Spironolactone
Aldosterone Antagonists
Sold as Qaialdo · Aldactone
- Drug class
- Aldosterone Antagonists
- Availability
- Prescription only
- Routes
- Oral
- Markets covered
- 4
- Products on record
- 58
- FDA reports (12 mo)
- 8,417
Overview
Spironolactone is an active pharmaceutical ingredient in the Aldosterone Antagonists group (C03DA). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| GB United Kingdom | MHRA | 36 | May 29, 2026 |
| CA Canada | Health Canada | 11 | May 6, 2026 |
| US United States | FDA | 10 | May 20, 2026 |
| EU European Union | EMA | 1 | March 24, 2026 |
GBUnited Kingdom· MHRA
36 products
Uses
1 Therapeutic indication • Congestive cardiac failure • Hepatic cirrhosis with ascites and oedema • Malignant ascites • Nephrotic syndrome • Diagnosis and treatment of primary aldosteronism Children should only be treated under guidance of a paediatric specialist.
2).
How to take
CACanada· Health Canada
11 products
Uses
Fixed-dose combination drugs are not indicated for initial therapy. Patients should be titrated on the individual drugs. If the fixed combination represents the dosage so determined, its use may be more convenient in patient management.
If during maintenance therapy dosage adjustment is necessary, it is advisable to use the individual drugs. TEVA-SPIRONOLACTONE/HCTZ (spironolactone and hydrochlorothiazide) is indicated for: 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.
The treatment of diuretic-induced hypokalemia in patients with congestive heart failure when other measures are considered inappropriate. The treatment of patients with congestive heart failure taking digitalis when other therapies are considered inadequate or inappropriate.
Cirrhosis of the liver accompanied by edema and/or ascites:
USUnited States· FDA
10 products
Uses
1 ). Use as an add-on therapy for the treatment of hypertension, to lower blood pressure. 2 ). 3 ). 1 Heart Failure Spironolactone is indicated for treatment of NYHA Class III-IV heart failure and reduced ejection fraction to increase survival, manage edema, and reduce the need for hospitalization for heart failure.
Spironolactone is usually administered in conjunction with other heart failure therapies. 2 Hypertension Spironolactone is indicated as add-on therapy for the treatment of hypertension, to lower blood pressure in patients who are not adequately controlled on other agents.
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.
EUEuropean Union· EMA
1 product
Uses
In the management of refractory oedema associated with congestive cardiac failure; hepatic cirrhosis with ascites and oedema, malignant ascites, nephrotic syndrome, diagnosis and treatment of primary aldosteronism, essential hypertension.
Neonates, children and adolescents should only be treated under guidance of a paediatric specialist. 2).
How to take
Drug interactions
Known interactions involving Spironolactone. Select one for details. This list is informational and not a complete interaction checker.
Showing 240 of 598. Type above to find a specific drug.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
- [1]MHRA (UK) · PL344240050 · revised February 20, 2026
- [2]Health Canada (DPD) · 00613231 · revised March 22, 2025
- [3]FDA DailyMed · 08738ad4-1607-4d… · revised November 19, 2025 [PDF]
- [4]European Medicines Agency · EMEA/H/C/005535 · revised March 24, 2026
- [5]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.