Skip to the answer

Tolvaptan

Tolvaptan is a vasopressin V2-receptor blocker used to raise low blood sodium (hyponatremia) in hospital-started treatment, and, in specific products, to slow kidney function decline in autosomal dominant polycystic kidney disease (ADPKD).

Brand names JynarqueSamsca
Drug class Vasopressin V2 Receptor Antagonist
Rx Form 1
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 Where this information comes from

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 10 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

✓No current FDA shortage listed · checked Oct 9, 2026
Tolvaptan at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Tolvaptan (Samsca, Jynarque) is a specialist drug, available generically and on the market since about 2009, that blocks vasopressin (a hormone telling the kidneys to hold water) so the kidneys shed extra water. It raises low blood sodium (hyponatremia) or, in separate products, slows kidney decline in ADPKD, an inherited kidney disease. Most people notice intense thirst and a lot of urine, the effects some find hardest to live with. The boxed warning requires the low-sodium use to start in a hospital, since raising sodium too fast can cause a serious nerve injury (osmotic demyelination). It can also injure the liver, so report unusual tiredness, nausea or yellow eyes right away.

Clinical pearls

  • Take Jynarque-type tablets on waking and again about 8 hours later, so the heaviest urine flow passes before bedtime.
  • Avoid grapefruit juice, and tell every prescriber you take it, because ketoconazole and other strong CYP3A enzyme blockers sharply raise levels.
  • Keep water within reach and drink whenever thirsty unless told otherwise; dizziness or very low urine output can signal dehydration.
  • Samsca and Jynarque are not interchangeable; Jynarque requires regular liver blood tests through a restricted safety program (REMS).
How we write & review this content — our editorial policy →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾

Tolvaptan tablets for low blood sodium must be started or restarted in a hospital where sodium can be checked closely. Raising sodium too fast (more than 12 mEq/L in 24 hours) can cause osmotic demyelination, a serious nerve injury. Symptoms include trouble speaking or swallowing, drowsiness, mood changes, stiff or weak limbs, seizures, coma and death.

People with severe malnutrition, alcoholism or advanced liver disease are more susceptible, and slower correction may be needed.

Tolvaptan should also not be used for ADPKD outside the FDA-approved REMS program because of the risk of liver injury.

Read the full warning on DailyMed →
How you get itPrescription only
Comes asTablet
Earliest FDA record2009
Companies listing it with the FDA9
FDA label last updatedNov 6, 2025
FDA’s strongest warning (boxed)Yes, read the warning

Patient Information Guide A plain-language walkthrough of Tolvaptan, written from its FDA label.

What Tolvaptan Is Used For

▾

Tolvaptan tablets are used for two different conditions, depending on the product.

  • Samsca (oral tablet): treats clinically significant hypervolemic and euvolemic hyponatremia (low blood sodium).
  • Jynarque (oral kit/tablet): dosed and monitored for ADPKD, an inherited kidney disease.
  • Tolvaptan products labeled like Samsca are used for low blood sodium; tolvaptan kit/tablet products labeled like Jynarque follow the ADPKD dosing and monitoring plan.

How Tolvaptan Works

▾

Tolvaptan blocks vasopressin, a hormone that makes the kidneys hold on to water, from attaching to V2 receptors in the kidney. Without that signal, the kidneys let more water out in the urine. This is called aquaresis, and it raises blood sodium concentration unless you drink enough to match the extra urine.

In lab and animal studies of ADPKD, the same action slowed kidney cyst growth and fluid buildup.

Tolvaptan Dosage

▾

Tolvaptan is taken by mouth as a tablet. Your dose and schedule depend on the product, so follow your prescriber and label.

  • Samsca: started in a hospital, once daily with or without food. The dose may be raised after at least 24 hours. It is not given for more than 30 days. Fluid restriction is avoided in the first 24 hours, and you can drink when thirsty. After stopping, you are advised to resume fluid restriction and be monitored.
  • Jynarque: taken twice daily, on waking and about 8 hours later. Doses may be raised weekly if tolerated, or lowered if not. Drink enough water to avoid thirst or dehydration. Missed dose: take the next one at its scheduled time.

Dosing details from the FDA-approved label

From the Tolvaptan prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • Jynarque / tolvaptan tablets (kit) - initial dosage
    • 60 mg orally per day as 45 mg taken on waking and 15 mg taken 8 hours later
    • Titrate to 60 mg plus 30 mg, then to 90 mg plus 30 mg per day if tolerated, with at least weekly intervals between titrations
    • Maximum: 90 mg and 30 mg (120 mg total daily dose)
    • Patients may down-titrate based on tolerability; encourage drinking enough water to avoid thirst or dehydration
  • Patients taking moderate CYP3A inhibitors (kit)
    • Standard 90 mg and 30 mg: 45 mg and 15 mg
    • Standard 60 mg and 30 mg: 30 mg and 15 mg
    • Standard 45 mg and 15 mg: 15 mg and 15 mg (morning and afternoon doses)
    • Consider further reductions if not tolerated; interrupt temporarily for short term moderate CYP3A inhibitor therapy if reduced doses are not available
  • Samsca / tolvaptan tablets - hyponatremia
    • Starting dose 15 mg once daily without regard to meals
    • Increase to 30 mg once daily after at least 24 hours, then to a maximum of 60 mg once daily, as needed to achieve the desired level of serum sodium
    • Maximum: 60 mg once daily
    • Initiate and re-initiate in a hospital; do not administer for more than 30 days; avoid fluid restriction during the first 24 hours
Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION Recommended dosage ( 2.1 ) Initial Dosage Titration Step Target Dosage 1 st Dose 45 mg 1 st Dose 60 mg 1 st Dose 90 mg 2 nd Dose (8 hours later) 15 mg 2 nd Dose (8 hours later) 30 mg 2 nd Dose (8 hours later) 30 mg Total Daily Dose 60 mg Total Daily Dose 90 mg Total Daily Dose 120 mg Dose adjustment is recommended for patients taking moderate CYP 3A inhibitors ( 2.4 , 5.4 , 7.1 ) 2.1 Recommended Dosage The initial dosage for tolvaptan tablets is 60 mg orally per day as 45 mg taken on waking and 15 mg taken 8 hours later. Titrate to 60 mg plus 30 mg then to 90 mg plus 30 mg per day if tolerated with at least weekly intervals between titrations. Patients may down-titrate based on tolerability. Encourage patients to drink enough water to avoid thirst or dehydration. 2.2 Monitoring To mitigate the risk of significant or irreversible liver injury, perform blood testing for ALT, AST and bilirubin prior to initiation of tolvaptan tablets, at 2 and 4 weeks after initiation, monthly for 18 months and every 3 months thereafter. Monitor for concurrent symptoms that may indicate liver injury [see Warnings and Precautions ( 5.1 )] . 2.3 Missed Doses If a dose of tolvaptan tablets is not taken at the scheduled time, take the next dose at its scheduled time. 2.4 Co-Administration with CYP 3A Inhibitors CYP 3A Inhibitors Concomitant use of strong CYP 3A inhibitors is contraindicated [see Contraindications ( 4 ) and Warnings and Precautions ( 5.4 )] . In patients taking concomitant moderate CYP 3A inhibitors, reduce the dose of tolvaptan tablets per Table 1. Consider further reductions if patients cannot tolerate the reduced dose [see Warnings and Precautions ( 5.4 ) and Drug Interactions ( 7.1)]. Interrupt tolvaptan tablets temporarily for short term therapy with moderate CYP 3A inhibitors if the recommended reduced doses are not available. Table 1: Dose Adjustment for Patients taking Moderate CYP 3A Inhibitors Standard Morning and Afternoon Dose (mg) Dose (mg) with Moderate CYP 3A Inhibitors 90 mg and 30 mg 45 mg and 15 mg 60 mg and 30 mg 30 mg and 15 mg 45 mg and 15 mg 15 mg and 15 mg

Read the full Dosage and Administration section on DailyMed →

Tolvaptan Side Effects

▾

The most common side effects are related to the extra urine and fluid loss.

Common side effects

  • Thirst
  • Dry mouth
  • Weakness or tiredness (asthenia)
  • Constipation
  • Frequent urination or large urine volume
  • High blood sugar (hyperglycemia)

When to get medical help

  • Call your doctor right away for signs of liver injury, such as unusual tiredness, nausea, or yellowing of the skin or eyes.
  • Get help for symptoms of too-rapid sodium correction: trouble speaking or swallowing, confusion or drowsiness, mood changes, muscle stiffness or weakness, seizures.
  • Seek care for signs of dehydration or low blood volume, such as extreme thirst, dizziness or very low urine output.
  • Get emergency help for an allergic reaction such as rash or anaphylaxis.
  • Tell your doctor if you cannot pass urine or have trouble urinating.

Tolvaptan Warnings and Precautions

▾
  • Too-rapid sodium correction can cause osmotic demyelination, a serious nerve injury. This is why Samsca-type use starts in a hospital.
  • Liver injury: low-sodium use is limited to 30 days. ADPKD use requires blood tests before starting, at 2 and 4 weeks, monthly for 18 months, then every 3 months. Stop and call your doctor if liver injury is suspected.
  • Not for ADPKD outside the FDA-approved REMS because of liver risk.
  • Dehydration and low blood volume may need treatment.
  • Urinary blockage: urine output must be secured.
  • Potassium: monitor if it is high or if you take drugs that raise it.

Tolvaptan Interactions

▾

Tolvaptan is broken down by an enzyme called CYP3A, so many drugs and foods can change its levels.

  • Strong CYP3A inhibitors (such as ketoconazole): contraindicated; they greatly raise tolvaptan levels.
  • Moderate CYP3A inhibitors: avoid, or reduce the dose per the product label.
  • Grapefruit juice: avoid it.
  • Strong CYP3A inducers: lower tolvaptan levels; avoid.
  • Desmopressin (V2-agonists): tolvaptan may interfere; avoid.
  • ACE inhibitors, ARBs, potassium-sparing diuretics: potassium can run higher, so it should be monitored.
  • Hypertonic saline: avoid with the low-sodium use.

Interactions listed in the FDA-approved label

From the Tolvaptan prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • Strong CYP3A inhibitors (e.g., ketoconazole): Tolvaptan AUC was 5.4 times as large and Cmax was 3.5 times as large after co-administration with 200 mg ketoconazole. Concomitant use is contraindicated.
  • Moderate CYP3A inhibitors: A substantial increase in the exposure to tolvaptan would be expected. Avoid co-administration (for the 15-60 mg tablets); for the kit, reduce the dose per Table 1.
  • Strong CYP3A inducers: Co-administration reduces exposure to tolvaptan. Avoid concomitant use.
  • Grapefruit juice beverages: Label advises patients to avoid grapefruit juice beverages while taking tolvaptan tablets. Avoid grapefruit juice while taking tolvaptan tablets.
  • Angiotensin receptor blockers: Hyperkalemia adverse reactions were approximately 1 to 2% higher than with placebo. Monitor serum potassium levels during concomitant therapy.
  • Angiotensin converting enzyme inhibitors: Hyperkalemia adverse reactions were approximately 1 to 2% higher than with placebo. Monitor serum potassium levels during concomitant therapy.
  • Potassium sparing diuretics: Hyperkalemia adverse reactions were approximately 1 to 2% higher than with placebo. Monitor serum potassium levels during concomitant therapy.
  • V2-receptor agonist (desmopressin, dDAVP): As a V2-receptor antagonist, tolvaptan may interfere with the V2-agonist activity of desmopressin (dDAVP). Avoid concomitant use with a V2-agonist.
Read the label’s full interactions text

5.5 Drug Interactions Tolvaptan is a substrate of CYP3A. Moderate to strong CYP3A inhibitors can lead to a marked increase in tolvaptan concentrations [see Drug Interactions ( 7.1 )] . Do not use tolvaptan tablets with strong inhibitors of CYP3A [see Contraindications ( 4 )] and avoid concomitant use with moderate CYP3A inhibitors.

7 DRUG INTERACTIONS Avoid concomitant use with: Moderate CYP3A inhibitors (7.1) Strong CYP3A inducers (7.1) V2-receptor antagonists (7.3) Monitor serum potassium during concomitant therapy with ( 7.2 ) Angiotensin receptor blockers Angiotensin converting enzyme inhibitors Potassium sparing diuretics 7.1 CYP3A Inhibitors and Inducers Strong CYP3A Inhibitors Tolvaptan AUC was 5.4 times as large and C max was 3.5 times as large after co-administration of tolvaptan and 200 mg ketoconazole [see Warnings and Precautions ( 5.5 ) and Clinical Pharmacology ( 12.3 ) ]. Larger doses of the strong CYP3A inhibitor would be expected to produce larger increases in tolvaptan exposure. Concomitant use of tolvaptan with strong CYP3A inhibitors is contraindicated [see Contraindications ( 4 )]. Moderate CYP3A Inhibitors A substantial increase in the exposure to tolvaptan would be expected when tolvaptan tablets are co-administered with moderate CYP3A inhibitors. Avoid co-administration of tolvaptan tablets with moderate CYP3A inhibitors [see Warnings and Precautions ( 5.5 )]. Patients should avoid grapefruit juice beverages while taking tolvaptan tablets [see Clinical Pharmacology ( 12.3 )] . Strong CYP3A Inducers Co-administration of tolvaptan tablets with strong CYP3A inducers reduces exposure to tolvaptan tablets [see Clinical Pharmacology ( 12.3 )] . Avoid concomitant use of tolvaptan tablets with strong CYP3A inducers.

Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

Check Tolvaptan against a supplement or herb →

Before Taking Tolvaptan

▾
  • Not for people with significant liver impairment or history of liver injury.
  • Not for people unable to sense or respond to thirst, with low blood volume, abnormal uncorrected sodium, anuria or an uncorrected urinary blockage.
  • Not for people allergic to tolvaptan or its ingredients.
  • May cause fetal harm; tell your doctor if pregnant.
  • Breastfeeding is not recommended.
  • Safety and effectiveness in children are not established.
  • Older adults are generally started cautiously.
  • Use extra care with severe malnutrition, alcoholism or advanced liver disease.

Tolvaptan Overdose

▾

Too much tolvaptan can be expected to cause a rise in blood sodium, heavy urination, thirst and dehydration. There is no specific antidote. Care includes checking vital signs, electrolytes, ECG and fluid status, and replacing water and electrolytes until the extra urine output stops. Dialysis may not work well.

What Tolvaptan Does in the Body

▾

The increase in urine output starts within 1 to 2 hours of a dose and peaks around 4 to 8 hours. Urine output returns to baseline within 24 hours after the highest recommended dose. The extra water loss raises blood sodium unless fluid intake keeps pace. Small, reversible drops in kidney filtration (about 6% to 10%) are expected during treatment. No QT prolongation was seen in the study.

How Your Body Processes Tolvaptan

▾

Peak blood levels occur about 2 to 4 hours after a dose. Absolute bioavailability after a 30 mg dose was 56%. A high-fat meal doubled peak levels but did not change total exposure, so it may be taken with or without food. Tolvaptan is more than 98% bound to blood proteins and is broken down by the CYP3A enzyme. Dialysis may not remove it well.

How to Store Tolvaptan

▾

Store at 20°C to 25°C (68°F to 77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) . Keep out of reach of children.

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

Tolvaptan: Pharmacist Answers to Common Questions

Quick, plain-English answers to the questions patients ask most about Tolvaptan — the kind of thing our pharmacy team would talk through with you at the counter.

What is tolvaptan for?

▾
It depends on the product. Samsca-type tablets treat low blood sodium when the body holds too much or a normal amount of fluid. Jynarque-type tablets are dosed and monitored for ADPKD, an inherited kidney disease. Make sure you know which one you were prescribed.

Why does low-sodium treatment have to start in a hospital?

▾
Raising sodium too fast can cause serious nerve damage called osmotic demyelination. In the hospital, your sodium can be checked closely so the pace stays safe.

Should I limit how much I drink?

▾
Not at the start of Samsca-type treatment. You can drink when you are thirsty. For Jynarque-type products, drink enough water to avoid thirst or dehydration. Follow your prescriber’s advice, especially after stopping.

What side effects are normal?

▾
Thirst, dry mouth, frequent urination, tiredness, constipation and higher blood sugar are the most common. Call your doctor if you notice signs of liver problems, dehydration, an allergic reaction, or trouble speaking or swallowing.

Can I drink grapefruit juice or take my other medicines?

▾
Avoid grapefruit juice. Strong CYP3A inhibitors like ketoconazole are not allowed with tolvaptan. Other drugs, including desmopressin, certain blood pressure medicines and some that affect this enzyme, may need changes or monitoring, so show your pharmacist your full list.

Is it safe in pregnancy?

▾
It may cause fetal harm, so tell your doctor if you are pregnant or planning to be. Breastfeeding is not recommended while taking it.

Is Tolvaptan available over the counter?

▾
No. Tolvaptan is a prescription medicine: every Tolvaptan product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

When was Tolvaptan first available?

▾
The earliest FDA record we hold for Tolvaptan is from 2009: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Tolvaptan was first used.

Who makes Tolvaptan?

▾
9 companies currently list Tolvaptan products in the FDA's NDC Directory, including Ascend Laboratories, LLC, Otsuka America Pharmaceutical, Inc., Lupin Pharmaceuticals, Inc.. That count includes repackagers and distributors as well as manufacturers (companies that sell only the raw ingredient are not counted), so fewer companies actually make it; the label on your bottle names the one that supplied yours.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More About Tolvaptan on HelloPharmacist

🌿Drug & Supplement CheckerTolvaptan vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Tolvaptan NDCs & costs 🅰️Browse Drugs A–ZLook up any medication
Detailed Data & References for Tolvaptan Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Tolvaptan Forms and Strengths (How It Comes)

Tolvaptan is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Tolvaptan inactive ingredients by manufacturer.

Tablet

By mouth
Brands Jynarque Samsca
How this form is used
What it may be used for
  • Samsca treats clinically significant hypervolemic and euvolemic hyponatremia (low blood sodium).
  • Jynarque is a tolvaptan tablet product for ADPKD, with its own dosing and liver monitoring.
Important instructions
  • Samsca is started or restarted in a hospital and taken once daily with or without food.
  • Samsca is not given for more than 30 days to limit liver injury risk.
  • Jynarque is taken twice daily, on waking and 8 hours later, with regular liver blood tests.
  • Jynarque: if a dose is missed, take the next dose at its scheduled time.
Available strengths 5 strengths
15 mg 30 mg 45 mg 60 mg 90 mg
42 FDA-listed product records ⓘ

Tolvaptan on the U.S. Market: Products, Makers and Brands

How Tolvaptan appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

9 companies list 44 Tolvaptan product records with the FDA, mostly as tablet; the earliest marketing or approval year on record is 2009. Brand names on the directory include Jynarque, Samsca; the rest are generics.

1
Dose forms ⓘ
9
Labelers (makers, repackagers, distributors)
3
Brand names
44
FDA-listed product records ⓘ
2009
Earliest FDA record ⓘ

Also listed with the FDA, not a patient dose form: Kit (30) · Unfinished tablet (10) · Powder (7) — bulk drug substance and unfinished product sold to compounders and other manufacturers to finish, and multi-item kits. These aren’t counted in the dose-form total above.

Ascend Laboratories, LLC30%
Otsuka America Pharmaceutical, Inc.20%
Lupin Pharmaceuticals, Inc.16%
Teva Pharmaceuticals, Inc.11%
Apotex Corp.5%
Camber Pharmaceuticals, Inc.5%
Other makers14%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

How Widely Tolvaptan Is Used (Medicaid Data)

A general measure of how commonly Tolvaptan is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Tolvaptan is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

5,692
Medicaid prescriptions filled (Q1–Q4 2025)
$113M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Tolvaptan prescribed? Of the 1,603 medications we measure, Tolvaptan ranks #1,029 by Medicaid prescriptions — more than 36% of them.

Where Tolvaptan ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #1,029 of 1,603
#1,024 Lasmiditan 5,898 Rx #1,025 Sarilumab Injection 5,765 Rx #1,026 Isavuconazonium 5,727 Rx #1,027 Deferoxamine 5,720 Rx #1,028 Doravirine, Lamivudine... 5,704 Rx #1,029 Tolvaptan (low blood s... 5,692 Rx #1,030 Tolvaptan (kidney dise... 5,692 Rx #1,031 Tolvaptan 5,692 Rx #1,032 Aminocaproic Acid 5,657 Rx #1,033 Ceftazidime Injection 5,585 Rx #1,034 Methylergonovine 5,549 Rx

Utilization by Tolvaptan product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 15 mg oral tablet is the most-dispensed Tolvaptan product — about 3% of these Medicaid prescriptions.

Hyponatremia tolvaptan 15 MG Oral Tablet Most dispensed

179 Medicaid prescriptions (Q1–Q4 2025) 3% of Tolvaptan prescriptions shown $191,023 gross reimbursement (before rebates) ≈ $1,067 per prescription (gross)

Summed across the 3 of 17 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 849827

Hyponatremia tolvaptan 30 MG Oral Tablet

11 Medicaid prescriptions (Q1–Q4 2025) <1% of Tolvaptan prescriptions shown $27,101 gross reimbursement (before rebates) ≈ $2,464 per prescription (gross)

Summed across the 1 of 17 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 849833

Other Tolvaptan products — combination packs and listings not yet matched to a specific clinical product (kept visible so every prescription is accounted for)

5,502 Medicaid prescriptions (Q1–Q4 2025) 97% of Tolvaptan prescriptions shown $112.8M gross reimbursement (before rebates) ≈ $20,502 per prescription (gross)

Summed across the 9 of 20 listed NDC products with Medicaid activity.

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Tolvaptan, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 13 of 54 listed Tolvaptan NDCs with Medicaid activity.

Compare Tolvaptan Products

A representative set of FDA-listed product records for Tolvaptan — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 44 of 44 products — FDA National Drug Code Directory. See every product, package size and price: browse all 44 Tolvaptan NDCs →

Tolvaptan Side Effects Reported to the FDA (FAERS)

After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Tolvaptan — a signal of what to watch for, not proof the drug caused it.

The effects most often named in FDA reports that mention Tolvaptan are death, thirst, renal impairment; about 80% of the reports were classed as serious. These are voluntary reports, so they show what people report, not how often it happens.

14,448
Reports mentioning it
80%
Reported as serious
12
Distinct effects shown
Most reported effects
Death
1,018
Thirst
954
Renal Impairment
856
Cardiac Failure
814
Pollakiuria
552
Underdose
480
Dehydration
472
Polyuria
448
Blood Creatinine Increased
445
Nausea
436
Age groups
Elderly · 758Adult · 493Child · 26Adolescent · 9Infant · 7Neonate · 2

Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Tolvaptan in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.

Tolvaptan FDA Approval History

How Tolvaptan went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.

Tolvaptan was first approved by the FDA in 2009 (Brand: SAMSCA · Otsuka); the first generic version was approved in 2020. It remains available in U.S. pharmacies today.

2009
Brand approved
Brand: SAMSCA · Otsuka
2020
First generic approved
Lower-cost ANDA competition begins
2026
Available today
Active in U.S. pharmacies

Source: Drugs@FDA.

Tolvaptan Recall History

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list no Tolvaptan recalls since July 2021.

✅No Tolvaptan recalls on record since July 2021

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Oct 8, 2026.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Tolvaptan RxCUI 358257 1 dose form · 7 strengths

Look up RxCUI 358257 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

💵 What Tolvaptan Costs Pharmacies (NADAC Benchmark)

The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Oct 7, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.

FormStrengthPharmacy acquisition benchmark
Tablet · Oral 15 mg $14.57 per tablet NDC details & price history
Why show this? Your out-of-pocket cost depends on insurance, pharmacy markup, and discounts — but the acquisition benchmark tells you whether the medication itself is inexpensive or costly, which strengths cost more per dose, and whether a cash-price quote is in a reasonable range. Each row links to the NDC-level record with its full price history.

Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.

Tolvaptan Brand Names

Tolvaptan is sold under 2 brand names in the FDA directory — Jynarque, Samsca. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Jynarque Samsca

Who Makes Tolvaptan: Manufacturers and Labelers

9 companies list Tolvaptan products with the FDA. By number of product records, the largest are Ascend Laboratories, LLC, Otsuka America Pharmaceutical, Inc., Lupin Pharmaceuticals, Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Ascend Laboratories, LLC 13 Otsuka America Pharmaceutical, Inc. 9 Lupin Pharmaceuticals, Inc. 7 Teva Pharmaceuticals, Inc. 5 Apotex Corp. 2 Camber Pharmaceuticals, Inc. 2 Endo USA, Inc. 2 Northstar Rx LLC 2 Novadoz Pharmaceuticals LLC 2

Tolvaptan Drug Class (RxNorm)

Tolvaptan belongs to the Vasopressin V2 Receptor Antagonist class.

Pharmacologic class Vasopressin V2 Receptor Antagonist
Drug family (ATC) Vasopressin antagonists
How it works Vasopressin V2 Receptor Antagonists

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

Sources for This Tolvaptan Page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Nov 6, 2025
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Tolvaptan.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Tolvaptan after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
10
Finished products in the current FDA directory
44
Companies listing them (makers, repackagers, distributors)
9
FDA labeler codes behind them ⓘ
9
Linked representative label ⓘ
Otsuka America Pharmaceutical, Inc.
Linked label effective
Nov 6, 2025
Composite sections available
24
Linked SPL Set ID
3febc0a1-9e5a-4ce0-843d-210f21d862c4
Linked SPL Document ID
3be8a6fe-a8d0-43ca-a84d-183b522a3cf4
Open the linked representative label on DailyMed ↗

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Otsuka America Pharmaceutical, Inc. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →