Does BCG VACCINE Cause Sepsis? 8 Reports in FDA Database

Q: Does BCG VACCINE cause Sepsis?

8 reports of Sepsis have been filed with the FDA for BCG VACCINE, representing 1.9% of all BCG VACCINE adverse event reports.

Q: How dangerous is Sepsis from BCG VACCINE?

Of 8 reports, 6 (75.0%) resulted in death and 5 required hospitalization.

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According to the FDA Adverse Event Reporting System (FAERS), 8 reports of Sepsis have been filed in association with BCG VACCINE. This represents 1.9% of all adverse event reports for BCG VACCINE.

Reports of Sepsis with BCG VACCINE

1.9%

of all BCG VACCINE reports

Deaths

Hospitalizations

How Dangerous Is Sepsis From BCG VACCINE?

Of the 8 reports, 6 (75.0%) resulted in death, 5 (62.5%) required hospitalization.

Is Sepsis Listed in the Official Label?

This adverse event is not currently listed in the official FDA drug label for BCG VACCINE. However, 8 reports have been filed with the FAERS database.

What Other Side Effects Does BCG VACCINE Cause?

Disseminated bacillus calmette-guerin infection (87) Immune reconstitution inflammatory syndrome (60) Pyrexia (39) Drug ineffective (35) Off label use (35) Granuloma (16) Mycobacterial infection (16) Vaccination complication (15) Lymphadenopathy (14) Disease progression (12)

What Other Drugs Cause Sepsis?

RITUXIMAB (4,043) CYCLOPHOSPHAMIDE (4,041) METHOTREXATE (3,933) ADALIMUMAB (3,169) DEXAMETHASONE (3,150) LENALIDOMIDE (2,956) VINCRISTINE (2,791) DOXORUBICIN (2,740) PREDNISONE (2,634) PREDNISOLONE (2,281)

Which BCG VACCINE Alternatives Have Lower Sepsis Risk?

BCG VACCINE vs BEBTELOVIMAB BCG VACCINE vs BECLOMETHASONE BCG VACCINE vs BECLOMETHASONE DIPROPIONATE BCG VACCINE vs BECLOMETHASONE DIPROPIONATE\FORMOTEROL BCG VACCINE vs BECLOMETHASONE\FORMOTEROL

BCG VACCINE Full Profile All Sepsis Reports All Drugs Causing Sepsis BCG VACCINE Demographics