Tice BCG Vaccine Side Effects

Please note - some side effects for Tice BCG Vaccine 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 by Body System

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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