Spironolactone 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.
spironolactone tablets, USP
Aldactone oral tablets contain 25 mg, 50 mg, or 100 mg of the aldosterone antagonist spironolactone.
Aldactone (spironolactone) is indicated in the management of:
Primary hyperaldosteronism for:
Establishing the diagnosis of primary hyperaldosteronism by therapeutic trial.
Short-term preoperative treatment of patients with primary hyperaldosteronism.
Long-term maintenance therapy for patients with discrete aldosterone-producing adrenal adenomas who are judged to be poor operative risks or who decline surgery.
Long-term maintenance therapy for patients with bilateral micro- or macronodular adrenal hyperplasia (idiopathic hyperaldosteronism).
Edematous conditions for patients with:
Congestive heart failure
For the management of edema and sodium retention when the patient is only partially responsive to, or is intolerant of, other therapeutic measures. Aldactone is also indicated for patients with congestive heart failure taking digitalis when other therapies are considered inappropriate.
Cirrhosis of the liver accompanied by edema and/or ascites
Aldosterone levels may be exceptionally high in this condition. Aldactone is indicated for maintenance therapy together with bed rest and the restriction of fluid and sodium.
The nephrotic syndrome
For nephrotic patients when treatment of the underlying disease, restriction of fluid and sodium intake, and the use of other diuretics do not provide an adequate response.
Usually in combination with other drugs, Aldactone is indicated for patients who cannot be treated adequately with other agents or for whom other agents are considered inappropriate.
For the treatment of patients with hypokalemia when other measures are considered inappropriate or inadequate. Aldactone is also indicated for the prophylaxis of hypokalemia in patients taking digitalis when other measures are considered inadequate or inappropriate.
Usage in Pregnancy
The routine use of diuretics in an otherwise healthy woman is inappropriate and exposes mother and fetus to unnecessary hazard. Diuretics do not prevent development of toxemia of pregnancy, and there is no satisfactory evidence that they are useful in the treatment of developing toxemia.
Edema during pregnancy may arise from pathologic causes or from the physiologic and mechanical consequences of pregnancy.
Aldactone is indicated in pregnancy when edema is due to pathologic causes just as it is in the absence of pregnancy (however, see Precautions: Pregnancy ). Dependent edema in pregnancy, resulting from restriction of venous return by the expanded uterus, is properly treated through elevation of the lower extremities and use of support hose; use of diuretics to lower intravascular volume in this case is unsupported and unnecessary. There is hypervolemia during normal pregnancy which is not harmful to either the fetus or the mother (in the absence of cardiovascular disease), but which is associated with edema, including generalized edema, in the majority of pregnant women. If this edema produces discomfort, increased recumbency will often provide relief. In rare instances, this edema may cause extreme discomfort which is not relieved by rest. In these cases, a short course of diuretics may provide relief and may be appropriate.
Published Studies Related to Aldactone (Spironolactone)
Effects of spironolactone treatment in elderly women with heart failure and
preserved left ventricular ejection fraction. 
CONCLUSIONS: Spironolactone stabilizes functional capacity and symptoms and
Spironolactone to prevent cardiovascular events in early-stage chronic kidney
disease (STOP-CKD): study protocol for a randomized controlled pilot trial. 
BACKGROUND: Chronic kidney disease is associated with increased arterial
stiffness even in the early stages and this is thought to be a key mediator in
the pathophysiology of the increased cardiovascular risk associated with this
condition. The use of low-dose spironolactone has previously been shown to
improve arterial stiffness and reduce left ventricular mass safely in early-stage
chronic kidney disease in the context of careful monitoring at a university
Race influences the safety and efficacy of spironolactone in severe heart
CONCLUSIONS: AAs with HF exhibited less hyperkalemia and more hypokalemia with
Comparison of the efficacy of 5% topical spironolactone gel and placebo in the
treatment of mild and moderate acne vulgaris: a randomized controlled trial. 
mild to moderate acne vulgaris... CONCLUSION: The 5% spironolactone topical gel resulted in a decrease in the TLC
Rationale and design of the Treatment of Preserved Cardiac Function Heart Failure with an Aldosterone Antagonist Trial: A randomized, controlled study of spironolactone in patients with symptomatic heart failure and preserved ejection fraction. [2011.12]
BACKGROUND: Despite increasing prevalence of heart failure (HF) in patients with preserved ejection fraction (PEF), there are no available therapies proven to reduce morbidity and mortality. Aldosterone, a potent stimulator of myocardial and vascular fibrosis, may be a key mediator of HF progression in this population and is therefore an important therapeutic target. OBJECTIVE: The TOPCAT trial is designed to evaluate the effect of spironolactone, an aldosterone antagonist, on morbidity, mortality, and quality of life in patients with HF-PEF... CONCLUSION: TOPCAT is designed to assess definitively the role of spironolactone in the management of HF-PEF. Copyright (c) 2011 Mosby, Inc. All rights reserved.
Clinical Trials Related to Aldactone (Spironolactone)
High-Dose Aldactone for Treatment of Diuretic Resistant Heart Failure [Recruiting]
Prospective, open-label, randomized cohort study comparing adding high-dose spironolactone
to usual heart failure care versus usual care in patients with acute decompensated heart
failure. Patients will be randomized in a 1: 1 fashion to either usual care or high-dose
spironolactone plus usual care. Both arms of the study will continue with treatment of ADHF
until euvolemia as defined as the resolution of pulmonary edema, peripheral edema, abdominal
bloating and/or jugular venous distention. Assessment of clinical status and serum
electrolytes, symptoms and renal function will be performed in accordance to standard of
Acetazolamide and Spironolactone to Increase Natriuresis in Congestive Heart Failure [Recruiting]
This study has two primary objectives:
1. To compare combination therapy with acetazolamide and low-dose loop diuretics versus
high-dose loop diuretics (standard of care) in patients with acute decompensated heart
failure at high risk for diuretic resistance.
2. To demonstrate the safety and efficacy of upfront therapy with spironolactone in
addition to loop diuretic therapy in patients with acute decompensated heart failure at
high risk for diuretic resistance.
Effects of Spironolactone on Collagen Metabolism in Patients With Pulmonary Arterial Hypertension [Recruiting]
The purpose of this study is to determine the effects of spironolactone on collagen
markers in a large number of patients with pulmonary hypertension. In addition, safety and
tolerability of spironolactone, an aldosterone receptor antagonist, in patients with
pulmonary arterial hypertension, will be determined.
Short Term Spironolactone for Prevention of Acute Kidney Injury After Cardiac Surgery [Recruiting]
Our aim is to test whether short term perioperative administration of oral spironolactone
could reduce incidence of postoperative acute kidney injury (AKI) in cardiac surgical
The Combination Ambrisentan Plus Spironolactone in Pulmonary Arterial Hypertension Study [Not yet recruiting]
The purpose of this study is to find out if spironolactone added to ambrisentan for
Pulmonary Arterial Hypertension (PAH) will increase exercise capacity. We also want to find
out if spironolactone and ambrisentan effect the cardiac output (amount of blood the heart
pumps every minute), right ventricle function and quality of life.
Reports of Suspected Aldactone (Spironolactone) Side Effects
Renal Failure Acute (124),
Drug Interaction (62),
Renal Failure (30),
Lactic Acidosis (28),
Hepatic Encephalopathy (24), more >>
PATIENT REVIEWS / RATINGS / COMMENTS
Based on a total of 8 ratings/reviews, Aldactone has an overall score of 6.62. The effectiveness score is 8.25 and the side effect score is 7.25. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
Aldactone review by 62 year old female patient
|Overall rating:|| || |
|Effectiveness:|| || Highly Effective|
|Side effects:|| || No Side Effects|
|Condition / reason:|| || swollen knee|
|Dosage & duration:|| || 50mg taken 2x per day for the period of 2 yrs|
|Other conditions:|| || none|
|Other drugs taken:|| || vitamin supplements|
|Benefits:|| || NO LONGER ANY KNEE SWELLING.....TOTAL KNEE MOBILITY... NO PAIN...|
|Side effects:|| || THERE WERE NO NOTICABLE SIDE EFFECTS...SPIRALACTONE ACTS AS A WATER PILL SO THERE WAS AN INCREASE OF URINATION. THATS ALL...|
|Comments:|| || after two shots of cortisone to my knee, I had an mri done...this showed no problems yet the cortisone injections lasted only about four months. My dr did not want to give additional injections and prescribed physical therapy, which I did, but it only aleviated the pain for a short time and never for an entire day. My job requires me to be on my feet and I needed more relief. I went to an internist (the first doctor was a bone and joint specialist) who prescribed spiralactone. OK, I didnt have much faith in a water pill, but it worked and still continues to work. I do not take many medications but I do make sure I never run out of this miracle.|
Aldactone review by 33 year old female patient
|Overall rating:|| || |
|Effectiveness:|| || Marginally Effective|
|Side effects:|| || Moderate Side Effects|
|Condition / reason:|| || hair loss/ facial hair|
|Dosage & duration:|| || 100mg day taken 2 daily for the period of 2 months|
|Other conditions:|| || acne|
|Other drugs taken:|| || yasmin|
|Benefits:|| || so far combo of spirolonactone and yasmin has regulate my periods, however i have not seen any improvement on acne nor any decrease in facial hair|
|Side effects:|| || frequent urination, always thristy, dizziness.|
|Comments:|| || sprioloctone has been prescibed to help with hair loss of the scalp, but so far has not shown to be of much effectiveness..second month on it and hair sill falls out a lot. |
Aldactone review by 50 year old female patient
|Overall rating:|| || |
|Effectiveness:|| || Highly Effective|
|Side effects:|| || Extremely Severe Side Effects|
|Condition / reason:|| || acne|
|Dosage & duration:|| || 100mg taken daily for the period of 12 months|
|Other conditions:|| || none|
|Other drugs taken:|| || none|
|Benefits:|| || Takes about 3 months to show results, but cleared up my skin, reduced overall oiliness and enlarged pores, and eliminated my very greasy hair, caused by excess oil on my scalp. My skin looked hydrated, clarity was good and the improvement was constant with no variations after the first 3 months. Also contributed a significant improvement to my libido. |
|Side effects:|| || Periods about every 14 days. After 12 months of use, DCIS detected in my right breast. No history of breast cancer in the family at all, and I was in good health otherwise. Malignant tumour of the breast was one of the side effects I located on the internet. |
|Comments:|| || I am happy to complete this but dont know what you mean, I have already given the dosage. Can you email me what it is you want here?|
Page last updated: 2015-08-10