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)
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.
Addition of spironolactone in patients with resistant arterial hypertension (ASPIRANT): a randomized, double-blind, placebo-controlled trial. [2011.06]
There is currently limited data on which drug should be used to improve blood pressure (BP) control in patients with resistant hypertension. This study was designed to assess the effect of the addition of 25 mg of spironolactone on BP in patients with resistant arterial hypertension... In conclusion, spironolactone is an effective drug for lowering systolic BP in patients with resistant arterial hypertension.
A double-blind, randomized study comparing the antihypertensive effect of eplerenone and spironolactone in patients with hypertension and evidence of primary aldosteronism. [2011.05]
BACKGROUND: Eplerenone is claimed to be a more selective blocker of the mineralocorticoid receptor than spironolactone being associated with fewer antiandrogenic side-effects. We compared the efficacy, safety and tolerability of eplerenone versus spironolactone in patients with hypertension associated with primary aldosteronism... CONCLUSION: The antihypertensive effect of spironolactone was significantly greater than that of eplerenone in hypertension associated with primary aldosteronism. (c) 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins
Clinical Trials Related to Aldactone (Spironolactone)
Interest of Topical Spironolactone's Administration to Prevent Corticoid-induced Epidermal Atrophy [Recruiting]
The purpose of this study is to determine whether spironolactone could significantly reduce
cutaneous atrophy due to corticosteroids.
The Efficacy of Spironolactone in Patients With Resistant Hypertension [Not yet recruiting]
To determine the efficacy of the addition of spironolactone to modern blood pressure
lowering treatment regimens in patients with resistant hypertension (whose blood pressure is
uncontrolled despite three blood pressure lowering drugs)
Hemodynamic Effects of Chronic Administration of Spironolactone and/or Propranolol in Alcoholic Cirrhotic Patients [Terminated]
The aim of this study was assesment of splanchnic and systemic hemodynamic effects of chronic
administration (2 month) of spironolactone or propranolol, alone or in association in
alcoholic cirrhotic patients. The patients were randomized in 4 groups (aldactone 150 mg/day,
propranolol 160 mg/day, aldactone 150 mg/day + propranolol 160 mg/day, placebo). Systemic and
splanchnic hemodynamic effect were evaluated by hepatic venous pressure gradient measurements
before and after 2 month of treatment.
Effect of Spironolactone and Vitamin E in Patients With Nonalcoholic Fatty Liver Disease [Recruiting]
The primary aim of the study is the effect of spironolactone and vitamin E versus vitamin E
on serum levels of adipokines 52 weeks post-treatment.
Spironolactone Versus Amiloride as an Add on Agent in Resistant Hypertension [Not yet recruiting]
Joint National Committee 7 (JNC-7) defines resistant hypertension as a persistent elevation
of blood pressure (BP) above goal - ≥ 140/90 mm Hg for the general hypertensive population
or ≥ 130/80 mm Hg for persons with diabetes mellitus or chronic kidney disease - for at
least three months despite treatment with three or more optimally dosed antihypertensive
agents, including a diuretic. The exact prevalence of resistant hypertension is uncertain
but may include 5-20% of hypertensive persons in primary care settings and 15-35% of the
older, higher cardiovascular risk hypertensive patients incorporated into recent clinical
trials of antihypertensive therapy. Observational studies demonstrate that patients with
resistant hypertension experience a higher rate of cardiovascular and renal target organ
damage such as left ventricular hypertrophy, microalbuminuria, and renal insufficiency and
more cardiovascular disease (CVD) events than patients whose hypertension is
well-controlled. Additionally, resistant hypertension patients may be subjected to the
considerable expense of multiple office visits, diagnostic testing for secondary causes of
hypertension, and referral to hypertension specialists. Because multiple factors can
contribute to resistant hypertension, an explicit, sequential approach to evaluation and
management is essential to optimize blood pressure, reduce cardiorenal morbidity and
mortality, and avoid unnecessary expense. A number of observational studies have suggested
the potential efficacy of both spironolactone and amiloride when added to a 3 drug
antihypertensive regimen, but to date no randomized study has directly compared the two
agents. The goal of this study is to determine whether spironolactone or amiloride is the
more effective fourth agent to add to a three drug regimen in patients with resistant
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: 2014-11-30