Prescription medication · Angiotensin II Receptor Blocker (ARB)
valsartan
Also sold as Diovan. Entresto is used to treat heart failure in adults and children aged one year and older.
Data updated 2026-05-15
- 102,306
- FDA reportsOften reported
- 8
- InteractionsFew interactions
- 98% less
- Generic vs brandHuge savings
- In shortage
- FDA status
What the data shows
valsartan (Diovan) is a prescription Angiotensin II Receptor Blocker (ARB), more reported than most tracked drugs (102,306 FDA reports), whose generic costs a fraction of the brand (about 98% less).
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
valsartan (Diovan) is a prescription Angiotensin II Receptor Blocker (ARB). Entresto is used to treat heart failure in adults and children aged one year and older.
Entresto is a medicine that combines two drugs to help adults and children with heart failure. It can lower the risk of death and hospitalization.
Verify with FDA → · CMS NADAC pricing →
Drug Shortage Alert
valsartan is currently listed as to be discontinued by the FDA. Affected manufacturer: Mylan Pharmaceuticals Inc., a Viatris Company.
View all drug shortages →Drug Pricing (NADAC)
Brand Price
$9.53/unit
Generic Price
$0.15/unit
Generic Savings
98%
Generic Available
Yes (26 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
Entresto is used to treat heart failure in adults and children aged one year and older.
Common side effects
Low blood pressure, High potassium levels in your blood, Cough
Key warnings
Entresto can harm your unborn baby, even causing death.
The sections below are summarized in plain English from valsartan's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
Entresto works by blocking two substances in your body that can worsen heart failure. One substance is neprilysin, and the other is angiotensin II. By blocking these, Entresto helps your heart pump blood more easily and reduces strain.
How to Take It
Take Entresto exactly as your doctor tells you. Adults usually start with 49 mg/51 mg twice a day. Your doctor may increase the dose every 2 to 4 weeks up to a target dose of 97 mg/103 mg twice a day. For children, the dose depends on their weight and comes as a tablet or capsule.
This is a plain-language summary of valsartan's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.
Pregnancy & Breastfeeding
Entresto can cause serious harm or death to an unborn baby. Do not take this medicine if you are pregnant. Breastfeeding is not recommended while taking Entresto.
This is a plain-language summary of valsartan's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.
Missed Dose
If you miss a dose, take it as soon as you remember. If it is close to your next dose, skip the missed dose and continue with your regular schedule.
This is a plain-language summary of valsartan's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.
Storage
Store Entresto at room temperature (68°F to 77°F) and protect it from moisture.
Side Effects (from patient reports)
Based on 102,306 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for valsartan, by number of reports
- Feeling tired
Feeling tired
5,476 reports
- Feeling lightheaded
Feeling lightheaded
5,251 reports
- Difficulty breathing
Difficulty breathing
5,251 reports
- Feeling sick to your stomach
Feeling sick to your stomach
5,164 reports
- Loose stools
Loose stools
4,581 reports
- Pain in your head
Pain in your head
4,506 reports
- High blood pressure
High blood pressure
4,276 reports
- Blood pressure went up
Blood pressure went up
4,206 reports
- Discomfort
Discomfort
3,809 reports
- Accidentally falling down
Accidentally falling down
3,604 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for valsartan each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where valsartan sits
valsartan has more FDA adverse-event reports than 85% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is valsartan; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 102,306 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2001–2025.
Total Reports
102,306
Reports Mentioning Death
9,430
9.2% of reports — not proof of cause
Hospitalization Reports
38,453
Top Indication
Hypertension
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 2 | FATIGUE | 5,474 |
| 3 | DYSPNOEA | 5,250 |
| 4 | DIZZINESS | 5,249 |
| 5 | NAUSEA | 5,162 |
| 6 | DIARRHOEA | 4,578 |
| 7 | HEADACHE | 4,504 |
| 8 | HYPERTENSION | 4,273 |
| 9 | BLOOD PRESSURE INCREASED | 4,207 |
| 10 | PAIN | 3,810 |
| 11 | FALL | 3,601 |
| 12 | ASTHENIA | 3,587 |
| 13 | MALAISE | 3,586 |
| 14 | ACUTE KIDNEY INJURY | 3,145 |
| 15 | ARTHRALGIA | 2,971 |
| 16 | COUGH | 2,897 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
Entresto can harm your unborn baby, even causing death. If you are pregnant or become pregnant, stop taking Entresto right away and tell your doctor.
Known Drug Interactions
( 7.4 ) 7.1 Dual Blockade of the Renin-Angiotensin-Aldosterone System Concomitant use of ENTRESTO with an ACE inhibitor is contraindicated because of the increased risk of angioedema [see Contraindications (4)] . Avoid use of ENTRESTO with an ARB, because ENTRESTO contains the angiotensin II receptor blocker valsartan. The concomitant use of ENTRESTO with aliskiren is contraindicated in patients with diabetes [see Contraindications (4)] .
Mechanism: Entresto already contains the drug valsartan as one of its ingredients. Taking both together would result in a double dose of the same medicine, which increases the risk of side effects.
What to do: Avoid taking these two medications at the same time. Your doctor will likely stop your separate valsartan pill before you start taking Entresto.
7 DRUG INTERACTIONS Avoid concomitant use with aliskiren in patients with estimated glomerular filtration rate (eGFR) less than 60. The concomitant use of ENTRESTO with aliskiren is contraindicated in patients with diabetes [see Contraindications (4)] . Avoid use with aliskiren in patients with renal impairment (eGFR less than 60 mL/min/1.73 m 2 ).
Mechanism: Both drugs work on the same system in the body to control blood pressure, which can put too much stress on the kidneys. This is especially risky for people who have diabetes or existing kidney problems.
What to do: Do not use these drugs together if you have diabetes or kidney disease. Your doctor will monitor your kidney health and blood pressure very closely if these are used together.
( 7.3 ) Lithium: Increased risk of lithium toxicity. 7.4 Lithium Increases in serum lithium concentrations and lithium toxicity have been reported during concomitant administration of lithium with angiotensin II receptor antagonists. Monitor serum lithium levels during concomitant use with ENTRESTO.
Mechanism: Valsartan can make it harder for the body to get rid of lithium, which may lead to dangerously high lithium levels in the blood.
What to do: Your doctor should monitor your lithium levels closely to avoid lithium toxicity.
7.2 Potassium-Sparing Diuretics As with other drugs that block angiotensin II or its effects, concomitant use of potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride), potassium supplements, or salt substitutes containing potassium may lead to increases in serum potassium [see Warnings and Precautions (5.5)] .
Mechanism: Both of these drugs can cause the body to hold onto potassium, which may lead to high potassium levels in the blood.
What to do: Your doctor should monitor your blood potassium levels regularly while you are taking this combination.
7.2 Potassium-Sparing Diuretics As with other drugs that block angiotensin II or its effects, concomitant use of potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride), potassium supplements, or salt substitutes containing potassium may lead to increases in serum potassium [see Warnings and Precautions (5.5)] .
Mechanism: These medications both prevent the kidneys from removing potassium, which can cause potassium to build up to unsafe levels.
What to do: Have your blood potassium levels checked frequently by your healthcare provider.
This is a plain-language summary of interactions documented in FDA labeling, not individualized advice. Ask a pharmacist or prescriber before combining medications.
Common Questions
Can I take Entresto with my other heart medications?
What should I do if I feel dizzy after taking Entresto?
Can Entresto affect my kidneys?
Is it okay to use salt substitutes while taking Entresto?
How long will I need to take Entresto?
Can Entresto cause swelling?
What if I have kidney problems?
Can I drink alcohol while taking Entresto?
What are the symptoms of high potassium?
Does Entresto interact with NSAIDs like ibuprofen?
What are the common side effects of valsartan?
Does valsartan interact with other medications?
What drug class is valsartan?
Is there a generic version of valsartan?
Is valsartan safe during pregnancy?
Has valsartan been recalled?
Is valsartan currently in shortage?
Active Recalls
CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA) found in finished products
Rising Pharmaceuticals, Inc.
CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA) found in finished products
Rising Pharmaceuticals, Inc.
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
Aurobindo Pharma USA Inc.
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Aurobindo Pharma USA Inc.
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Mylan Laboratories Limited, (Nashik FDF)
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Mylan Laboratories Limited, (Nashik FDF)
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Mylan Laboratories Limited, (Nashik FDF)
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
Mylan Pharmaceuticals Inc.
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Torrent Pharma Inc.
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
A-S Medication Solutions LLC.
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Teva Pharmaceuticals USA
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Teva Pharmaceuticals USA
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Teva Pharmaceuticals USA
Related Medications in Angiotensin II Receptor Blocker (ARB)
Other drugs grouped near valsartan - same-class peers and common alternatives.
acebutolol
Sectral
Acebutolol is a medicine that helps lower blood pressure and control irregular heartbeats.
Compare with valsartan →
aliskiren
Tekturna
Tekturna is a medicine used to treat high blood pressure.
Compare with valsartan →
amiloride
Midamor
Amiloride is a water pill that helps your body hold onto potassium.
Compare with valsartan →
amlodipine
Norvasc
Amlodipine (Norvasc) is a drug that lowers blood pressure and treats chest pain.
Compare with valsartan →
amlodipine/benazepril
Lotrel
Lotrel is a combination medicine that contains amlodipine and benazepril.
Compare with valsartan →
Medication Guides
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Narrow Therapeutic Index Drugs
Why some drugs demand precise dosing and monitoring
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
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What the FDA Data Shows for valsartan
The FDA label for valsartan (sold under brand names such as Diovan) classifies it as a prescription-only medication in the Angiotensin II Receptor Blocker (ARB) class. Entresto is used to treat heart failure in adults and children aged one year and older. Official labeling lists 5 commonly reported side effects, including Low blood pressure, High potassium levels in your blood, Cough.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 102,306 voluntary reports. The database also lists 8 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated major severity. NADAC pricing from CMS shows a generic unit cost of $0.15 versus $9.53 for the brand - a 98% generic savings.
Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history (currently 13 recall records on file), and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice, always consult a licensed healthcare provider before starting, stopping, or changing any medication.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC). Shortage status: FDA Drug Shortages Database.
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.
Last updated: October 29, 2025
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages