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Spironolactone (Spironolactone) - Summary



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



Spironolactone oral tablets contain 25 mg, 50 mg, or 100 mg of the aldosterone antagonist spironolactone, USP 17-hydroxy-7α-mercapto-3-oxo-17α-pregn-4-ene-21-carboxylic acid γ- lactone acetate.

Spironolactone tablets, USP are 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. Spironolactone tablets, USP are 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. Spironolactone tablets, USP are indicated for maintenance therapy together with bed rest and the restriction of fluid and sodium.

  • 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.

Essential hypertension

Spironolactone tablets, USP are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes.

Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC).

Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly.

Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.

Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.

Usually in combination with other drugs, spironolactone tablets, USP are 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. Spironolactone tablets, USP are also indicated for the prophylaxis of hypokalemia in patients taking digitalis when other measures are considered inadequate or inappropriate.

Severe heart failure (NYHA class III – IV)

To increase survival, and to reduce the need for hospitalization for heart failure when used in addition to standard therapy.

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.

Spironolactone tablets, USP are 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 that is not relieved by rest. In these cases, a short course of diuretics may provide relief and may be appropriate.

See all Spironolactone indications & dosage >>


Published Studies Related to Spironolactone

Effects of spironolactone treatment in elderly women with heart failure and preserved left ventricular ejection fraction. [2014]
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. [2014]
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 hospital...

Race influences the safety and efficacy of spironolactone in severe heart failure. [2013]
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. [2012]
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.

more studies >>

Clinical Trials Related to Spironolactone

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 patients.

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.

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.

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 care.

Interest of Topical Spironolactone's Administration to Prevent Corticoid-induced Epidermal Atrophy [Completed]
The purpose of this study is to determine whether spironolactone could significantly reduce cutaneous atrophy due to corticosteroids.

more trials >>

Reports of Suspected Spironolactone Side Effects

Hyperkalaemia (117)Renal Failure Acute (104)Blood Creatinine Increased (49)Dyspnoea (42)Hypotension (41)Atrial Fibrillation (36)Drug Interaction (35)Nausea (34)Dehydration (32)Oedema Peripheral (31)more >>


Based on a total of 20 ratings/reviews, Spironolactone has an overall score of 7.50. The effectiveness score is 7.70 and the side effect score is 7.50. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.

Spironolactone review by 33 year old female patient

Overall rating:  
Effectiveness:   Considerably Effective
Side effects:   No Side Effects
Treatment Info
Condition / reason:   acne
Dosage & duration:   100mg taken once a day for the period of 1 yr and continuing
Other conditions:   small acne also
Other drugs taken:   retinol A
Reported Results
Benefits:   the spironolactone has prevented the large cycst types of acne from forming. My skin looks a lot smoother.
Side effects:   if not taken daily it will not work. you can not miss a day or there will be some cycsts that will form.
Comments:   spironolactone is a water pill that has the side effect of clearer skin. the spironolactone only is effective on the large cycst types of acne. If not taken daily there will be some cycsts that will form the week before you cycle. The small acne is taken care of with a retinol A cream.


Spironolactone review by 39 year old female patient

Overall rating:  
Effectiveness:   Considerably Effective
Side effects:   Mild Side Effects
Treatment Info
Condition / reason:   adult moderate hormone related acne
Dosage & duration:   50mgs taken once a day for the period of 4mths
Other conditions:   hair loss middle of the scalp, thinning mainly
Other drugs taken:   none
Reported Results
Benefits:   my usually oily skin dried up considerably and as a result the frequency of spots reduced.
Side effects:   in the first week i experienced headaces, pulpitations,nausea,insomnia and halusinations,dry mouth and lips along with frequent urination. i almost stopped taking the drug but i gave it a little more time and eventually felt better..most side effects disappeared and i remained with dry mouth lips and sorish throat.drinking alot of water helped.
Comments:   50mg tab once a day for 4 months


Spironolactone review by 30 year old female patient

Overall rating:  
Effectiveness:   Ineffective
Side effects:   Severe Side Effects
Treatment Info
Condition / reason:   POCS, elevated testosterone, hirsutism
Dosage & duration:   50mg reduced to 25mg taken twice a day for the period of 2 months
Other conditions:   none
Other drugs taken:   none
Reported Results
Benefits:   No benefits in 2 months, no reduction in body hair
Side effects:   Tiredness, thinning of the hair, hair loss, stomach ache
Comments:   Not effective for me at all, wanted to reduce body hair - no change after two months. But noticed hair thinning and some hair loss on the top of my scalp, have to stop it.

See all Spironolactone reviews / ratings >>

Page last updated: 2015-08-10

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