Valrubicin Side Effects

Please note - some side effects for Valrubicin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Valrubicin - for the Consumer

Valrubicin

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Valrubicin:

Bladder pain or spasm; burning or discomfort of the urethra; headache; irritable bladder symptoms (eg, frequent or painful urination, urgent need to urinate); loss of bladder control; mild dizziness, weakness, or tiredness; nausea; stomach pain.

Severe allergic reactions (difficulty breathing; hives; itching; rash; swelling of the mouth, face, lips, or tongue; tightness in the chest); blood in the urine; chest pain; fever; inability to urinate; persistent red discoloration of the urine; severe or persistent bladder pain or spasms; severe or persistent painful urination, trouble urinating, or urinary urgency.

Side Effects by Body System

Local

Local adverse reactions associated with valrubicin usually occurred during or shortly after instillate and resolve within one to seven days after the instillation is removed from the bladder.

Local side effects including any local bladder symptom (88%) and procedure related burning symptoms (5%) have been reported.

Genitourinary

Genitourinary side effects including urinary frequency (61%), urinary urgency (57%), dysuria (56%), bladder spasm (31%), hematuria (29%), bladder pain (28%), urinary incontinence (22%), urinary tract infection (15%), cystitis (15%), nocturia (7%), urinary retention (4%), microscopic hematuria (3%), urethral pain (3%), pelvic pain (1%), and gross hematuria (1%) have been reported.

General

General side effects including abdominal pain (5%), asthenia (4%), headache (4%), malaise (4%), back pain (3%), chest pain (3%), and fever (2%) have been reported.

Gastrointestinal

Gastrointestinal side effects including nausea (5%), diarrhea (3%), vomiting (2%), and flatulence (1%) have been reported.

Nervous system

Nervous system side effects including dizziness (3%) have been reported.

Dermatologic

Dermatologic side effects including rash (3%) have been reported.

Cardiovascular

Cardiovascular side effects including vasodilation (2%) have been reported.

Hematologic

Hematologic side effects including anemia (2%) have been reported.

Metabolic

Metabolic side effects including hyperglycemia (1%) and peripheral edema (1%) have been reported.

Musculoskeletal

Musculoskeletal side effects including myalgia (1%) have been reported.

Respiratory

Respiratory side effects including pneumonia (1%) have been reported.

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