FDA-filed SPL labeling · retrieved through openFDA

Uridine Triacetate

Uridine triacetate is an oral medication used to treat a life-threatening overdose or severe early toxicity from certain chemotherapy drugs, and to treat a rare genetic disorder called hereditary orotic aciduria.

Brand names VistogardXuriden
Drug class Pyrimidine Analog
Rx Form 1 Route Oral
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 2 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 →

At a glance
Linked label effectiveFeb 18, 2025
Clinical labels in scope 2
AvailabilityRx
Earliest approval/marketing year 2015
FDA-listed product records 5
Boxed warningNone found in compared labels
How we combine label and product data →
No current FDA shortage listed · checked Sep 19, 2026
Uridine Triacetate at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Uridine triacetate comes in two forms for two very different situations: Vistogard is an emergency treatment for dangerous fluorouracil or capecitabine overdose or severe early toxicity, while Xuriden is a daily replacement therapy for the rare genetic disorder hereditary orotic aciduria. Both are oral granule powders mixed into food or liquid. Always follow your care team's exact instructions — in the emergency setting especially, completing the full course of treatment on schedule matters greatly.

📖 Uridine Triacetate: Patient Information Guide

A plain-language walkthrough of Uridine Triacetate — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for

Uridine triacetate is the active ingredient in two distinct FDA-approved products used for different medical situations.

  • Vistogard is approved for emergency treatment of adults and children who have had an overdose of the chemotherapy drugs fluorouracil or capecitabine — regardless of whether symptoms are present — or who develop severe, early, or life-threatening toxicity (such as heart or central nervous system problems, severe digestive side effects, or dangerously low white blood cell counts) within 96 hours of their last chemotherapy dose.
  • Xuriden is approved for adults and children to treat hereditary orotic aciduria, a rare inherited metabolic disorder in which the body cannot produce enough uridine, leading to a buildup of orotic acid and widespread effects on cell function and blood production.
⚙️How it works

Uridine triacetate is a prodrug — meaning it converts into its active form (uridine) after you swallow it. Natural enzymes throughout the body break it down quickly, releasing uridine into the bloodstream. In the case of Vistogard, that flood of uridine competes directly with the toxic byproducts of fluorouracil for incorporation into RNA, reducing the damage those byproducts cause to normal cells. Fluorouracil harms cells by blocking DNA repair and inserting damaging molecules into RNA; extra uridine essentially crowds out those harmful molecules. For Xuriden, the released uridine compensates for what the body cannot make due to a genetic defect in an enzyme called uridine monophosphate synthase (UMPS). When uridine levels are restored, the overproduction of orotic acid is also reduced through a natural feedback process.

💊How it's taken

Dosing is very different between the two products and must not be confused. Vistogard is taken every 6 hours for a total of 20 doses, without regard to meals — timing and completing the full course are critical in this emergency setting. Xuriden is taken once daily with food, with the dose based on body weight; the dose may be adjusted by a doctor if the condition is not adequately controlled.

  • Both are oral granule powders mixed into soft foods such as applesauce, pudding, or yogurt before swallowing — never chew the granules.
  • Vistogard doses should be taken within 30 minutes of mixing and followed by at least 4 ounces of water.
  • If a Vistogard dose is vomited within 2 hours, repeat that dose as soon as possible, then resume the regular schedule.
  • Discard any unused granules from an opened packet for either product.
🤒Side effects — in detail

Uridine triacetate is generally well tolerated. The most commonly reported side effects from Vistogard clinical studies were:

  • Vomiting (reported in about 10% of patients)
  • Nausea (about 5%)
  • Diarrhea (about 3%)

Serious side effects were rare — in clinical studies, grade 3 nausea and vomiting occurred in only one patient. If vomiting is severe or persistent and interferes with completing the full course of Vistogard, contact your medical team right away, as finishing treatment is important.

⚠️Warnings & precautions
  • Vistogard is for emergencies only — it should not be used for routine or non-urgent management of fluorouracil or capecitabine side effects, because doing so can reduce how well those chemotherapy drugs fight cancer.
  • Timing matters with Vistogard — safety and effectiveness have only been established when treatment is started within 96 hours of the last fluorouracil or capecitabine dose. Starting later is not supported by current evidence.
  • There are no absolute contraindications (reasons someone must not take it) listed for either product.
🔀What it interacts with

There are limited known drug interactions, but one area of caution exists based on laboratory data.

  • P-glycoprotein substrate drugs (e.g., digoxin): In lab studies, uridine triacetate inhibited P-glycoprotein, a protein that helps move certain drugs across cell membranes. This could potentially affect how much of a co-administered oral P-gp substrate drug is absorbed from the gut. Human data are not yet available, so tell your doctor about all medications you take.
  • Fluorouracil and capecitabine: Uridine triacetate is specifically designed to counteract these drugs' effects on normal cells — so using Vistogard outside an emergency context can reduce their cancer-fighting activity.

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

📋Before taking it
  • Pregnancy: Human safety data are very limited. Animal studies did not show harm to the fetus, but this cannot be assumed to apply in humans. Discuss with your doctor before using either product if you are pregnant or planning to become pregnant.
  • Breastfeeding: It is not known whether uridine triacetate passes into breast milk or what effects it might have on a breastfed infant. Your doctor will weigh the benefits and risks with you.
  • Children: Both Vistogard and Xuriden are approved for pediatric use, including in young children and infants. Pediatric dosing is weight-based or body-surface-area-based and should be calculated by your care team.
  • Older adults: About 30% of patients in Vistogard studies were 65 or older. Numbers were not large enough to determine if older adults respond differently, so standard monitoring applies.
  • P-glycoprotein substrate drugs: Tell your prescriber if you take digoxin or any other medication flagged as a P-glycoprotein substrate.
📡Pharmacodynamics — effects in the body

In hereditary orotic aciduria, a defective enzyme (uridine monophosphate synthase, or UMPS) blocks the body's ability to make uridine nucleotides — the building blocks cells need — and causes orotic acid to accumulate and spill into the urine, where it can form crystals and block the urinary tract. Xuriden delivers uridine directly into the bloodstream, where cells throughout the body can use it to restore normal nucleotide levels. Once those levels normalize, the body's own feedback system reduces overproduction of orotic acid, so less of it is excreted in the urine.

🔬Pharmacokinetics — how your body processes it

After swallowing uridine triacetate granules, the body's natural enzymes rapidly convert it into uridine, which then circulates in the blood. Following oral Xuriden, uridine levels in the blood typically peak within 2 to 3 hours, and the half-life (the time it takes for half the drug to be cleared) is roughly 2 to 2.5 hours. Xuriden delivers approximately 4 to 6 times more uridine into the bloodstream than an equivalent amount of plain uridine taken by mouth, making it a much more efficient way to raise uridine levels. Uridine is distributed into cells throughout the body via specialized transporters, crosses into the brain, and is cleared through the kidneys or broken down by normal metabolic pathways in body tissues. Food does not meaningfully change how much uridine reaches the bloodstream from uridine triacetate granules.

📦How to store it

Store at USP controlled room temperature, 25°C (77°F); excursions permitted to 15° to 30 °C (59° to 86°F).

📄 Written from Uridine Triacetate’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

17

Supplements & herbs that interact with Uridine Triacetate

17 supplements and herbal products have documented interactions with Uridine Triacetate in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 1
  • Moderate · 7
  • Minor · 9
Every supplement checked against Uridine Triacetate — ranked by severity The full interaction hub: 1 major · 7 moderate · 9 minor · every one linked to its full report. Check Uridine Triacetate against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

🩺 Pharmacist Counseling Corner

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

What exactly is Vistogard and why would I need it urgently?
Vistogard is an emergency antidote for people who have received too much of certain chemotherapy drugs — fluorouracil or capecitabine — or who develop serious, early reactions to them. These reactions can affect the heart, nervous system, or digestive tract, or cause a dangerous drop in infection-fighting white blood cells. Because the window for treatment is narrow — within 96 hours of the last chemotherapy dose — it needs to be started as quickly as possible. Your medical team will make that call.
What is Xuriden used for, and is it the same as Vistogard?
Xuriden and Vistogard are actually two different products, even though both contain uridine triacetate. Xuriden is a daily medication for people with hereditary orotic aciduria, a rare genetic condition where the body can't make enough of a molecule called uridine. That shortage causes problems with blood cell production and leads to a buildup of a substance called orotic acid. Xuriden replaces the missing uridine so the body can function more normally. It is not an emergency treatment — it's taken every day, long-term.
How do I take these granules? They look unusual.
You mix the measured amount of granules into soft food — applesauce, pudding, or yogurt work well — and swallow it right away. Do not chew the granules. After swallowing, drink at least 4 ounces of water. For Xuriden, smaller doses can also be mixed into milk or infant formula using an oral syringe, which is helpful for babies or young children. Always measure your dose carefully with a scale or graduated teaspoon, and throw away any leftover granules from an opened packet — don't save them for the next dose.
What side effects should I watch for, and when should I call for help?
The most common side effects reported with Vistogard are nausea, vomiting, and diarrhea. Serious side effects were rare in studies. For Vistogard specifically, if you vomit within 2 hours of taking a dose, you should take another full dose as soon as possible — completing all 20 doses on schedule is really important for the treatment to work. If vomiting is so severe that you can't keep doses down, contact your medical team right away. They can administer Vistogard through a tube if needed.
I'm pregnant. Is it safe to take uridine triacetate?
There is very limited human data on using uridine triacetate during pregnancy. Animal studies did not show harm to fetuses, but we can't automatically apply that to people. For Vistogard, in a true chemotherapy overdose emergency, your medical team will weigh the risks of not treating against any uncertainty about the medication. For Xuriden, if you are pregnant or planning to become pregnant, talk to your doctor so you can make an informed decision together.
Can Vistogard interfere with my other medications?
There aren't many known drug interactions, but one thing to be aware of is that uridine triacetate may affect how certain drugs — particularly digoxin and others in a category called P-glycoprotein substrates — are absorbed from the gut. In a real emergency, your medical team will be managing your medications closely. Make sure they know everything you take, including over-the-counter drugs and supplements, so they can watch for any potential interactions.
Is Uridine Triacetate available over the counter?
Uridine Triacetate is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.
When was Uridine Triacetate first available?
Uridine Triacetate has been available in the United States since at least 2015, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Uridine Triacetate?
Uridine Triacetate is supplied by 3 manufacturers listed in the FDA NDC Directory, including BTG International Inc, Wellstat Therapeutics Corporation, Metrochem API Private Limited.

💬 Answers drafted from Uridine Triacetate’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

🧰 Keep exploring

💊 How Uridine Triacetate comes

Uridine Triacetate 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.

Oral powder

By mouth
Brands Vistogard Xuriden
How this form is used
What it may be used for
  • Vistogard is used for emergency treatment of adults and children after a fluorouracil or capecitabine overdose, or with severe early toxicity from those drugs within 96 hours
  • Xuriden is used to treat hereditary orotic aciduria in adults and children by replacing uridine the body cannot produce
Important instructions
  • Vistogard granules should be mixed into 3–4 ounces of soft food (applesauce, pudding, or yogurt) and swallowed within 30 minutes; do not chew the granules; drink at least 4 ounces of water after each dose
  • Vistogard can be given through a nasogastric (NG) tube or gastrostomy (G-tube) when a patient cannot swallow due to severe mucositis or unconsciousness
  • Xuriden granules should be mixed into soft food (applesauce, pudding, or yogurt) or, for smaller doses, into milk or infant formula; take with food once daily and do not chew the granules
  • For both products, measure the dose carefully using a scale or graduated teaspoon, and discard any unused granules from an opened packet — do not save them for later
Available strengths 1 strength
4 FDA-listed product records

📊 Uridine Triacetate across the U.S. market

How Uridine Triacetate 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.

1
Dose forms
3
Manufacturers
2
Brand names
5
FDA-listed product records
2015
First marketed

Also listed with the FDA, not a patient dose form: Powder (1) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

BTG International Inc40%
Wellstat Therapeutics Corporation40%
Metrochem API Private Limited20%

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

🔍 Compare Uridine Triacetate products

A representative set of FDA-listed product records for Uridine Triacetate — 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.)

Strength Route Manufacturer / Labeler Category Details
💊Oral powder
951 mg/g Oral BTG International Inc × 2 listings NDA View NDC →
951 mg/g Oral Wellstat Therapeutics Corporation × 2 listings NDA View NDC →
💊Bulk drug substance
1 kg/kg Metrochem API Private Limited BULK INGREDIENT View NDC →

Showing 5 of 5 products — FDA National Drug Code Directory. See every product, package size and price: browse all 5 Uridine Triacetate NDCs →

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) Uridine Triacetate RxCUI 1665222 1 dose form · 2 strengths
  1. Dose form (SCDF) Oral Granules RxCUI 1665466 In current FDA listings
    Clinical drug / strength (SCD) 2000 MG RxCUI 1665467 10000 MG RxCUI 1739794

Look up RxCUI 1665222 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.

🏷️ Sold under these brand names

Vistogard Xuriden

🏭 Manufacturers & labelers

BTG International Inc 2 Wellstat Therapeutics Corporation 2 Metrochem API Private Limited 1

RxNorm drug class

Uridine Triacetate belongs to the Various alimentary tract and metabolism products class.

Drug family (ATC) Various alimentary tract and metabolism products

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.

🔬 Where this comes from

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 Feb 18, 2025
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Uridine Triacetate.
📈
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 Uridine Triacetate after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
2
NDC products indexed
5
Distinct labelers/manufacturers represented
3
Linked representative label
BTG International Inc
Linked label effective
Feb 18, 2025
Composite sections available
21
Linked SPL Set ID
88ca4d2b-3905-474b-9fd6-c81474f2fb4b
Linked SPL Document ID
2e671cf8-09be-ac40-e063-6294a90aaf8f
Open the linked representative label on DailyMed ↗
NDC package records associated with this linked SPL 1

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 2 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. BTG International Inc is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.