What the label lists and what reports show
Valrubicin side effects
Valrubicin's FDA label: “The most frequently reported adverse reactions ( > 5%) after administration of VALSTAR are urinary frequency, dysuria, urinary urgency, bladder spasm, hematuria, bladder pain, urinary incontinence, cystitis, urinary tract infection, nocturia, local burning …” FAERS holds 177 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 bladder instillation procedure (24 reports).
- Generic listed
Check it at the source: the valrubicin FDA label on DailyMed (effective October 31, 2024, Endo USA, Inc.); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsThe most frequently reported adverse reactions ( > 5%) after administration of VALSTAR are urinary frequency, dysuria, urinary urgency, bladder spasm, hematuria, bladder pain, urinary incontinence, cystitis, urinary tract infection, nocturia, local burning symptoms, abdominal pain, and nausea.
TABLE 2 Systemic Adverse Reactions (≥ 1%) Following Intravesical Administration of VALSTAR (N=230)
| Reaction | Body System Preferred Term Body as a Whole |
|---|---|
| Abdominal Pain | 5% |
| Asthenia | 4% |
| Headache | 4% |
| Malaise | 4% |
| Back Pain | 3% |
| Chest Pain | 3% |
| Fever | 2% |
| Vasodilation | 2% |
| Nausea | 5% |
| Diarrhea | 3% |
| Vomiting | 2% |
| Flatulence | 1% |
| Anemia | 2% |
| Hyperglycemia | 1% |
| Peripheral Edema | 1% |
| Myalgia | 1% |
| Dizziness | 3% |
| Pneumonia | 1% |
| Rash | 3% |
| Urinary Tract Infection | 15% |
| Urinary Retention | 4% |
| Hematuria (miscroscopic) | 3% |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe most frequently reported adverse reactions ( > 5%) after administration of VALSTAR are urinary frequency, dysuria, urinary urgency, bladder spasm, hematuria, bladder pain, urinary incontinence, cystitis, urinary tract infection, nocturia, local burning symptoms, abdominal pain, and nausea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Endo at 1-800-462-3636 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, 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 VALSTAR was assessed in 230 patients with transitional cell carcinoma of the bladder, including 205 patients who received multiple weekly doses. One hundred seventy-nine of the 205 patients received the approved dose and schedule of 800 mg weekly for multiple weeks. Approximately 84% of patients who received intravesical VALSTAR in clinical studies experienced local adverse reactions. The local adverse reactions associated with VALSTAR usually occur during or shortly after instillation and resolve within 1 to 7 days after the instillate is removed from the bladder. …
Source: FDA drug label, Endo USA, Inc., effective October 31, 2024 (SPL set e96f30a0-6662-11de-8f80-0002a5d5c51b), via openFDA; the full label on DailyMed
What do FAERS reports show?
177 reports list valrubicin among the medicines taken, each a report of something that happened, not proof the medicine caused it; 5 are coded as a death and 8 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 23 reactions below, 10 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
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Valrubicin: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions