Enalapril

ATC code

C09AA02

Therapeutic class

Angiotensin-converting enzyme (ACE) inhibitor · Angiotensin-converting enzyme (ACE) inhibitor

Forms

oral tablet

Brand names

Enalapril Maleate (US) · Vasotec (US) · Enalapril Cinfa (ES) · Aqumeldi (EU) · Zanextra (FR)

Overall confidence

high

Regulatory sources consulted

openfda-label-074fb8a1-3ea1-0d6b-e063-6394a90aaf60
aemps-ft-73300
ansm-rcp-69974066
ema-epar-EMEA/H/C/005731
Clinical Pharmacology Knowledge Base
OpenFDA · C09AA02
RxNorm rxcui 3827 ↗

Approved indications

Treatment of hypertension, alone or in combination with other antihypertensive agents, especially thiazide-type diuretics.
Treatment of symptomatic congestive heart failure, usually in combination with diuretics and digitalis.
Treatment of asymptomatic left ventricular dysfunction (ejection fraction ≤35 percent) to decrease the rate of development of overt heart failure.
Treatment of heart failure.

Contraindications

Absolute

Hypersensitivity to enalapril or any other ACE inhibitor.
History of angioedema related to previous treatment with an ACE inhibitor.
Hereditary or idiopathic angioedema.
Concomitant use with sacubitril/valsartan (do not administer within 36 hours).
Concomitant use with aliskiren in patients with diabetes.
Second and third trimesters of pregnancy.

Clinical warnings

Boxed warning · Fetal Toxicity: Drugs that act on the renin-angiotensin system can cause injury and death to the developing fetus. Discontinue enalapril as soon as pregnancy is detected. — FDA
Major warning · Angioedema: Angioedema of the face, extremities, lips, tongue, glottis and/or larynx has been reported. Angioedema associated with laryngeal edema may be fatal. Risk is increased with concomitant use of mTOR inhibitors or neprilysin inhibitors. — FDA
Hypotension: Excessive reduction of blood pressure may occur, especially in volume-depleted patients, heart failure, or those on diuretic therapy. — FDA
Hyperkalemia: Risk of increased serum potassium, especially in patients with renal insufficiency, diabetes mellitus, or those concomitantly using potassium-sparing diuretics or potassium supplements. — EMA SPC

Drug interactions

HighSacubitril/ValsartanC09DX04
Mechanism: Increased risk of angioedema from concomitant inhibition of neprilysin (NEP) by sacubitril and ACE by enalapril.
Recommendation: Contraindicated. Do not administer enalapril within 36 hours of switching to or from sacubitril/valsartan.
FDA labelEMA SPC
HighAliskirenC09XA02
Mechanism: Dual blockade of the renin-angiotensin-aldosterone system (RAAS) increases the risk of hypotension, hyperkalemia, and renal impairment.
Recommendation: Contraindicated in patients with diabetes. Avoid use in patients with renal impairment (GFR < 60 mL/min).
FDA labelEMA SPC
ModeratePotassium-sparing diureticsC03D
Mechanism: Additive effect that can lead to hyperkalemia, as ACE inhibitors can decrease diuretic-induced potassium loss.
Recommendation: Use with caution. Monitor serum potassium frequently, especially in patients with renal impairment.
FDA labelEMA SPC
ModerateNSAIDs (Nonsteroidal anti-inflammatory drugs)M01A
Mechanism: May result in deterioration of renal function and a reduction of the antihypertensive effect of enalapril.
Recommendation: Monitor renal function periodically, especially in elderly, volume-depleted, or renally impaired patients.
FDA label

Adverse events

Common (≥1%)

dizziness · cough · headache · fatigue · hypotension

Rare but serious

angioedema · hyperkalemia · acute renal failure · agranulocytosis · hepatotoxicity

Pregnancy and lactation

FDA category: D

Contraindicated in the second and third trimesters of pregnancy due to fetal toxicity (fetal injury and death). Discontinue as soon as pregnancy is detected. Enalapril is excreted in human milk; a decision should be made whether to discontinue nursing or the drug.