Spironolactone: clinical trials recruiting now
FDA drug label
- FDA-approved
- Yes. Spironolactone appears in the FDA drug-label database. Marketed as Spironolactone.
- Drug class
- Aldosterone Antagonist (FDA established pharmacologic class)
- Mechanism of action
- Aldosterone Antagonists (as stated on the FDA label)
- Boxed warning
- The FDA label for Spironolactone carries a boxed warning (the FDA's most serious warning). See the full label for details.
FDA-approved use
Spironolactone tablets 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 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 are indicated for maintenance therapy together with bed rest and the restriction of fluid and sodium. Nephrotic Syndrome For nephrotic patients w…
FDA recalls / enforcement
| Reason (FDA) | Classification | Status | Initiated |
|---|---|---|---|
| Presence of foreign substance: identified as aluminum. — SUN PHARMACEUTICAL INDUSTRIES INC | Class II (FDA: may cause temporary or reversible harm) | Ongoing | 2025-08-05 |
| Marketed without an Approved NDA/ANDA: This recall is being initiated because of changes to the dissolution profile in distributed lots resulting from a manufacturing site change. There is currently no approved application supporting the alternate manufacturing site. — Pfizer Us Pharmaceutical Group | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2013-09-04 |
Phase breakdown
Conditions being studied
Recruiting trials involving Spironolactone
- Blockade of the Renin-angiotensin-aldosterone System in Patients With ARVD
- Does Spironolactone Normalize Sleep-wake Luteinizing Hormone Pulse Frequency in Pubertal Girls With Hyperandrogenism?
- Efficacy of Spironolactone Combined With Antihypertensive Drugs in Patients With Primary Aldosteronism
- Evaluation of Spironolactone Efficacy in Patient with Rheumatoid Arthritis (RA)
- Hyperandrogenemia and Altered Day-night LH Pulse Patterns
- Spironolactone Initiation Registry Randomized Interventional Trial in Heart Failure With Preserved Ejection Fraction
- Spironolactone for Pulmonary Arterial Hypertension
- Superselective Adrenal Arterial Embolization Versus Oral Spironolactone for Treatment of Idiopathic Hyperaldosteronism
- The Role of Skin Sodium Accumulation in Chronic Kidney Disease
Common questions
Is Spironolactone FDA-approved?
Yes, marketed as Spironolactone. Its FDA label carries a boxed warning.
How many recruiting trials involve Spironolactone?
9 recruiting trials across 15 conditions.
Is this list of trials complete?
No. For the full record, search ClinicalTrials.gov.