Ramipril

ATC code

C09AA05

Therapeutic class

Angiotensin-converting enzyme (ACE) inhibitor · ACE inhibitor

Forms

oral capsule, oral tablet

Brand names

Ramipril (US) · Altace (US) · Ramipril Cinfa (ES) · Ramipril Teva Sante (FR) · Tritace (EU)

Overall confidence

high

Regulatory sources consulted

openfda-label-cada6f46-f67d-41d9-8dbe-53740c3dac62
aemps-cima-ft-72290
ansm-bdpm-rcp-69888044
PubMed PMID:36018037 ↗
PubMed PMID:37417783 ↗
PubMed PMID:34758252 ↗
PubMed PMID:38771738 ↗
OpenFDA · C09AA05
RxNorm rxcui 35296 ↗

Approved indications

Treatment of hypertension. It may be used alone or in combination with thiazide diuretics.
Reduction of risk of death, heart failure-related hospitalization, and progression to severe heart failure in stable patients with clinical signs of congestive heart failure post-acute myocardial infarction.
Prevention of myocardial infarction, stroke, or death from cardiovascular causes in patients with high cardiovascular risk (manifest coronary artery disease, previous stroke, peripheral arterial disease, or diabetes with at least one additional cardiovascular risk factor).

Contraindications

Absolute

Hypersensitivity to ramipril or any other ACE inhibitor. History of angioedema (hereditary, idiopathic, or due to previous ACE inhibitor).
Concomitant use with sacubitril/valsartan. Do not initiate until 36 hours after the last dose of sacubitril/valsartan.
Concomitant use with aliskiren in patients with diabetes or renal impairment (GFR < 60 ml/min).
Second and third trimesters of pregnancy.
Hemodynamically significant bilateral renal artery stenosis, or stenosis in a single functioning kidney.

Clinical warnings

Boxed warning · Fetal Toxicity: Drugs that act on the renin-angiotensin system can cause injury and death to the developing fetus. Discontinue ramipril as soon as pregnancy is detected. — FDA
Major warning · Dual Blockade of the RAAS: The combined use of ACE inhibitors, ARBs, or aliskiren increases the risk of hypotension, hyperkalemia, and renal failure. Generally not recommended, especially in patients with diabetic nephropathy. — EMA SPC

Drug interactions

HighSacubitril/ValsartanC09DX04
Mechanism: Concomitant inhibition of neprilysin and ACE increases the risk of angioedema.
Recommendation: Contraindicated. Do not co-administer. Allow a 36-hour washout period when switching between drugs.
ANSM RCP
HighAliskirenC09XA02
Mechanism: Dual blockade of the renin-angiotensin-aldosterone system (RAAS), which increases the risk of hypotension, hyperkalemia, and renal impairment.
Recommendation: Contraindicated in patients with diabetes or renal impairment (GFR < 60 ml/min). Avoid in other patients.
ANSM RCP
ModeratePotassium-sparing diureticsC03D
Mechanism: Additive effect on serum potassium, increasing the risk of hyperkalemia.
Recommendation: Use with caution. Monitor serum potassium frequently, especially in patients with renal impairment.
OpenFDA labelANSM RCP
ModerateNSAIDsM01A
Mechanism: May reduce the antihypertensive effect and increase the risk of renal function deterioration, especially in at-risk patients (elderly, dehydrated).
Recommendation: Monitor blood pressure and renal function. Ensure adequate hydration.
OpenFDA label

Adverse events

Common (≥1%)

dry cough · headache · dizziness · fatigue · hypotension · syncope · hyperkalemia

Rare but serious

angioedema · acute renal failure · hepatotoxicity · pancreatitis · neutropenia · agranulocytosis

Pregnancy and lactation

FDA category: D

Contraindicated in the second and third trimesters of pregnancy due to fetal toxicity (renal failure, oligohydramnios, death). Discontinue as soon as pregnancy is detected. Use during breastfeeding is not recommended.

Recent literature (PubMed)

Polypill Strategy in Secondary Cardiovascular Prevention.
Castellano JM, et al. · N Engl J Med · 2022 · Relevance 5/5
El ensayo SECURE demostró que una polipíldora (aspirina, ramipril, atorvastatina) después de un infarto de miocardio redujo significativamente el riesgo de eventos cardiovasculares adversos mayores en comparación con el tratamiento habitual, con una mejor adherencia.
Angiotensin Receptor-Neprilysin Inhibition in Acute Myocardial Infarction.
Pfeffer MA, et al. · N Engl J Med · 2021 · Relevance 5/5
El ensayo PARADISE-MI comparó sacubitril-valsartán con ramipril en pacientes con infarto de miocardio agudo. No se encontró una reducción significativamente menor en la incidencia de muerte por causas cardiovasculares o insuficiencia cardíaca con sacubitril-valsartán en comparación con ramipril.
Angiotensin-converting enzyme inhibitor induced cough compared with placebo, and other antihypertensives: A systematic review, and network meta-analysis.
Hu Y, et al. · J Clin Hypertens (Greenwich) · 2023 · Relevance 4/5
Una revisión sistemática y metaanálisis en red encontró que los IECA tienen un riesgo 2.21 veces mayor de tos en comparación con el placebo. Ramipril se clasificó como uno de los IECA con mayor riesgo de inducir tos, reforzando que la tos es un efecto de clase común.
Drugs for hypertension.
Unknown · Med Lett Drugs Ther · 2024 · Relevance 3/5
Revisión de las opciones de tratamiento para la hipertensión, donde los IECA como el ramipril siguen siendo una terapia de primera línea para muchos pacientes, especialmente aquellos con comorbilidades como insuficiencia cardíaca, enfermedad renal crónica o diabetes.