BCG Side Effects

Brand Names: BCG Vaccine, TheraCys, Theracys

Please note - some side effects for BCG may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of BCG - for the Consumer

BCG Live

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 BCG Live:

Diarrhea; increased pain or frequency of urination; loss of appetite; nausea; stomach pain.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood in urine; burning or pain when urinating; chills; cough; fever; flu-like symptoms; frequent or urgent urination; general feeling of discomfort; joint pain; tiredness; vomiting.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Side Effects by Body System - for Healthcare Professionals

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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