1Hyperkalemia Spironolactone can cause hyperkalemia. This risk is increased by impaired renal function or concomitant potassium supplementation, potassium-containing salt substitutes or drugs that increase potassium, such as angiotensin converting enzyme inhibitors and angiotensin receptor blockers [see Drug Interactions ( 7.1 )] . Monitor serum potassium within 1 week of initiation or titration of spironolactone and regularly thereafter.

More frequent monitoring may be needed when spironolactone is given with other drugs that cause hyperkalemia or in patients with impaired renal function. If hyperkalemia occurs, decrease the dose or discontinue spironolactone and treat hyperkalemia.

5.2Hypotension and Worsening Renal Function Excessive diuresis may cause symptomatic dehydration, hypotension and worsening renal function, particularly in salt-depleted patients or those taking angiotensin converting enzyme inhibitors and angiotensin II receptor blockers. 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.

5.3Electrolyte and Metabolic Abnormalities In addition to causing hyperkalemia, spironolactone can cause hyponatremia, hypomagnesemia, hypocalcemia, hypochloremic alkalosis, and hyperglycemia. Asymptomatic hyperuricemia can occur and rarely gout is precipitated. Monitor serum electrolytes, uric acid and blood glucose periodically.

5.4Gynecomastia Spironolactone can cause gynecomastia. In Randomized Spironolactone Evaluation Study, patients with heart failure treated with a mean dose of 26 mg of spironolactone once daily, about 9% of the male subjects developed gynecomastia. The risk of gynecomastia increases in a dose-dependent manner with an onset that varies widely from 1 to 2 months to over a year. Gynecomastia is usually reversible.

🤒 Adverse Reactions ~1 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: • Hyperkalemia [see Warnings and Precautions ( 5.1 )] • Hypotension and Worsening Renal Function [see Warnings and Precautions ( 5.2 )] • Electrolyte and Metabolic Abnormalities [see Warnings and Precautions ( 5.3 )] • Gynecomastia [see Warnings and Precautions ( 5.4 )] • Impaired neurological function/ coma in patients with hepatic impairment, cirrhosis and ascites [see Use in Specific Populations ( 8.7 )] The following adverse reactions associated with the use of spironolactone were identified in clinical trials or postmarketing reports.

Because these reactions were reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency, reliably, or to establish a causal relationship to drug exposure. Digestive: Gastric bleeding, ulceration, gastritis, diarrhea and cramping, nausea, vomiting. Reproductive: Decreased libido, inability to achieve or maintain erection, irregular menses or amenorrhea, postmenopausal bleeding, breast and nipple pain.

Hematologic: Leukopenia (including agranulocytosis), thrombocytopenia. Hypersensitivity: Fever, urticaria, maculopapular or erythematous cutaneous eruptions, anaphylactic reactions, vasculitis. Metabolism: Hyperkalemia, electrolyte disturbances [see Warnings and Precautions ( 5.1 , 5.3 )] , hyponatremia, hypovolemia.

Musculoskeletal : Leg cramps. Nervous system/psychiatric: Lethargy, mental confusion, ataxia, dizziness, headache, drowsiness. Liver/biliary: A very few cases of mixed cholestatic/hepatocellular toxicity, with one reported fatality, have been reported with spironolactone administration.

Renal: Renal dysfunction (including renal failure). Skin: Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), drug rash with eosinophilia and systemic symptoms (DRESS), alopecia, pruritis. The most common adverse reaction with spironolactone treatment is gynecomastia ( 5.4 , 6 ).

To report SUSPECTED ADVERSE REACTIONS, contact Zydus Pharmaceuticals (USA) Inc. at 1-877-993-8779 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS • Agents increasing serum potassium: Concomitant administration can lead to hyperkalemia ( 5.1 , 7.1 ). • Lithium: Increased risk of lithium toxicity ( 7.2 ). • NSAIDs: May reduce the diuretic, natriuretic and antihypertensive effect of spironolactone ( 7.3 ). • Digoxin: Spironolactone can interfere with radioimmunologic assays of digoxin exposure ( 7.4 ). • Cholestyramine: Hyperkalemic metabolic acidosis has been reported with concomitant use ( 7.5 ). • Acetylsalicylic Acid (ASA): ASA may reduce the efficacy of spironolactone ( 7.6 ). • Abiraterone: May increase prostate-specific antigen (PSA) levels ( 7.7 ). • Mitotane: Avoid concomitant use of spironolactone and mitotane ( 7.8 ).

7.1Drugs and Supplements Increasing Serum Potassium Concomitant administration of spironolactone with potassium supplementation or drugs that can increase potassium may lead to severe hyperkalemia. In general, discontinue potassium supplementation in heart failure patients who start spironolactone [see Warnings and Precautions ( 5.1 ) and Clinical Pharmacology ( 12.3 )] . Check serum potassium levels when ACE inhibitor or ARB therapy is altered in patients receiving spironolactone.

Examples of drugs that can increase potassium include: • ACE inhibitors • angiotensin receptor blockers • non-steroidal anti-inflammatory drugs (NSAIDs) • heparin and low molecular weight heparin • trimethoprim

7.2Lithium Like other diuretics, spironolactone reduces the renal clearance of lithium, thus increasing the risk of lithium toxicity. Monitor lithium levels periodically when spironolactone is coadministered [see Clinical Pharmacology ( 12.3 )] .

7.3Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) In some patients, the administration of an NSAID can reduce the diuretic, natriuretic, and antihypertensive effect of diuretics. Therefore, when spironolactone and NSAIDs are used concomitantly, monitor closely to determine if the desired effect of the diuretic is obtained [see Clinical Pharmacology ( 12.3 )] .

7.4Digoxin Spironolactone and its metabolites interfere with radioimmunoassays for digoxin and increase the apparent exposure to digoxin. It is unknown to what extent, if any, spironolactone may increase actual digoxin exposure. In patients taking concomitant digoxin, use an assay that does not interact with spironolactone.

7.5Cholestyramine Hyperkalemic metabolic acidosis has been reported in patients given spironolactone concurrently with cholestyramine.

7.6Acetylsalicylic Acid Acetylsalicylic acid may reduce the efficacy of spironolactone. Therefore, when spironolactone and acetylsalicylic acid are used concomitantly, spironolactone may need to be titrated to higher maintenance dose and the patient should be observed closely to determine if the desired effect is obtained [see Clinical Pharmacology ( 12.3 )] .

7.7Abiraterone 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.

7.8Mitotane Avoid concomitant use of spironolactone and mitotane. Spironolactone reduces mitotane plasma levels [see Clinical Pharmacology ( 12.3 )] .

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS • Pregnancy: Based on animal data, spironolactone may affect sex differentiation of the male during embryogenesis ( 8.1 )

8.1Pregnancy Risk Summary Based on mechanism of action and findings in animal studies, spironolactone may affect sex differentiation of the male during embryogenesis (see Data) . Rat embryofetal studies report feminization of male fetuses and endocrine dysfunction in females exposed to spironolactone in utero . Limited available data from published case reports and case series did not demonstrate an association of major malformations or other adverse pregnancy outcomes with spironolactone .

There are risks to the mother and fetus associated with heart failure, cirrhosis and poorly controlled hypertension during pregnancy (see Clinical Considerations) . Because of the potential risk to the male fetus due to anti-androgenic properties of spironolactone and animal data, avoid spironolactone in pregnant women or advise a pregnant woman of the potential risk to a male fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.

All pregnancies have a background risk of birth defect, loss or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Pregnant women with congestive heart failure are at increased risk for preterm birth.

Stroke volume and heart rate increase during pregnancy, increasing cardiac output, especially during the first trimester. Clinical classification of heart disease may worsen with pregnancy and lead to maternal death. Closely monitor pregnant patients for destabilization of their heart failure.

Pregnant women with symptomatic cirrhosis generally have poor outcomes including hepatic failure, variceal hemorrhage, preterm delivery, fetal growth restriction and maternal death. Outcomes are worse with coexisting esophageal varices. Pregnant women with cirrhosis of the liver should be carefully monitored and managed accordingly.

Hypertension in pregnancy increases the maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (e.g., need for cesarean section, and post-partum hemorrhage). Hypertension increases the fetal risk for intrauterine growth restriction and intrauterine death. Data Animal Data Teratology studies with spironolactone have been carried out in mice and rabbits at doses of up to 20 mg/kg/day.

On a body surface area basis, this dose in the mouse is substantially below the maximum recommended human dose and, in the rabbit, approximates the maximum recommended human dose. No teratogenic or other embryotoxic effects were observed in mice, but the 20 mg/kg dose caused an increased rate of resorption and a lower number of live fetuses in rabbits. Because of its antiandrogenic activity and the requirement of testosterone for male morphogenesis, spironolactone may have the potential for adversely affecting sex differentiation of the male during embryogenesis.

When administered to rats at 200 mg/kg/day between gestation days 13 and 21 (late embryogenesis and fetal development), feminization of male fetuses was observed. Offspring exposed during late pregnancy to 50 and 100 mg/kg/day doses of spironolactone exhibited changes in the reproductive tract including dose-dependent decreases in weights of the ventral prostate and seminal vesicle in males, ovaries and uteri that were enlarged in females, and other indications of endocrine dysfunction, that persisted into adulthood.

Spironolactone has known endocrine effects in animals including progestational and antiandrogenic effects.

8.2Lactation Risk Summary Spironolactone is not present in breastmilk; however, limited data from a lactating woman at 17 days postpartum reports the presence…

🤰 Pregnancy ~2 min read ▾

Spironolactone has known endocrine effects in animals including progestational and antiandrogenic effects.

🧒 Pediatric Use 13 words ▾

8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established.

🧓 Geriatric Use 42 words ▾

8.5Geriatric Use Spironolactone is substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, monitor renal function.

🆘 Overdosage 110 words ▾

10 OVERDOSAGE The oral LD 50 of spironolactone is greater than 1,000 mg/kg in mice, rats, and rabbits. Acute overdosage of spironolactone may be manifested by drowsiness, mental confusion, maculopapular or erythematous rash, nausea, vomiting, dizziness, or diarrhea. Rarely, instances of hyponatremia, hyperkalemia, or hepatic coma may occur in patients with severe liver disease, but these are unlikely due to acute overdosage.

Hyperkalemia may occur, especially in patients with impaired renal function. Treatment: Induce vomiting or evacuate the stomach by lavage. There is no specific antidote.

Treatment is supportive to maintain hydration, electrolyte balance, and vital functions. Patients who have renal impairment may develop hyperkalemia. In such cases, discontinue spironolactone.

🧬 Clinical Pharmacology ~2 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action 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 renal tubule. Spironolactone causes increased amounts of sodium and water to be excreted, while potassium is retained. Spironolactone acts both as a diuretic and as an antihypertensive drug by this mechanism.

It may be given alone or with other diuretic agents that act more proximally in the renal tubule.

12.2Pharmacodynamics Aldosterone antagonist activity: Increased levels of the mineralocorticoid, aldosterone, are present in primary and secondary hyperaldosteronism. Edematous states in which secondary aldosteronism is usually involved include congestive heart failure, hepatic cirrhosis, and nephrotic syndrome. By competing with aldosterone for receptor sites, spironolactone provides effective therapy for the edema and ascites in those conditions.

Spironolactone counteracts secondary aldosteronism induced by the volume depletion and associated sodium loss caused by active diuretic therapy.

12.3Pharmacokinetics Absorption The mean time to reach peak plasma concentration of spironolactone and the active metabolite, canrenone, in healthy volunteers is 2.6 and 4.3 hours, respectively. Effect of food: Food increased the bioavailability of spironolactone (as measured by AUC) by approximately 95.4%. Patients should establish a routine pattern for taking spironolactone with regard to meals [see Dosage and Administration ( 2.1 )] .

Distribution Spironolactone and its metabolites are more than 90% bound to plasma proteins. Elimination The mean half-life of spironolactone is 1.4 hour. The mean half-life values of its metabolites including canrenone, 7-α-(thiomethyl) spirolactone (TMS), and 6-ß-hydroxy-7-α-(thiomethyl) spirolactone (HTMS) are 16.5, 13.8, and 15 hours, respectively.

Metabolism: Spironolactone is rapidly and extensively metabolized. Metabolites can be divided into two main categories: those in which sulfur of the parent molecule is removed (e.g., canrenone) and those in which the sulfur is retained (e.g., TMS and HTMS). In humans, the potencies of TMS and 7-α-thiospirolactone in reversing the effects of the synthetic mineralocorticoid, fludrocortisone, on urinary electrolyte composition were approximately a third relative to spironolactone.

However, since the serum concentrations of these steroids were not determined, their incomplete absorption and/or first-pass metabolism could not be ruled out as a reason for their reduced in vivo activities. Excretion: The metabolites are excreted primarily in the urine and secondarily in bile. Specific Populations The impact of age, sex, race/ethnicity, and renal impairment on the pharmacokinetics of spironolactone have not been specifically studied.

Patients with Hepatic Impairment: The terminal half-life of spironolactone has been reported to be increased in patients with cirrhotic ascites [see Use in Specific Populations ( 8.7 )] . Drug Interaction Studies: Drugs and Supplements Increasing Serum Potassium: Concomitant administration of spironolactone with potassium supplementation, salt substitutes containing potassium, a diet rich in potassium, or drugs that can increase potassium, including ACE inhibitors, angiotensin II antagonists, non-steroidal anti-inflammatory drugs (NSAIDs), heparin and low molecular weight heparin, may lead to severe hyperkalemia [see Warnings and Precautions ( 5.1 ) and Drug Interactions ( 7.1 )] .

Lithium: Spironolactone reduces the renal clearance of lithium, inducing a high risk of lithium toxicity [ see Drug Interactions ( 7.2 )]. Nonsteroidal Anti-Inflammatory Drugs (NSAIDs): In some patients, the administration of an NSAID can reduce the diuretic, natriuretic, and antihypertensive effect of loop, potassium-sparing, and thiazide diuretics [see Drug Interactions (…

🧬 Mechanism of Action 81 words ▾

It may be given alone or with other diuretic agents that act more proximally in the renal tubule.

📦 How Supplied / Storage and Handling 102 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Spironolactone Tablets USP, 25 mg are white to off-white, round, biconvex, film-coated tablets debossed with '660' on one side and plain on the other side and are supplied as follows: Cartons of 100 film-coated tablets (10 film-coated tablets each blister pack x 10), NDC 0904-6927-61 WARNING: This Unit Dose package is not child resistant and is Intended for Institutional Use Only. Keep this and all drugs out of the reach of children. Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature] .

Protect from light. Dispense in a tight, light-resistant container (USP).

📋 Description 105 words ▾

11 DESCRIPTION Spironolactone tablets, USP contain 25 mg, 50 mg, or 100 mg of the aldosterone antagonist spironolactone, 17-hydroxy-7α-mercapto-3-oxo-17α-pregn-4-ene-21-carboxylic acid γ-lactone acetate, which has the following structural formula: Spironolactone, USP is practically insoluble in water, soluble in ethyl acetate and alcohol, freely soluble in benzene and in chloroform, slightly soluble in menthanol and very slightly soluble in fixed oils. Inactive ingredients include calcium sulfate dihydrate, colloidal silicon dioxide, corn starch, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, peppermint flavor, povidone and sodium lauryl sulfate.

Additionally each tablet contains opadry II white 33F28398 which contains hydroxylpropyl methyl cellulose, lactose monohydrate, polyethylene glycol, talc and titanium dioxide. Image

💬 Information for Patients 61 words ▾

17 PATIENT COUNSELING INFORMATION Patients who receive spironolactone should be advised to avoid potassium supplements and foods containing high levels of potassium, including salt substitutes. Manufactured by: Zydus Lifesciences Ltd., Baddi, India Distributed by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ 08534 Packaged and Distributed by: MAJOR® PHARMACEUTICALS Indianapolis, IN 46268 USA Refer to package label for Distributor's NDC Number Rev.: 12/25

Glossary — plain-language definitions of medical terms used in this label:

case series: A report describing what happened to a small group of patients, with no comparison group.

contraindicated: Should not be used in that situation, because the risk is considered too high.

in vivo: In a living person or animal rather than in a laboratory dish.

Absorption: How a medicine moves from where it is taken, such as the stomach or gut, into the bloodstream.

active metabolite: A substance made when the body breaks down a medicine that still has an effect of its own.

adverse reaction: An unwanted or harmful effect that a medicine causes in the body.

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

agranulocytosis: A severe drop in a certain type of infection-fighting white blood cell, greatly raising the risk of serious infections.

alopecia: Loss of hair from the scalp or body.

amenorrhea: The absence of monthly menstrual periods.

antagonist: A substance that blocks a target in the body so a natural signal or another medicine cannot produce its usual effect.

antidote: A treatment that reverses or counteracts the effects of a specific medicine or poison.

ascites: A buildup of fluid inside the belly.

ataxia: Loss of muscle coordination that makes walking, balance, and controlled movements clumsy or unsteady.

AUC: A measure of total drug exposure over time, showing how much medicine the blood is exposed to overall.

Bioavailability: The share of a dose that actually reaches the bloodstream and is able to have an effect.

cirrhosis: Long-term scarring of the liver that gradually replaces healthy tissue and reduces how well the liver works.

clearance: How quickly the body removes a medicine from the blood, usually through the liver and kidneys.

Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.

Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.

diarrhea: Loose, watery bowel movements that happen more often than normal.

Distribution: How a medicine spreads from the blood into the body's tissues and organs after it is absorbed.

Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.

Drug Interactions: The label section listing other medicines, foods, or substances that can change how a medicine works or raise the chance of side effects.

edema: Swelling caused by extra fluid trapped in the body's tissues.

efficacy: How well a treatment works under the controlled conditions of a clinical study.

eGFR: Estimated glomerular filtration rate, a blood-test-based estimate of how well the kidneys filter; lower numbers mean weaker function.

ejection fraction: The share of blood in the heart's main pumping chamber that gets pushed out with each beat, given as a percentage.

electrolyte: A mineral in the blood and body fluids, such as sodium, potassium, or calcium, that carries a small electric charge and helps the body work.

Elimination: The overall removal of a medicine from the body by breaking it down and passing it out.

eosinophilia: A higher-than-normal level of eosinophils, a type of white blood cell often linked to allergies or drug reactions.

estimated background risk: The normal chance that any pregnancy will have a birth defect or problem, even without taking any medicine.

Excretion: How the body removes a medicine or its leftover pieces, mainly through the urine or stool.

first-pass metabolism: The breakdown of a swallowed medicine by the liver before it reaches the rest of the body.

gastritis: Swelling or irritation of the lining of the stomach.

gout: A type of arthritis with sudden, painful, swollen joints caused by uric acid crystals.

gynecomastia: Swelling or enlargement of breast tissue in males.

Half-life: The time it takes for the amount of medicine in the blood to drop by half.

heart failure: A condition in which the heart cannot pump blood as well as it should, causing tiredness, breathlessness, and swelling.

hemorrhage: Bleeding, especially heavy or uncontrolled bleeding, either inside the body or from an outside wound.

hepatic impairment: Reduced liver function, meaning the liver does not work as well as normal at processing substances, including medicines.

How Supplied/Storage and Handling: The label section describing the forms and strengths a medicine comes in and how to store it properly.

hyperglycemia: High blood sugar, meaning there is more glucose (sugar) in the blood than normal.

hyperkalemia: A higher-than-normal level of potassium, an important mineral, in the blood.

hypersensitivity: An overreaction of the body's defense system to a substance, causing symptoms such as rash, swelling, or trouble breathing.

hypertension: Blood pressure that stays higher than normal, commonly called high blood pressure.

hyperuricemia: A higher-than-normal level of uric acid in the blood, which can lead to gout.

hypocalcemia: A lower-than-normal level of calcium, a mineral, in the blood.

hypomagnesemia: A lower-than-normal level of magnesium, a mineral, in the blood.

hyponatremia: A lower-than-normal level of sodium (salt) in the blood.

hypotension: Blood pressure that is lower than normal, which can cause dizziness or fainting.

in utero: Inside the womb, describing a baby before it is born.

Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.

inhibitor: A substance that blocks an enzyme or transporter, which can raise the levels of drugs it normally handles.

intrauterine growth restriction: When a baby grows more slowly than expected in the womb and is smaller than normal at birth.

lactation: The making and release of milk from a mother's breasts after giving birth.

lethargy: A state of tiredness and sluggishness, often with slowed thinking or movement.

leukopenia: A low level of white blood cells, the cells that help the body fight off infections.

maintenance dose: The regular ongoing dose taken to keep a steady, effective amount of medicine in the body over time.

Mechanism of Action: How a medicine produces its effect in the body, described at the level of cells or body chemistry.

metabolic acidosis: A condition where too much acid builds up in the body's blood and fluids.

Metabolism: How the body chemically changes a medicine, usually in the liver, into other substances.

metabolite: A new substance formed when the body breaks a medicine down.

monotherapy: Treatment using a single medicine by itself.

myocardial infarction: The medical term for a heart attack, when blood flow to part of the heart muscle is blocked.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

Overdosage: The label section describing what can happen if too much of a medicine is taken and how it may be treated.

Patient Counseling Information: The label section telling health professionals what to explain to patients about using a medicine safely.

Pharmacokinetics: The study of how the body takes in a medicine, spreads it around, breaks it down, and removes it over time.

plasma concentration: The amount of medicine measured in the liquid part of the blood at a given time.

postpartum: The period of time right after a woman gives birth.

preterm birth: Birth of a baby earlier than usual, before 37 weeks of pregnancy.

randomized: Assigned to a treatment group purely by chance, like a coin flip, so the groups being compared start out fair and similar.

receptor: A special docking spot on a cell that a medicine or natural body chemical attaches to in order to trigger an effect.

relative risk: A number comparing the chance of an event in one group with the chance of that same event in another group.

renal impairment: Reduced kidney function, meaning the kidneys do not filter waste and fluid from the blood as well as normal.

Stevens-Johnson syndrome: A rare, serious reaction causing painful blistering and peeling of the skin and the moist linings of the mouth, eyes, and other areas.

teratogenic: Able to cause physical birth defects in a developing baby when a medicine is taken during pregnancy.

terminal half-life: The time it takes blood levels to fall by half during the final, slowest stage of removal.

thrombocytopenia: A low level of platelets, the blood cells that help form clots, which can lead to easier bruising or bleeding.

titration: Slowly adjusting a medicine's dose up or down in small steps to find the amount that works best with the fewest side effects.

toxic epidermal necrolysis: A rare, life-threatening reaction in which large areas of the top layer of skin blister and peel away, like a severe burn.

trimester: One of the three roughly three-month stages that a pregnancy is divided into.

ulceration: The forming of an open sore on the skin or on a lining inside the body, such as the stomach.

urticaria: Raised, itchy welts on the skin, commonly called hives.

Use in Specific Populations: The label section describing how a medicine affects particular groups, such as pregnant people, children, or older adults.

Warnings and Precautions: The label section describing serious risks to know about and safety steps to follow while using a medicine.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

← 00904-6926-61 · Major 00904-6928-61 · Major →

For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.

spironolactone 25 mg Tablet, Film Coated, 100-count

🆔 Identity & classification

🏷️ RxNorm drug class

🏭 Manufacturer & labeler

🩺 Clinical

Patient education

Supplement & herbal interactions

🧪 Inactive Ingredients / Excipients

Inactive ingredient FAQ

💲 Pricing

🔁 Therapeutic equivalents

⏳ Availability & generic status

🗺️ Medicaid utilization & spend

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

📦 Packaging — all sizes for this product

📄 Full prescribing information FDA SPL

1.3 Edema Associated with Hepatic Cirrhosis or Nephr…

12 CLINICAL PHARMACOLOGY

🔗 Related NDC lookups

💊 Related drugs in this class