FDA-filed SPL labeling · retrieved through openFDA

Spironolactone and Hydrochlorothiazide

Spironolactone and hydrochlorothiazide is a combination diuretic (water pill) tablet used to treat fluid retention (edema) in heart failure, liver cirrhosis, and nephrotic syndrome, and to lower high blood pressure.

Brand name Aldactazide
Drug classes Aldosterone Antagonist
Rx Form 1 Route Oral
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 11 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

At a glance
Linked label effectiveFeb 10, 2026
Clinical labels in scope 11
AvailabilityRx
Earliest approval/marketing year 1979
FDA-listed product records 33
Boxed warningNone found in compared labels
How we combine label and product data →
No current FDA shortage listed · checked Sep 24, 2026
Spironolactone and Hydrochlorothiazide at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Spironolactone and hydrochlorothiazide is a two-in-one diuretic tablet that reduces fluid buildup and lowers high blood pressure, while the spironolactone component helps protect against the potassium loss that hydrochlorothiazide can cause. Because it can raise potassium levels significantly, avoid potassium supplements and certain other medications unless your doctor directs otherwise. Take it exactly as prescribed, and contact your doctor right away if you notice muscle weakness, irregular heartbeat, or sudden eye pain.

📖 Spironolactone and Hydrochlorothiazide: Patient Information Guide

A plain-language walkthrough of Spironolactone and Hydrochlorothiazide — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for

Spironolactone and hydrochlorothiazide tablets are approved for several conditions involving fluid overload and high blood pressure. Supported uses include:

  • Congestive heart failure: managing edema and sodium retention when other treatments haven't worked well enough, or correcting low potassium caused by other diuretics, including in patients also taking digitalis
  • Liver cirrhosis with edema or ascites (abdominal fluid): used as maintenance therapy alongside rest and fluid/sodium restriction, since aldosterone levels can be very high in this condition
  • Nephrotic syndrome: for patients who haven't responded adequately to treating the underlying disease, fluid/sodium restriction, or other diuretics
  • Essential hypertension (high blood pressure): to lower blood pressure when other measures are inadequate, and to correct diuretic-induced low potassium in patients with high blood pressure
  • Pregnancy-related edema: only when edema is due to a medical (pathologic) cause — routine use for normal pregnancy swelling is not recommended
⚙️How it works

Spironolactone blocks aldosterone — a hormone that signals the kidneys to retain sodium and water and excrete potassium. By blocking aldosterone receptors in the kidney's collecting tubules, spironolactone helps the body shed excess fluid while holding onto potassium. Hydrochlorothiazide works in a separate part of the kidney (the cortical diluting segment) to block sodium and water reabsorption, adding a second, complementary diuretic effect. Together, the two drugs reduce blood volume, body weight, and blood pressure more effectively than either alone — and spironolactone's potassium-sparing action helps counterbalance the potassium loss that hydrochlorothiazide tends to cause.

💊How it's taken

Spironolactone and hydrochlorothiazide tablets are taken by mouth, either as a single daily dose or split into smaller doses throughout the day. Your prescriber will adjust the dose based on how you respond — the right amount varies from person to person. Food can nearly double the absorption of spironolactone, so it's worth asking your doctor or pharmacist whether to take it consistently with or without a meal.

  • Do not take extra potassium supplements or potassium-rich salt substitutes unless your doctor specifically recommends it
  • The diuretic (fluid-removing) effect starts quickly and can last two to three days after you stop taking the medication
  • If you miss a dose, follow your prescriber's or pharmacist's guidance — do not double up
🤒Side effects — in detail

Like all medications, this combination can cause side effects. Common ones include:

  • Dizziness or lightheadedness, especially when standing up quickly (orthostatic hypotension)
  • Nausea, vomiting, stomach cramps, or diarrhea
  • Headache, drowsiness, or mental confusion
  • Muscle cramps or weakness
  • Breast tenderness or enlargement (gynecomastia) in men or women
  • Irregular menstrual periods or missed periods
  • Increased sensitivity to sunlight (photosensitivity)

Seek medical help right away for serious reactions: severe skin blistering or peeling (Stevens-Johnson Syndrome or toxic epidermal necrolysis), sudden eye pain or vision loss, signs of very high potassium (muscle weakness, irregular heartbeat), yellowing of the skin or eyes, or signs of a severe allergic reaction (trouble breathing, facial swelling).

⚠️Warnings & precautions
  • High potassium (hyperkalemia): The biggest risk with this combination. Avoid potassium supplements, potassium-containing salt substitutes, ACE inhibitors, angiotensin receptor blockers, NSAIDs, and other potassium-sparing diuretics unless your doctor closely monitors you. Symptoms include muscle weakness, irregular heartbeat, and tingling.
  • Acute angle-closure glaucoma: Hydrochlorothiazide can rarely trigger sudden-onset eye pain, blurred vision, or a sharp drop in vision — usually within hours to weeks of starting. Stop the medication and get medical attention immediately. People with a history of sulfonamide or penicillin allergy may be at higher risk.
  • Liver disease: Even small changes in fluid and electrolyte balance can trigger hepatic coma (a serious loss of brain function) in people with liver problems. Use with caution.
  • Kidney disease: Thiazide diuretics may worsen kidney function in people with significant kidney impairment. People with no urine output (anuria) or acute kidney failure should not take this medication.
  • Skin cancer risk: Long-term hydrochlorothiazide use has been associated with a small increased risk of squamous cell skin cancer, particularly in white patients taking high cumulative doses. Use sun protection and get regular skin checks.
  • Tumor risk in rats: Spironolactone has caused tumors in rat studies. The label states this medication should only be used for the conditions described, and unnecessary use should be avoided.
🔀What it interacts with

This combination interacts with several medications and substances — always tell your doctor and pharmacist everything you take:

  • ACE inhibitors, angiotensin receptor blockers, other potassium-sparing diuretics, aldosterone blockers: Raise the risk of dangerously high potassium
  • NSAIDs (e.g., ibuprofen, indomethacin): Can raise potassium to dangerous levels and weaken the diuretic and blood-pressure-lowering effects
  • Lithium: Diuretics slow the kidneys' removal of lithium, sharply raising the risk of lithium toxicity — generally should not be combined
  • Digoxin: Spironolactone can increase digoxin blood levels, raising the risk of digoxin toxicity and potentially fatal heart rhythm problems
  • Potassium supplements or salt substitutes with potassium: Can push potassium levels dangerously high
  • Alcohol, barbiturates, or opioid pain relievers: Can worsen low blood pressure and dizziness when standing
  • Diabetes medications (pills or insulin): Thiazides can affect blood sugar; dose adjustments of your diabetes medication may be needed
  • Aspirin: May reduce the effectiveness of spironolactone
  • Mitotane (a cancer drug): Spironolactone lowers mitotane levels in the blood — concurrent use should be avoided
  • Cholestyramine: Has been linked to a serious acid-base imbalance (hyperkalemic metabolic acidosis) when used with spironolactone

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

📋Before taking it
  • You have kidney disease, no urine output, or acute kidney failure — this medication is contraindicated in those situations
  • You have Addison's disease (adrenal gland insufficiency) — contraindicated
  • You have high potassium (hyperkalemia) or high calcium (hypercalcemia) levels — contraindicated
  • You have severe or acute liver failure — may also be contraindicated
  • You are allergic to sulfonamide drugs or thiazide diuretics — the hydrochlorothiazide component is a thiazide and sulfonamide derivative
  • You are pregnant or trying to become pregnant — routine use is not recommended; discuss with your doctor if edema has a medical cause
  • You take other diuretics, blood pressure medications, heart medications, or over-the-counter pain relievers — many interact with this combination
  • You have or have had systemic lupus erythematosus — thiazides may worsen it
🚑If you take too much

Taking too much of this combination can cause drowsiness, mental confusion, nausea, vomiting, dizziness, or a skin rash. Electrolyte imbalances — either high potassium or low potassium and sodium — are the main dangers, and people with kidney problems are at highest risk of severe potassium buildup. If overdose is suspected, seek emergency medical help; treatment focuses on supporting hydration, electrolyte balance, and vital functions — there is no specific antidote.

📡Pharmacodynamics — effects in the body

Both spironolactone and hydrochlorothiazide reduce the amount of exchangeable sodium, blood plasma volume, body weight, and blood pressure. Spironolactone blocks aldosterone receptors in the kidney, while hydrochlorothiazide prevents sodium and water reabsorption in a different kidney segment — giving additive effects when used together. The combination lowers both systolic (top number) and diastolic (bottom number) blood pressure in many patients with essential hypertension, even when aldosterone levels are within the normal range.

🔬Pharmacokinetics — how your body processes it

Spironolactone is rapidly and extensively broken down by the body into active metabolites that carry out most of its therapeutic effects; these metabolites have half-lives ranging from roughly 14 to 17 hours. Taking spironolactone with food can nearly double the amount absorbed, so consistency matters. Hydrochlorothiazide, by contrast, is absorbed quickly after an oral dose — its effects begin within about one hour, peak at one to two hours, and last six to twelve hours. Hydrochlorothiazide is excreted largely unchanged in the urine, with a half-life of four to five hours.

📦How to store it

Store below 77°F (25°C).

📄 Written from Spironolactone and Hydrochlorothiazide’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

🩺 Pharmacist Counseling Corner

Quick, plain-English answers to the questions patients ask most about Spironolactone and Hydrochlorothiazide — the kind of thing our pharmacy team would talk through with you at the counter.

Why am I taking two drugs in one pill?
Great question. Spironolactone and hydrochlorothiazide are two different diuretics (water pills) that work in different parts of the kidney. Together, they remove excess fluid and lower blood pressure better than either one alone. And here's the bonus: spironolactone helps hold onto potassium, which hydrochlorothiazide tends to wash out. So the combination is more effective and gentler on your potassium levels.
Should I be taking a potassium supplement with this?
Usually no — and this is really important. Spironolactone already protects your potassium, so adding extra potassium through supplements, salt substitutes, or a very high-potassium diet can push your levels dangerously high. High potassium can cause muscle weakness and serious heart rhythm problems. Only take potassium supplements if your doctor specifically prescribes them and is monitoring your levels.
What side effects should I expect, and which ones should I call my doctor about right away?
Common things you might notice include dizziness when you stand up quickly, some nausea or stomach upset, headache, or muscle cramps — those are generally manageable. Men sometimes notice breast tenderness or swelling, and women may have changes in their periods. Call your doctor right away if you have muscle weakness, an irregular heartbeat, sudden eye pain or vision changes, severe skin blistering or peeling, or yellowing of your skin or eyes. Those are warning signs that need prompt attention.
Are there any over-the-counter medications I should avoid?
Yes — be careful with NSAIDs like ibuprofen (Advil, Motrin) and naproxen (Aleve). Those can raise your potassium to dangerous levels and also reduce how well this medication lowers your blood pressure and removes fluid. Aspirin may also reduce the effectiveness of spironolactone. Check with your pharmacist before picking up any over-the-counter pain relievers while you're on this combination.
I'm pregnant — is this medication safe?
The label is pretty clear that routine use of diuretics during pregnancy is not recommended — they don't prevent or treat normal pregnancy-related swelling, and they expose you and your baby to unnecessary risk. That said, if your doctor has determined your swelling is caused by a specific medical condition rather than normal pregnancy changes, it may be appropriate in your case. Don't stop or change the medication on your own — talk to your doctor about what's right for your situation.
I heard this medication has a cancer warning — should I be worried?
There are two things worth knowing here. First, spironolactone caused tumors in rats in long-term animal studies — that's why the label says to use it only when it's truly needed and to avoid unnecessary use. Whether this translates to a real risk in people hasn't been clearly established. Second, hydrochlorothiazide has been linked to a small increased risk of a type of non-melanoma skin cancer (squamous cell carcinoma), especially in people with fair skin who take it for a long time. The absolute risk is small, but it's worth protecting your skin from sun exposure and getting regular skin checks. Talk to your doctor if you have concerns — they weighed these risks against the benefits when prescribing it for you.
Is Spironolactone and Hydrochlorothiazide available over the counter?
Spironolactone and Hydrochlorothiazide is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.
When was Spironolactone and Hydrochlorothiazide first available?
Spironolactone and Hydrochlorothiazide has been available in the United States since at least 1979, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Spironolactone and Hydrochlorothiazide?
Spironolactone and Hydrochlorothiazide is supplied by 8 manufacturers listed in the FDA NDC Directory, including Bryant Ranch Prepack, Pfizer Laboratories Div Pfizer Inc, Mylan Pharmaceuticals Inc..

💬 Answers drafted from Spironolactone and Hydrochlorothiazide’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

🧰 Keep exploring

💊 How Spironolactone and Hydrochlorothiazide comes

Spironolactone and Hydrochlorothiazide is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Tablet

By mouth
Brands Aldactazide
How this form is used
What it may be used for
  • Treats edema (fluid retention) in adults with congestive heart failure, liver cirrhosis, or nephrotic syndrome when other treatments haven't been adequate
  • Treats essential hypertension (high blood pressure) when other measures are considered inadequate
  • Treats diuretic-induced low potassium (hypokalemia) in patients with heart failure or high blood pressure
  • Used in pregnancy only when edema is caused by a medical condition, not for routine pregnancy swelling
Important instructions
  • Take by mouth once daily or in divided doses, as directed by your prescriber
  • Food can increase how much spironolactone your body absorbs — take consistently with or without food as your doctor advises
  • Do not take potassium supplements or use high-potassium salt substitutes unless your doctor tells you to
  • Diuretic effect begins promptly and may persist for two to three days after stopping the medication
Available strengths 2 strengths
33 FDA-listed product records

📊 Spironolactone and Hydrochlorothiazide across the U.S. market

How Spironolactone and Hydrochlorothiazide appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

1
Dose forms
8
Manufacturers
2
Brand names
33
FDA-listed product records
1979
First marketed
Bryant Ranch Prepack42%
Pfizer Laboratories Div Pfizer Inc9%
Mylan Pharmaceuticals Inc.9%
Mylan Institutional Inc.9%
Sun Pharmaceutical Industries, Inc.9%
Prasco Laboratories9%
Other makers12%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

📈 How widely Spironolactone and Hydrochlorothiazide is used

A general measure of how commonly Spironolactone and Hydrochlorothiazide is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Spironolactone and Hydrochlorothiazide is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

24,202
Medicaid prescriptions filled (Q1–Q4 2025)
$754,280 gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Spironolactone and Hydrochlorothiazide prescribed? Of the 1,596 medications we measure, Spironolactone and Hydrochlorothiazide ranks #772 by Medicaid prescriptions — more than 52% of them.

Where Spironolactone and Hydrochlorothiazide ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Spironolactone and Hydrochlorothiazide product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

hydrochlorothiazide 25 MG / spironolactone 25 MG Oral Tablet

24,202 Medicaid prescriptions (Q1–Q4 2025) 100% of Spironolactone and Hydrochlorothiazide prescriptions shown $754,280 gross reimbursement (before rebates) ≈ $31 per prescription (gross)

Summed across the 5 of 27 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 198224

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Spironolactone and Hydrochlorothiazide, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 5 of 27 listed Spironolactone and Hydrochlorothiazide NDCs with Medicaid activity.

🔍 Compare Spironolactone and Hydrochlorothiazide products

A representative set of FDA-listed product records for Spironolactone and Hydrochlorothiazide — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 33 of 33 products — FDA National Drug Code Directory. See every product, package size and price: browse all 33 Spironolactone and Hydrochlorothiazide NDCs →

🏷️ Sold under these brand names

Aldactazide

🏭 Manufacturers & labelers

Bryant Ranch Prepack 14 Pfizer Laboratories Div Pfizer Inc 3 Mylan Pharmaceuticals Inc. 3 Mylan Institutional Inc. 3 Sun Pharmaceutical Industries, Inc. 3 Prasco Laboratories 3 Greenstone LLC 2 Safecor Health LLC 2

RxNorm drug class

Spironolactone and Hydrochlorothiazide belongs to the Thiazide Diuretic class.

Pharmacologic class Thiazide Diuretic
Drug family (ATC) Renin-inhibitors, Thiazides, plain

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

🔬 Where this comes from

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Feb 10, 2026
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Spironolactone and Hydrochlorothiazide.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Spironolactone and Hydrochlorothiazide after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
11
NDC products indexed
33
Distinct labelers/manufacturers represented
8
Linked representative label
Prasco Laboratories
Linked label effective
Feb 10, 2026
Composite sections available
18
Linked SPL Set ID
9d350fa2-d568-4970-a7a5-d128ff5d0a2f
Linked SPL Document ID
eca75090-9808-4673-bd7e-1ecd571d3b3e
Open the linked representative label on DailyMed ↗

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 11 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Prasco Laboratories is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.