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Last reviewed on RxList: 11/28/2017
Valstar Side Effects Center

Last reviewed on RxList 11/28/2017

Valstar (valrubicin) is a cancer (antineoplastic) medication used to treat bladder cancer. Common side effects of Valstar include bladder irritation (symptoms such as pain, spasm, frequent urge to urinate, and blood in the urine), urinary incontinence, urinary tract infection, and nausea. Valstar usually will cause urine to turn a reddish color for about 24 hours following a dose. This is a normal, harmless side effect of Valstar and should not be mistaken for blood in the urine.

Valstar is recommended at a dose of 800 mg administered intravesically (instilled into the bladder) once a week for six weeks. Valstar may interact with "live" vaccines. Tell your doctor all medications and supplements you use. Valstar is not recommended for use during pregnancy. It may harm a fetus. If you become pregnant or think you may be pregnant, tell your doctor. Both males and females using this drug should use birth control (e.g., birth control pills, condoms) during treatment. Consult your doctor to discuss birth control. It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breastfeeding while using this drug is not recommended.

Our Valstar (valrubicin) 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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Valstar Consumer Information

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

Call your doctor at once if you have:

  • pain or burning when you urinate;
  • blood in your urine or painful urination lasting for longer than 24 hours; or
  • fever, stomach pain, nausea, diarrhea.

Common side effects may include:

  • red or pink urine within the first 24 hours after you receive valrubicin;
  • increased urge to urinate, urine leakage;
  • increase in night-time urinating; or
  • feeling like your bladder isn't completely empty.

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 Valstar (Valrubicin)


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Valstar Professional Information


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 receive all of the planned doses because of the occurrence of local bladder symptoms.

TABLE 1 displays the frequency of the local adverse reactions at baseline and during treatment among 179 patients who received 800 mg doses of VALSTAR in a multiple-cycle treatment regimen.

TABLE 1 Local Adverse Reactions Before and During Treatment with VALSTAR (N=179)

Adverse Reaction Before Treatment During 6-week Course of Treatment
Urinary Frequency 30% 61%
Dysuria 11% 56%
Urinary Urgency 27% 57%
Bladder Spasm 3% 31%
Hematuria 11% 29%
Bladder Pain 6% 28%
Urinary Incontinence 7% 22%
Cystitis 4% 15%
Nocturia 2% 7%
Local Burning Symptoms – Procedure Related 0% 5%
Urethral Pain 0% 3%
Pelvic Pain 1% 1%
Hematuria (Gross) 0% 1%

TABLE 2 displays the adverse reactions other than local bladder symptoms that occurred in 1% or more of the 230 patients who received at least one dose of VALSTAR in a clinical trial.

TABLE 2 Systemic Adverse Reactions (> 1%) Following Intravesical Administration of VALSTAR (N=230)

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%
Hemic and Lymphatic
Anemia 2%
Metabolic and Nutritional
Hyperglycemia 1%
Peripheral Edema 1%
Myalgia 1%
Dizziness 3%
Pneumonia 1%
Skin and Appendages
Rash 3%
Urinary Tract Infection 15%
Urinary Retention 4%
Hematuria (miscroscopic) 3%

Adverse reactions other than local reactions that occurred in less than 1% of the patients who received VALSTAR intravesically in clinical trials are listed below.

Digestive System: Tenesmus

Metabolic and Nutritional: Nonprotein nitrogen increased

Skin and Appendages: Pruritus

Special Senses: Taste loss

Urogenital System: Local skin irritation, poor urine flow, and urethritis

Read the entire FDA prescribing information for Valstar (Valrubicin)

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


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