BCG VACCINE for Bladder neoplasm: Side Effects & Safety Data
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There are 7 adverse event reports in the FDA FAERS database where BCG VACCINE was used for Bladder neoplasm.
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
Bladder cancer (135)
Immunisation (98)
Bladder transitional cell carcinoma (49)
Product used for unknown indication (30)
Transitional cell carcinoma (23)
Mantle cell lymphoma (9)
Prophylaxis (9)
Other Drugs Used for Bladder neoplasm
CISPLATIN (15)
GEMCITABINE (15)
CARBOPLATIN (14)
PEMBROLIZUMAB (13)
GEMCITABINE\GEMCITABINE (11)
BACILLUS CALMETTE-GUERIN SUBSTRAIN TICE LIVE ANTIGEN (10)
EPIRUBICIN (9)
ETOPOSIDE (7)
PAZOPANIB (7)
ATEZOLIZUMAB (6)