Aldactone

Nephrotic Syndrome, Ascites, Hypokalemia + 14 more
Treatment
18 FDA approvals
20 Active Studies for Aldactone

What is Aldactone

SpironolactoneThe Generic name of this drug
Treatment SummarySpironolactone is a medication used to treat high blood pressure, heart failure, and other conditions caused by too much aldosterone in the body. It works by preventing the body from reabsorbing too much sodium and water, while allowing the body to retain potassium. It was first developed in 1957 and approved by the FDA in 1960. Off-label uses of spironolactone include treating hirsutism, female pattern hair loss, adult acne, and aiding in medical gender transition.
Spironolactoneis the brand name
image of different drug pills on a surface
Aldactone Overview & Background
Brand Name
Generic Name
First FDA Approval
How many FDA approvals?
Spironolactone
Spironolactone
1960
288

Approved as Treatment by the FDA

Spironolactone, also known as Spironolactone, is approved by the FDA for 18 uses such as Swollen feet or ankles and Ascites .
Swollen feet or ankles
Helps manage Edema
Ascites
Helps manage Ascites
Hypokalemia
chronic heart failure with reduced ejection fraction (NYHA Class IV)
Helps manage chronic heart failure with reduced ejection fraction (NYHA Class IV)
Cirrhosis of the Liver
Helps manage Cirrhosis of the Liver
Primary Hyperaldosteronism
Helps manage Primary Hyperaldosteronism
idiopathic hyperaldosteronism
Helps manage idiopathic hyperaldosteronism
Congestive Heart Failure (CHF)
Helps manage Congestive Heart Failure (CHF)
Hypesthesia
Helps manage chronic heart failure with reduced ejection fraction (NYHA Class IV)
Edema
Helps manage Edema
Hypesthesia
Helps manage chronic heart failure with reduced ejection fraction (NYHA Class III)
Cirrhosis
Helps manage Cirrhosis of the Liver
Hyperaldosteronism
Helps manage Primary Hyperaldosteronism
Nephrotic Syndrome
Helps manage Nephrotic Syndrome
Congestive Heart Failure
Helps manage Congestive Heart Failure (CHF)
Hypertensive disease
Helps manage High Blood Pressure (Hypertension)
Ascites
Helps manage Ascites
Hyperaldosteronism
Helps manage idiopathic hyperaldosteronism

Effectiveness

How Aldactone Affects PatientsSpironolactone was originally studied for the way it helps the body get rid of water without losing too much potassium. It does this by blocking certain receptors in the kidneys that help regulate sodium, water, and potassium levels. It is similar in structure to a hormone called progesterone, and as a result has some of the same effects, such as increased progesterone levels and anti-androgenic effects.
How Aldactone works in the bodySpironolactone works by blocking sodium and potassium channels in the kidneys. This causes more sodium and water to be released from the body, which is how the drug produces its diuretic and anti-hypertension effects. Potassium is the only ion that is not affected, and instead is retained in the body.

When to interrupt dosage

The endorsed dosage of Aldactone is contingent upon the diagnosed condition, such as Hypesthesia, Congestive Heart Failure and Cirrhosis. The measure of dosage fluctuates, depending on the method of administration specified in the accompanying table.
Condition
Dosage
Administration
Nephrotic Syndrome
50.0 mg, , 100.0 mg, 25.0 mg, 25.0 mg/mL, 0.02 mg/mg, 0.05 mg/mg
, Tablet, film coated, Oral, Tablet, film coated - Oral, Tablet, Tablet - Oral, Suspension, Suspension - Oral, Topical, Gel - Topical, Gel, Tablet, coated - Oral, Tablet, coated
Ascites
50.0 mg, , 100.0 mg, 25.0 mg, 25.0 mg/mL, 0.02 mg/mg, 0.05 mg/mg
, Tablet, film coated, Oral, Tablet, film coated - Oral, Tablet, Tablet - Oral, Suspension, Suspension - Oral, Topical, Gel - Topical, Gel, Tablet, coated - Oral, Tablet, coated
Hypokalemia
50.0 mg, , 100.0 mg, 25.0 mg, 25.0 mg/mL, 0.02 mg/mg, 0.05 mg/mg
, Tablet, film coated, Oral, Tablet, film coated - Oral, Tablet, Tablet - Oral, Suspension, Suspension - Oral, Topical, Gel - Topical, Gel, Tablet, coated - Oral, Tablet, coated
Acne Vulgaris
50.0 mg, , 100.0 mg, 25.0 mg, 25.0 mg/mL, 0.02 mg/mg, 0.05 mg/mg
, Tablet, film coated, Oral, Tablet, film coated - Oral, Tablet, Tablet - Oral, Suspension, Suspension - Oral, Topical, Gel - Topical, Gel, Tablet, coated - Oral, Tablet, coated
Hyperaldosteronism
50.0 mg, , 100.0 mg, 25.0 mg, 25.0 mg/mL, 0.02 mg/mg, 0.05 mg/mg
, Tablet, film coated, Oral, Tablet, film coated - Oral, Tablet, Tablet - Oral, Suspension, Suspension - Oral, Topical, Gel - Topical, Gel, Tablet, coated - Oral, Tablet, coated
Hyperaldosteronism
50.0 mg, , 100.0 mg, 25.0 mg, 25.0 mg/mL, 0.02 mg/mg, 0.05 mg/mg
, Tablet, film coated, Oral, Tablet, film coated - Oral, Tablet, Tablet - Oral, Suspension, Suspension - Oral, Topical, Gel - Topical, Gel, Tablet, coated - Oral, Tablet, coated
Swollen feet or ankles
50.0 mg, , 100.0 mg, 25.0 mg, 25.0 mg/mL, 0.02 mg/mg, 0.05 mg/mg
, Tablet, film coated, Oral, Tablet, film coated - Oral, Tablet, Tablet - Oral, Suspension, Suspension - Oral, Topical, Gel - Topical, Gel, Tablet, coated - Oral, Tablet, coated
Hypesthesia
50.0 mg, , 100.0 mg, 25.0 mg, 25.0 mg/mL, 0.02 mg/mg, 0.05 mg/mg
, Tablet, film coated, Oral, Tablet, film coated - Oral, Tablet, Tablet - Oral, Suspension, Suspension - Oral, Topical, Gel - Topical, Gel, Tablet, coated - Oral, Tablet, coated
Hypesthesia
50.0 mg, , 100.0 mg, 25.0 mg, 25.0 mg/mL, 0.02 mg/mg, 0.05 mg/mg
, Tablet, film coated, Oral, Tablet, film coated - Oral, Tablet, Tablet - Oral, Suspension, Suspension - Oral, Topical, Gel - Topical, Gel, Tablet, coated - Oral, Tablet, coated
Congestive Heart Failure
50.0 mg, , 100.0 mg, 25.0 mg, 25.0 mg/mL, 0.02 mg/mg, 0.05 mg/mg
, Tablet, film coated, Oral, Tablet, film coated - Oral, Tablet, Tablet - Oral, Suspension, Suspension - Oral, Topical, Gel - Topical, Gel, Tablet, coated - Oral, Tablet, coated
Hirsutism
50.0 mg, , 100.0 mg, 25.0 mg, 25.0 mg/mL, 0.02 mg/mg, 0.05 mg/mg
, Tablet, film coated, Oral, Tablet, film coated - Oral, Tablet, Tablet - Oral, Suspension, Suspension - Oral, Topical, Gel - Topical, Gel, Tablet, coated - Oral, Tablet, coated
Hypertensive disease
50.0 mg, , 100.0 mg, 25.0 mg, 25.0 mg/mL, 0.02 mg/mg, 0.05 mg/mg
, Tablet, film coated, Oral, Tablet, film coated - Oral, Tablet, Tablet - Oral, Suspension, Suspension - Oral, Topical, Gel - Topical, Gel, Tablet, coated - Oral, Tablet, coated
Hyperaldosteronism
50.0 mg, , 100.0 mg, 25.0 mg, 25.0 mg/mL, 0.02 mg/mg, 0.05 mg/mg
, Tablet, film coated, Oral, Tablet, film coated - Oral, Tablet, Tablet - Oral, Suspension, Suspension - Oral, Topical, Gel - Topical, Gel, Tablet, coated - Oral, Tablet, coated
Cirrhosis
50.0 mg, , 100.0 mg, 25.0 mg, 25.0 mg/mL, 0.02 mg/mg, 0.05 mg/mg
, Tablet, film coated, Oral, Tablet, film coated - Oral, Tablet, Tablet - Oral, Suspension, Suspension - Oral, Topical, Gel - Topical, Gel, Tablet, coated - Oral, Tablet, coated
Edema
50.0 mg, , 100.0 mg, 25.0 mg, 25.0 mg/mL, 0.02 mg/mg, 0.05 mg/mg
, Tablet, film coated, Oral, Tablet, film coated - Oral, Tablet, Tablet - Oral, Suspension, Suspension - Oral, Topical, Gel - Topical, Gel, Tablet, coated - Oral, Tablet, coated
Hypertension
50.0 mg, , 100.0 mg, 25.0 mg, 25.0 mg/mL, 0.02 mg/mg, 0.05 mg/mg
, Tablet, film coated, Oral, Tablet, film coated - Oral, Tablet, Tablet - Oral, Suspension, Suspension - Oral, Topical, Gel - Topical, Gel, Tablet, coated - Oral, Tablet, coated
inadequate response to other therapeutic measures
50.0 mg, , 100.0 mg, 25.0 mg, 25.0 mg/mL, 0.02 mg/mg, 0.05 mg/mg
, Tablet, film coated, Oral, Tablet, film coated - Oral, Tablet, Tablet - Oral, Suspension, Suspension - Oral, Topical, Gel - Topical, Gel, Tablet, coated - Oral, Tablet, coated

Warnings

Aldactone has six contra-indications. Any of the conditions given in the table below should preclude the utilization of Aldactone.Aldactone Contraindications
Condition
Risk Level
Notes
Renal Insufficiency
Do Not Combine
Anuria
Do Not Combine
Acute Kidney Injury
Do Not Combine
Hyperkalemia
Do Not Combine
Pulse Frequency
Do Not Combine
Addison Disease
Do Not Combine
There are 20 known major drug interactions with Aldactone.
Common Aldactone Drug Interactions
Drug Name
Risk Level
Description
Amiodarone
Major
The metabolism of Amiodarone can be decreased when combined with Spironolactone.
Brigatinib
Major
The metabolism of Brigatinib can be decreased when combined with Spironolactone.
Cabazitaxel
Major
The metabolism of Cabazitaxel can be decreased when combined with Spironolactone.
Cyclosporine
Major
The risk or severity of hyperkalemia can be increased when Spironolactone is combined with Cyclosporine.
Dabrafenib
Major
The metabolism of Dabrafenib can be decreased when combined with Spironolactone.
Aldactone Toxicity & Overdose RiskPeople who overdose on spironolactone may feel drowsy, confused, have a rash, feel sick to their stomach, become dizzy, or have diarrhea. Treatment for overdose includes keeping hydrated and maintaining electrolyte balance and other vital functions. The toxic dose in mice, rats, and rabbits is greater than 1g/kg. Pregnant women should avoid spironolactone, as it has been reported to cause feminization of male fetuses in animal studies. Spironolactone is present in breast milk, but its long-term effects are still unknown. Animal studies have shown that spironol
image of a doctor in a lab doing drug, clinical research

Aldactone Novel Uses: Which Conditions Have a Clinical Trial Featuring Aldactone?

165 active clinical trials are currently underway to evaluate the utility of Aldactone in managing Hypokalemia, Hirsutism and Nephrotic Syndrome.
Condition
Clinical Trials
Trial Phases
Cirrhosis
52 Actively Recruiting
Phase 1, Phase 2, Not Applicable, Phase 3, Phase 4, Early Phase 1
Hypesthesia
8 Actively Recruiting
Not Applicable, Phase 1
Ascites
2 Actively Recruiting
Not Applicable, Phase 2
Nephrotic Syndrome
5 Actively Recruiting
Phase 2, Not Applicable, Phase 3
Hypertension
0 Actively Recruiting
Congestive Heart Failure
11 Actively Recruiting
Not Applicable, Phase 1, Phase 2
Hirsutism
0 Actively Recruiting
Hypokalemia
0 Actively Recruiting
Acne Vulgaris
0 Actively Recruiting
Hyperaldosteronism
0 Actively Recruiting
inadequate response to other therapeutic measures
0 Actively Recruiting
Hyperaldosteronism
0 Actively Recruiting
Hypertensive disease
27 Actively Recruiting
Not Applicable, Phase 1, Phase 2, Phase 3
Swollen feet or ankles
5 Actively Recruiting
Phase 2, Not Applicable, Phase 4
Hypesthesia
4 Actively Recruiting
Not Applicable, Phase 1
Hyperaldosteronism
0 Actively Recruiting
Edema
0 Actively Recruiting

Aldactone Reviews: What are patients saying about Aldactone?

4.7Patient Review
4/16/2018
Aldactone for High Blood Pressure
I've been taking this medication for six months to help with my high blood pressure. It's been great, but I started noticing some fatty tissue in my chest recently so I went to the doctor. He got an x-ray and diagnosed it as gynecomastia. Other than that, and a little potassium spike, I believe the benefits of this outweigh the harms.
4.3Patient Review
10/23/2015
Aldactone for High Blood Pressure
I'm currently using this medication to treat my adult acne, under the guidance of a dermatologist. When I started the drug, my skin broke out pretty badly; however, it's since calmed down. I was supposed to take 50mg each day, but find that 25mg does the trick just fine. The only downside is that it makes me really tired, so I have to be careful about taking it at night. Otherwise, no real side effects to speak of other than an upset stomach on occasion.
3.7Patient Review
11/29/2015
Aldactone for Accumulation of Fluid caused by Cirrhosis of the Liver
I use this medication for adult acne as well as to help manage my borderline blood pressure. However, I would caution anyone taking this drug against consuming ginger before or while driving and/or operating machinery, as it can cause heart palpitations in large doses.
2.3Patient Review
4/7/2020
Aldactone for Accumulation of Fluid Resulting from Chronic Heart Failure
I'm an 84-year-old woman who had been taking this medication for three years to address heart problems and water retention. However, after about two and a half years, I started growing breasts. Six months ago, they started getting tender, so I notified my cardiologist. He took me off the medication and told me to check my blood pressure for a week before getting back in touch with him. My blood pressure was good, so I stopped taking the medication.
1.7Patient Review
1/27/2014
Aldactone for Male Pattern of Hair Distribution or Hirsutism in a Woman
1.3Patient Review
9/21/2016
Aldactone for Accumulation of Fluid Resulting from Chronic Heart Failure
I had a really terrible reaction to this drug. I developed hives, breathing problems, and extreme dehydration. My blood sugar levels were all over the place, and I was in a lot of pain.
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about aldactone

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is Aldactone a steroid?

"Aldactone is not a steroid, but it does have some steroid-like effects on the hormones aldosterone and testosterone. Aldactone belongs to a class of drugs known as diuretics, which are potassium-sparing."

Answered by AI

What is a Aldactone used for?

"High blood pressure is a major problem because it can lead to strokes, heart attacks, and kidney problems. However, by lowering high blood pressure, these risks can be prevented. In addition, high blood pressure can also be treated by removing excess fluid and improving symptoms such as breathing problems."

Answered by AI

What is Aldactone used for and what are the side effects?

"Aldactone is a medication used to treat heart failure, high blood pressure, or low potassium levels in the blood. It can also be used to treat fluid retention in people with congestive heart failure, cirrhosis of the liver, or a kidney disorder called nephrotic syndrome."

Answered by AI

What type of drug is Aldactone?

"Aldactone is a diuretic, meaning it helps your body get rid of water. It also helps your body retain potassium, which can raise the level of potassium in your blood to too high."

Answered by AI

Clinical Trials for Aldactone

Image of Cedars-Sinai Medical Center in Los Angeles, United States.

AI-Enabled Identification for Fatty Liver Disease

18+
All Sexes
Los Angeles, CA
The goal of this prospective, multicenter, open-label, blinded end-point pragmatic study is to evaluate an artificial intelligence (AI)-augmented echocardiography screening approach for early detection of metabolic dysfunction associated steatotic liver disease (MASLD) and/or cirrhosis, in patients undergoing routine transthoracic echocardiograms (TTEs). The main question it aims to answer is to: 1. Evaluate notification responsiveness and rates of confirmatory testing for patients identified as high risk for having liver disease to determine whether optimized notifications increase timely confirmatory testing and treatment initiation versus standard of care assessment. 2. Compare time to diagnosis, treatment uptake, and clinical outcomes (hospitalizations, incident ASCVD, mortality) between cohorts identified as high risk by the AI algorithm and comparison groups to determine whether AI guided screening shortens time to diagnosis and increases appropriate treatment.
Waitlist Available
Has No Placebo
Cedars-Sinai Medical Center (+3 Sites)
Have you considered Aldactone clinical trials? We made a collection of clinical trials featuring Aldactone, we think they might fit your search criteria.Go to Trials
Image of Cleveland Clinic Main Campus in Cleveland, United States.

Metabolic Surgery and TIPS for Liver Cirrhosis

18 - 70
All Sexes
Cleveland, OH
Cirrhosis is a form of advanced liver disease that can lead to serious complications, especially when combined with severe obesity. Many patients with cirrhosis also develop a condition called clinically significant portal hypertension (CSPH), which is increased pressure in the veins of the liver. CSPH raises the risk of life-threatening events like internal bleeding and liver failure. Unfortunately, treatment options for people who have both cirrhosis and severe obesity are very limited, especially when portal hypertension is present. This study, called the OPTIMAL Trial, is a randomized clinical trial designed to evaluate whether combining two procedures improves health outcomes in this high-risk population. The first procedure, called TIPS (Transjugular Intrahepatic Portosystemic Shunt), is a minimally invasive treatment that reduces pressure in the liver by creating a pathway for blood to flow more easily. The second procedure is sleeve gastrectomy, a form of metabolic (bariatric) surgery that helps patients lose weight and improve related conditions like diabetes. The study will compare two groups: 1. One group will receive TIPS followed by sleeve gastrectomy (TIPS+SG). 2. The other group will receive medical weight management (standard non-surgical care, including diet, lifestyle changes, and weight loss medications). All participants will have severe obesity and cirrhosis with CSPH but will not have decompensated liver disease (such as large amounts of fluid in the abdomen, a history of variceal bleeding, or recent liver failure). Eligible participants will be randomly assigned to one of the two groups. The main goal of the study is to determine whether the combination of TIPS + SG improves quality of life and leads to greater weight loss compared to medical therapy alone. The study will also monitor for any complications from either the procedures or the medical treatment. Participants will be followed for 6 months after their treatment starts, with periodic assessments of their physical health, liver function, and overall well-being. Some participants may also be followed for a longer period to assess long-term outcomes. This study hopes to provide high-quality evidence for a novel, stepwise treatment strategy that may help people with obesity and liver disease live longer, healthier lives. If successful, it could change how advanced liver disease and obesity are managed together, especially in patients who currently have few safe and effective options. All study care is provided at Cleveland Clinic, Cleveland, Ohio, USA.
Phase 4
Recruiting
Cleveland Clinic Main CampusSobia Laique, MD
Image of NewYork-Presbyterian/Weill Cornell Medical Center in New York, United States.

Melatonin for Liver Cirrhosis

18+
All Sexes
New York, NY
The goal of this clinical trial is to learn the affect of melatonin on sleep, cognitive function, and quality of life (QoL) in patients with cirrhosis and a complication called hepatic encephalopathy (HE). The main questions this study aims to answer are: * Does taking melatonin increase REM sleep, an important part of healthy sleep that is reduced in cirrhosis? * Does taking melatonin improve cognitive function and reported QoL? This is a pilot study, where participants will: * take one month of melatonin, followed by one month of thiamine, which is another supplement but is not suspected to impact sleep significantly. * Undergo cognitive testing and take surveys * Wear a commercial wearable sleep tracker * Have a formal sleep study and salivary melatonin collection at the end of taking each supplement at our sleep center Participants will be blinded, and neither they nor the researchers will know which supplement they are taking first and which they are taking second. They will also be randomized, with half starting with melatonin and the other half starting with thiamine.
Recruiting
Has No Placebo
NewYork-Presbyterian/Weill Cornell Medical CenterAdam Buckholz, MD MS
Have you considered Aldactone clinical trials? We made a collection of clinical trials featuring Aldactone, we think they might fit your search criteria.Go to Trials
Image of Virginia Commonwealth University in Richmond, United States.

Endovascular Treatment for Stroke

18+
All Sexes
Richmond, VA
Endovascular therapy (EVT) has proven to be more beneficial for patients with AIS caused by large vessel occlusions (LVO) than medical management alone. A recent meta-analysis of 5 RCTs showed that EVT significantly reduced disability at 90 days compared to medical management \[1\]. Despite its obvious benefits, patients may have neurological deterioration despite successful thrombectomy due to ischemia progression, intracranial hemorrhage, re-occlusion, or vasogenic edema. The incidence of early neurological deterioration (END) following EVT for acute stroke has been reported to be ranging from 14.1-35.2% with some studies defining END up to 7 days and some restricting the definition between 6-72 hours post thrombectomy. A small proportion of these patients, approximately 5.9-10.5%, experienced sICH following EVT. Whether END occurs due to ischemic or hemorrhagic it leads to worse outcomes.
Waitlist Available
Has No Placebo
Virginia Commonwealth UniversityAarti Sarwal
Image of Future Life Clinical Trials in Miami, United States.

Extended vs Immediate Release Torsemide for Heart Failure

18+
All Sexes
Miami, FL
The primary objective of this study is to learn whether a morning dose of extended-release torsemide enhances renal sodium excretion after lunch (4-8 hours after dosing) compared to immediate-release torsemide. This is a randomized, double-blind, crossover study in patients with heart failure who are on a stable dose of a loop diuretic. During the study period, participants' current loop diuretics will be replaced with an equivalent dose of either immediate-release or extended-release torsemide. Following a one-week stabilization period on the assigned torsemide formulation, patients will report to the clinical site for an assessment visit. On the study day, patients will take a single dose of the same torsemide formulation they have been on for the past week, administered after breakfast. Urine samples be collected are: * 0-4 hours post-dosing (pre-lunch period) * 4-8 hours post-dosing (post-lunch period) * 8-24 hours post-dosing (24 hours period) The primary endpoint will be urinary sodium excretion (4-8 hours after dosing). This will be compared between the extended-release arm and the immediate-release arm to assess the efficacy of prolonged diuretic action. In addition, urinary potassium and creatinine excretion and creatinine clearance will be measured in all urine samples as the safety endpoints.
Phase 4
Recruiting
Future Life Clinical TrialsSalim Shah, PhD, JDSarfez Pharmaceuticals, Inc.
Have you considered Aldactone clinical trials? We made a collection of clinical trials featuring Aldactone, we think they might fit your search criteria.Go to Trials
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