Baby Safety / Compounds / Spironolactone

Is Spironolactone safe for babies and kids?

Context-dependent for kids

Infants have immature drug-metabolizing enzymes (CYP450 ontogeny), reduced renal clearance, and different volume of distribution. Accidental exposure or breast milk transfer of Spironolactone poses heightened risk.

What is spironolactone?

Also known as: Aldactone, Verospirone, Spirolactone, Spiresis.

CAS number
52-01-7
Molecular formula
C24H32O4S
Molecular weight
416.6 g/mol
SMILES
CC(=O)SC1CC2=CC(=O)CCC2(C3C1C4CCC5(C4(CC3)C)CCC(=O)O5)C
PubChem CID
5833

Risk for babies

Context-dependent

Infants have immature drug-metabolizing enzymes (CYP450 ontogeny), reduced renal clearance, and different volume of distribution. Accidental exposure or breast milk transfer of Spironolactone poses heightened risk.

Neonates and infants up to 12 months have incomplete blood-brain barrier development, immature Phase I/II metabolic enzymes (particularly CYP3A4, UGT1A1), and higher gastrointestinal permeability. Equivalent doses produce higher internal concentrations and longer residence times.

What to do: Minimize infant exposure through source control. For breastfeeding mothers: reduce maternal exposure. For formula-fed infants: use certified low-migration bottles and verified water sources. Consult pediatrician regarding any concerns.

Risk for pregnant and nursing people

Context-dependent

Regulatory consensus

2 regulatory and scientific bodies have classified Spironolactone. The classifications differ — that's the data.

AgencyYearClassificationNotes
EDC Assessment—Confirmed endocrine disruptor
Regulatory Framework—Regulated as pharmaceutical (FDA/EMA); not typically classified under industrial chemical regulations

Regulators apply different standards of evidence — animal-data weighting, exposure-pattern assumptions, epidemiological power thresholds — which is why two scientific bodies can review the same data and reach different conclusions. The disagreement is the data.

Where kids encounter spironolactone

  • Consumer Products — heart failure medication, acne/hirsutism (off-label)

Safer alternatives

Lower-risk approaches that achieve a similar outcome to Spironolactone:

  • Alternative drug class; Non-pharmacological therapy; Lowest effective dose
    Trade-offs: Direct chemical substitution requires verification that the replacement does not introduce new hazards (regrettable substitution). Conduct full hazard assessment of proposed alternative before adoption.
    Relative cost: 1.2-2×

Frequently asked questions

Is spironolactone safe for kids?

Infants have immature drug-metabolizing enzymes (CYP450 ontogeny), reduced renal clearance, and different volume of distribution. Accidental exposure or breast milk transfer of Spironolactone poses heightened risk.

What products contain spironolactone?

Spironolactone appears in: heart failure medication (Consumer products); acne/hirsutism (off-label) (Consumer products).

What should I do if my child is exposed to spironolactone?

Minimize infant exposure through source control. For breastfeeding mothers: reduce maternal exposure. For formula-fed infants: use certified low-migration bottles and verified water sources. Consult pediatrician regarding any concerns.

See Spironolactone in the baby app

Look up products containing spironolactone, compare to alternatives, and explore the full data record.

Open in baby View raw API data

Sources (1)
  1. PubChem (2026) — database

Reference data, not professional advice. Aggregates publicly available regulatory and scientific data; not a substitute for veterinary, medical, legal, or regulatory advice. Why we built ALETHEIA →