Valsartan

ATC code

C09CA03

Therapeutic class

Angiotensin II receptor blocker (ARB) · Angiotensin II receptor blocker

Forms

film-coated tablet

Brand names

Diovan (ES) · Diovan (US) · Tareg (FR)

Overall confidence

high

Regulatory sources consulted

AEMPS SPC: https://cima.aemps.es/cima/dochtml/ft/64473/FT_64473.html
ANSM RCP: https://base-donnees-publique.medicaments.gouv.fr/affichageDoc.php?specid=69969418&typedoc=R
AEMPS CIMA · nº registro 64473 ↗
ANSM BDPM · CIS 69969418 ↗
RxNorm rxcui 69749 ↗

Approved indications

Treatment of essential hypertension in adults, and hypertension in children and adolescents aged 6 to 18 years.
Treatment of clinically stable adult patients with symptomatic heart failure or asymptomatic left ventricular systolic dysfunction after a recent myocardial infarction (12 hours – 10 days).
Treatment of adult patients with symptomatic heart failure (NYHA class II-IV) when angiotensin converting enzyme (ACE) inhibitors are not tolerated, or as add-on therapy to ACE inhibitors when beta-blockers are not tolerated.

Contraindications

Absolute

Hypersensitivity to the active substance or to any of the excipients.
Second and third trimesters of pregnancy.
Severe hepatic impairment, biliary cirrhosis and cholestasis.
Concomitant use of angiotensin receptor blockers (ARBs)—including valsartan—or angiotensin-converting enzyme inhibitors (ACEIs) 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 valsartan 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 · Hyperkalemia: Concomitant use with potassium supplements, potassium-sparing diuretics, or other agents that may increase potassium levels is not recommended. Serum potassium should be monitored. — EMA SPC
Major warning · Dual RAAS Blockade: Combined use with ACE inhibitors or aliskiren increases the risk of hypotension, hyperkalemia, and renal failure. Generally not recommended. — EMA SPC

Drug interactions

HighLithiumN05AN01
Mechanism: Decreased renal clearance of lithium, increasing the risk of lithium toxicity.
Recommendation: Combination not recommended. If necessary, strict monitoring of serum lithium levels is required.
ANSM RCP
ModeratePotassium-sparing diuretics or potassium supplementsC03D
Mechanism: Additive effect that can lead to hyperkalemia, especially in patients with renal impairment.
Recommendation: Concomitant use is not recommended. If deemed necessary, monitor serum potassium frequently.
ANSM RCP
ModerateNSAIDs (Nonsteroidal anti-inflammatory drugs)M01A
Mechanism: May attenuate the antihypertensive effect and increase the risk of worsening renal function.
Recommendation: Monitor blood pressure and renal function, especially at the start of treatment. Ensure adequate patient hydration.
ANSM RCP
ModerateUptake transporter inhibitors (e.g., Rifampin, Cyclosporine)L04AD01
Mechanism: Concomitant administration of uptake transporter inhibitors (OATP1B1/OATP1B3) may increase systemic exposure to valsartan.
Recommendation: Use caution when initiating or ending concomitant treatment with such drugs.
ANSM RCP

Adverse events

Common (≥1%)

dizziness · hypotension · renal impairment

Rare but serious

angioedema · hyperkalemia · rhabdomyolysis

Pregnancy and lactation

FDA category: D

Contraindicated in the second and third trimesters of pregnancy. Not recommended during the first trimester. Can cause fetal (renal toxicity, oligohydramnios, skull ossification retardation) and neonatal harm. Lactation is not recommended.