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Spironolactone

Spironolactone is a potassium-sparing diuretic (water pill) used to treat heart failure, high blood pressure, fluid buildup from liver or kidney disease, and a condition called primary hyperaldosteronism.

Brand names AldactoneCarospir
Drug class Aldosterone Antagonist
Rx Forms 2
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 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 148 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 →

Spironolactone at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Spironolactone is a potassium-sparing water pill that blocks the hormone aldosterone, so the kidneys shed salt and water but keep potassium; in use since about 1960 and available as a generic, it is a standard add-on for heart failure and high blood pressure, and treats fluid buildup from liver or kidney disease and overactive adrenal glands. Most people tolerate it well, though some feel dizzy and men may notice tender, enlarged breasts (gynecomastia), which usually fades. Its boxed warning (tumors in long-term rat studies) reserves it for approved uses, but the real day-to-day danger is high potassium, so expect potassium and kidney blood tests after starting or changing the dose.

Clinical pearls

  • Take it the same way every day, always with food or always without, because food changes how much you absorb.
  • Skip potassium supplements and potassium salt substitutes such as “lite” salts unless your prescriber specifically wants you on them.
  • For routine aches, acetaminophen is the safer pick, since ibuprofen and naproxen can blunt spironolactone and strain the kidneys.
  • Muscle weakness, numbness or an irregular heartbeat can signal high potassium and deserve a call to your doctor right away.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾

Spironolactone has been shown to cause tumors in rats when given at high doses over a long time. While this finding comes from animal studies, it is the reason spironolactone should only be used for the conditions it is specifically approved to treat. Unnecessary or casual use of this medication should be avoided. If you have questions about whether spironolactone is right for your situation, ask your doctor or pharmacist.

Read the full warning on DailyMed →
How you get itPrescription only
Comes asTablet, Oral suspension
Earliest FDA record1960
Companies listing it with the FDA38
FDA label last updatedNov 28, 2025
FDA’s strongest warning (boxed)Yes, read the warning

Patient information guide A plain-language walkthrough of Spironolactone, written from its FDA label.

What Spironolactone is used for

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Spironolactone is approved for several conditions across its tablet and oral suspension formulations.

  • Heart failure (NYHA Class III–IV): Spironolactone tablets and spironolactone oral suspension are both used to help patients with severe heart failure and reduced pumping function live longer, reduce fluid buildup, and stay out of the hospital. Usually given alongside other heart failure medicines.
  • High blood pressure (hypertension): Both tablet and oral suspension forms are approved as add-on therapy for adults whose blood pressure isn't controlled on other medications alone. Lowering blood pressure reduces the risk of stroke and heart attack.
  • Edema (fluid buildup) from liver cirrhosis: Both forms treat fluid buildup in adults with liver cirrhosis when cutting back on salt and fluids isn't enough.
  • Edema from heart failure or nephrotic syndrome (tablets only): Spironolactone tablets (including Aldactone) are approved to manage edema in congestive heart failure and nephrotic syndrome when other treatments haven't provided enough relief.
  • Primary hyperaldosteronism (tablets only): Aldactone and spironolactone tablets are used short-term before surgery to treat this adrenal gland disorder, and long-term for patients who are not surgical candidates or who have a type of adrenal gland overgrowth that doesn't require surgery.

How Spironolactone works

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Spironolactone works by blocking aldosterone — a hormone made by the adrenal glands that tells the kidneys to hold onto sodium (salt) and water while releasing potassium. By competing with aldosterone at its receptor in the kidney, spironolactone flips that equation: excess salt and water get flushed out in urine, while potassium is retained. This reduces fluid overload, lowers blood pressure, and eases the strain on the heart.

In conditions like heart failure, liver cirrhosis, and nephrotic syndrome, the body often overproduces aldosterone — making fluid buildup worse. Spironolactone counteracts this directly, which is why it's particularly useful in these settings.

Spironolactone dosage

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Spironolactone is taken by mouth — as a tablet or oral suspension — typically once daily or in divided doses depending on the condition. The key rule for both forms: take it consistently with respect to food (always with food or always without), because food nearly doubles how much of the drug your body absorbs.

  • Tablets (Aldactone and spironolactone tablets): taken once daily or in divided doses; edema treatment is usually started slowly in a hospital setting.
  • Spironolactone oral suspension: dosed differently than tablets — it is not interchangeable with Aldactone; follow the suspension-specific instructions from your prescriber. Doses above 100 mg should use a different formulation.

Never adjust your dose on your own. Your prescriber will monitor your potassium and kidney function and fine-tune the dose based on your results.

Dosing details from the FDA-approved label

From the Spironolactone prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • Heart Failure
    • Initiate treatment at 25 mg once daily (serum potassium ≤5.0 mEq/L and eGFR >50 mL/min/1.73 m2)
    • May be increased to 50 mg once daily as clinically indicated
    • May be reduced to 25 mg every other day if hyperkalemia develops
    • eGFR between 30 and 50 mL/min/1.73 m2: consider initiating at 25 mg every other day because of the risk of hyperkalemia
  • Essential Hypertension
    • Initial daily dose 25 to 100 mg in either single or divided doses
    • Dosage can be titrated at two-week intervals
    • Maximum: Doses greater than 100 mg/day generally do not provide additional reductions in blood pressure
  • Edema (cirrhosis, congestive heart failure, nephrotic syndrome)
    • Initial daily dosage 100 mg in single or divided doses, but may range from 25 to 200 mg daily
    • When given as sole agent for diuresis, administer for at least five days before increasing dose
    • In patients with cirrhosis, initiate therapy in a hospital setting and titrate slowly
  • Primary Hyperaldosteronism
    • 100 to 400 mg daily in preparation for surgery
    • For patients unsuitable for surgery, long-term maintenance at the lowest effective dosage determined for the individual patient
  • Primary hyperaldosteronism diagnostic test (long test)
    • 400 mg daily for three to four weeks
  • Primary hyperaldosteronism diagnostic test (short test)
    • 400 mg daily for four days
  • Hypokalemia (diuretic-induced)
    • 25 mg to 100 mg daily
    • When oral potassium supplements or other potassium-sparing regimens are considered inappropriate
  • Heart Failure, oral suspension
    • Initiate at 20 mg (4 mL) once daily
    • May be increased to 37.5 mg (7.5 mL) once daily as clinically indicated
    • Suspension is not therapeutically equivalent to Aldactone; in patients requiring a dose greater than 100 mg, use another formulation
  • Hypertension, oral suspension
    • Initiate treatment at 20 to 75 mg daily in either single or divided doses
  • Edema associated with Hepatic Cirrhosis, oral suspension
    • Initial recommended daily dose is 75 mg in either single or divided doses
    • Initiate therapy in a hospital setting and titrate slowly
Read the label’s full dosing text

DOSAGE AND ADMINISTRATION Primary hyperaldosteronism. Spironolactone tablets may be employed as an initial diagnostic measure to provide presumptive evidence of primary hyperaldosteronism while patients are on normal diets. Long test: Spironolactone is administered at a daily dosage of 400 mg for three to four weeks. Correction of hypokalemia and of hypertension provides presumptive evidence for the diagnosis of primary hyperaldosteronism. Short test: Spironolactone is administered at a daily dosage of 400 mg for four days. If serum potassium increases during spironolactone administration but drops when spironolactone is discontinued, a presumptive diagnosis of primary hyperaldosteronism should be considered. After the diagnosis of hyperaldosteronism has been established by more definitive testing procedures, spironolactone may be administered in doses of 100 to 400 mg daily in preparation for surgery. For patients who are considered unsuitable for surgery, spironolactone may be employed for long-term maintenance therapy at the lowest effective dosage determined for the individual patient. Edema in adults (congestive heart failure, hepatic cirrhosis, or nephrotic syndrome) . An initial daily dosage of 100 mg of spironolactone administered in either single or divided doses is recommended, but may range from 25 to 200 mg daily. When given as the sole agent for diuresis, spironolactone should be continued for at least five days at the initial dosage level, after which it may be adjusted to the optimal therapeutic or maintenance level administered in either single or divided daily doses. If, after five days, an adequate diuretic response to spironolactone has not occurred, a second diuretic that acts more proximally in the renal tubule may be added to the regimen. Because of the additive effect of spironolactone when administered concurrently with such diuretics, an enhanced diuresis usually begins on the first day of combined treatment; combined therapy is indicated when more rapid diuresis is desired. The dosage of spironolactone should remain unchanged when other diuretic therapy is added. Essential hypertension. For adults, an initial daily dosage of 50 to 100 mg of spironolactone administered in either single or divided doses is recommended.

Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →

Spironolactone side effects

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The most commonly reported side effect of spironolactone is breast tissue enlargement in men (gynecomastia), but there are others to know about:

Common side effects

  • Gynecomastia (breast tissue enlargement in men)
  • Nausea or vomiting
  • Diarrhea or stomach cramps
  • Dizziness or headache
  • Drowsiness or lethargy
  • Irregular menstrual periods or missed periods
  • Decreased sex drive or difficulty with erections
  • Leg cramps
  • Gynecomastia (enlarged breast tissue in men) — usually reversible; risk increases with higher doses
  • Irregular or missed menstrual periods in women
  • Decreased sex drive or difficulty maintaining an erection
  • Hair loss

When to get medical help

  • Call your doctor right away if you notice muscle weakness, irregular heartbeat, or numbness — these can be signs of dangerously high potassium (hyperkalemia)
  • Get medical help if you feel lightheaded or faint, especially when standing up — this may signal low blood pressure or dehydration
  • Tell your doctor if you notice decreased urination or swelling — signs that kidney function may be worsening
  • Seek care immediately for severe skin reactions such as blistering, peeling, or a widespread rash (possible Stevens-Johnson Syndrome or toxic epidermal necrolysis)
  • Contact your doctor if you develop signs of liver problems: confusion, extreme fatigue, or yellowing of the skin
  • Seek care if you experience signs of a serious allergic reaction: hives, difficulty breathing, or swelling of the face

Seek medical attention right away if you notice signs of dangerously high potassium (muscle weakness, irregular heartbeat), severe skin reactions (blistering or peeling rash), signs of kidney failure (little to no urination), or symptoms of liver problems (confusion, yellowing skin). Rare but serious blood and liver reactions have also been reported.

Spironolactone warnings and precautions

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  • High potassium (hyperkalemia): This is the most serious risk — it can be fatal, especially in people with heart failure or kidney disease. Potassium and kidney labs must be checked within a week of starting and regularly thereafter. Avoid potassium supplements and potassium-containing salt substitutes unless directed.
  • Low blood pressure and worsening kidney function: Too much fluid loss can cause dehydration, dizziness, and kidney stress — especially in people on ACE inhibitors or ARBs. Report symptoms like lightheadedness or decreased urination promptly.
  • Electrolyte imbalances: Spironolactone can lower sodium, magnesium, and calcium, and can raise uric acid and blood sugar. Regular monitoring is needed.
  • Liver disease: In patients with cirrhosis, sudden fluid or electrolyte shifts can trigger confusion or coma. Treatment should be started in a hospital for these patients, and doses should be increased very slowly.
  • Tumor risk in animals (boxed warning): Long-term high-dose use caused tumors in rats. Use only for approved indications — unnecessary use should be avoided.

Spironolactone interactions

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Spironolactone has several important drug and food interactions — mostly centered around potassium levels and kidney function:

  • Potassium supplements, high-potassium foods, and potassium-based salt substitutes: Can push potassium to dangerous levels when combined with spironolactone.
  • ACE inhibitors and ARBs (e.g., lisinopril, losartan): Both raise potassium — combining with spironolactone significantly increases hyperkalemia risk; close monitoring required.
  • NSAIDs (e.g., ibuprofen, naproxen): Can reduce spironolactone's diuretic and blood pressure effects and increase kidney stress.
  • Lithium: Spironolactone slows the kidney's clearance of lithium, raising the risk of lithium toxicity; levels should be monitored.
  • Aspirin (acetylsalicylic acid): May reduce spironolactone's effectiveness — your prescriber may need to adjust your dose.
  • Cholestyramine: Combined use has been linked to a dangerous acid imbalance in the blood.
  • Digoxin: Spironolactone interferes with certain lab tests that measure digoxin — make sure your lab uses an assay that doesn't interact with spironolactone.
  • Abiraterone: Combination is not recommended — may affect PSA (prostate cancer marker) test results.
  • Mitotane: Avoid combining — spironolactone significantly reduces mitotane blood levels, reducing its effectiveness.

Interactions listed in the FDA-approved label

From the Spironolactone prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • Agents increasing serum potassium (potassium supplements, ACE inhibitors, angiotensin receptor blockers, NSAIDs, heparin and low molecular weight heparin, trimethoprim): Concomitant administration can lead to severe hyperkalemia. In general, discontinue potassium supplementation in heart failure patients who start spironolactone; check serum potassium levels when ACE inhibitor or ARB therapy is altered.
  • Lithium: Spironolactone reduces the renal clearance of lithium, increasing the risk of lithium toxicity. Monitor lithium levels periodically when coadministered.
  • NSAIDs: May reduce the diuretic, natriuretic and antihypertensive effect of spironolactone. Monitor closely to determine if the desired effect of the diuretic is obtained.
  • Digoxin: Spironolactone and its metabolites interfere with radioimmunoassays for digoxin and increase the apparent exposure to digoxin. In patients taking concomitant digoxin, use an assay that does not interact with spironolactone.
  • Cholestyramine: Hyperkalemic metabolic acidosis has been reported with concurrent use.
  • Acetylsalicylic acid (ASA): Acetylsalicylic acid may reduce the efficacy of spironolactone. Spironolactone may need to be titrated to a higher maintenance dose and the patient observed closely to determine if the desired effect is obtained.
  • Abiraterone: Spironolactone binds to the androgen receptor and may increase prostate-specific antigen (PSA) levels in abiraterone-treated prostate cancer patients. Concomitant use is not recommended.
  • Mitotane: Spironolactone reduces mitotane plasma levels. Avoid concomitant use.
Read the label’s full interactions text

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 tablets ( 7.3 ). • Digoxin: Spironolactone tablets 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 tablets ( 7.6 ). • Abiraterone: May increase prostate-specific antigen (PSA) levels ( 7.7 ). • Mitotane: Avoid concomitant use of spironolactone tablets and mitotane ( 7.8 ). 7.1 Drugs and Supplements Increasing Serum Potassium Concomitant administration of spironolactone tablets 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 tablets [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 tablets. 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 7.2 Lithium Like other diuretics, spironolactone tablets reduce the renal clearance of lithium, thus increasing the risk of lithium toxicity. Monitor lithium levels periodically when spironolactone tablets are coadministered [see Clinical Pharmacology (12.3) ] . 7.3 Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) In some patients, the administration of an NSAID can reduce the diuretic, natriuretic, and antihypertensive effect of diuretics.

Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

Before taking Spironolactone

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  • Do not take spironolactone if you currently have high potassium levels (hyperkalemia), Addison's disease (adrenal gland insufficiency), or are taking eplerenone — these are absolute contraindications.
  • Kidney disease: Spironolactone is cleared through the kidneys; impaired kidney function increases the risk of dangerous potassium buildup. Closer monitoring and possibly lower doses are needed.
  • Liver disease (cirrhosis): Fluid and electrolyte changes from this drug can worsen liver encephalopathy (brain function impairment). These patients should begin treatment in a hospital at the lowest possible dose.
  • Pregnancy: Spironolactone may affect the sexual development of a male fetus. Pregnant women or those who may become pregnant should discuss the risks with their doctor before taking this medication.
  • Breastfeeding: An active metabolite (canrenone) has been found in breast milk in small amounts. Discuss with your doctor whether to continue breastfeeding.
  • Children: Safety and effectiveness in pediatric patients have not been established.
  • Older adults: Decreased kidney function with age raises the risk of side effects — kidney function should be monitored closely.

Spironolactone overdose

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Taking too much spironolactone may cause drowsiness, confusion, nausea, vomiting, dizziness, diarrhea, or a skin rash. In people with impaired kidney or liver function, dangerous high potassium or low sodium levels may develop. There is no specific antidote — treatment focuses on supportive care, maintaining hydration and electrolyte balance. If you think you or someone else has taken too much, seek emergency medical help immediately.

What Spironolactone does in the body

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Spironolactone works by blocking aldosterone receptors in the kidneys, causing the body to excrete extra sodium and water in the urine while retaining potassium. This results in reduced fluid overload (edema), lower blood volume, and lower blood pressure. In conditions like heart failure, cirrhosis, and nephrotic syndrome — where the body produces excess aldosterone in response to fluid shifts — spironolactone directly counters that hormonal signal to relieve fluid buildup.

How your body processes Spironolactone

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After an oral dose, spironolactone reaches peak blood levels in about 2.6 hours on average, though its active metabolite canrenone peaks later (around 4.3 hours). Food nearly doubles the amount of drug absorbed, which is why consistent habits around meals matter. Spironolactone itself is broken down quickly (half-life of about 1.4 hours), but its active metabolites last much longer — canrenone, for example, has a half-life of about 16.5 hours — meaning the drug's effects persist well beyond the initial dose. Metabolites are eliminated mainly through the urine, and clearance is slowed in patients with liver cirrhosis.

How to store Spironolactone

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Store below 77°F (25°C).

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

206

Supplements & herbs that interact with Spironolactone

206 supplements and herbal products have documented interactions with Spironolactone in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 7
  • Moderate · 174
  • Minor · 25
Every supplement checked against Spironolactone — ranked by severity The full interaction hub: 7 major · 174 moderate · 25 minor · every one linked to its full report. Check Spironolactone against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

1

Nutrient depletion considerations

Spironolactone has been associated with lower levels of 1 nutrient in the clinical literature. This does not mean a deficiency will occur — it means these may be worth discussing with your pharmacist or healthcare provider, especially with long-term use.

See the full Spironolactone nutrient depletion report

Educational information from a licensed clinical database (Natural Medicines) — not medical advice. Do not start or stop medications or supplements without professional guidance.

Spironolactone: pharmacist answers to common questions

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

What is spironolactone actually used for?

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Spironolactone is used for a few different conditions depending on the form you're prescribed. Most commonly, it treats heart failure, high blood pressure, and fluid buildup (swelling) caused by liver or kidney disease. Tablets are also used for a condition called primary hyperaldosteronism, where the adrenal glands make too much of a hormone called aldosterone. Your prescriber chose it for a specific reason — if you're not sure why you're on it, that's a great question to ask them.

Should I take spironolactone with food or on an empty stomach?

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Either is fine — but pick one and stick with it. Food can nearly double how much spironolactone your body absorbs, so if you take it with food some days and without food others, your drug levels can fluctuate. The key is consistency. If you usually take it with breakfast, keep doing that every day.

I've heard it can raise potassium levels — should I be worried?

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This is one of the most important things to know about spironolactone. Yes, it does raise potassium, and if potassium gets too high, it can cause serious heart problems. That's why your doctor will check your blood work regularly — usually within a week of starting and then on a schedule after that. In the meantime, avoid potassium supplements and potassium-based salt substitutes unless your doctor specifically tells you to use them. Signs of high potassium to watch for include muscle weakness, an irregular heartbeat, or numbness.

Men sometimes worry about breast changes — is that a real thing with this drug?

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It is, and it's actually the most commonly reported side effect. Spironolactone can cause gynecomastia — breast tissue enlargement in men — and the risk increases with higher doses. It usually appears anywhere from a month to over a year into treatment. The good news is that it's typically reversible once the medication is stopped or the dose is reduced. If you notice any breast tenderness or swelling, let your doctor know.

Can I take ibuprofen or other anti-inflammatory painkillers while on spironolactone?

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Be careful with those. NSAIDs like ibuprofen or naproxen can reduce spironolactone's diuretic and blood pressure benefits, and they can also put extra strain on your kidneys when combined with this medication. It's best to check with your pharmacist or doctor before regularly using these painkillers. Acetaminophen (Tylenol) is generally a better option for pain when you're on spironolactone.

Is spironolactone safe to take during pregnancy?

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This one requires a real conversation with your doctor. Based on animal studies, spironolactone may affect the development of male fetuses due to its anti-hormonal effects. If you're pregnant, planning to become pregnant, or are breastfeeding, tell your doctor right away. An active metabolite of spironolactone has been detected in breast milk in small amounts, so the decision to continue while breastfeeding should be made together with your healthcare provider based on your individual situation.

Is Spironolactone available over the counter?

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No. Spironolactone is a prescription medicine: every Spironolactone product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

When was Spironolactone first available?

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The earliest FDA record we hold for Spironolactone is from 1960: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Spironolactone was first used.

Who makes Spironolactone?

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38 companies currently list Spironolactone products in the FDA's NDC Directory, including Bryant Ranch Prepack, A-S Medication Solutions, Proficient Rx LP. That count includes repackagers and distributors as well as manufacturers (companies that sell only the raw ingredient are not counted), so fewer companies actually make it; the label on your bottle names the one that supplied yours.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Spironolactone on HelloPharmacist

Detailed data & references for Spironolactone Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Spironolactone forms and strengths (how it comes)

Spironolactone is available in 2 forms. 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 Aldactone
How this form is used
What it may be used for
  • Treats NYHA Class III–IV heart failure with reduced ejection fraction to improve survival, reduce edema, and lower hospitalization risk
  • Used as add-on therapy for high blood pressure when other medicines aren't enough
  • Manages fluid buildup (edema) in adults with liver cirrhosis or nephrotic syndrome when other treatments haven't worked
  • Treats primary hyperaldosteronism — both short-term before surgery and long-term for patients who cannot or will not have surgery
Important instructions
  • Aldactone tablets can be taken with or without food, but take them the same way every day (always with food or always without) to keep drug levels consistent
  • Spironolactone tablets can also be taken with or without food — consistency with meals is key
  • Edema treatment with tablets is typically started in a hospital setting with slow dose adjustment
  • Follow your prescriber's dose and schedule — do not adjust on your own
Available strengths 3 strengths
385 FDA-listed product records ⓘ

Oral suspension

By mouth
How this form is used
What it may be used for
  • Treats NYHA Class III–IV heart failure with reduced ejection fraction in adults to improve survival, manage edema, and reduce hospitalization
  • Used as add-on therapy for high blood pressure in adults when other medicines aren't enough
  • Manages fluid buildup (edema) in adult patients with liver cirrhosis when fluid and sodium restriction alone hasn't worked
Important instructions
  • Spironolactone oral suspension is not therapeutically equivalent to Aldactone tablets — do not swap between them without your prescriber's guidance
  • The oral suspension can be taken with or without food, but take it the same way every day
  • Spironolactone oral suspension should not be used at doses above 100 mg — higher doses can result in unexpectedly high drug levels; a different formulation is needed for higher doses
  • Follow the dosing instructions provided with the suspension specifically — tablet dosing instructions do not apply
Available strengths 1 strength
8 FDA-listed product records ⓘ

Spironolactone on the U.S. market: products, makers and brands

How Spironolactone 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.

38 companies list 176 Spironolactone product records with the FDA, mostly as tablet, oral suspension; the earliest marketing or approval year on record is 1960. Brand names on the directory include Aldactone, Carospir; the rest are generics.

2
Dose forms ⓘ
38
Labelers (makers, repackagers, distributors)
2
Brand names
176
FDA-listed product records ⓘ
1960
Earliest FDA record ⓘ

FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

Also listed with the FDA, not a patient dose form: Powder (15) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Bryant Ranch Prepack19%
A-S Medication Solutions7%
Proficient Rx LP7%
Remedyrepack Inc.5%
Asclemed USA, Inc.5%
NuCare Pharmaceuticals,Inc.5%
Other makers52%

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

How widely Spironolactone is used (Medicaid data)

A general measure of how commonly Spironolactone 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 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.

2,528,169
Medicaid prescriptions filled (Q1–Q4 2025)
$35.9M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Spironolactone prescribed? Of the 1,601 medications we measure, Spironolactone ranks #94 by Medicaid prescriptions — more than 94% of them.

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

Utilization by Spironolactone 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.

The 25 mg oral tablet is the most-dispensed Spironolactone product — about 52% of these Medicaid prescriptions.

spironolactone 25 MG Oral Tablet Most dispensed

1,321,362 Medicaid prescriptions (Q1–Q4 2025) 52% of Spironolactone prescriptions shown $12.5M gross reimbursement (before rebates) ≈ $9.47 per prescription (gross)

Summed across the 32 of 279 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 313096

spironolactone 50 MG Oral Tablet

733,154 Medicaid prescriptions (Q1–Q4 2025) 29% of Spironolactone prescriptions shown $9.8M gross reimbursement (before rebates) ≈ $13 per prescription (gross)

Summed across the 20 of 197 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 198223

spironolactone 100 MG Oral Tablet

457,628 Medicaid prescriptions (Q1–Q4 2025) 18% of Spironolactone prescriptions shown $8.3M gross reimbursement (before rebates) ≈ $18 per prescription (gross)

Summed across the 17 of 187 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 198222

spironolactone 5 MG/ML Oral Suspension

14,454 Medicaid prescriptions (Q1–Q4 2025) <1% of Spironolactone prescriptions shown $4.5M gross reimbursement (before rebates) ≈ $309 per prescription (gross)

Summed across the 6 of 15 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 104232

Other Spironolactone products — combination packs and listings not yet matched to a specific clinical product (kept visible so every prescription is accounted for)

1,571 Medicaid prescriptions (Q1–Q4 2025) <1% of Spironolactone prescriptions shown $779,026 gross reimbursement (before rebates) ≈ $496 per prescription (gross)

Summed across the 2 of 52 listed NDC products with Medicaid activity.

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 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 77 of 730 listed Spironolactone NDCs with Medicaid activity.

Compare Spironolactone products

A representative set of FDA-listed product records for Spironolactone — 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 102 of 176 products — FDA National Drug Code Directory. See every product, package size and price: browse all 176 Spironolactone NDCs →

Spironolactone recall history

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list one Spironolactone recall since July 2021. It is still ongoing. A recall names specific lots from one company, so check the lot number on your own bottle rather than assuming every product is affected; your pharmacist can check whether your supply came from an affected lot.

Ongoing Class II Aug 5, 2025 · SUN PHARMACEUTICAL INDUSTRIES INC
Presence of foreign substance: identified as aluminum.
  • Spironolactone Tablets, USP, 25 mg, 100-count bottle, Rx only, Mfg. by: Frontida BioPharm, Inc., 1100 Orthodox St, Philadelphia, PA 19124, Dist. by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ… Lots: Lot # P3314, Exp 11/30/2026 FDA record D-0574-2025 →

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Spironolactone RxCUI 9997 2 dose forms · 7 strengths
  1. Dose form (SCDF) Oral Suspension RxCUI 379251 In current FDA listings
    Clinical drug / strength (SCD) 1 MG/ML RxCUI 104230 2 MG/ML RxCUI 104231 5 MG/ML RxCUI 104232 10 MG/ML RxCUI 104233
  2. Dose form (SCDF) Oral Tablet RxCUI 373946 In current FDA listings
    Clinical drug / strength (SCD) 25 MG RxCUI 313096 50 MG RxCUI 198223 100 MG RxCUI 198222

Look up RxCUI 9997 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

💵 What Spironolactone costs pharmacies (NADAC benchmark)

The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.

FormStrengthPharmacy acquisition benchmark
Suspension · Oral 25 mg/5 mL $1.62–$1.81 per mL NDC details & price history
Why show this? Your out-of-pocket cost depends on insurance, pharmacy markup, and discounts — but the acquisition benchmark tells you whether the medication itself is inexpensive or costly, which strengths cost more per dose, and whether a cash-price quote is in a reasonable range. Each row links to the NDC-level record with its full price history.

Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.

Spironolactone brand names

Spironolactone is sold under 2 brand names in the FDA directory — Aldactone, Carospir. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Aldactone Carospir

Who makes Spironolactone: manufacturers and labelers

38 companies list Spironolactone products with the FDA. By number of product records, the largest are Bryant Ranch Prepack, A-S Medication Solutions, Proficient Rx LP. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Bryant Ranch Prepack 33 A-S Medication Solutions 13 Proficient Rx LP 13 Remedyrepack Inc. 9 Asclemed USA, Inc. 8 NuCare Pharmaceuticals,Inc. 8 Aphena Pharma Solutions - Tennessee, LLC 6 PD-Rx Pharmaceuticals, Inc. 6 Camber Pharmaceuticals, Inc. 4 Northwind Health Company, LLC 4 Preferred Pharmaceuticals Inc. 4 Accord Healthcare, Inc. 3 American Health Packaging 3 Amneal Pharmaceuticals LLC 3 Amneal Pharmaceuticals of New York LLC 3 Aurobindo Pharma Limited 3 Coupler LLC 3 Direct_Rx 3 Jubilant Cadista Pharmacuticals Inc. 3 Mylan Institutional Inc. 3 Mylan Pharmaceuticals Inc. 3 NorthStar Rx LLC 3 Oxford Pharmaceuticals, LLC 3 Pfizer Laboratories Div Pfizer Inc 3

…and 14 more on the FDA NDC directory.

Spironolactone drug class (RxNorm)

Spironolactone belongs to the Aldosterone Antagonist class.

Pharmacologic class Aldosterone Antagonist
Drug family (ATC) Aldosterone antagonists
How it works Aldosterone Antagonists

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.

Sources for this Spironolactone page

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 Nov 28, 2025
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Spironolactone.
📈
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 after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
148
Finished products in the current FDA directory
176
Companies listing them (makers, repackagers, distributors)
38
FDA labeler codes behind them ⓘ
44
Linked representative label ⓘ
Pfizer Laboratories Div Pfizer Inc
Linked label effective
Nov 28, 2025
Composite sections available
26
Linked SPL Set ID
0fed2822-3a03-4b64-9857-c682fcd462bc
Linked SPL Document ID
22946678-dcad-4518-9bc6-cbdf51a38c16
Open the linked representative label on DailyMed ↗

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Pfizer Laboratories Div Pfizer Inc is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →