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Prescription oral tabletAn aldosterone antagonist, a type of prescription medicine the FDA classifies this way

Spironolactone

Spironolactone · Say it: speer-on-OL-ak-tone

Spironolactone is a prescription tablet, classed as an aldosterone antagonist, that the label describes for heart failure, high blood pressure, edema (fluid buildup), and a condition called primary hyperaldosteronism.

Brand names: Aldactone

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Used for

Heart failure with reduced ejection fraction (NYHA Class III-IV), to help increase survival, manage edema, and reduce the need for hospital stays for heart failure. The label says it is usually given with other heart failure medicines.

Comes as

25 mg tablets: white, round, unscored, debossed MP 35; 50 mg tablets: white, round, film coated, scored, debossed MP 542

Common side effects

Breast enlargement in men (gynecomastia). The label calls this the most common side effect. It is usually reversible, and it may take from 1 to 2 months to over a year to begin., Breast and nipple pain, Diarrhea, cramping, nausea, or vomiting

Key facts
Generic nameSpironolactone
Brand namesAldactone
Type of medicineAn aldosterone antagonist, a type of prescription medicine the FDA classifies this way
How it is soldPrescription oral tablet
Comes as25 mg tablets: white, round, unscored, debossed MP 35; 50 mg tablets: white, round, film coated, scored, debossed MP 542; 100 mg tablets: white, oval, film coated, scored, debossed MP 303
Routeoral
Boxed warningNo
Label date2026-09-09

💊 What is Spironolactone used for?

  • Heart failure with reduced ejection fraction (NYHA Class III-IV), to help increase survival, manage edema, and reduce the need for hospital stays for heart failure. The label says it is usually given with other heart failure medicines.
  • High blood pressure, as an add-on medicine for people not adequately controlled on other medicines. The label notes that lowering blood pressure reduces the risk of strokes and heart attacks.
  • Edema in adults who have cirrhosis when fluid and sodium restriction has not helped, or in nephrotic syndrome when other treatments have given an inadequate response.
  • Primary hyperaldosteronism: short-term treatment before surgery, or long-term maintenance for people who cannot have surgery, such as those with aldosterone-producing adrenal adenomas or bilateral adrenal hyperplasia.

How it works

How it is usually taken

  • The label says spironolactone can be taken with or without food, but it should be taken consistently with respect to food. The dose and schedule vary by condition and are set by your prescriber. Follow the instructions from your prescriber or pharmacist.

Comes as

  • 25 mg tablets: white, round, unscored, debossed MP 35
  • 50 mg tablets: white, round, film coated, scored, debossed MP 542
  • 100 mg tablets: white, oval, film coated, scored, debossed MP 303

⚠️ Spironolactone side effects

Common side effects

  • Breast enlargement in men (gynecomastia). The label calls this the most common side effect. It is usually reversible, and it may take from 1 to 2 months to over a year to begin.
  • Breast and nipple pain
  • Diarrhea, cramping, nausea, or vomiting
  • Dizziness, headache, drowsiness, or lethargy
  • Leg cramps
  • Decreased sex drive, trouble getting or keeping an erection, or irregular menstrual periods

Get medical help right away if

  • Get medical help right away if you have signs of severe allergy, such as swelling, trouble breathing, or a serious allergic reaction (anaphylaxis). The label also lists fever, hives, or rash with blistering or peeling skin (Stevens-Johnson Syndrome, toxic epidermal necrolysis, or DRESS), and vasculitis.
  • Get medical help right away if you notice signs of bleeding in the stomach or intestines (gastric bleeding), such as black or bloody stools or vomiting blood.
  • Get medical help right away if you have signs of liver problems, such as yellowing of the skin or eyes. The label notes a very few cases of liver toxicity, including one reported death.
  • Get medical help right away if you have symptomatic dehydration, very low blood pressure, or signs of kidney problems, since the label warns of these, especially in salt-depleted people.
  • Get medical help right away if you have confusion, unusual drowsiness, or loss of consciousness. The label links impaired neurological function or coma to people with liver disease, cirrhosis, and ascites.
  • Get medical help right away if you have signs of a low white blood cell count or low platelets, such as unusual infections, bruising, or bleeding.

🛑 Who should not take Spironolactone, and who should be careful

The label says not to take it if

Tell your doctor before taking it if

  • The label says high potassium (hyperkalemia) is a key risk. Your prescriber should monitor potassium levels within one week of starting and regularly after that.
  • Avoid potassium supplements, foods high in potassium, and salt substitutes, as the label advises.
  • Tell your prescriber about kidney problems, liver problems, or dehydration, because the label describes higher risks in these situations.
  • Your prescriber may also check electrolytes, uric acid, blood glucose, and kidney function from time to time.
  • The label says lithium levels should be checked periodically if you take lithium.

🔀 Spironolactone with other medicines, food and alcohol

The label says to discuss these with your doctor or pharmacist

  • Potassium supplements, salt substitutes, or drugs that raise potassium, such as ACE inhibitors, angiotensin receptor blockers, NSAIDs, heparin, and trimethoprim. Combining these can lead to severe high potassium.
  • Lithium: spironolactone can increase the risk of lithium toxicity.
  • NSAIDs (such as ibuprofen): may reduce the diuretic and blood-pressure-lowering effect of spironolactone.
  • Digoxin: spironolactone can interfere with some lab tests for digoxin levels. The label says to use an assay that does not interact with spironolactone.
  • Cholestyramine: high potassium with acid buildup (hyperkalemic metabolic acidosis) has been reported.
  • Acetylsalicylic acid (aspirin): may reduce how well spironolactone works.
  • Abiraterone: may increase prostate-specific antigen (PSA) levels.
  • Mitotane: the label says to avoid using it with spironolactone.
  • Drugs that harm the kidneys, such as aminoglycosides, cisplatin, and NSAIDs, can worsen kidney function.

Alcohol and food

The label says spironolactone can be taken with or without food, but it should be taken consistently with respect to food. The label does not give specific alcohol guidance in the text provided.

🤰 Spironolactone in pregnancy and breastfeeding

Pregnancy

The label says that because of the potential risk to a male fetus, spironolactone should be avoided in pregnant women, or a pregnant woman should be told about the potential risk to a male fetus. The label also notes that heart failure, cirrhosis, and poorly controlled high blood pressure carry their own risks during pregnancy. Talk with your prescriber about any pregnancy.

Breastfeeding

The label does not say.

🗓️ Storage, missed doses and taking too much

Storage

The label says to store at 20° to 25°C (68° to 77°F), in a tight, light-resistant container.

If a dose is missed

The label does not say.

If too much is taken

The label says acute overdose may cause drowsiness, mental confusion, a rash, nausea, vomiting, dizziness, or diarrhea. Hyperkalemia may also occur, especially in people with impaired kidney function. The label says there is no specific antidote, and treatment is supportive, focusing on hydration, electrolyte balance, and vital functions. Get emergency medical help right away if an overdose is suspected.

🗒️ Questions to ask about Spironolactone

🎯 Check what you understood

1. According to the summary, what is the most common side effect listed in the label?

2. What does the label say about potassium and salt substitutes?

3. What does the label say about taking spironolactone with food?

❓ Spironolactone: frequently asked questions

What is spironolactone used for?

The label describes use for heart failure with reduced ejection fraction, high blood pressure as an add-on treatment, edema in certain adults with cirrhosis or nephrotic syndrome, and primary hyperaldosteronism. The prescriber decides which use applies to you.

Can I take spironolactone with food?

The label says it can be taken with or without food, but it should be taken consistently with respect to food. Ask your pharmacist if you have questions about your routine.

Why is potassium a concern with spironolactone?

The label says spironolactone can cause high potassium (hyperkalemia), and the risk is higher with kidney problems or with potassium supplements or salt substitutes. Your prescriber should monitor potassium levels.

What is the most common side effect?

The label says the most common side effect is gynecomastia, which is breast enlargement in men. The label says it is usually reversible.

Who should not take spironolactone?

The label says spironolactone is contraindicated in people with hyperkalemia, Addison's disease, or who are using eplerenone. Talk with your prescriber or pharmacist about your health history.

🧪 Tests and reports linked to Spironolactone

The label text mentions these. If you have one of these reports, get every line of it explained.

📖 Medical words used on this page

  • Acute vs chronic

    Acute means something started recently or suddenly. Chronic means it has lasted a long time or keeps coming back.

  • Adrenal insufficiency

    Adrenal insufficiency means the adrenal glands do not make enough cortisol. A sudden severe form, adrenal crisis, is an emergency.

  • Allergic reaction

    An allergic reaction is when the immune system overreacts to something harmless, such as a medicine or food, causing symptoms from a rash to swelling.

  • Anaphylaxis

    Anaphylaxis is a severe, whole-body allergic reaction that comes on fast and is a medical emergency needing urgent help.

  • Bilateral and unilateral

    Bilateral means on both sides of the body and unilateral means on one side only, and reports usually also name the side.

  • Cirrhosis

    Cirrhosis is long-term scarring of the liver, where healthy tissue is replaced by scar tissue so the liver cannot work as well.

  • Contraindication

    A contraindication is a reason not to use a particular medicine, test or procedure for a person because it could cause harm.

  • Dehydration

    Dehydration means the body has lost more fluid than it has taken in, so it does not have enough water to work normally.

  • Diuretic

    A diuretic is a medicine that helps the kidneys remove extra salt and water from the body, so you pass more urine.

  • Edema

    Edema is swelling caused by extra fluid trapped in the body's tissues, often in the feet, ankles and legs.

  • Ejection fraction

    Ejection fraction is the percentage of blood the heart's main pumping chamber pushes out with each beat. It is one measure of heart pumping.

  • Electrolytes

    Electrolytes are minerals in the blood, such as sodium, potassium and chloride, that carry an electric charge and help the body work.

  • Heart failure

    Heart failure means the heart is not pumping or filling as well as it should, so it struggles to meet the body's needs. It does not mean the heart has stopped.

  • Hepatotoxicity

    Hepatotoxicity means damage to the liver caused by a medicine, chemical or supplement.

📖 Medical words on this page

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Source: official FDA drug label (label updated 2026-09-09). Read the full label on DailyMed

MedicDecode explains the official label in plain words. It is not medical advice and does not replace your doctor or pharmacist. Never start, stop or change a medicine because of what you read here.