Enalapril
1. Pregnancy Evidence & Regulatory Labeling
FDA Pregnancy and Lactation Labeling Rule (PLLR 8.1) & EMA SmPC Section 4.6
Clinical Risk Summary
Pregnancy Nursing Mothers Enalapril and enalaprilat have been detected in human breast milk. Because of the potential for serious adverse reactions in nursing infants from enalapril, a decision should be made whether to discontinue nursing or to discontinue enalapril maleate, taking into account the importance of the drug to the mother.
Regulatory Warnings & Contraindications
FDA Boxed Warning: This medication carries an official Boxed Warning regarding embryo-fetal toxicity or pregnancy-related adverse outcomes.
CONTRAINDICATIONS Enalapril maleate is contraindicated in patients who are hypersensitive to this product and in patients with a history of angioedema related to previous treatment with an angiotensin-converting enzyme inhibitor and in patients with hereditary or idiopathic angioedema. Do not coadminister aliskiren with enalapril maleate in patients with diabetes (see PRECAUTIONS, Drug Interactions ). Enalapril maleate is contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). Do not administer enalapril maleate within 36 hours of switching to or from sacubitril/valsartan, a neprilysin inhibitor (see WARNINGS, Head and Neck Angioedema ).
2. Lactation & Breastfeeding Safety
NIH / NLM LactMed® Database & FDA Labeling Section 8.2
Summary of Use during Lactation
Nursing Mothers Enalapril and enalaprilat have been detected in human breast milk. Because of the potential for serious adverse reactions in nursing infants from enalapril, a decision should be made whether to discontinue nursing or to discontinue enalapril maleate, taking into account the importance of the drug to the mother.
Drug Levels in Breast Milk & Relative Infant Dose
Evaluated in human/animal pharmacokinetic models.
3. Females & Males of Reproductive Potential
FDA Labeling Section 8.3 — Pregnancy Testing, Contraception & Infertility
Standard pre-treatment clinical assessment as indicated.
Review contraception duration based on drug elimination half-life.
No significant drug-induced impairment reported in standard models.
4. Regulatory Source Provenance & Comparison
Direct attribution to official regulatory documents without synthesized consensus
| Regulatory Organization | Jurisdiction | Document / Framework | Effective Date | Official Source Link |
|---|---|---|---|---|
|
U.S. Food and Drug Administration (FDA)
FDA Prescribing Information (PLLR)
|
United States | regulatory_label | 2026-07-28 | Official Record |
|
European Medicines Agency (EMA)
EMA Summary of Product Characteristics (SmPC 4.6)
|
European Union | regulatory_label | Recent | Official Record |