No black box warning on record for Valsartan

As of the latest FDA labeling reviewed, Valsartan (valsartan) does not carry a black box warning. Standard warnings and precautions still apply — see the full Valsartan medicine page for the complete safety profile.

Other warnings & precautions

Pregnancy Category D (Second/Third Trimester) — CONTRAINDICATED: ARBs can cause fetal and neonatal harm — renal dysfunction, oligohydramnios, skull hypoplasia, limb contractures, and fetal death. Discontinue immediately when pregnancy is detected. (First trimester: Category C in some guidelines, but avoid throughout.)
Hypotension: First-dose hypotension can be significant, especially in volume-depleted patients (high-dose diuretics, low-salt diet, dialysis). Start at lower doses and ensure patient is not volume-depleted before initiating.
Renal Function: ARBs can precipitate acute renal failure in patients with bilateral renal artery stenosis or a single functioning kidney. Monitor renal function and electrolytes within 2 weeks of initiation and after dose increases.
NDMA Contamination (2018 Recalls): Multiple valsartan products were recalled in 2018–2019 due to contamination with N-nitrosodimethylamine (NDMA), a probable human carcinogen, from manufacturing processes using specific solvents. Products from unaffected manufacturers remain safe. Patients should verify their specific product has not been recalled.

No black box warning on record for Valsartan

Other warnings & precautions

Pregnancy Category D (Second/Third Trimester) — CONTRAINDICATED: ARBs can cause fetal and neonatal harm — renal dysfunction, oligohydramnios, skull hypoplasia, limb contractures, and fetal death. Discontinue immediately when pregnancy is detected. (First trimester: Category C in some guidelines, but avoid throughout.)
Hypotension: First-dose hypotension can be significant, especially in volume-depleted patients (high-dose diuretics, low-salt diet, dialysis). Start at lower doses and ensure patient is not volume-depleted before initiating.
Renal Function: ARBs can precipitate acute renal failure in patients with bilateral renal artery stenosis or a single functioning kidney. Monitor renal function and electrolytes within 2 weeks of initiation and after dose increases.
NDMA Contamination (2018 Recalls): Multiple valsartan products were recalled in 2018–2019 due to contamination with N-nitrosodimethylamine (NDMA), a probable human carcinogen, from manufacturing processes using specific solvents. Products from unaffected manufacturers remain safe. Patients should verify their specific product has not been recalled.

Valsartan Black Box Warning

No black box warning on record for Valsartan

Other warnings & precautions

Valsartan Black Box Warning

No black box warning on record for Valsartan

Other warnings & precautions