July 29, 2016
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Valstar Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 3/05/2016

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Valstar in Detail - Patient Information: Side Effects

If you experience an allergic reaction (including difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives) to valrubicin, seek emergency medical attention.

Other, less serious side effects may be more likely to occur. Continue taking valrubicin and talk to your doctor if you experience:

  • bladder irritation (increased frequency of urination, painful urination, a very strong feeling of needing to urinate, blood in the urine);
  • urinary incontinence;
  • urinary tract infection;
  • red colored urine for 24 hours following a dose; or
  • nausea.

Talk to your doctor immediately if you have prolonged (longer than 24 hours after a dose) red-colored urine or prolonged bladder irritation.

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)

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Valstar Overview - Patient Information: Side Effects

SIDE EFFECTS: Bladder irritation, with symptoms such as pain, spasm, and frequent urge to urinate, usually occurs. This medication usually will cause your urine to turn a reddish color. This is a normal, harmless effect of the drug and should not be mistaken for blood in your urine. If any of these effects persist or worsen after 24 hours, contact your doctor immediately.

Infrequent side effects include nausea, abdominal/stomach pain, diarrhea, headache, weakness, dizziness, or back pain. If any of these effects persist or worsen, tell your doctor.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: bloody urine, signs of infection (e.g., fever, chills), unusual tiredness.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), trouble breathing, severe dizziness.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Valstar (Valrubicin)

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Valstar FDA Prescribing Information: Side Effects
(Adverse Reactions)


Approximately 84% of patients who received intravesical VALSTAR (valrubicin) in clinical studies experienced local adverse events, but approximately half of the patients reported irritable bladder symptoms prior to treatment. The local adverse reactions associated with VALSTAR (valrubicin) usually occur during or shortly after instillation and resolve within 1 to 7 days after the instillate is removed from the bladder.

TABLE 1 displays the frequency of the local adverse experiences at baseline and during treatment among 170 patients who received 800 mg doses of VALSTAR®(valrubicin) Sterile Solution for Intravesical Instillation in a multiple-cycle treatment regimen. Only 7 of 143 patients who were scheduled to receive six doses failed to receive all of the planned doses because of the occurrence of local bladder symptoms.

TABLE 1 - Occurrence of Local Adverse Reactions Before and During Treatment with Intravesical VALSTAR (valrubicin) (% of Patients)

Reaction Patients Who Received Multiple-Cycle Treatment Regimen at 800 mg/dose
(N = 170)
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%

Most systemic adverse events associated with use of VALSTAR (valrubicin) have been mild in nature and self-limited, resolving within 24 hours after drug administration. TABLE 2 displays the adverse events other than local bladder symptoms that occurred in 1% or more of the 230 patients who received at least one dose of VALSTAR (valrubicin) (200 to 900 mg) in a clinical trial. It cannot be determined whether these events are drug-related.

TABLE 2 - Most Commonly Reported Systemic Adverse Reactions Following Intravesical Administration of VALSTAR (valrubicin) (% of Patients)

Body System
Preferred Term
All Patients Who Received VALSTAR
(N = 230)
Body as a Whole
  Abdominal Pain 5%
  Asthenia 4%
  Back Pain 3%
  Chest Pain 3%
  Fever 2%
  Headache 4%
  Malaise 4%
  Vasodilation 2%
  Diarrhea 3%
  Flatulence 1%
  Nausea 5%
  Vomiting 2%
Hemic and Lymphatic
  Anemia 2%
Metabolic and Nutritional
  Hyperglycemia 1%
  Peripheral Edema 1%
  Myalgia 1%
  Dizziness 3%
  Pneumonia 1%
Skin and Appendages
  Rash 3%
  Hematuria (microscopic) 3%
  Urinary Retention 4%
  Urinary Tract Infection 15%

Adverse reactions other than local reactions that occurred in less than 1% of the patients who received VALSTAR (valrubicin) intravesically in clinical trials are listed below. This list includes only adverse reactions that were suspected of being related to treatment.

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.

Inadvertent paravenous extravasation of VALSTAR (valrubicin) was not associated with skin ulceration or necrosis.

Read the entire FDA prescribing information for Valstar (Valrubicin)

Valstar - User Reviews

Valstar User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Valstar sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration


You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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