Tice BCG Side Effects

Generic name: bcg

Note: This document contains side effect information about bcg. Some of the dosage forms listed on this page may not apply to the brand name Tice BCG.

Some side effects of Tice BCG may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to bcg: intravesical powder for reconstitution

Get emergency medical help if you have any of these signs of an allergic reaction while taking bcg (the active ingredient contained in Tice BCG) hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Report any side effects to your doctor. Some side effects may be serious, including:

• fever, chills, cough, body aches, joint pain, weakness, vomiting, or other flu symptoms;

• nausea, vomiting, stomach pain, jaundice (yellowing of your skin or eyes);

• pain or burning when you urinate;

• difficult urination;

• more frequent or urgent urinating;

• blood in your urine, lower back pain;

• pain or swelling in your testicles;

• easy bruising or bleeding;

• eye pain, redness, watering, severe burning or itching; or

• vision changes, increased sensitivity to light.

Common side effects may include:

• mild nausea, stomach pain, or loss of appetite;

• mild bladder or groin pain;

• urine leakage or incontinence;

• diarrhea, constipation;

• headache;

• mild skin rash;

• dizziness, tired feeling; or

• tissue particles in your urine (not blood).

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

For Healthcare Professionals

Applies to bcg: intravesical powder for reconstitution, percutaneous powder for injection

Genitourinary

Genitourinary side effects including dysuria (54%), urinary frequency (40%), hematuria (39%), cystitis (29%), urinary tract infection (18%), urgency (18%), genital pain (10%), urinary incontinence (6%), cramps (6%), and contracted bladder (5%) were most commonly reported.

Nervous system

Nervous system side effects including malaise (40%) and arthralgia/myalgia (7%) have been reported.

Hematologic

Hematologic side effects including anemia (21%), leukopenia (5%), and coagulopathy (3%) have been reported.

Gastrointestinal

Gastrointestinal side effects including nausea/vomiting (16%), anorexia (11%), diarrhea (6%), and abdominal pain (3%) have been reported.

General

General side effects including fever (38%), chills (34%), and headache (2%) have been reported.

Immunologic

Immunologic side effects including systemic infection (3%) and pulmonary infection (3%) have been reported. Four cases of immune reconstitution syndrome have also been reported.

Renal

Renal side effects including renal toxicity (10%) have been reported.

Dermatologic

Dermatologic side effects including skin rash (2%) have been rarely reported.

Cardiovascular

Unclassified cardiovascular side effects were infrequently reported (3%).

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