Jynarque
Jynarque (tolvaptan) is a vasopressin-2 (V2) receptor antagonist that helps protect kidney function in adults with autosomal dominant polycystic kidney disease (ADPKD) who are at risk of their condition worsening quickly. It comes as a tablet that's taken by mouth twice a day, with doses spaced 8 hours apart. Treatment starts with a low dose and is slowly raised based on how you respond. Common side effects include feeling thirsty and needing to urinate often. Because this medication can cause serious liver damage, it's only available through a Risk Evaluation and Mitigation Strategy (REMS) program to make sure it's used safely.
What is Jynarque (tolvaptan)?
What is Jynarque (tolvaptan) used for?
Protect kidney function in people with autosomal dominant polycystic kidney disease (ADPKD) at risk of their condition worsening quickly
How Jynarque (tolvaptan) works
Jynarque (tolvaptan) is a vasopressin-2 (V2) receptor antagonist. It blocks vasopressin, a hormone in the body, from attaching to the V2 receptor. This helps prevent cysts from growing on the kidneys in people with ADPKD, which protects kidney function by slowing kidney damage.
Drug Facts
What are the side effects of Jynarque (tolvaptan)?
Common Side Effects
- Frequent urination (70%)
- Feeling very thirsty (64%)
- Dry mouth (16%)
- Tiredness (14%)
- Diarrhea (13%)
- Dizziness (11%)
- Indigestion (8%)
- Poor appetite (7%)
- Feeling bloated (5%)
- Dry skin (5%)
Other Side Effects
- Rash
- High uric acid levels
- Palpitations
Serious Side Effects
- Liver damage: tiredness, loss of appetite, nausea, stomach pain, vomiting, fever, rash, itching, yellowing of the skin or eyes, dark urine
Source: DailyMed
The following side effects have also been reported
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common
Blurred vision
flushed, dry skin
fruit-like breath odor
increased hunger
increased thirst
increased urination
increased volume of pale, dilute urine
stomach pain
sweating
thirst
troubled breathing
unexplained weight loss
unusual tiredness or weakness
vomiting
Less common
blood in the urine
bloody stools
blue lips, fingernails, or skin
bruising
confusion
coughing or vomiting blood
dark urine
dizziness or lightheadedness
fainting
fast, slow, irregular, or shallow heartbeat
irregular, fast or slow, or shallow breathing
loss of consciousness
muscle cramp, spasm, pain, or stiffness
pain, redness, or swelling in the arm or leg
persistent bleeding or oozing from puncture sites, mouth, or nose
pink or red urine
rash
rectal bleeding
stomach tenderness
troubled breathing
sweating
vaginal bleeding
Incidence not known
Difficulty swallowing
general feeling of tiredness or weakness
headache
irritability
light-colored stools
muscle twitching
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
restlessness
seizures
stomach pain, continuing
swelling of the feet or lower legs
tightness in the chest
yellow eyes or skin
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
Difficulty having a bowel movement
lack or loss of strength
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Pros and cons of Jynarque (tolvaptan)
Pros
The only FDA-approved ADPKD treatment option to slow kidney function decline
Comes as a tablet that's taken by mouth
Can be taken with or without food
Cons
Must be taken twice a day
Can make you urinate more often
Need to get blood work done regularly to check your liver
Pharmacist tips for Jynarque (tolvaptan)
Check the shape of your Jynarque (tolvaptan) tablet before taking it to make sure you have the right dose. The 15 mg tablet is triangle-shaped, 30 mg tablet is round, 45 mg tablet is square, 60 mg tablet is rectangular, and 90 mg tablet is shaped like a pentagons (five sides).
You can take Jynarque (tolvaptan) with or without food. If it upsets your stomach, try taking it with food to help ease discomfort.
If you miss your dose of Jynarque (tolvaptan), take your next dose at the usual time. Don't double up to make up for the missed dose.
Avoid grapefruit or grapefruit juice while taking Jynarque (tolvaptan) because they interact. Taking them together can cause your body to absorb more medication which can raise your risk for side effects.
Jynarque (tolvaptan) will make you thirsty and urinate more. Keep a water bottle nearby and drink water regularly to avoid dehydration. If you feel lightheaded, dizzy, or faint, rehydrate quickly. If these symptoms don't go away, get medical attention right away.
You'll need regular blood tests while taking Jynarque (tolvaptan), such as liver tests and electrolyte levels. Mark your test dates on your calendar so you don’t miss them.
Jynarque (tolvaptan) interacts with many prescription and over-the-counter medications. Tell your care team about all medications you're taking before starting Jynarque (tolvaptan). Don't start any new medications without checking with your prescriber first.
The safety of Jynarque (tolvaptan) during pregnancy isn’t fully known. Studies in animals found no harm at normal doses, but higher doses led to fetal loss and development problems. Let your prescriber or OB-GYN provider know right away if you're pregnant or thinking of becoming pregnant while you're taking this medication.
It's not recommended to breastfeed while you're taking Jynarque (tolvaptan) because it has the potential to cause serious side effects. Speak with your prescriber if you have questions about the risks and benefits of taking this medication while breastfeeding.
Frequently asked questions about Jynarque (tolvaptan)
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What are the risks and warnings for Jynarque (tolvaptan)?
Jynarque (tolvaptan) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Liver damage
Jynarque (tolvaptan) can cause serious liver problems that can lead to liver failure or death. Because of this risk, Jynarque (tolvaptan) is available only through the Jynarque REMS program. You'll need to get regular blood tests done to make sure your liver is working properly. Make sure you keep track of your lab appointments. Get medical attention right away if you notice tiredness, loss of appetite, nausea, stomach pain, vomiting, fever, rash, itching, yellowing of the skin or eyes, dark urine. If this happens, you might need to stop using the medication to prevent further liver damage.
High sodium levels, dehydration, and low blood volume
Jynarque (tolvaptan) makes you urinate more, which can put you at risk for dehydration, low blood volume, and high sodium levels. To help prevent this, stay hydrated by drinking fluids regularly, especially when you feel thirsty. Before starting Jynarque (tolvaptan), your prescriber will check your sodium level to make sure you have enough body fluids. Your fluid level must stay in the normal range to continue taking this medication. If you experience dry mouth, weight loss, high heart rate, or low blood pressure (feeling dizzy, lightheaded, or faint), rehydrate quickly and contact your prescriber because these could be signs of dehydration.
Interactions with other medications
Some medications, such as itraconazole, Kaletra (lopinavir/ritonavir), ritonavir (Norvir), can raise Jynarque (tolvaptan) levels in your body. This can put you at higher risk for serious side effects, such as liver problems. If you're taking a medication that affects Jynarque (tolvaptan) levels, your prescriber might need to make changes to one or both of your medications. Before starting Jynarque (tolvaptan), tell your care team about all prescription and over-the-counter medications you're taking. Don't start any new medications without checking with your prescriber to make sure they're safe to take together.
Jynarque (tolvaptan) dosage forms
Typical dosing for Jynarque (tolvaptan)
The typical starting dose is 45 mg by mouth when you wake up and 15 mg about 8 hours later. Your prescriber might raise your dose based on how you respond. The maximum recommended dose is 90 mg in the morning and 30 mg 8 hours later.
Your dose might differ if you're taking certain medications that interact with Jynarque (tolvaptan).
More on Jynarque (tolvaptan) dosage forms
Interactions between Jynarque (tolvaptan) and other drugs
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Boceprevir
- Clarithromycin
- Cobicistat
- Conivaptan
- Delavirdine
- Idelalisib
- Indinavir
- Itraconazole
- Ketoconazole
- Lopinavir
- Nefazodone
- Nelfinavir
- Posaconazole
- Ritonavir
- Saquinavir
- Telaprevir
- Telithromycin
- Tipranavir
- Voriconazole
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Amobarbital
- Amprenavir
- Aprepitant
- Atazanavir
- Butabarbital
- Capmatinib
- Carbamazepine
- Ceritinib
- Ciprofloxacin
- Crizotinib
- Cyclosporine
- Desmopressin
- Digoxin
- Diltiazem
- Dronedarone
- Duvelisib
- Efavirenz
- Enzalutamide
- Erythromycin
- Fluconazole
- Fluvoxamine
- Fosamprenavir
- Fosaprepitant
- Fosnetupitant
- Fosphenytoin
- Imatinib
- Ivosidenib
- Larotrectinib
- Lasmiditan
- Lefamulin
- Letermovir
- Lorlatinib
- Lumacaftor
- Mitotane
- Modafinil
- Netupitant
- Nevirapine
- Nilotinib
- Oxcarbazepine
- Pentobarbital
- Phenobarbital
- Phenytoin
- Pioglitazone
- Rifabutin
- Rifampin
- Rifapentine
- Secobarbital
- Simeprevir
- St John's Wort
- Venetoclax
- Verapamil
Jynarque (tolvaptan) contraindications
History or signs or symptoms of severe liver problems (except for uncomplicated polycystic liver disease)
Taking certain medications that interact with Jynarque (tolvaptan) (strong CYP3A inhibitors)
Uncorrected abnormal blood sodium levels
Unable to sense or respond to thirst
Low blood volume
Lack of urination due to blockage
Inability to make urine
What is the latest news about Jynarque (tolvaptan)?
Jynarque (tolvaptan) images
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References
Best studies we foundCuzzo, B., et al. (2023). Physiology, vasopressin. StatPearls.
National Organization for Rare Disorders. (2023). Polycystic liver disease.
Otsuka America Pharmaceutical, Inc. (2023). Tips for managing the most common side effects of Jynarque® (tolvaptan).
Otsuka America Pharmaceuticals, Inc. (2025). Jynarque- tolvaptan kit; Jynarque-tolvaptan tablet [package insert]. DailyMed.
PKD Foundation. (n.d.). Available treatment.
Torres, V. E., et al. (2018). Multicenter, open-label, extension trial to evaluate the long-term efficacy and safety of early versus delayed treatment with tolvaptan in autosomal dominant polycystic kidney disease: The TEMPO 4:4 Trial. Nephrology, Dialysis, Transplantation.
U.S. Food and Drug Administration. (2017). FDA Drug Safety Communication: FDA limits duration and usage of Samsca (tolvaptan) due to possible liver injury leading to organ transplant or death.
U.S. Food and Drug Administration. (2021). Grapefruit juice and some drugs don’t mix.
U.S. Food and Drug Administration. (2023). Drug development and drug interactions | Table of substrates, inhibitors and inducers.
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