Vistogard

Last reviewed on RxList: 2/27/2019
Vistogard Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 2/27/2019

Vistogard (uridine triacetate) oral granules is a pyrimidine analog indicated for the emergency treatment of adult and pediatric patients following a fluorouracil or capecitabine overdose regardless of the presence of symptoms, or who exhibit early-onset, severe or life-threatening toxicity affecting the cardiac or central nervous system, and/or early-onset, unusually severe adverse reactions (e.g., gastrointestinal toxicity and/or neutropenia) within 96 hours following the end of fluorouracil or capecitabine administration. Common side effects of Vistogard include:

The recommended adult dose of Vistogard is 10 grams (1 packet) orally every 6 hours for 20 doses. Pediatric dose of Vistogard is based on body surface area. Vistogard may interact with other drugs. Tell your doctor all medications and supplements you use. During pregnancy, Vistogard should only be taken if prescribed. Tell your doctor if you are pregnant before taking Vistogard. It is unknown if Vistogard passes into breast milk or if it would affect a nursing baby. Consult your doctor before breastfeeding.

Our Vistogard (uridine triacetate) oral granules Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Vistogard Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives, itching; difficult breathing; swelling of your face, lips, tongue, or throat.

Common side effects may include:

  • nausea;
  • vomiting; or
  • diarrhea.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Vistogard (Uridine Triacetate Oral Granules)

Vistogard Professional Information

SIDE EFFECTS

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions and using a wide range of doses, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety of VISTOGARD was assessed in 135 patients (median age 59 years, 56% male) treated in 2 single-arm, open-label, multi-center trials. VISTOGARD was administered at 10 grams orally every 6 hours for 20 doses or at a body surface area adjusted dosage of 6.2 grams/m2 /dose for 20 doses in four patients between 1 and 7 years of age. The median duration of exposure was 4.8 days, with a median of 20 doses (range 1 to 23). VISTOGARD was discontinued for adverse reactions in two (1.4%) patients.

Serious adverse reactions and Grade ≥3 adverse reactions were seen in one patient receiving VISTOGARD (Grade 3 nausea and vomiting). Table 2 summarizes the adverse reactions that occurred in greater than 2% of patients in Studies 1 and 2 combined.

Table 2 Adverse Reactions in > 2% of Patients Receiving VISTOGARD in Studies 1 and 2

Adverse Reaction N=135 Patients
Vomiting 13 (10%)
Nausea 7 (5%)
Diarrhea 4 (3%)

Read the entire FDA prescribing information for Vistogard (Uridine Triacetate Oral Granules)

© Vistogard Patient Information is supplied by Cerner Multum, Inc. and Vistogard Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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