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VISTOGARD

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name
VISTOGARD
Generic name
URIDINE TRIACETATE
Manufacturer
BTG International Inc
Product type
HUMAN PRESCRIPTION DRUG
SPL set ID
269f7363-63ed-444e-85f1-f0009e44818b
SPL ID
4e4e69bd-abb4-4632-e063-6394a90ab642
Version
3
Effective date
2026-03-31
Source export date
2026-09-28
Source partition
2
Source file
https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/f7d2b6e3f8600cd856280ab55a9c6fa54a642647191d164f9d1110e89f3f4097/drug-label-0002-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:15:44
Harmonized routes table
Harmonized routes
ORAL

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings and cautions

5 WARNINGS AND PRECAUTIONS None. None. ( 5 )

Adverse reactions cross-check#

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Adverse reactions sections page 1 of 1 · 2 matching rows.

adverse reactions

6 ADVERSE REACTIONS Adverse reactions occurring in >2% of patients receiving VISTOGARD included vomiting, nausea, and diarrhea. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact BTG International Inc at (1-877-377-3784) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 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/m 2 /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%)

adverse reactions table

<table width="60%"><caption>Table 2 Adverse Reactions in &gt; 2% of Patients Receiving VISTOGARD in Studies 1 and 2</caption><col width="50%" align="center" valign="middle"/><col width="50%" align="center" valign="middle"/><thead><tr><th>Adverse Reaction</th><th>N=135 Patients</th></tr></thead><tbody><tr><td>Vomiting</td><td>13 (10%)</td></tr><tr><td>Nausea</td><td>7 (5%)</td></tr><tr><td>Diarrhea</td><td>4 (3%)</td></tr></tbody></table>

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.