Aldactone

Nephrotic Syndrome, Ascites, Hypokalemia + 14 more

Treatment

18 FDA approvals

20 Active Studies for Aldactone

What is Aldactone

Spironolactone

The Generic name of this drug

Treatment Summary

Spironolactone 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.

Spironolactone

is 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

Primary Hyperaldosteronism

Helps manage Primary Hyperaldosteronism

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

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 Patients

Spironolactone 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 body

Spironolactone 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, Tablet, film coated - Oral, Oral, Tablet, Tablet - Oral, Suspension - Oral, Suspension, Topical, Gel, Gel - Topical, Tablet, coated, Tablet, coated - Oral

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, Tablet, film coated - Oral, Oral, Tablet, Tablet - Oral, Suspension - Oral, Suspension, Topical, Gel, Gel - Topical, Tablet, coated, Tablet, coated - Oral

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, Tablet, film coated - Oral, Oral, Tablet, Tablet - Oral, Suspension - Oral, Suspension, Topical, Gel, Gel - Topical, Tablet, coated, Tablet, coated - Oral

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, Tablet, film coated - Oral, Oral, Tablet, Tablet - Oral, Suspension - Oral, Suspension, Topical, Gel, Gel - Topical, Tablet, coated, Tablet, coated - Oral

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, Tablet, film coated - Oral, Oral, Tablet, Tablet - Oral, Suspension - Oral, Suspension, Topical, Gel, Gel - Topical, Tablet, coated, Tablet, coated - Oral

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, Tablet, film coated - Oral, Oral, Tablet, Tablet - Oral, Suspension - Oral, Suspension, Topical, Gel, Gel - Topical, Tablet, coated, Tablet, coated - Oral

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, Tablet, film coated - Oral, Oral, Tablet, Tablet - Oral, Suspension - Oral, Suspension, Topical, Gel, Gel - Topical, Tablet, coated, Tablet, coated - Oral

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, Tablet, film coated - Oral, Oral, Tablet, Tablet - Oral, Suspension - Oral, Suspension, Topical, Gel, Gel - Topical, Tablet, coated, Tablet, coated - Oral

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, Tablet, film coated - Oral, Oral, Tablet, Tablet - Oral, Suspension - Oral, Suspension, Topical, Gel, Gel - Topical, Tablet, coated, Tablet, coated - Oral

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, Tablet, film coated - Oral, Oral, Tablet, Tablet - Oral, Suspension - Oral, Suspension, Topical, Gel, Gel - Topical, Tablet, coated, Tablet, coated - Oral

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, Tablet, film coated - Oral, Oral, Tablet, Tablet - Oral, Suspension - Oral, Suspension, Topical, Gel, Gel - Topical, Tablet, coated, Tablet, coated - Oral

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, Tablet, film coated - Oral, Oral, Tablet, Tablet - Oral, Suspension - Oral, Suspension, Topical, Gel, Gel - Topical, Tablet, coated, Tablet, coated - Oral

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, Tablet, film coated - Oral, Oral, Tablet, Tablet - Oral, Suspension - Oral, Suspension, Topical, Gel, Gel - Topical, Tablet, coated, Tablet, coated - Oral

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, Tablet, film coated - Oral, Oral, Tablet, Tablet - Oral, Suspension - Oral, Suspension, Topical, Gel, Gel - Topical, Tablet, coated, Tablet, coated - Oral

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, Tablet, film coated - Oral, Oral, Tablet, Tablet - Oral, Suspension - Oral, Suspension, Topical, Gel, Gel - Topical, Tablet, coated, Tablet, coated - Oral

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, Tablet, film coated - Oral, Oral, Tablet, Tablet - Oral, Suspension - Oral, Suspension, Topical, Gel, Gel - Topical, Tablet, coated, Tablet, coated - Oral

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, Tablet, film coated - Oral, Oral, Tablet, Tablet - Oral, Suspension - Oral, Suspension, Topical, Gel, Gel - Topical, Tablet, coated, Tablet, coated - Oral

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 Risk

People 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

Hypesthesia

10 Actively Recruiting

Not Applicable, Phase 1, Phase 2, Phase 3

Cirrhosis

55 Actively Recruiting

Phase 1, Phase 2, Not Applicable, Phase 3, Phase 4, Early Phase 1

Ascites

2 Actively Recruiting

Not Applicable, Phase 2

Nephrotic Syndrome

6 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

39 Actively Recruiting

Not Applicable, Phase 1, Phase 2, Phase 3

Swollen feet or ankles

3 Actively Recruiting

Phase 2, Not Applicable

Hypesthesia

5 Actively Recruiting

Not Applicable, Phase 1

Hyperaldosteronism

0 Actively Recruiting

Edema

0 Actively Recruiting

Aldactone Reviews: What are patients saying about Aldactone?

4.7

Patient 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.

4.3

Patient 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.

3.7

Patient 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.

2.3

Patient 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.

1.7

Patient Review

1/27/2014

Aldactone for Male Pattern of Hair Distribution or Hirsutism in a Woman

1.3

Patient 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 Vanderbilt University Medical Center in Nashville, United States.

2-HOBA for Salt Sensitivity of Blood Pressure

18+
All Sexes
Nashville, TN

Hypertension is the leading cause of preventable deaths globally, driven by complications such as myocardial infarction, stroke, heart failure, and kidney disease. Recent updates in hypertension classification by the American Heart Association (AHA) place nearly half of the U.S. population in the hypertensive category. Excess dietary salt is a major risk factor for hypertension, with 50% of hypertensive individuals exhibiting salt-sensitivity of blood pressure (SSBP). SSBP is an independent predictor of cardiovascular events and death. While kidney mechanisms in salt-sensing have been extensively studied, emerging evidence suggests that immune cells can also sense sodium (Na+). This trial hypothesizes that myeloid cell-derived isolevuglandins (IsoLGs) drive endothelial dysfunction, perpetuating the salt-sensitive phenotype. Preliminary data indicate that targeting IsoLGs with the IsoLG scavenger 2-hydroxybenzylamine (2-HOBA) may interrupt this immune-vascular axis, reducing salt sensitivity and associated cardiovascular risks. This phase 2 clinical trial aims to investigate the role of 2-HOBA in modulating immune cell function within blood vessels in hypertensive patients. The study will explore the impact of immunity on salt sensitivity and assess 2-HOBA's potential to reduce endothelial dysfunction, improve immune cell activation, and alleviate SSBP.

Phase 2
Waitlist Available

Vanderbilt University Medical Center

Image of UPMC Magee Womens Hospital in Pittsburgh, United States.

Mobile Health Program for High Blood Pressure After Preeclampsia

18+
Female
Pittsburgh, PA

Strategies targeted to optimize hypertension (HTN) control for midlife women after hypertensive disorders of pregnancy (HDP) have not been studied, despite evidence of a critical need. This proposal targets the 10-20 years postpartum as a key time when women have subclinical cardiovascular (CV) sequelae of uncontrolled HTN and are primed for CV prevention interventions. Before proceeding with large-scale intervention trials of a home blood pressure monitoring (HBPM) and coaching intervention following HDP, further pilot testing is necessary. The overarching hypothesis of this proposal is that a new monitoring and treatment paradigm utilizing HBPM combined with a virtual coaching intervention would be better than standard of care for mid-life women with prior HDP who develop HTN. Women will be assigned in an unblinded manner to the intervention or standard of care control group.

Waitlist Available
Has No Placebo

UPMC Magee Womens Hospital

Malamo Countouris, MD, MS

Image of UCSF Medical Center at Parnassus in San Francisco, United States.

Blood Pressure Monitoring for Atrial Fibrillation

18+
All Sexes
San Francisco, CA

The goal of this clinical trial is to learn if screening for atrial fibrillation (AFib), a common irregular heart rhythm, through daily home blood pressure monitoring will decrease the time to atrial fibrillation diagnosis in older adults with hypertension. The main question it aims to answer is: \-- Does introducing screening for AFib using a blood pressure monitor with AFib detection technology decrease time to AFib diagnosis in patients with high blood pressure, compared to usual care using a conventional home blood pressure monitor with no AFib detection? Participants will participate in two phases of the study: (1) clinical trial and (2) the registry. During the 6-month clinical trial period, participants will be asked to: * Take blood pressure measurements twice daily * Answer short weekly mobile app-based surveys * If assigned, complete continuous heart monitoring for 2 weeks and complete 1 blood test During the 12-month registry period, participants will be asked to: * Take blood pressure measurements twice daily * Answer monthly mobile app-based surveys Researchers will compare standard blood pressure measurements and AFib screening blood pressure measurements to see if there is a difference in the time to AFib diagnosis and other cardiovascular events. Participants will participate in two phases of the study: (1) trial and (2) the registry. During the 6-month trial period, participants will be asked to: * Take daily blood pressure measurements * Answer short weekly mobile app-based surveys * If assigned, complete continuous heart monitoring for 2 weeks and complete 1 blood test During the 12-month registry period, participants will be asked to: * Take daily blood pressure measurements * Answer monthly mobile app-based surveys

Waitlist Available
Has No Placebo

UCSF Medical Center at Parnassus

Gregory M Marcus, MD, MAS

Omron Healthcare Co., Ltd.

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Image of University of Washington Medical Center in Seattle, United States.

Copper Supplementation for Liver Cirrhosis

18+
All Sexes
Seattle, WA

End stage liver disease or cirrhosis is a major cause of mortality in the United States and the world. Other than targeting the underlying cause, such as alcohol cessation and antiviral therapy, very few medical treatments can change the natural history of cirrhosis. Malnutrition is one of the few potentially modifiable factors that have been associated with cirrhosis severity and poor prognosis. The transition metal copper (Cu) is an essential trace metal that must be acquired from diet. Its metabolism is primarily regulated by the liver in its role as a master regulator of nutrients. In 2019, the investigators reported that Cu deficiency defined by below normal serum or liver concentrations occurred in a wide range of liver disorders and was associated with a severe disease phenotype. Improvement in liver function was observed in 2 of the 3 patients who received Cu supplementation. In 2023, the investigators conducted a longitudinal cohort study utilizing clinical, serum and liver explant tissue data from 183 cirrhosis patients. The investigators showed that Cu deficiency was associated with 2-fold higher infection rate and a more than 3-fold increase in the risk of death compared to patients with normal Cu status. These preliminary findings and the well-established importance of Cu in human health prompted the investigators to design the current pilot randomized, placebo-controlled, crossover trial to determine the effect of Cu supplementation on Cu dependent biochemical changes, patient safety and patient reported outcomes in cirrhosis.

Recruiting
Has No Placebo

University of Washington Medical Center

Lei Yu, MD

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Image of University of California, San Diego in San Diego, United States.

BPCARE Intervention for High Blood Pressure

18+
All Sexes
San Diego, CA

The goal of this randomized clinical trial is to determine whether a community health worker-delivered, multi-component behavioral intervention can improve antihypertensive medication adherence and blood pressure control among adult refugees with hypertension who are prescribed antihypertensive medications. The main questions it aims to answer are: 1. Does participation in the BPCARE intervention improve antihypertensive medication adherence compared to enhanced usual care? 2. Does participation in the BPCARE intervention improve blood pressure control and persistence over time compared to enhanced usual care? Researchers will compare participants randomized to the BPCARE intervention to those receiving enhanced usual care (hypertension information and a home blood pressure monitor) to determine the effects on medication adherence, blood pressure control, and persistence. Participants will: * Be randomly assigned to either the BPCARE intervention or enhanced usual care * Receive hypertension education and a home blood pressure monitor * Participate in community health worker-delivered sessions that include hypertension and medication education, motivational interviewing, problem-solving, and action planning (intervention arm only) * Complete questionnaires assessing medication adherence and related psychosocial factors * Have blood pressure monitored using connected home blood pressure devices * Complete pill counts to assess medication adherence over a nine-month follow-up period

Recruiting
Has No Placebo

University of California, San Diego (+1 Sites)

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