BCG VACCINE for Bladder cancer: Side Effects & Safety Data
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There are 135 adverse event reports in the FDA FAERS database where BCG VACCINE was used for Bladder cancer.
Most Reported Side Effects for BCG VACCINE
| Side Effect | Reports | % | Deaths | Hosp. |
|---|---|---|---|---|
| Disseminated bacillus calmette-guerin infection | 87 | 20.8% | 15 | 32 |
| Immune reconstitution inflammatory syndrome | 60 | 14.4% | 5 | 13 |
| Pyrexia | 39 | 9.3% | 5 | 18 |
| Drug ineffective | 35 | 8.4% | 15 | 21 |
| Off label use | 35 | 8.4% | 8 | 8 |
| Granuloma | 16 | 3.8% | 1 | 5 |
| Mycobacterial infection | 16 | 3.8% | 5 | 14 |
| Vaccination complication | 15 | 3.6% | 0 | 5 |
| Lymphadenopathy | 14 | 3.4% | 2 | 1 |
| Disease progression | 12 | 2.9% | 2 | 0 |
| Infection | 12 | 2.9% | 1 | 9 |
| Neutropenia | 12 | 2.9% | 1 | 1 |
| Skin lesion | 12 | 2.9% | 3 | 0 |
| Acute kidney injury | 11 | 2.6% | 1 | 3 |
| Bladder cancer | 11 | 2.6% | 0 | 2 |
Other Indications for BCG VACCINE
Immunisation (98)
Bladder transitional cell carcinoma (49)
Product used for unknown indication (30)
Transitional cell carcinoma (23)
Mantle cell lymphoma (9)
Prophylaxis (9)
Bladder neoplasm (7)
Other Drugs Used for Bladder cancer
BACILLUS CALMETTE-GUERIN SUBSTRAIN TICE LIVE ANTIGEN (1,279)
PEMBROLIZUMAB (869)
GEMCITABINE (841)
CISPLATIN (780)
ENFORTUMAB VEDOTIN-EJFV (530)
NIVOLUMAB (512)
ATEZOLIZUMAB (487)
CARBOPLATIN (332)
BACILLUS CALMETTE-GUERIN ANTIGEN, UNSPECIFIED SUBSTRAIN (326)
GEMCITABINE\GEMCITABINE (240)