Prescription medicine
Tolvaptan Brand names: Jynarque, Samsca
Tolvaptan (Jynarque) is a prescription medicine with an FDA approval on record since 2009. FDA's NDC Directory lists it from 8 generic labelers, and pharmacies paid $14.57 per tolvaptan 15 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the tolvaptan FDA label on DailyMed (effective May 7, 2026, Otsuka America Pharmaceutical, Inc.); the NDA 22275 record on Drugs@FDA; every tolvaptan label on DailyMed.
Highlights of the record
FDA label of May 7, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
(A) INITIATE AND RE-INITIATE IN A HOSPITAL AND MONITOR SERUM SODIUM; (B) NOT FOR USE FOR AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE (ADPKD) WARNING:; (B) NOT FOR USE FOR AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE (ADPKD).
See full prescribing information for complete boxed warning. (A) Initiate and re-initiate in a hospital and monitor serum sodium SAMSCA should be initiated and re-initiated in patients only in a hospital where serum sodium can be monitored closely. Too rapid correction of hyponatremia (e.g., >12 mEq/L/24 hours) can cause osmotic demyelination resulting in dysarthria, mutism, dysphagia, lethargy, affective changes, spastic quadriparesis, seizures, coma and death. In susceptible patients, including those with severe malnutrition, alcoholism or advanced liver disease, slower rates of correction may be advisable. (B) Not for use for autosomal dominant polycystic kidney disease (ADPKD) Because of the risk of hepatotoxicity, tolvaptan should not be used for ADPKD outside of the FDA-approved REMS (4) (A) Initiate and re-initiate in a hospital and monitor serum sodium SAMSCA should be initiated and re-initiated in patients only in a hospital where serum sodium can be monitored closely. […]
Used for
From the label: indications and usageSAMSCA ® is indicated for the treatment of clinically significant hypervolemic and euvolemic hyponatremia (serum sodium <125 mEq/L or less marked hyponatremia that is symptomatic and has resisted correction with fluid restriction), including patients with heart failure and Syndrome of Inappropriate Antidiuretic Hormone (SIADH).
Forms and strengths
- 15 mg
- 30 mg
- 45 mg
- 60 mg
- 90 mg
Tablet; kit.
On the market
- Earliest approval on file
- May 19, 2009 Samsca, Otsuka; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 9 first May 19, 2020; 9 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 9 of which 8 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- April 7, 2030 Jynarque tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $14.57 per tablet Tolvaptan 15 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 14,448 through July 30, 2026
What is tolvaptan used for?
From the label: indications and usageSAMSCA ® is indicated for the treatment of clinically significant hypervolemic and euvolemic hyponatremia (serum sodium <125 mEq/L or less marked hyponatremia that is symptomatic and has resisted correction with fluid restriction), including patients with heart failure and Syndrome of Inappropriate Antidiuretic Hormone (SIADH). […]
FDA pharmacologic class: Vasopressin V2 Receptor Antagonist.
Source: FDA drug label (SAMSCA), Otsuka America Pharmaceutical, Inc., effective May 7, 2026 (SPL set 5526617c-c7b9-4556-886d-729bbabbc566), via openFDA; the full label on DailyMed
What does the patient leaflet for tolvaptan say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about SAMSCA?SAMSCA may make the salt (sodium) level in your blood rise too fast. This can increase your risk of a serious condition called osmotic demyelination syndrome (ODS). ODS can lead to coma or death. ODS can also cause new symptoms such as: trouble speaking swallowing trouble or feeling like food or liquid gets stuck while swallowing drowsiness confusion mood changes trouble controlling body movement (involuntary movement) and weakness in muscles of the arms and legs seizures You or a family member should tell your healthcare provider right away if you have any of these symptoms even if they begin later in treatment. Also tell your healthcare provider about any other new symptoms while taking SAMSCA. […] Tell your doctor right away if you develop or have worsening of any of these signs and symptoms of liver problems: Loss of appetite, nausea, vomiting Fever, feeling unwell, unusual tiredness Itching Yellowing of the skin or the whites of the eyes (jaundice) Unusual darkening of the urine Right upper stomach area pain or discomfort 3) If you have autosomal dominant polycystic kidney disease (ADPKD), do not use SAMSCA because you should receive the medicine (tolvaptan) through a program that ensures laboratory monitoring of your liver. […]
From the patient leaflet: How should I store SAMSCA?Store SAMSCA between 59°F to 86°F (15°C to 30°C). Keep SAMSCA and all medicines out of the reach of children. General Information about SAMSCA Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use SAMSCA for a condition for which it was not prescribed. Do not give SAMSCA to other people, even if they have the same symptoms you have. It may harm them. This Medication Guide summarizes the most important information about SAMSCA. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about SAMSCA that is written for healthcare professionals. For more information about SAMSCA, call 1-877-726-7220 or go to www.samsca.com.
Source: FDA drug label (SAMSCA), Otsuka America Pharmaceutical, Inc., effective May 7, 2026 (SPL set 5526617c-c7b9-4556-886d-729bbabbc566), via openFDA; the full label on DailyMed
Is there a generic for tolvaptan (Jynarque)?
The FDA approved the first generic tolvaptan on May 19, 2020. 9 generic applications are approved; 9 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists tolvaptan from 8 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists 2 patents for Jynarque tablets: the compound patent runs to September 1, 2026, and the last listed entry to April 7, 2030. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2009 earliest approval on file
- 2020 first generic approved
- 2030 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for tolvaptan (Jynarque)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $14.57 per Tolvaptan 15 mg tablet, down 68% from $45.69 on October 8, 2025. The survey records the price, not the reason for a change; large moves often follow a new generic or a list-price change. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Tolvaptan 15 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Tolvaptan 15 mg tablet | Generic | $14.57 per tablet | $437.22 | -68% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the tolvaptan label say about other medicines?
The tolvaptan label names 5 other medicines in its interaction, contraindication or warning sections. The labels of 6 other medicines name tolvaptan. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Desmopressin | drug interactions | V 2 -Receptor Agonist As a V 2 -receptor antagonist, tolvaptan may interfere with the V 2 -agonist activity of desmopressin (dDAVP). |
| Itraconazole | warnings and precautions | Inhibitors of CYP3A Concomitant use of JYNARQUE with drugs that are moderate or strong CYP3A inhibitors (e.g., ketoconazole, itraconazole, lopinavir/ritonavir, indinavir/ritonavir, ritonavir, and conivaptan) increases tolvaptan exposure [see Drug Interactions (7.1) and Clinical Pharmacology (12.3) ]. |
| Ketoconazole | drug interactions | … 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) ]. |
| Lopinavir and ritonavir | warnings and precautions | Inhibitors of CYP3A Concomitant use of JYNARQUE with drugs that are moderate or strong CYP3A inhibitors (e.g., ketoconazole, itraconazole, lopinavir/ritonavir, indinavir/ritonavir, ritonavir, and conivaptan) increases tolvaptan exposure [see Drug Interactions (7.1) and Clinical Pharmacology (12.3) ]. |
| Ritonavir | warnings and precautions | Inhibitors of CYP3A Concomitant use of JYNARQUE with drugs that are moderate or strong CYP3A inhibitors (e.g., ketoconazole, itraconazole, lopinavir/ritonavir, indinavir/ritonavir, ritonavir, and conivaptan) increases tolvaptan exposure [see Drug Interactions (7.1) and Clinical Pharmacology (12.3) ]. |
Other labels that name tolvaptan
Source: FDA drug label (SAMSCA), Otsuka America Pharmaceutical, Inc., effective May 7, 2026 (SPL set 5526617c-c7b9-4556-886d-729bbabbc566), via openFDA; the full label on DailyMed
What do FAERS reports show for tolvaptan?
The FDA Adverse Event Reporting System holds 14,448 reports that list tolvaptan among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 3,190 are coded as a death and 4,653 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Tolvaptan side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other