Valrubicin: uses, dosing, side effects & brands
Valrubicin is a medicine sold in the U.S. under one brand, for urinary bladder neoplasms. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Treats
- Urinary Bladder Neoplasms
- Available as
- Solution
- Sold as
- Valstar Preservative Free
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
How valrubicin is dosed
From the FDA label for Valstar Preservative Free (application NDA020892). Other valrubicin products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
For Intravesical Use Only. ( 2.1 ) VALSTAR is recommended at a dose of 800 mg administered intravesically once a week for six weeks. ( 2.1 ) Delay administration at least two weeks after transurethral resection and/or fulguration. ( 2.1 ) Warm VALSTAR slowly to room temperature, but do not heat. ( 2.1 ) Use caution when handling and preparing the solution of VALSTAR. ( 2.2 ) 2.1 Recommended Dosing For Intravesical Use Only. Do NOT administer by intravenous or intramuscular routes. VALSTAR is recommended at a dose of 800 mg administered intravesically once a week for six weeks. Delay administration at least two weeks after transurethral resection and/or fulguration [ see Warnings and Precautions ( 5.2 , 5.3 )]. 2.2 Preparation, Handling, and Administration Handle and dispose of VALSTAR in a manner consistent with other cytotoxic drugs. 1 The use of goggles, gloves, and protective gowns is recommended during preparation and administration of the drug. VALSTAR contains polyoxyl castor oil, which has been known to cause leaching of di(2-ethylhexyl) phthalate (DEHP) a hepatotoxic plasticizer, from polyvinyl chloride (PVC) bags and intravenous tubing. VALSTAR should be prepared and stored in glass, polypropylene, or polyolefin containers and tubing. It is recommended that non-DEHP containing administration sets, such as those that are polyethylene-lined, be used. VALSTAR is a…
Valrubicin side effects
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 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. Seven out of 143 patients (5%) who were scheduled to receive six doses of VALSTAR failed to…
Who shouldn’t take valrubicin
VALSTAR is contraindicated in patients with: Perforated bladder [ see Warnings and Precautions ( 5.2 )] Known hypersensitivity to anthracyclines or polyoxyl castor oil Active urinary tract infection Small bladder capacity and unable to tolerate a 75 mL instillation Perforated bladder or compromised bladder mucosa ( 4 , 5.2 ) Hypersensitivity to anthracyclines or polyoxyl castor oil. ( 4 ) Concurrent urinary tract infections. ( 4 ) Patients with a small bladder capacity unable to tolerate a 75 mL instillation. ( 4 )
Valrubicin drug interactions
No drug interaction studies were conducted.
Every valrubicin product we track (1)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
Only one: Valstar Preservative Free.
What people report to the FDA about valrubicin
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 12 reports naming valrubicin, and the FDA flagged 50% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- bladder pain2 reports
- bladder spasm2 reports
- micturition urgency2 reports
- pollakiuria2 reports
- abasia1 reports
- ageusia1 reports
- asthenia1 reports
- bladder cancer1 reports
Read these as a signal, not a rate. A report does not mean valrubicin caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved July 26, 2026.
Related calculators
Frequently asked questions
What is valrubicin?
VALSTAR contains valrubicin (N-trifluoroacetyladriamycin-14-valerate), which is a semisynthetic analog of the anthracycline doxorubicin as a cytotoxic agent.
Can you take valrubicin with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run valrubicin against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What forms does valrubicin come in?
Across the brands we track, valrubicin is currently marketed as solution, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic valrubicin?
We do not currently list a generic-labelled valrubicin product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.
Cite this page
- APA
- pharmaranks. (2026, July 24). Valrubicin: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/valrubicin
- MLA
- “Valrubicin: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/valrubicin.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for valrubicin on DailyMed (NIH) ↗.