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Spironolactone Uses, Dosage, Side Effects & Warnings | DrugsAtlas

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Therapeutic Class

Diuretic

Subclass

Potassium-sparing diuretic; Aldosterone antagonist

Speciality

Cardiology

Schedule (India)

Schedule H

Routes

Oral

Formulations

Form	Available Strengths
Tablets	25 mg, 50 mg, 100 mg
Oral Suspension/Syrup	5 mg/mL (select brands)
FDC with Furosemide	Spironolactone 50 mg + Furosemide 20 mg

Adult indications

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Congestive Heart Failure (NYHA Class III–IV) — Adjunct to Standard Therapy

Parameter	Recommendation
Starting dose	25 mg orally once daily
Titration	Increase to 50 mg once daily after 4–8 weeks if K⁺ <5.0 mEq/L and serum creatinine <2.5 mg/dL
Usual maintenance dose	25–50 mg once daily
Maximum dose	50 mg/day (some guidelines allow up to 100 mg/day under specialist supervision)
Duration	Long-term; mortality benefit demonstrated

Clinical Notes:

Evidence-based mortality reduction in NYHA III–IV HF (RALES trial)
Add to ACE inhibitor/ARB + beta-blocker + loop diuretic backbone
Avoid if baseline K⁺ >5.0 mEq/L or creatinine >2.5 mg/dL

2. Resistant Hypertension (Fourth-line Agent)

Parameter	Recommendation
Starting dose	25 mg orally once daily
Titration	Increase by 25 mg every 2–4 weeks based on BP response
Usual maintenance dose	25–50 mg once daily
Maximum dose	100 mg/day (specialist supervision if >50 mg/day)

Clinical Notes:

Particularly effective in low-renin hypertension and primary aldosteronism
Check aldosterone:renin ratio before initiating if hyperaldosteronism suspected
Synergistic effect when added to ACEi/ARB + CCB + thiazide

3. Primary Hyperaldosteronism

A) Diagnostic Testing (Short-term Aldosterone Suppression Test)

Parameter	Recommendation
Dose	100–400 mg/day in divided doses
Duration	3–5 days
Note	Specialist/endocrinology use only

B) Long-term Medical Management (Non-surgical candidates)

Parameter	Recommendation
Starting dose	50–100 mg/day in 1–2 divided doses
Titration	Adjust every 2–4 weeks based on BP and serum potassium
Usual maintenance dose	100–200 mg/day
Maximum dose	400 mg/day
Note	Endocrinology specialist supervision mandatory

4. Liver Cirrhosis with Ascites

Parameter	Recommendation
Starting dose	100 mg orally once daily (with furosemide 40 mg/day)
Titration	Increase both drugs proportionally every 3–5 days; maintain 100:40 ratio (spironolactone:furosemide)
Usual maintenance dose	100–200 mg/day
Maximum dose	400 mg/day (with furosemide up to 160 mg/day)

Clinical Notes:

First-line diuretic for cirrhotic ascites (secondary hyperaldosteronism)
Aim for weight loss of 0.5 kg/day (without peripheral oedema) or 1 kg/day (with oedema)
Monitor for encephalopathy, hyponatraemia, hyperkalaemia
Avoid in hepatorenal syndrome (HRS) — specialist input required

5. Nephrotic Syndrome — Adjunctive Therapy

Parameter	Recommendation
Starting dose	25–50 mg orally once daily
Titration	Increase based on diuretic response and potassium tolerance
Usual maintenance dose	50–100 mg/day
Maximum dose	100 mg/day
Note	Specialist (nephrologist) supervision advised

Clinical Notes:

Used when response to loop diuretics is inadequate
Aldosterone escape contributes to oedema in nephrotic syndrome
Caution in patients with reduced GFR

6. Oedema (Generalised) — Adjunct to Loop Diuretics

Parameter	Recommendation
Starting dose	25 mg orally once daily
Titration	Increase by 25 mg every 3–5 days based on response
Usual maintenance dose	25–100 mg/day
Maximum dose	200 mg/day

Secondary Indications — Adults (Off-label)

Indication	Dose	Duration	Notes
Hormonal acne (females)	25–100 mg/day orally	3–6 months trial; long-term if effective	OFF-LABEL; Dermatology specialist only; contraception mandatory
Hirsutism (females)	50–200 mg/day orally	≥6 months for visible effect	OFF-LABEL; Dermatology/Endocrinology specialist; established Indian practice
Polycystic Ovary Syndrome (PCOS)	50–100 mg/day orally	Long-term with metabolic monitoring	OFF-LABEL; Endocrinology/Gynaecology specialist; contraception essential
Androgenetic alopecia (female pattern)	50–200 mg/day orally	≥12 months for response	OFF-LABEL; Dermatology specialist only

Evidence Basis: Small RCTs and extensive case series; established dermatology/endocrinology practice in India; antiandrogenic mechanism well-documented.

Critical Warning: Teratogenic — strict contraception required in all females of reproductive age on spironolactone for antiandrogenic indications.

Paediatric indications

PAEDIATRIC DOSING (Specialist Only)

Primary Indications

1. Oedema (Heart Failure, Nephrotic Syndrome, Hepatic Ascites)

Weight/Age	Dose	Maximum	Frequency
Infants (>1 month)	1–3 mg/kg/day	3.3 mg/kg/day or 100 mg/day (whichever lower)	Once daily or divided BID
Children 1–12 years	1–3 mg/kg/day	100 mg/day	Once daily or divided BID
Adolescents >12 years	Adult dosing	100 mg/day	Once daily

Alternative calculation: 30–90 mg/m²/day

Parameter	Recommendation
Starting dose	1 mg/kg/day
Titration	Increase by 0.5–1 mg/kg/day every 3–5 days based on response
Usual maintenance dose	1–3 mg/kg/day
Maximum dose	3.3 mg/kg/day or 100 mg/day

2. Paediatric Heart Failure (Cardiomyopathy, Congenital Heart Disease)

Parameter	Recommendation
Starting dose	1 mg/kg/day orally
Titration	Increase every 5–7 days based on clinical response
Usual maintenance dose	1–3 mg/kg/day
Maximum dose	100 mg/day
Note	Paediatric cardiology supervision essential

3. Bronchopulmonary Dysplasia (Neonates — NICU use)

Parameter	Recommendation
Dose	1–2 mg/kg/day orally
Note	NICU specialist supervision only

Secondary Indications — Paediatrics (Off-label)

Indication	Age	Dose	Duration	Notes
Congenital adrenal hyperplasia (as adjunct)	>1 month	1–3 mg/kg/day	Long-term	OFF-LABEL; Paediatric endocrinology specialist only
Bartter syndrome	>1 month	1–3 mg/kg/day	Long-term	OFF-LABEL; Specialist only

Paediatric Safety Notes

Parameter	Recommendation
Minimum age	>1 month (neonatal use only under NICU/specialist supervision)
Monitoring	Serum electrolytes (K⁺, Na⁺), creatinine, weight, BP, hydration status
Frequency	Baseline → 1 week after initiation → every 2–4 weeks during titration → monthly when stable
Formulation	Use oral suspension for accurate dosing in infants/young children

Renal Adjustments

eGFR (mL/min/1.73 m²)	Dose Modification
>50	No adjustment; standard dosing with routine K⁺ monitoring
30–50	Start 12.5–25 mg/day; cautious titration; monitor K⁺ every 3–5 days
15–30	Start 12.5 mg alternate days; close monitoring; avoid if K⁺ >5.0 mEq/L
<15 or Dialysis	Avoid use or use only under specialist (nephrologist) supervision with intensive monitoring

Haemodialysis: Not significantly dialysed; avoid in ESRD unless specialist-directed.

Peritoneal Dialysis: Avoid; risk of severe hyperkalaemia.'

Hepatic adjustment

Contraindications

Hyperkalaemia (serum K⁺ >5.5 mEq/L)
Addison's disease or primary adrenal insufficiency
Severe renal impairment (eGFR <15 mL/min/1.73 m²) not on dialysis
Anuria
Known hypersensitivity to spironolactone or any excipient
Concurrent use with eplerenone (overlapping mechanism; additive hyperkalaemia)
Concurrent potassium supplementation (relative — avoid unless documented hypokalaemia)

Cautions

Elderly patients — increased risk of hyperkalaemia, hyponatraemia, renal impairment
Concurrent RAAS inhibitors (ACE inhibitors, ARBs, direct renin inhibitors) — additive hyperkalaemia risk
Diabetes mellitus, especially with nephropathy — higher hyperkalaemia risk
Mild-to-moderate renal impairment (eGFR 30–60 mL/min) — closer monitoring needed
Pre-existing electrolyte abnormalities
Metabolic or respiratory acidosis — potentiates hyperkalaemia
Long-term use — gynaecomastia, menstrual irregularities, sexual dysfunction
Patients on digoxin — altered digoxin clearance

Pregnancy

Parameter	Recommendation
Overall safety	Not recommended — antiandrogenic effects; feminisation of male fetus in animal studies
First trimester	Contraindicated
Second/Third trimester	Avoid; use only if no alternative and benefit clearly outweighs risk — specialist decision
Preferred alternatives	For hypertension: Labetalol, Nifedipine, Methyldopa; For oedema: Furosemide (if essential)
Monitoring	If inadvertently exposed: detailed fetal anomaly scan; monitor maternal electrolytes

Lactation

Parameter	Recommendation
Compatibility	Generally compatible with breastfeeding
Drug levels in milk	Low (active metabolite canrenone detected in low concentrations)
Preferred alternatives	For hypertension: Amlodipine, Labetalol, Enalapril
Infant monitoring	Hydration status, weight gain, urine output; watch for signs of electrolyte disturbance

Elderly

Parameter	Recommendation
Starting dose	12.5–25 mg once daily
Titration	Slow; increase by 12.5–25 mg every 1–2 weeks
Maximum dose	Generally limit to 50 mg/day unless specialist supervision
Extra risks	Hyperkalaemia (reduced renal K⁺ excretion), hyponatraemia, postural hypotension, falls, acute kidney injury, gynaecomastia
Monitoring frequency	Electrolytes and creatinine: baseline → 1 week → 1 month → every 1–3 months

Major drug interactions

Interacting Drug	Effect	Recommendation
ACE inhibitors (Enalapril, Ramipril, etc.)	Additive hyperkalaemia; synergistic RAS blockade	Can be used together with close K⁺ monitoring (standard in HF); avoid in CKD 4–5
ARBs (Losartan, Telmisartan, etc.)	Additive hyperkalaemia	Same as ACEi — monitor closely
Potassium supplements	Severe hyperkalaemia risk	Avoid combination unless documented hypokalaemia
Potassium-containing salt substitutes	Hidden potassium load	Counsel patients to avoid
Eplerenone	Overlapping mechanism; additive toxicity	Contraindicated — do not combine
Trimethoprim / Co-trimoxazole	Trimethoprim blocks renal K⁺ excretion	Avoid or monitor K⁺ very closely (especially in elderly, CKD)
NSAIDs (Ibuprofen, Diclofenac, etc.)	Reduced diuretic efficacy; increased renal toxicity; hyperkalaemia	Avoid long-term combination; if essential, monitor renal function and K⁺
Heparin / LMWH	Aldosterone suppression; additive hyperkalaemia	Monitor K⁺ especially in CKD/elderly

Mechanism: Spironolactone blocks aldosterone → reduced K⁺ excretion → synergistic hyperkalaemia with other K⁺-sparing mechanisms.

Moderate drug interactions

Interacting Drug	Effect	Recommendation
Digoxin	Spironolactone increases digoxin half-life by ~20%; may interfere with digoxin assays	Monitor digoxin levels; watch for toxicity (especially elderly)
Lithium	Reduced lithium clearance → toxicity risk	Monitor lithium levels closely; avoid if possible
Antidiabetic agents (Insulin, Sulfonylureas)	Altered glycaemic control with volume status changes	Monitor blood glucose during diuretic initiation/adjustment
Corticosteroids	May antagonise diuretic and potassium-sparing effects	Higher spironolactone doses may be needed; monitor BP and oedema
Carbenoxolone	Antagonises spironolactone effect	Avoid combination
Cholestyramine	May reduce spironolactone absorption	Separate administration by 2–4 hours
Aspirin (high-dose)	May reduce diuretic efficacy	Monitor clinical response

Common Adverse effects

Hyperkalaemia (dose-dependent; up to 10–15% in high-risk patients)
Gynaecomastia and breast tenderness (dose and duration dependent; 10% at 50 mg/day)
Menstrual irregularities (amenorrhoea, breakthrough bleeding)
Decreased libido, erectile dysfunction
Gastrointestinal upset (nausea, vomiting, diarrhoea, cramping)
Fatigue, lethargy
Dizziness, headache
Skin rash

Serious Adverse effects

Adverse Effect	Clinical Notes
Life-threatening hyperkalaemia	Especially in CKD, elderly, diabetes, concurrent RAS blockers; may cause fatal arrhythmias; requires immediate discontinuation and treatment
Severe hyponatraemia	Particularly in cirrhosis; may precipitate encephalopathy
Acute kidney injury	Risk with volume depletion, NSAIDs, RAS blockers
Agranulocytosis	Rare; discontinue if unexplained fever/infection
Stevens-Johnson syndrome / TEN	Very rare; immediate discontinuation required
Hepatotoxicity	Rare; monitor LFTs if symptoms suggest
Deep vein thrombosis	Reported rarely; unclear mechanism

Monitoring requirements

Timing	Parameters
Baseline	Serum potassium, sodium, creatinine, eGFR, BP; LFTs in hepatic disease patients
After initiation / dose change	Potassium and creatinine: 3–7 days (high-risk) or 1–2 weeks (standard-risk)
First 3 months	Monthly electrolytes and renal function
Long-term (stable patients)	Every 3–6 months; more frequent if CKD, diabetes, elderly, or on RAS blockers
Clinical monitoring	Signs of hyperkalaemia (weakness, palpitations), gynaecomastia, volume status, BP

When to hold/discontinue:

K⁺ ≥5.5 mEq/L — hold and recheck
K⁺ ≥6.0 mEq/L — discontinue; treat hyperkalaemia
Creatinine increase >30% from baseline — reassess

Brands in India

Brand Name	Manufacturer	Formulation
Aldactone	Pfizer/RPG	Tablets 25 mg, 50 mg, 100 mg
Spiromide	Micro Labs	Tablets
Spironol	Intas	Tablets
Lactone	Sun Pharma	Tablets
Silectone	Alkem	Tablets
Spiractin	Cadila	Tablets

Fixed-Dose Combinations (FDCs):

Brand Name	Composition	Manufacturer
Lasilactone	Spironolactone 50 mg + Furosemide 20 mg	Sanofi
Fruselac	Spironolactone 50 mg + Furosemide 20 mg	Cadila
Spirolac	Spironolactone 50 mg + Furosemide 20 mg	Sun Pharma

Price range (INR)

Formulation	Approximate Price per Tablet
Spironolactone 25 mg (strip of 10)	₹15–40 (₹1.5–4 per tablet)
Spironolactone 50 mg (strip of 10)	₹25–60 (₹2.5–6 per tablet)
Spironolactone 100 mg (strip of 10)	₹50–100 (₹5–10 per tablet)
Lasilactone (50 mg + 20 mg) strip of 10	₹50–80 (₹5–8 per tablet)

NLEM 2022 Status: Spironolactone 25 mg tablet included — NPPA price ceiling applicable

Jan Aushadhi Availability: Yes — available at subsidised rates

Clinical pearls

Potassium is paramount: Hyperkalaemia is the most dangerous adverse effect — always check K⁺ before starting, after each dose change, and regularly during therapy. Risk is highest in CKD, diabetes, and elderly patients on ACEi/ARBs.
Heart failure mortality benefit: Spironolactone is one of the few drugs with proven mortality reduction in HFrEF — do not omit unless genuinely contraindicated. Start low (25 mg) and monitor.
Cirrhosis ratio rule: In ascites management, maintain spironolactone:furosemide ratio of approximately 100:40 to balance potassium and optimise diuresis.
Gynaecomastia management: If gynaecomastia is intolerable at ≥100 mg/day, consider dose reduction or switching to eplerenone (more selective, less antiandrogenic — but more expensive in India).
Contraception for antiandrogenic use: In women using spironolactone for acne, hirsutism, or PCOS — strict contraception is mandatory due to risk of feminising male fetus.
Delayed onset: Full antihypertensive effect may take 2–4 weeks; anti-androgenic effects (hirsutism, acne) may take 3–6 months — counsel patients appropriately.

Version

RxIndia v1.1 — 30 May 2025

Reference

CDSCO Product Database and approved prescribing information
Indian Pharmacopoeia (IP)
National List of Essential Medicines (NLEM) 2022
API Textbook of Medicine
ICMR Guidelines for Hypertension and CKD Management
AIIMS Drug Formulary
IAP Guidelines for Paediatric Diuretics
Cardiological Society of India — Heart Failure Guidelines
RALES Trial (off-label HF mortality evidence — NEJM 1999)
Goodman & Gilman's The Pharmacological Basis of Therapeutics

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Clinical Responsibility

This platform is designed strictly for healthcare professionals. Data provided is synthesized from authoritative pharmacological sources and clinical registries. Do not use for consumer medical decisions. Always verify critical dosing and contraindications with official institutional protocols and peer-reviewed journals.

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