spironolactone
Spironolactone is an aldosterone antagonist used to treat Ascites, Edema, Heart Failure, Hirsutism.
Aldosterone Antagonist · by Jubilant Generics
Generic of Carospir
Key facts
- Active ingredient
- Spironolactone
- Drug class
- Aldosterone Antagonist
- Form
- Suspension, Tablet
- Strength
- Spironolactone 100MG · Spironolactone 25MG · Spironolactone 50MG
- Type
- Prescription (Rx)
- Brand or generic
- Generic
- May treat
- ascites, edema, heart failure
- Manufacturer
- Jubilant Generics
- Half-life
- about 1.4 hours (how long it stays in your system)
- What the pharmacy pays
- ~$2.68 for 30 — not your price
- FDA application
- ANDA203253
What is Spironolactone?
From the FDA label: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, which has the following structural formula: Spironolactone, USP is freely soluble in benzene and chloroform; soluble in ethyl acetate and in alcohol, slightly soluble in ether, in methanol and in fixed oils and practically insoluble in water. Inactive ingredients include calcium sulfate dihydrate, corn starch, ferric oxide black, ferric oxide red, ferric oxide yellow, peppermint, hypromellose, magnesium stearate, polyethylene glycol, povidone, and titanium dioxide. image description
How to use
Spironolactone is sold in more than one form (Suspension and Tablet), and each is dosed differently. The instructions below come from the FDA label for application ANDA203253 — follow the label that came with the product you were actually prescribed.
Heart Failure: Initiate treatment at 25 mg once daily (2.2). Hypertension: Initiate treatment at 25 to 100 mg daily in either single or divided doses (2.3). Edema: Initiate therapy in a hospital setting and titrate slowly. The recommended initial daily dose is 100 mg in single or divided doses (2.4) . Primary hyperaldosteronism: Initiate treatment at 100 to 400 mg in preparation for surgery. In patients unsuitable for surgery use the lowest effective dosage determined for the individual patient ( 2.5) . 2.1 General Considerations Spironolactone tablets can be taken with or without food, but should be taken consistently with respect to food [see Clinical Pharmacology (12.3) ] . 2.2 Treatment of Heart Failure In patients with serum potassium ≤5.0 mEq/L and eGFR >50 mL/min/1.73 m², initiate treatment at 25 mg once daily. Patients who tolerate 25 mg once daily may have their dosage increased to 50 mg once daily as clinically indicated. Patients who develop hyperkalemia on 25 mg once daily may have their dosage reduced to 25 mg every other day [see Warnings and Precautions (5.1)] . In patients with an eGFR between 30 and 50 mL/min/1.73 m 2 consider initiating therapy at 25 mg every other day because of the risk of hyperkalemia [see Use in Specific Populations (8.6) ]. 2.3 Treatment of Essential Hypertension The recommended initial daily dose is 25 to 100 mg of spironolactone…
Side effects
The following clinically significant adverse reactions are described elsewhere in the labeling: Hyperkalemia [see Warnings and Precautions (5.1)] Hypotension and Worsening Renal Function [see Warnings and Precautions (5.2)] Electrolyte and Metabolic Abnormalities [see Warnings and Precautions (5.3) ] Gynecomastia [see Warnings and Precautions (5.4] Impaired neurological function/coma in patients with hepatic impairment, cirrhosis and ascites [see Use in Specific Populations (8.7) ] The following adverse reactions associated with the use of spironolactone were identified in clinical trials or postmarketing reports. Because these reactions were reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency, reliably, or to establish a causal relationship to drug exposure. Digestive: Gastric bleeding, ulceration, gastritis, diarrhea and cramping, nausea, vomiting. Reproductive: Decreased libido, inability to achieve or maintain erection, irregular menses or amenorrhea, postmenopausal bleeding, breast and nipple pain. Hematologic: Leukopenia (including agranulocytosis), thrombocytopenia. Hypersensitivity: Fever, urticaria, maculopapular or erythematous cutaneous eruptions, anaphylactic reactions, vasculitis. Metabolism: Hyperkalemia, electrolyte disturbances [see Warnings and Precautions (5.1, 5.3 )] , hyponatremia, hypovolemia.…
Warnings
Important safety information
Hyperkalemia: Monitor serum potassium within one week of initiation and regularly thereafter (5.1). Hypotension and Worsening Renal Function: Monitor volume status and renal function periodically (5.2). Electrolyte and Metabolic Abnormalities: Monitor serum electrolytes, uric acid and blood glucose periodically (5.3). Gynecomastia: Spironolactone can cause gynecomastia (5.4 ). 5.1 Hyperkalemia Spironolactone can cause hyperkalemia. This risk is increased by impaired renal function or concomitant potassium supplementation, potassium-containing salt substitutes or drugs that increase potassium, such as angiotensin converting enzyme inhibitors and angiotensin receptor blockers [see Drug Interactions (7.1) ] . Monitor serum potassium within 1 week of initiation or titration of spironolactone and regularly thereafter. More frequent monitoring may be needed when spironolactone is given with other drugs that cause hyperkalemia or in patients with impaired renal function. If hyperkalemia occurs, decrease the dose or discontinue spironolactone and treat hyperkalemia. 5.2 Hypotension and Worsening Renal Function Excessive diuresis may cause symptomatic dehydration, hypotension and worsening renal function, particularly in salt-depleted patients or those taking angiotensin converting enzyme inhibitors and angiotensin II receptor blockers. Worsening of renal function can also occur with concomitant use of nephrotoxic drugs (e.g., aminoglycosides, cisplatin, and NSAIDs). Monitor volume status and renal function periodically. 5.3 Electrolyte and Metabolic Abnormalities In addition to causing hyperkalemia, spironolactone can cause hyponatremia, hypomagnesemia, hypocalcemia, hypochloremic alkalosis, and hyperglycemia. Asymptomatic hyperuricemia can occur and rarely gout is precipitated. Monitor serum electrolytes, uric acid and blood glucose periodically. 5.4 Gynecomastia Spironolactone can cause gynecomastia. In Randomized Spironolactone Evaluation Study, patients with heart failure treated with a mean dose of 26 mg of spironolactone once daily, about 9% of the male subjects developed gynecomastia. The risk of gynecomastia increases in a dose-dependent manner with an onset that varies widely from 1-2 months to over a year. Gynecomastia is usually reversible.
Who should not take Spironolactone
Spironolactone is contraindicated in the patients with: Hyperkalemia Addison’s disease Concomitant use of eplerenone Spironolactone tablets are contraindicated in patients with (4): Hyperkalemia Addison's disease Concomitant use of eplerenone
Overdose — what happens if you take too much
The oral LD 50 of spironolactone is greater than 1000 mg/kg in mice, rats, and rabbits. Acute overdosage of spironolactone may be manifested by drowsiness, mental confusion, maculopapular or erythematous rash, nausea, vomiting, dizziness, or diarrhea. Rarely, instances of hyponatremia, hyperkalemia, or hepatic coma may occur in patients with severe liver disease, but these are unlikely due to acute overdosage. Hyperkalemia may occur, especially in patients with impaired renal function. Treatment: Induce vomiting or evacuate the stomach by lavage. There is no specific antidote. Treatment is supportive to maintain hydration, electrolyte balance, and vital functions. Patients who have renal impairment may develop hyperkalemia. In such cases, discontinue spironolactone.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Interactions
Agents increasing serum potassium: Concomitant administration can lead to hyperkalemia ( 5.1 , 7.1 ). Lithium: Increased risk of lithium toxicity ( 7.2 ). NSAIDs: May reduce the diuretic, natriuretic and antihypertensive effect of spironolactone ( 7.3 ). Digoxin: Spironolactone can interfere with radioimmunologic assays of digoxin exposure ( 7.4 ). Cholestyramine: Hyperkalemic metabolic acidosis has been reported with concomitant use ( 7.5 ). Acetylsalicylic Acid (ASA): ASA may reduce the efficacy of spironolactone ( 7.6 ). Abiraterone: May increase prostate-specific antigen (PSA) levels (7.7). 7.1 Drugs and Supplements Increasing Serum Potassium Concomitant administration of spironolactone with potassium supplementation or drugs that can increase potassium may lead to severe hyperkalemia. In general, discontinue potassium supplementation in heart failure patients who start spironolactone [see Warnings and Precautions (5.1) and Clinical Pharmacology (12.3) ] . Check serum potassium levels when ACE inhibitor or ARB therapy is altered in patients receiving spironolactone. Examples of drugs that can increase potassium include: ACE inhibitors angiotensin receptor blockers non-steroidal anti-inflammatory drugs (NSAIDs) heparin and low molecular weight heparin trimethoprim 7.2 Lithium Like other diuretics, spironolactone reduces the renal clearance of lithium, thus increasing the risk of lithium toxicity. Monitor lithium levels periodically when spironolactone is coadministered [see Clinical Pharmacology (12.3)] . 7.3 Nonsteroidal anti-inflammatory drugs (NSAIDs) In some patients, the administration of an NSAID can reduce the diuretic, natriuretic, and antihypertensive effect of diuretics. Therefore, when spironolactone and NSAIDs are used concomitantly, monitor closely to determine if the desired effect of the diuretic is obtained [see Clinical Pharmacology (12.3) ] . 7.4 Digoxin Spironolactone and its metabolites interfere with radioimmunoassays for digoxin and increase the apparent exposure to digoxin. It is unknown to what extent, if any, spironolactone may increase actual digoxin exposure. In patients taking concomitant digoxin, use an assay that does not interact with spironolactone. 7.5 Cholestyramine Hyperkalemic metabolic acidosis has been reported in patients given spironolactone concurrently with cholestyramine. 7.6 Acetylsalicylic Acid Acetylsalicylic acid may reduce the efficacy of spironolactone. Therefore, when spironolactone and acetylsalicylic acid are used concomitantly, spironolactone may need to be titrated to higher maintenance dose and the patient should be observed closely to determine if the desired effect is obtained [see Clinical Pharmacology (12.3) ] . 7.7 Abiraterone Spironolactone binds to the androgen receptor and may increase prostate-specific antigen (PSA) levels in abiraterone-treated prostate cancer patients. Concomitant use of spironolactone and abiraterone is not recommended.
How long does Spironolactone stay in your body?
The elimination half-life of spironolactone is about 1.4 hours — the time it takes the body to clear about half of it. As a rule of thumb, a medicine is mostly gone after roughly 4 to 5 half-lives, though this varies from person to person with age and kidney or liver function. The parent drug clears fast, but that number is misleading on its own: spironolactone is rapidly and extensively metabolized (mainly by CYP3A4/5, less by CYP2C8) into active metabolites that far outlast it. Canrenone has a mean half-life of 16.5 hours, 7-alpha-(thiomethyl)spirolactone (TMS) 13.8 hours, and 6-beta-hydroxy-7-alpha-(thiomethyl)spirolactone (HTMS) 15 hours — these metabolites are themselves aldosterone antagonists, so the drug's effect persists long after the parent is gone. The Aldactone label states the impact of age, sex, race/ethnicity, and renal impairment on spironolactone pharmacokinetics has NOT been specifically studied, so no labeled numbers exist for older adults or kidney impairment. In hepatic impairment the label does report that the terminal half-life is increased in patients with cirrhotic ascites, without giving a figure. There is no extended-release spironolactone in the US; the one alternative formulation, CaroSpir oral suspension, is immediate-release and lists a similar parent half-life of roughly 1 to 2 hours with metabolite half-lives of 10 to 35 hours, though it is not interchangeable with tablets (15-37% higher serum concentration at an equivalent dose). Food roughly doubles absorption (AUC up about 90-95%), which is why intake should be kept consistent relative to meals.
This is general information, not medical advice. It doesn’t tell you when a drug test would read negative (tests detect substances for different, often longer, windows) or when it’s safe to take another dose — ask your pharmacist or prescriber. Source: ALDACTONE (spironolactone) tablets, USP — FDA prescribing information, Section 12.3 Pharmacokinetics (Pfizer).
Drug class
May treat (source: NIH RxClass)
See how Spironolactone ranks — best-rated aldosterone antagonist for:
Dosage forms
Suspension and Tablet
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
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Request a 90-day supply
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Frequently asked questions
- What does Spironolactone treat?
- Spironolactone (Spironolactone) may be used to treat ascites, edema, heart failure, hirsutism, hyperaldosteronism, hypertension, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How much does Spironolactone cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $2.68 for 30, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins.
- Is there a coupon or discount for Spironolactone?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Spironolactone. To pay less, Spironolactone is already a generic — usually the lowest-cost version — so the main levers are comparing cash prices between pharmacies and using a pharmacy discount-card service. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Spironolactone?
- Spironolactone is marketed by Jubilant Generics. You can see Jubilant Generics's full profile, rating, and other products on pharmaranks.
- Is Spironolactone a brand-name or generic drug?
- Spironolactone is a generic medication; its active ingredient is Spironolactone. Generics contain the same active ingredient as the brand-name original and are usually lower cost.
- Is Spironolactone available over the counter?
- No. Spironolactone is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Spironolactone come in?
- Spironolactone is currently marketed as suspension and tablet, per the FDA's National Drug Code Directory.
- What class of drug is Spironolactone?
- Spironolactone is classified as aldosterone antagonist, per the FDA's Established Pharmacologic Class.
- Is Spironolactone FDA-registered?
- Spironolactone is on record with the U.S. FDA under application number ANDA203253. You can verify this on its official FDA label.
- Is Spironolactone safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Spironolactone. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Spironolactone?
- Spironolactone's side effects are taken directly from its FDA label. From the label: The following clinically significant adverse reactions are described elsewhere in the labeling: Hyperkalemia [see Warnings and Precautions (5.1)] Hypotension and Worsening Renal Function [see Warnings and Precautions (5.2)] Electrolyte and Metabolic Abnormalities [see Warnings and Precautions (5.3)… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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