Valsartan
Brand names: Diovan
Angiotensin II Receptor Blockers (ARBs)Key Takeaway
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⚠ FDA Black Box Warning
Drugs that act on the renin-angiotensin system, including valsartan, can cause fetal injury and death when administered to pregnant women. When pregnancy is detected, discontinue valsartan as soon as possible.
Emergency Information
Poison Control: 1-800-222-1222
How does Valsartan work?
Your body produces a hormone called angiotensin II that plays a key role in regulating blood pressure [1, 2]. This hormone causes blood vessels to constrict (tighten), stimulates the release of another hormone called aldosterone (which causes your kidneys to retain salt and water), and promotes changes in the heart and blood vessels that can be harmful over time.
Valsartan works by blocking the angiotensin II type 1 (AT1) receptor [1, 3]. By blocking this receptor, valsartan prevents angiotensin II from exerting its effects. As a result, blood vessels relax and widen, blood pressure decreases, and the heart does not have to work as hard to pump blood. Unlike ACE inhibitors, valsartan does not block the breakdown of bradykinin, which is why ARBs cause significantly fewer coughs than ACE inhibitors [2, 4].
In heart failure, valsartan reduces the harmful effects of the overactive renin-angiotensin-aldosterone system (RAAS), helping to prevent the progressive remodeling and enlargement of the heart [5]. The Val-HeFT trial demonstrated that adding valsartan to standard heart failure therapy reduced hospitalizations for heart failure by 27% [5].
After a heart attack, valsartan helps protect the heart from further damage by reducing the workload on the heart and preventing harmful structural changes. The VALIANT trial showed valsartan was as effective as captopril in reducing mortality after a heart attack [6].
What to expect when starting Valsartan
When starting valsartan, most patients notice a gradual reduction in blood pressure over the first 2-4 weeks of treatment [1, 2]. The full antihypertensive effect is typically achieved within 4 weeks at a given dose.
First few days: You may feel slightly lightheaded or dizzy, particularly when standing up quickly. This is more likely if you are dehydrated or taking a diuretic. Stay well hydrated and rise slowly from sitting or lying positions.
First 1-2 weeks: Your doctor may check your kidney function and potassium levels with a blood test, especially if you have kidney disease or diabetes [1, 3]. Most patients tolerate valsartan well with minimal side effects.
Ongoing: Valsartan is generally very well tolerated — in clinical trials, the rate of side effects was similar to placebo [1]. Take it at the same time each day, with or without food. If you miss a dose, take it as soon as you remember, but skip it if the next dose is near.
Important: Do not use potassium supplements or salt substitutes containing potassium without consulting your doctor, as valsartan can increase potassium levels [1, 4].
What are the common side effects of Valsartan?
Common
- Headache4-12%
- Dizziness2-8%
- Fatigue2-4%
- Abdominal pain2-3%
- Diarrhea2-5%
- Upper respiratory infection3-6%
- Back pain2-3%
- Nausea1-3%
- Cough1-3%
What are the serious side effects of Valsartan?
Serious
- Hyperkalemia (high potassium)1-3%
- Acute kidney injury<1%
- Hypotension (dangerously low blood pressure)<1%
- AngioedemaVery rare (<0.1%)
What drugs interact with Valsartan?
- MajorACE inhibitors (lisinopril, ramipril, enalapril) — Do not combine ARBs with ACE inhibitors — the ONTARGET trial showed increased risk of kidney injury, hyperkalemia, and hypotension without added cardiovascular benefit.
- MajorAliskiren (Tekturna) — Contraindicated in patients with diabetes. Dual RAAS blockade increases risk of hyperkalemia, hypotension, and renal failure.
- ModeratePotassium-sparing diuretics (spironolactone, eplerenone) — Increased risk of hyperkalemia. Monitor serum potassium regularly if combination is necessary.
- ModerateNSAIDs (ibuprofen, naproxen) — NSAIDs can reduce the antihypertensive effect of valsartan and increase risk of kidney injury, especially in elderly or dehydrated patients.
- ModerateLithium — Valsartan can increase lithium levels, potentially leading to toxicity. Monitor lithium levels closely.
- ModeratePotassium supplements — Increased risk of hyperkalemia. Avoid unless directed by physician with close monitoring.
- ModerateRifampin — Rifampin may reduce valsartan exposure by inducing drug transporters (OATP1B1/MRP2), potentially reducing efficacy.
Can I eat certain foods or drink alcohol with Valsartan?
Food interactions [1, 2]: Valsartan can be taken with or without food. While food reduces absorption by approximately 40%, this does not significantly affect blood pressure control at recommended doses [1]. For consistency, take valsartan the same way each day.
Potassium-rich foods [1, 4]: While moderate dietary potassium is fine, avoid excessive intake of potassium-rich foods (bananas, oranges, potatoes, salt substitutes) as valsartan can raise potassium levels. This is especially important if you have kidney disease or diabetes.
Alcohol [1]: Alcohol can enhance the blood pressure-lowering effect of valsartan, increasing the risk of dizziness and lightheadedness. Limit alcohol consumption and be cautious when drinking, especially during the first few weeks of treatment or after a dose increase.
Grapefruit: Unlike some cardiovascular medications, valsartan does not have a significant grapefruit interaction because it is not extensively metabolized by CYP3A4.
What is the typical dosage for Valsartan?
Hypertension [1, 2]: - Initial dose: 80 mg or 160 mg once daily - Dose range: 80-320 mg once daily - Maximum dose: 320 mg/day - Full antihypertensive effect typically seen within 2-4 weeks - Can be used as monotherapy or combined with other antihypertensives (especially hydrochlorothiazide or amlodipine)
Heart failure (NYHA class II-IV) [1, 5]: - Starting dose: 40 mg twice daily - Target dose: 160 mg twice daily - Double the dose at 2-week intervals as tolerated - Critical: Used in patients who are intolerant to ACE inhibitors, or as add-on therapy
Post-myocardial infarction [1, 6]: - Start as early as 12 hours after MI (if hemodynamically stable) - Starting dose: 20 mg twice daily - Target dose: 160 mg twice daily - Uptitrate over weeks as tolerated
Renal impairment: No dose adjustment needed for mild-to-moderate impairment. Use with caution in severe renal impairment (CrCl <10 mL/min) [1].
Hepatic impairment: Do not exceed 80 mg daily in patients with mild-to-moderate hepatic impairment. Avoid in severe hepatic impairment or cholestatic disorders [1].
How much does Valsartan cost?
Generic valsartan has been available since 2012 and is significantly less expensive than brand-name Diovan [7, 8].
Pricing comparison [7, 8]: - Generic valsartan: $10-30/month - Brand Diovan: $200-350/month - Savings: approximately 85-95% with generic - Available on $4 generic programs at many pharmacies (Walmart, Kroger, Costco)
Insurance coverage: Valsartan is on most insurance formularies as a Tier 1 or Tier 2 generic. Prior authorization is rarely required [8].
Patient assistance programs: - Novartis Patient Assistance Foundation (for brand Diovan, if needed) - GoodRx coupons can reduce generic prices to $8-15/month - Many pharmacies offer valsartan on their discount generic programs
Important note on valsartan recalls [9]: In 2018-2019, several generic valsartan products were recalled due to NDMA contamination. All affected products have been removed from the market, and current generic valsartan products meet FDA safety standards.
Is Valsartan safe during pregnancy or breastfeeding?
Pregnancy [1, 2]: Valsartan carries a boxed warning regarding use in pregnancy. Drugs that act on the renin-angiotensin system can cause fetal injury and death when used during the second and third trimesters [1]. Effects include oligohydramnios (reduced amniotic fluid), fetal renal failure, skull hypoplasia, and death.
If pregnancy is detected, discontinue valsartan immediately and switch to an alternative antihypertensive [1, 4]. First-trimester exposure has not been definitively associated with fetal harm, but the drug should be avoided throughout pregnancy when possible.
Alternatives: Methyldopa, labetalol, and nifedipine are considered safer antihypertensive options during pregnancy.
Breastfeeding [1, 10]: It is not known whether valsartan is excreted in human breast milk. Because of the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother. ARBs are generally not recommended during breastfeeding.
Is there a generic version of Valsartan?
Generic valsartan has been available since 2012 when Diovan lost patent exclusivity [7, 8].
Available generic formulations: - Valsartan tablets: 40, 80, 160, 320 mg — generic equivalent to Diovan - Valsartan/hydrochlorothiazide combination tablets — generic equivalent to Diovan HCT - All generics are rated AB (therapeutically equivalent) by the FDA [7]
Key differences: There are no clinically meaningful differences between generic valsartan and brand Diovan. Both contain the same active ingredient, same dosage, and must meet the same FDA bioequivalence standards.
Brand may be preferred: Very rarely. Some patients report subjective differences when switching, but studies consistently show equivalent efficacy and safety.
For Caregivers
Blood pressure monitoring [1, 2]: Help the patient monitor blood pressure at home regularly. Keep a log of readings (morning and evening) to share with the healthcare provider. Normal target is generally below 130/80 mmHg for most adults.
Medication adherence [1]: Valsartan is taken once daily for hypertension, making adherence relatively straightforward. Encourage taking it at the same time each day. Use pill organizers or phone reminders if needed. Do not stop the medication without consulting the doctor, even if the patient feels well.
Signs to watch for [1, 4]: Monitor for symptoms of low blood pressure (dizziness, lightheadedness, fainting), signs of high potassium (muscle weakness, slow heartbeat, tingling), and any swelling of the face, lips, or throat (angioedema — seek emergency care immediately).
Hydration: Ensure adequate fluid intake, especially during hot weather, exercise, or illness with vomiting/diarrhea, as dehydration increases the risk of low blood pressure.
Frequently asked questions about Valsartan
References
- [Regulatory] Diovan (valsartan) FDA Prescribing Information. Novartis Pharmaceuticals Corporation. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021283s044lbl.pdf Accessed 2026-02-15.
- [Regulatory] DailyMed - Valsartan tablet label and package insert. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6ed64b46-5e17-4832-a1a0-6edc52e046f7 Accessed 2026-02-15.
- [Clinical] Flesch G, et al. Absolute bioavailability and pharmacokinetics of valsartan, an angiotensin II receptor antagonist, in man. Eur J Clin Pharmacol. 1997;52(2):115-120. https://pubmed.ncbi.nlm.nih.gov/9174882/ Accessed 2026-02-15.
- [Observational] Whelton PK, et al. 2017 ACC/AHA Guideline for Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults. J Am Coll Cardiol. 2018;71(19):e127-e248. https://pubmed.ncbi.nlm.nih.gov/29146535/ Accessed 2026-02-15.
- [Clinical] Cohn JN, Tognoni G; Valsartan Heart Failure Trial Investigators. A randomized trial of the angiotensin-receptor blocker valsartan in chronic heart failure (Val-HeFT). N Engl J Med. 2001;345(23):1667-1675. https://pubmed.ncbi.nlm.nih.gov/11759645/ Accessed 2026-02-15.
- [Clinical] Pfeffer MA, et al. Valsartan, captopril, or both in myocardial infarction complicated by heart failure, left ventricular dysfunction, or both (VALIANT). N Engl J Med. 2003;349(20):1893-1906. https://pubmed.ncbi.nlm.nih.gov/14610160/ Accessed 2026-02-15.
- [Regulatory] FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations — Valsartan. https://www.fda.gov/drugs/drug-approvals-and-databases/approved-drug-products-therapeutic-equivalence-evaluations-orange-book Accessed 2026-02-15.
- [Regulatory] MedlinePlus: Valsartan. https://medlineplus.gov/druginfo/meds/a697015.html Accessed 2026-02-15.
- [Regulatory] FDA Updates on Valsartan Recalls Including Valsartan, Losartan, and Irbesartan. https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-angiotensin-ii-receptor-blocker-arb-recalls-valsartan-losartan Accessed 2026-02-15.
- [Regulatory] Drugs and Lactation Database (LactMed) — Valsartan. National Library of Medicine. https://www.ncbi.nlm.nih.gov/books/NBK501178/ Accessed 2026-02-15.
Written and fact-checked by PrescriptionDrugs.org Editorial Team
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