Candesartan

ATC code

C09CA06

Therapeutic class

Angiotensin II Receptor Blocker (ARB) · Renin-angiotensin system blocker

Forms

oral tablet

Brand names

CANDESARTAN CILEXETIL (US) · Atacand (US) · CANDESARTAN CINFA (ES) · KENZEN (FR)

Overall confidence

high

Regulatory sources consulted

openfda-label-55b443a9-6652-4408-a91d-7aa4dbc457f9
aemps-ft-75655
ansm-rcp-69641318
PubMed PMID:36346411 ↗
PubMed PMID:37432701 ↗
PubMed PMID:38861046 ↗
PubMed PMID:38771738 ↗
PubMed PMID:39412629 ↗
OpenFDA · C09CA06
RxNorm rxcui 214354 ↗

Approved indications

Treatment of hypertension in adults and children 1 to <17 years of age, to lower blood pressure.
Treatment of heart failure (NYHA class II-IV) to reduce cardiovascular death and heart failure hospitalization.

Contraindications

Absolute

Hypersensitivity to candesartan or any of the components.
Second and third trimesters of pregnancy.
Concomitant use with aliskiren in patients with diabetes or renal impairment (GFR <60 ml/min/1.73 m²).
Severe hepatic impairment and/or cholestasis.
Children under 1 year of age.

Clinical warnings

Boxed warning · Fetal Toxicity: Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. Discontinue as soon as pregnancy is detected. — FDA
Major warning · Hypotension: Symptomatic hypotension may occur, particularly in volume-depleted patients. Correct volume depletion prior to initiating therapy. — FDA
Major warning · Impaired Renal Function and Hyperkalemia: Monitor renal function and serum potassium. Dual blockade of the RAAS increases risk. — EMA SPC

Drug interactions

HighAliskirenC09XA02
Mechanism: Dual blockade of the renin-angiotensin system (RAAS), increasing the risk of hypotension, hyperkalemia, and renal impairment.
Recommendation: Contraindicated in patients with diabetes or renal impairment (GFR < 60 ml/min).
ANSM RCPFDA label
HighACE Inhibitors (ACEi) and other ARBsC09A
Mechanism: Dual blockade of the RAAS, with increased risk of adverse effects without demonstrated benefit.
Recommendation: Combination is not recommended. If considered absolutely necessary, it must be under specialist supervision with close monitoring of renal function, electrolytes, and blood pressure.
ANSM RCP
ModerateNSAIDs (including COX-2 inhibitors)M01A
Mechanism: Attenuation of antihypertensive effect and risk of deterioration of renal function due to inhibition of vasodilatory renal prostaglandin synthesis.
Recommendation: Monitor blood pressure and renal function periodically, especially in the elderly, volume-depleted, or patients with compromised renal function.
FDA label
ModerateLithiumN05AN01
Mechanism: Reduced renal clearance of lithium, leading to increased serum concentrations and toxicity.
Recommendation: Concomitant use is not recommended. If necessary, monitor serum lithium levels closely.
FDA labelANSM RCP
ModerateAgents increasing serum potassium
Mechanism: Additive effect on serum potassium (e.g., potassium-sparing diuretics, potassium supplements, heparin).
Recommendation: Monitor serum potassium in at-risk patients.
FDA label

Adverse events

Common (≥1%)

dizziness/vertigo · headache · respiratory infection

Rare but serious

angioedema · hyperkalemia · renal failure · leukopenia · hepatitis · rhabdomyolysis

Pregnancy and lactation

FDA category: D

Contraindicated in the second and third trimesters of pregnancy due to risk of fetal toxicity (reduced renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalemia). Discontinue therapy as soon as pregnancy is detected. In lactation, a decision should be made whether to discontinue nursing or discontinue the drug.

Recent literature (PubMed)

Treatment of Hypertension: A Review.
Carey RM, et al. · JAMA · 2022 · Relevance 5/5
Revisión exhaustiva sobre el tratamiento de la hipertensión que posiciona a los ARA II, como el candesartán, como terapia de primera línea junto con los IECA, diuréticos tiazídicos y bloqueadores de los canales de calcio. Destaca la importancia de la reducción de la PA para disminuir el riesgo de eventos cardiovasculares.
Comparative efficacy and safety of six angiotensin II receptor blockers in hypertensive patients: a network meta-analysis.
Zhang Z, et al. · Int J Clin Pharm · 2024 · Relevance 5/5
Metaanálisis en red que compara seis ARA II. Concluye que el candesartán tiene la clasificación más alta en la reducción de la presión arterial sistólica ambulatoria de 24 horas (95.4%), mientras que el olmesartán y el telmisartán mostraron el mejor equilibrio general de eficacia y seguridad.
Efficacy of single-pill combination in uncontrolled essential hypertension: A systematic review and network meta-analysis.
Xie M, et al. · Clin Cardiol · 2023 · Relevance 4/5
Metaanálisis en red que evalúa la eficacia de combinaciones a dosis fija, incluyendo Candesartán/HCTZ. Los resultados sugieren que las combinaciones de ARA/BCC (bloqueador de canales de calcio) tienen ventajas sobre otras combinaciones en la reducción de la presión arterial.
A Systematic Literature Review and Network Meta-analysis of Azilsartan Medoxomil Compared to Other Anti-hypertensives Efficacy in Lowering Blood Pressure Amongst Mild to Moderate Hypertensive Patients.
Qian J, et al. · Adv Ther · 2024 · Relevance 4/5
Metaanálisis en red que compara azilsartán con otros antihipertensivos. El candesartán fue uno de los comparadores activos. Los resultados mostraron que azilsartán 80 mg tuvo la clasificación más alta en la reducción de la PA, aunque el candesartán también demostró una eficacia significativa.
Drugs for hypertension.
Unknown · Med Lett Drugs Ther · 2024 · Relevance 3/5
Revisión general de los fármacos para la hipertensión que proporciona un contexto sobre el lugar de los ARA II, como el candesartán, en la terapia actual. Confirma su papel como opción de primera línea.