October 7, 2015
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(spironolactone) tablets, USP


ALDACTONE has been shown to be a tumorigen in chronic toxicity studies in rats (see PRECAUTIONS). ALDACTONE should be used only in those conditions described under Indications and Usage. Unnecessary use of this drug should be avoided.


ALDACTONE oral tablets contain 25 mg, 50 mg, or 100 mg of the aldosterone antagonist spironolactone, 17-hydroxy-7α-mercapto-3-oxo-17α-pregn-4-ene-21­carboxylic acid γ-lactone acetate, which has the following structural formula:

Aldactone® (spironolactone) Structural Formula Illustration

Spironolactone is practically insoluble in water, soluble in alcohol, and freely soluble in benzene and in chloroform.

Inactive ingredients include calcium sulfate, corn starch, flavor, hypromellose, iron oxide, magnesium stearate, polyethylene glycol, povidone, and titanium dioxide.

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

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using spironolactone and call your doctor at once if you have a serious side effect such as:

  • numbness or tingly feeling;
  • muscle pain or weakness;
  • slow, fast, or uneven heart rate;
  • feeling drowsy, restless, or light-headed;
  • urinating less than usual or not at all;
  • shallow breathing;
  • tremors, confusion;
  • nausea, upper stomach pain, itching, loss of...

Read All Potential Side Effects and See Pictures of Aldactone »

What are the precautions when taking spironolactone (Aldactone)?

Before taking spironolactone, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney problems, liver problems, untreated mineral imbalance (such as high potassium, low sodium), decreased adrenal gland function (Addison's disease).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This medication may increase your potassium levels. Before using potassium supplements or salt...

Read All Potential Precautions of Aldactone »

Last reviewed on RxList: 5/18/2015
This monograph has been modified to include the generic and brand name in many instances.

Aldactone - User Reviews

Aldactone User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Aldactone sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration


You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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