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Spironolactone: uses, dosing, side effects & brands

Spironolactone is an aldosterone antagonist sold in the U.S. under 2 brand and generic names, for ascites, edema and heart failure. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.

By the pharmaranks editorial teamReviewed against the FDA (openFDA label, NDC Directory & Enforcement) sourcesUpdated Jul 24, 2026How we research

Key facts

Drug class
Aldosterone Antagonist
Treats (across its forms)
Ascites, Edema and Heart Failure
Available as
Suspension · Tablet
Sold as
2 products — Carospir and Spironolactone
Prescription?
Prescription only
Generic available?
Yes
Half-life
about 1.4 hours
What the pharmacy pays
about $3 for a 30-count supply — not your price

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How Carospir is dosed

From the FDA label for Carospir (application NDA209478). Other spironolactone products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.

Spironolactone oral suspension is not therapeutically equivalent to Aldactone ( 2.1 ) Heart Failure: Initiate treatment at 20 mg once daily. ( 2.2 ) Hypertension: Initiate treatment at 20 to 75 mg daily in either single or divided doses ( 2.3 ) Edema associated with Hepatic Cirrhosis: Initiate therapy in a hospital setting and titrate slowly. The initial recommended daily dose is 75 mg in either single or divided doses ( 2.4 ) 2.1 General Considerations Spironolactone oral suspension is not therapeutically equivalent to Aldactone. Follow dosing instructions given here. In patients requiring a dose greater than 100 mg, use another formulation. Doses of the suspension greater than 100 mg may result in spironolactone concentrations higher than expected [see Clinical Pharmacology ( 12.3 )] . Spironolactone oral suspension can be taken with or without food, but should be taken consistently with respect to food [see Clinical Pharmacology ( 12.3 )] . 2.2 Treatment of Heart Failure In patients with serum potassium ≤5.0 mEq/L and eGFR >50 mL/min/1.73m 2 , initiate treatment at 20 mg (4 mL) once daily. Patients who tolerate 20 mg (4 mL) once daily may have their dosage increased to 37.5 mg (7.5 mL) once daily as clinically indicated. Patients who develop hyperkalemia on 20 mg (4 mL) once daily may have their dosage reduced to 20 mg (4 mL) every other day [see Warnings and Precautions (…

Everything below is the FDA label for Carospir (suspension). Spironolactone is also sold as tablet, and those are different medicines to take — follow the label for the one you were prescribed.

Carospir side effects

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: Gynecomastia [see Warnings and Precautions ( 5.4 )] , 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…

Who shouldn’t take Carospir

Spironolactone oral suspension is contraindicated for patients with the following conditions: Hyperkalemia Addison’s disease Concomitant use of eplerenone Spironolactone oral suspension is contraindicated in patients with ( 4 ): Hyperkalemia Addison’s disease Concomitant use of eplerenone

Carospir 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 oral suspension ( 7.3 ) Digoxin: Spironolactone oral suspension 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 ) 7.1 Drugs and Supplements Increasing Serum Potassium Concomitant administration of spironolactone oral suspension 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 oral suspension [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 oral suspension. Examples of drugs that can increase potassium include: ACE inhibitors angiotensin receptor blockers aldosterone blockers non-steroidal anti-inflammatory drugs (NSAIDs) heparin and low molecular weight heparin trimethoprim 7.2 Lithium Like other diuretics, spironolactone oral suspension reduces the renal clearance of lithium, thus increasing the risk of lithium toxicity. Monitor lithium levels periodically when spironolactone oral suspension is 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 loop, potassium-sparing, and thiazide diuretics. Therefore, when spironolactone oral suspension and NSAIDs are used concomitantly, monitor closely to determine if the desired effect of the diuretic is obtained [see Clinical Pharmacology ( 12.3 )] . 7.4 Digoxin Spironolactone and its metabolites increase the apparent exposure to digoxin. In patients taking concomitant digoxin, measure serum digoxin concentrations before initiating spironolactone using an assay that does not interact with spironolactone. Reduce digoxin concentrations by decreasing the dose by approximately 15-30% or by modifying the dosing frequency and continue monitoring [see Clinical Pharmacology ( 12.3 )] . 7.5 Cholestyramine Hyperkalemic metabolic acidosis has been reported in patients given spironolactone concurrently with cholestyramine. 7.6 Acetylsalicylic Acid Acetylsalicylic acid may reduce the efficacy of spironolactone. Therefore, when spironolactone oral suspension and acetylsalicylic acid are used concomitantly, spironolactone oral suspension 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 )] . 7.7 CYP2C8 and CYP3A Substrates Spironolactone is an irreversible inhibitor for CYP2C8 and CYP3A4/5 in vitro [see Clinical Pharmacology ( 12.3 )] . Therefore, spironolactone may increase the exposure of other coadministered drugs that are metabolized by CYP2C8 and CYP3A4/5. Dosage adjustments of the drugs metabolized by CYP2C8 (e.g., repaglinide) and CYP3A4/5 (e.g., midazolam, sirolimus and tacrolimus) may be necessary if they are given concurrently with spironolactone.

Every spironolactone product we track (2)

Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.

Spironolactone products
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What spironolactone pills look like

Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.

Spironolactone pill imprints
ImprintStrengthColourShape
MP;3525 mgwhiteround
MP;303100 mgwhiteoval
AN;515100 mgbrownround
852;O25 mgwhiteround
TL218100 mgbrownround
852;O25 mgwhiteround
MP;54250 mgwhiteround

Combination products containing spironolactone

A combination is a different drug — different dosing, different warnings. It is listed here so you can find it, not so you can substitute it.

Spironolactone recalls

From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.

How long spironolactone keeps

No spironolactone label we read sets a separate limit for after opening, but they do specify how it must be stored — and the stability behind any date assumes those conditions.

Does spironolactone expire? The in-use limits and storage rules from its labels

Spironolactone and breastfeeding

From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.

Limited data indicate that spironolactone is poorly excreted into breastmilk. Case of mothers breastfeeding during spironolactone therapy reported no adverse effects in infants. Spironolactone appears to be acceptable to use during breastfeeding.

Full LactMed record for spironolactone: levels in milk, effects in breastfed infants, and the drugs it would consider instead

National Institute of Child Health and Human Development, record revised November 15, 2023. LactMed states its information is not a substitute for professional judgement.

What people report to the FDA about spironolactone

The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 113,179 reports naming spironolactone, and the FDA flagged 77% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:

  • dyspnoea8,957 reports
  • fatigue7,306 reports
  • nausea6,853 reports
  • diarrhoea6,450 reports
  • acute kidney injury5,713 reports
  • dizziness5,573 reports
  • headache5,339 reports
  • hypotension4,840 reports

Read these as a signal, not a rate. A report does not mean spironolactone caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.

Source: openFDA drug/event (FAERS), retrieved July 26, 2026.

How long spironolactone stays in your system

The elimination half-life of spironolactone is about 1.4 hours. The parent drug clears fast, but that number is misleading on its own: spironolactone is rapidly and extensively metabolized (mainly by CYP3A4/5, less by CYP2C8) into active metabolites that far outlast it. Canrenone has a mean half-life of 16.5 hours, 7-alpha-(thiomethyl)spirolactone (TMS) 13.8 hours, and 6-beta-hydroxy-7-alpha-(thiomethyl)spirolactone (HTMS) 15 hours — these metabolites are themselves aldosterone antagonists, so the drug's effect persists long after the parent is gone. The Aldactone label states the impact of age, sex, race/ethnicity, and renal impairment on spironolactone pharmacokinetics has NOT been specifically studied, so no labeled numbers exist for older adults or kidney impairment. In hepatic impairment the label does report that the terminal half-life is increased in patients with cirrhotic ascites, without giving a figure. There is no extended-release spironolactone in the US; the one alternative formulation, CaroSpir oral suspension, is immediate-release and lists a similar parent half-life of roughly 1 to 2 hours with metabolite half-lives of 10 to 35 hours, though it is not interchangeable with tablets (15-37% higher serum concentration at an equivalent dose). Food roughly doubles absorption (AUC up about 90-95%), which is why intake should be kept consistent relative to meals.

ALDACTONE (spironolactone) tablets, USP — FDA prescribing information, Section 12.3 Pharmacokinetics (Pfizer)

Half-life is how long the body takes to clear half a dose. It is not the same as how long a drug test can detect it, and it varies with age, kidney and liver function.

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Frequently asked questions

What is Carospir?

Carospir (Spironolactone) is an aldosterone antagonist used to treat Ascites, Edema, Heart Failure, Hirsutism.

What kind of drug is spironolactone?

The FDA classifies spironolactone as an aldosterone antagonist. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.

How long does spironolactone stay in your system?

The elimination half-life of spironolactone is about 1.4 hours — that is how long the body takes to clear half of a dose. The parent drug clears fast, but that number is misleading on its own: spironolactone is rapidly and extensively metabolized (mainly by CYP3A4/5, less by CYP2C8) into active metabolites that far outlast it. Canrenone has a mean half-life of 16.5 hours, 7-alpha-(thiomethyl)spirolactone (TMS) 13.8 hours, and 6-beta-hydroxy-7-alpha-(thiomethyl)spirolactone (HTMS) 15 hours — these metabolites are themselves aldosterone antagonists, so the drug's effect persists long after the parent is gone. The Aldactone label states the impact of age, sex, race/ethnicity, and renal impairment on spironolactone pharmacokinetics has NOT been specifically studied, so no labeled numbers exist for older adults or kidney impairment. In hepatic impairment the label does report that the terminal half-life is increased in patients with cirrhotic ascites, without giving a figure. There is no extended-release spironolactone in the US; the one alternative formulation, CaroSpir oral suspension, is immediate-release and lists a similar parent half-life of roughly 1 to 2 hours with metabolite half-lives of 10 to 35 hours, though it is not interchangeable with tablets (15-37% higher serum concentration at an equivalent dose). Food roughly doubles absorption (AUC up about 90-95%), which is why intake should be kept consistent relative to meals. Half-life is not the same as how long a drug test can detect the drug, and it varies with age, kidney and liver function.

Can you take spironolactone with other medicines?

It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run spironolactone against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.

What brand names is spironolactone sold under?

We track 2 spironolactone-containing products in the U.S.: Carospir and Spironolactone. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.

What forms does spironolactone come in?

Across the brands we track, spironolactone is currently marketed as suspension and tablet, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.

Is there a generic spironolactone?

Yes. Our catalog lists 1 generic spironolactone product alongside the brand versions. A generic has the same active ingredient and must meet the FDA's bioequivalence standard; it usually costs less. Ask your pharmacist which one your plan covers.

Has spironolactone been recalled?

The FDA's Enforcement database lists 1 recall record whose product description mentions spironolactone. The most recent: Spironolactone Tablets (Aug 5, 2025). A recall applies to specific lots, not to the drug as a whole — check the record for the affected lot numbers.

How long does it take for spironolactone to work?

For fluid retention or blood pressure, spironolactone's diuretic effect begins within a day or two. But the use most people ask about, hormonal acne or female-pattern hair loss, is slow: this off-label use typically takes about 8 to 12 weeks, sometimes longer, before skin or hair visibly improves. Keep taking it daily and don't expect an overnight change.

What are the common side effects of Aldactone (spironolactone)?

Because Aldactone (spironolactone) blocks aldosterone and holds onto potassium while flushing out water and salt, Common effects include increased urination and dizziness; MedlinePlus additionally lists drowsiness or tiredness, stomach pain, vomiting or diarrhea, and hormone-related changes: breast enlargement or tenderness in men and women, irregular menstrual periods, and, in men, erectile dysfunction. Many are dose-related. This is not a complete list — ask your pharmacist about your specific dose.

When should Aldactone (spironolactone) be a medical emergency — what is the high-potassium risk?

The one you must not miss is hyperkalemia (high blood potassium), which can trigger dangerous, even fatal, heart rhythm changes. The FDA label warns: 'ALDACTONE 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 [ACE inhibitors] and [ARBs].' MedlinePlus says to call your doctor immediately for 'muscle weakness, pain, or cramps; ... numbness, or tingling in the hands or feet; inability to move arms or legs; changes in heartbeat; confusion; nausea; extreme tiredness.' Seek emergency care for irregular heartbeat or fainting.

Should I avoid potassium supplements and salt substitutes on Aldactone (spironolactone)?

Yes. Aldactone (spironolactone) makes your body keep potassium, so adding more can push you into dangerous hyperkalemia. Per the FDA label, the risk rises with 'potassium supplementation' and 'potassium-containing salt substitutes' — most 'lite' or 'no-salt' substitutes are potassium chloride. MedlinePlus advises avoiding potassium-containing salt substitutes and checking with your doctor before eating large amounts of potassium-rich foods. Your prescriber will also check a blood potassium level, typically within a week of starting or changing the dose.

Does Aldactone (spironolactone) cause breast enlargement (gynecomastia), and is it permanent?

It can. Gynecomastia (breast tissue enlargement in men) is a recognized hormonal effect because spironolactone has anti-androgen activity. In the RALES heart-failure trial cited in the FDA label, about 9% of men developed gynecomastia at a mean dose of ~26 mg daily, and the label describes it as 'usually reversible' — it often improves after the drug is stopped. Aldactone also carries a boxed warning that it 'has been shown to be a tumorigen in chronic toxicity studies in rats,' so it should be used only for its approved indications. Do not stop it on your own; discuss breast changes with your prescriber.

When do Aldactone (spironolactone) side effects start and how long do they last?

The diuretic effect — more urination — usually begins within hours to a couple of days, though the full blood-pressure or fluid benefit builds over about two weeks. Potassium can rise soon after starting or after a dose increase, which is why blood tests are done early. Hormonal effects like breast tenderness or menstrual changes tend to appear over weeks and often ease after stopping. Kidney disease raises the hyperkalemia risk, so those patients need clearance and closer monitoring.

What is spironolactone used for?

Spironolactone is FDA-approved to treat high blood pressure, heart failure, and fluid retention (edema) caused by heart failure, liver cirrhosis, or kidney disease. It also treats primary hyperaldosteronism (a hormone disorder) and low potassium levels. It's a potassium-sparing diuretic ("water pill") that works by blocking the hormone aldosterone, so the body releases water and sodium while holding on to potassium.

Is spironolactone used for acne or unwanted hair growth?

Yes, but off-label — these are not FDA-approved uses. Because spironolactone blocks androgens (male-type hormones), doctors commonly prescribe it off-label for hormonal acne, excess facial or body hair (hirsutism), and PCOS-related symptoms in women. Evidence supports these uses, but they aren't on the FDA label, and spironolactone isn't used this way in men because it can cause breast tissue growth (gynecomastia).

Why does spironolactone require potassium monitoring?

Because it makes the body retain potassium, spironolactone can raise potassium to dangerous levels (hyperkalemia), especially in people with kidney problems or those taking ACE inhibitors, ARBs, or potassium supplements. The FDA label advises checking potassium and kidney function periodically, and avoiding potassium-based salt substitutes without medical guidance.

Cite this page
APA
pharmaranks. (2026, July 24). Spironolactone: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/spironolactone
MLA
“Spironolactone: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/spironolactone.

We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.

Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.

Read the full FDA label for spironolactone on DailyMed (NIH) ↗.