Losartan

ATC code

C09CA01

Therapeutic class

Angiotensin II Receptor Blocker (ARB) · Angiotensin II receptor antagonists, plain

Forms

film-coated tablet

Brand names

Cozaar (ES) · Cozaar (US) · Losartan BGR (FR)

Overall confidence

high

Regulatory sources consulted

AEMPS CIMA SPC: https://cima.aemps.es/cima/dochtml/ft/64971/FT_64971.html
ANSM BDPM RCP: https://base-donnees-publique.medicaments.gouv.fr/affichageDoc.php?specid=69905668&typedoc=R
AEMPS CIMA · nº registro 64971 ↗
ANSM BDPM · CIS 69905668 ↗
RxNorm rxcui 52175 ↗

Approved indications

Treatment of essential hypertension in adults and in children and adolescents aged 6 to 18 years.
Treatment of renal disease in adult patients with hypertension and type 2 diabetes mellitus with proteinuria ≥ 0.5 g/day as part of an antihypertensive treatment.
Treatment of chronic heart failure in adult patients when treatment with angiotensin-converting enzyme (ACE) inhibitors is not considered suitable due to incompatibility (especially cough) or contraindication.
Reduction in the risk of stroke in adult hypertensive patients with left ventricular hypertrophy documented by electrocardiogram.

Contraindications

Absolute

Hypersensitivity to the active substance or to any of the excipients.
Second and third trimesters of pregnancy.
Severe hepatic impairment.
Concomitant use with aliskiren in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m2).

Clinical warnings

Boxed warning · Fetal Toxicity: When pregnancy is detected, discontinue losartan as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. — EMA SPC
Major warning · Angioedema: Patients with a history of angioedema should be closely monitored. — ANSM RCP
Hypotension in Volume- or Salt-Depleted Patients: Symptomatic hypotension may occur, particularly after the first dose. — ANSM RCP
Hyperkalemia: Concomitant use of potassium-sparing diuretics, potassium supplements, or salt substitutes containing potassium may lead to increases in serum potassium. — ANSM RCP

Drug interactions

ModerateNSAIDs (e.g., Ibuprofen)M01AE01
Mechanism: Concomitant administration may attenuate the antihypertensive effect and increase the risk of worsening renal function.
Recommendation: Monitor blood pressure and renal function, especially in the elderly or volume-depleted patients. Ensure adequate hydration.
ANSM RCP
HighLithiumN05AN01
Mechanism: Decreased renal clearance of lithium, leading to an increased risk of lithium toxicity.
Recommendation: The combination is not recommended. If necessary, careful monitoring of serum lithium levels is required.
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).
ANSM RCP
ModerateSpironolactoneC03DA01
Mechanism: Additive effect on increasing serum potassium due to RAAS blockade and potassium retention.
Recommendation: Combination is generally not recommended. If necessary, monitor serum potassium closely.
ANSM RCP

Adverse events

Common (≥1%)

dizziness · hypotension · asthenia · hyperkalemia · anemia

Rare but serious

angioedema · rhabdomyolysis · hepatitis · acute renal failure

Pregnancy and lactation

FDA category: D

Contraindicated in the second and third trimesters of pregnancy. Not recommended during the first trimester. Can cause fetal harm and death when administered to a pregnant woman.