pharmacopeia
GET
/api/v1/drug/valsartan

Boxed warning

FETAL TOXICITY When pregnancy is detected, discontinue valsartan tablets as soon as possible. ( 5.1 ) Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. ( 5.1 ) WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning. When pregnancy is detected, discontinue valsartan tablets as soon as possible. ( 5.1 ) Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. ( 5.1 )

2D structure
(2S)-3-methyl-2-[pentanoyl-[[4-[2-(2H-tetrazol-5-yl)phenyl]phenyl]methyl]amino]butanoic acid
SMILES CCCCC(=O)N(CC1=CC=C(C=C1)C2=CC=CC=C2C3=NNN=N3)[C@@H](C(C)C)C(=O)O
InChIKey ACWBQPMHZXGDFX-QFIPXVFZSA-N

Mechanism of action

Sourced from openFDA

Angiotensin II is formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzyme (ACE, kininase II). Angiotensin II is the principal pressor agent of the renin-angiotensin system, with effects that include vasoconstriction, stimulation of synthesis and release of aldosterone, cardiac stimulation, and renal reabsorption of sodium.

Angiotensin 2 Receptor

Indications

Sourced from openFDA
  • Valsartan tablets are an angiotensin II receptor blocker (ARB) indicated for: Hypertension ,to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions ( 1.1 ) Heart failure (NYHA class II-IV); valsartan tablets significantly reduced hospitalization for heart failure ( 1.2 ) Post-myocardial infarction ; for the reduction of cardiovascular mortality in clinically stable patients with left ventricular failure or left ventricular dysfunction following myocardial infarction ( 1.3 ) 1.1 Hypertension Valsartan tablets are indicated for the treatment of hypertension, to lower blood pressure in adults and pediatric patients six years of age and older.ICD-10: I10, I21.9, I50.9

Contraindications

Sourced from openFDA
  • Do not use in patients with known hypersensitivity to any component. Do not coadminister aliskiren with valsartan tablets in patients with diabetes [See Drug Interactions (7.3) ].contraindicated

Dosage & administration

Sourced from openFDA

Indication Starting Dose Dose Range * Adult Hypertension ( 2.2 ) 80 or 160 mg once daily 80-320 mg once daily 6-16 years ( 2.3 ) 1mg/kg once daily (up to 40 mg total) 1-4mg/kg once daily (up to 160 mg total) Heart Failure ( 2.4 ) 40 mg twice daily 40-160 mg twice daily Post-Myocardial Infarction ( 2.5 ) 20 mg twice daily 20-160 mg twice daily * As tolerated by patient 2.1 Important Dosage and Preparation Information Valsartan tablets and oral suspension are not substitutable on a milligram-per-milligram basis. Do not combine two dosage forms to achieve the total dose. The systemic exposure to valsartan (AUC) is 60% higher with the suspension compared to tablets [ S ee Clinical Pharmacology (12.3) ] . Use of the oral suspension is recommended: in patients ≥ 6 years of age who cannot swallow tablets and in pediatric patients for whom the calculated dose (mg/kg) does not correspond to the available tablet strengths of valsartan tablets When switching between suspension and tablets, the dose of valsartan may need to be adjusted. Preparation of Suspension (for 160 mL of a 4 mg/mL suspension) Add 80 mL of Ora-Plus ® * oral suspending vehicle to an amber glass bottle containing 8 valsartan 80 mg tablets and shake for a minimum of 2 minutes. Allow the suspension to stand for a minimum of 1 hour. After the standing time, shake the suspension for a minimum of 1 additional minute. Add 80 mL of Ora-Sweet SF ® * oral sweetening vehicle to the bottle and shake the suspension for at least 10 seconds to disperse the ingredients.

Warnings & precautions

Sourced from openFDA

Observe for signs and symptoms of hypotension ( 5.2 ) Monitor renal function and potassium in susceptible patients ( 5.3 , 5.4 ) 5.1 Fetal Toxicity Valsartan tablets can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue valsartan tablets as soon as possible [See Use in Specific Populations (8.1) ] . 5.2 Hypotension Excessive hypotension was rarely seen (0.1%) in patients with uncomplicated hypertension treated with valsartan tablets alone. In patients with an activated renin-angiotensin system, such as volume- and/or salt-depleted patients receiving high doses of diuretics, symptomatic hypotension may occur. This condition should be corrected prior to administration of valsartan tablets, or the treatment should start under close medical supervision. Patients with heart failure or post-myocardial infarction patients given valsartan tablets commonly have some reduction in blood pressure, but discontinuation of therapy because of continuing symptomatic hypotension usually is not necessary when dosing instructions are followed.

Adverse reactions

Sourced from openFDA

Hypertension: Most common adverse reactions are headache, dizziness, viral infection, fatigue and abdominal pain ( 6.1 ) Heart Failure :Most common adverse reactions are dizziness, hypotension, diarrhea, arthralgia, back pain, fatigue and hyperkalemia ( 6.1 ) Post-Myocardial Infarction : Most common adverse reactions which caused patients to discontinue therapy are hypotension, cough and increased blood creatinine ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact RK Pharma Inc at 1-844-757-4276 (1-844-RKPHARMA) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. Adult Hypertension Valsartan tablets have been evaluated for safety in more than 4,000 patients, including over 400 treated for over 6 months, and more than 160 for over 1 year. Adverse reactions have generally been mild and transient in nature and have only infrequently required discontinuation of therapy. The overall incidence of adverse reactions with valsartan tablets was similar to placebo. The overall frequency of adverse reactions was neither dose-related nor related to gender, age, race, or regimen. Discontinuation of therapy due to side effects was required in 2.3% of valsartan patients and 2.0% of placebo patients.

Use in specific populations

Sourced from openFDA

Lactation :Breastfeeding is not recommended ( 8.2 ) Pediatrics : Use of valsartan tablets is not recommended in children less than 1 year of age ( 6.1 , 8.4 , 13.2 ) See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. Additional pediatric use information is approved for Novartis Pharmaceuticals Corporation's Diovan (valsartan) tablets. However, due to Novartis Pharmaceuticals Corporation's marketing exclusivity rights, this drug product is not labeled with that information . Revised: 10/2022 8.1 Pregnancy Risk Summary Valsartan can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Most epidemiologic studies examining fetal abnormalities after exposure to antihypertensive use in the first trimester have not distinguished drugs affecting the renin-angiotensin system from other antihypertensive agents. Published reports include cases of anhydramnios and oligohydramnios in pregnant women treated with valsartan (See Clinical Considerations ). When pregnancy is detected, consider alternative drug treatment and discontinue valsartan tablets as soon as possible.

Pharmacokinetics

Sourced from openFDA
Metabolism
Absorption In healthy volunteers, valsartan peak plasma concentration is reached 2 to 4 hours after dosing. Valsartan shows bi-exponential decay kinetics following intravenous administration, with an average elimination half-life of about 6 hours.

Overdosage

Sourced from openFDA

Limited data are available related to overdosage in humans. The most likely manifestations of overdosage would be hypotension and tachycardia; bradycardia could occur from parasympathetic (vagal) stimulation. Depressed level of consciousness, circulatory collapse and shock have been reported. If symptomatic hypotension should occur, institute supportive treatment. Valsartan is not removed from the plasma by hemodialysis. Valsartan was without grossly observable adverse effects at single oral doses up to 2000 mg/kg in rats and up to 1000 mg/kg in marmosets, except for salivation and diarrhea in the rat and vomiting in the marmoset at the highest dose (60 and 31 times, respectively, the maximum recommended human dose on a mg/m 2 basis). (Calculations assume an oral dose of 320 mg/day and a 60-kg patient.)

Approval history

Sourced from openFDA
  • Mar 6, 1998NDANDA020818Novartis
  • Jul 18, 2001NDANDA021283Novartis
  • Jun 20, 2007NDANDA021990Novartis
  • Apr 30, 2009NDANDA022314Novartis
  • Sep 21, 2012ANDAANDA078020Mylan Pharms Inc
  • Mar 21, 2013ANDAANDA202519Aurobindo Pharma Ltd
  • Jul 7, 2015NDANDA207620Novartis Pharms Corp
  • Apr 12, 2024NDANDA218591Novartis

FDA shortages

View JSON

Reference statistics from the openFDA drug-shortage dataset. For a live view, consult the FDA database directly. Not clinical guidance.

  • Valsartan, Tablet, 160 mg (NDC 0378-5814-77)To be discontinued
    Sponsor: Mylan Pharmaceuticals Inc., a Viatris Company
    Updated
  • Valsartan, Tablet, 320 mg (NDC 0378-5815-77)To be discontinued
    Sponsor: Mylan Pharmaceuticals Inc., a Viatris Company
    Updated
  • Valsartan, Tablet, 40 mg (NDC 0378-5807-93)To be discontinued
    Sponsor: Mylan Pharmaceuticals Inc., a Viatris Company
    Updated
  • Valsartan, Tablet, 80 mg (NDC 0378-5813-77)To be discontinued
    Sponsor: Mylan Pharmaceuticals Inc., a Viatris Company
    Updated

FAERS reports

View JSON
Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
242,786 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Fatigue15,2226.3%
  2. 2Dizziness15,1626.2%
  3. 3Dyspnoea15,0496.2%
  4. 4Hypotension14,8166.1%
  5. 5Death13,0035.4%
  6. 6Cough11,2844.6%
  7. 7Drug Ineffective10,0604.1%
  8. 8Malaise9,0443.7%
  9. 9Weight Decreased8,5803.5%
  10. 10Wrong Technique In Product Usage Process8,4163.5%
  11. 11Hypertension8,0933.3%
  12. 12Nausea8,0873.3%
  13. 13Asthenia8,0623.3%
  14. 14Diarrhoea7,8773.2%
  15. 15Headache7,3703.0%

Literature

View JSON

Recent PubMed references pinned to Valsartan as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

View JSON

The 10 most recently updated of 562 ClinicalTrials.gov registrations naming Valsartan as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Valsartan work?
Angiotensin II is formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzyme (ACE, kininase II). Angiotensin II is the principal pressor agent of the renin-angiotensin system, with effects that include vasoconstriction, stimulation of synthesis and release of aldosterone, cardiac stimulation, and renal reabsorption of sodium.
What is Valsartan used for?
According to FDA labeling, Valsartan carries indications including: Valsartan tablets are an angiotensin II receptor blocker (ARB) indicated for: Hypertension ,to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions ( 1.1 ) Heart failure (NYHA class II-IV); valsartan tablets significantly reduced hospitalization for heart failure ( 1.2 ) Post-myocardial infarction ; for the reduction of cardiovascular mortality in clinically stable patients with left ventricular failure or left ventricular dysfunction following myocardial infarction ( 1.3 ) 1.1 Hypertension Valsartan tablets are indicated for the treatment of hypertension, to lower blood pressure in adults and pediatric patients six years of age and older.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Valsartan?
Valsartan is classified as Angiotensin II receptor blockers (ARBs), plain, Angiotensin 2 Receptor Blocker, Angiotensin 2 Receptor Antagonists, Decreased Blood Pressure, Decreased Intravascular Volume, Decreased Mineralocorticoid Secretion, Decreased Renal K+ Excretion, Increased Renal Na+ Excretion, Renal Arterial Vasoconstriction, Renal Arterial Vasodilation.
What are the brand names for Valsartan?
Valsartan is marketed under brand names including Byvalson, Diovan, Diovan HCT, Entresto, Exforge, Exforge HCT.
What are the contraindications for Valsartan?
Valsartan labeling lists contraindications including: Do not use in patients with known hypersensitivity to any component. Do not coadminister aliskiren with valsartan tablets in patients with diabetes [See Drug Interactions (7.3) ].. Always consult the full prescribing information and a clinician.
Note. Data for valsartan is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

Search pharmacopeia

Search drugs, classes, and ingredients