Does BACILLUS CALMETTE-GUERIN SUBSTRAIN TICE LIVE ANTIGEN Cause Product availability issue? 235 Reports in FDA Database
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According to the FDA Adverse Event Reporting System (FAERS), 235 reports of Product availability issue have been filed in association with BACILLUS CALMETTE-GUERIN SUBSTRAIN TICE LIVE ANTIGEN (TICE BCG). This represents 12.1% of all adverse event reports for BACILLUS CALMETTE-GUERIN SUBSTRAIN TICE LIVE ANTIGEN.
How Dangerous Is Product availability issue From BACILLUS CALMETTE-GUERIN SUBSTRAIN TICE LIVE ANTIGEN?
Of the 235 reports, 2 (0.9%) resulted in death, 10 (4.3%) required hospitalization, and 2 (0.9%) were considered life-threatening.
Is Product availability issue Listed in the Official Label?
This adverse event is not currently listed in the official FDA drug label for BACILLUS CALMETTE-GUERIN SUBSTRAIN TICE LIVE ANTIGEN. However, 235 reports have been filed with the FAERS database.