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What the label lists and what reports show

Uridine triacetate side effects

Uridine triacetate's FDA label lists its adverse reactions in its own words. FAERS holds 139 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is complication associated with device (22 reports).

  • No generic listed

Check it at the source: the uridine triacetate FDA label on DailyMed (effective March 31, 2026, BTG International Inc); the FDA FAERS public dashboard.

What does the patient leaflet say about side effects?

From the patient leaflet: What are the possible side effects of VISTOGARD?

Common side effects of VISTOGARD include: vomiting, nausea, and diarrhea. These are not all the possible side effects of VISTOGARD. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Source: FDA drug label, NDA208159 (Btg Intl), as published by BTG International Inc, effective March 31, 2026 (SPL set 269f7363-63ed-444e-85f1-f0009e44818b), via openFDA; the full label on DailyMed

What does the label list?

From the label: 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. …

Source: FDA drug label, NDA208159 (Btg Intl), as published by BTG International Inc, effective March 31, 2026 (SPL set 269f7363-63ed-444e-85f1-f0009e44818b), via openFDA; the full label on DailyMed

What do FAERS reports show?

139 reports list uridine triacetate among the medicines taken, each a report of something that happened, not proof the medicine caused it; 27 are coded as a death and 32 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. Of the 18 reactions below, 3 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.

The 25 most reported reactions

  • Complication Associated With Device22
  • Diarrhoea (named in the label)21
  • Vomiting (named in the label)21
  • Off Label Use (a use or a product term, not a reaction)16
  • Thrombocytopenia13
  • Mucosal Inflammation12
  • Nausea (named in the label)12
  • Death (an outcome recorded in the report)10
  • Neutropenia (a use or a product term, not a reaction)10
  • Hypokalaemia8
  • Inappropriate Schedule Of Product Administration (a use or a product term, not a reaction)8
  • Asthenia7
  • Dysphagia6
  • Product Dose Omission Issue (a use or a product term, not a reaction)6
  • Decreased Appetite5
  • Stomatitis5
  • Toxicity To Various Agents5
  • Weight Decreased5
  • Dehydration4
  • Drug Ineffective (a use or a product term, not a reaction)4
  • Medication Error (a use or a product term, not a reaction)4
  • Pancytopenia4
  • Abdominal Pain3
  • Blood Creatinine Increased3
  • Dizziness3

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Uridine triacetate: the full record
label, generics, price, shortages, recalls
Side effects hub
the most reported medicines and reactions