Lisinopril
Regulatory sources consulted
- openfda-label-00b256d4-1691-cc3b-e063-6294a90a47ec
- AEMPS-CIMA-FT-64562
- ANSM-BDPM-RCP-62606357
- Clinical Pharmacist Knowledge
- OpenFDA · C09AA03
- AEMPS CIMA · nº registro 64562 ↗
- ANSM BDPM · CIS 62606357 ↗
- RxNorm rxcui 29046 ↗
Approved indications
- Treatment of hypertension, to lower blood pressure and the risk of fatal and non-fatal cardiovascular events.
- Treatment of symptomatic heart failure.
- Short-term treatment (6 weeks) of hemodynamically stable patients within 24 hours of an acute myocardial infarction.
- Treatment of renal complications of diabetes mellitus (nephropathy in hypertensive patients with type 2 diabetes and microalbuminuria).
Contraindications
Absolute
- Hypersensitivity to lisinopril 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 initiate until 36 hours after the last dose).
- Second and third trimesters of pregnancy.
- Concomitant use with aliskiren in patients with diabetes or renal impairment (GFR < 60 ml/min/1.73 m²).
Clinical warnings
- Boxed warning · Fetal Toxicity: Discontinue as soon as pregnancy is detected. Drugs that act on the renin-angiotensin system can cause injury and death to the developing fetus. — FDA
- Major warning · Angioedema: Angioedema of the face, extremities, lips, tongue, glottis and/or larynx may occur. Higher risk in Black patients. Requires immediate discontinuation of treatment. — FDA
- Hypotension: Excessive blood pressure reduction may occur, especially in volume-depleted patients, heart failure, or on diuretic therapy. — FDA
- Hyperkalemia: ACE inhibitors can cause hyperkalemia. Risk factors include renal insufficiency, diabetes mellitus, and concomitant use of potassium-sparing diuretics or potassium supplements. — ANSM BDPM
Drug interactions
- HighSacubitril/ValsartanC09DX04
Mechanism: Concomitant inhibition of neprilysin and ACE significantly increases the risk of angioedema.
Recommendation: Contraindicated. Do not administer lisinopril within 36 hours of switching to or from sacubitril/valsartan.
ANSM BDPMOpenFDA label
- ModeratePotassium-sparing diuretics or potassium supplementsC03D
Mechanism: Additive effect on serum potassium, leading to an increased risk of hyperkalemia, especially in patients with renal impairment.
Recommendation: Use with caution. Frequent monitoring of serum potassium is recommended.
ANSM BDPM
- ModerateNSAIDs (Nonsteroidal anti-inflammatory drugs)M01A
Mechanism: May attenuate the antihypertensive effect and increase the risk of deterioration in renal function, including acute renal failure.
Recommendation: Monitor blood pressure and renal function periodically, especially in elderly, volume-depleted, or renally-impaired patients.
OpenFDA label
- HighLithiumN05AN01
Mechanism: ACE inhibitors decrease the renal excretion of lithium, increasing the risk of lithium toxicity.
Recommendation: Combination is not recommended. If necessary, strict monitoring of serum lithium levels is required.
ANSM BDPM
Adverse events
Common (≥1%)
dizziness · headache · cough · fatigue · orthostatic effects
Rare but serious
angioedema · acute renal failure · severe hyperkalemia · hepatotoxicity · pancreatitis · agranulocytosis
Pregnancy and lactation
FDA category: D
Contraindicated in the second and third trimesters of pregnancy. Causes fetal toxicity (decreased renal function, oligohydramnios, delayed skull ossification) and neonatal toxicity (renal failure, hypotension, hyperkalemia). Discontinue as soon as pregnancy is detected.