Does BISMUTH SUBGALLATE Cause Off label use? 6 Reports in FDA Database
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According to the FDA Adverse Event Reporting System (FAERS), 6 reports of Off label use have been filed in association with BISMUTH SUBGALLATE (Devrom). This represents 28.6% of all adverse event reports for BISMUTH SUBGALLATE.
6
Reports of Off label use with BISMUTH SUBGALLATE
28.6%
of all BISMUTH SUBGALLATE reports
6
Deaths
6
Hospitalizations
How Dangerous Is Off label use From BISMUTH SUBGALLATE?
Of the 6 reports, 6 (100.0%) resulted in death, 6 (100.0%) required hospitalization, and 6 (100.0%) were considered life-threatening.
Is Off label use Listed in the Official Label?
This adverse event is not currently listed in the official FDA drug label for BISMUTH SUBGALLATE. However, 6 reports have been filed with the FAERS database.
What Other Side Effects Does BISMUTH SUBGALLATE Cause?
Abdominal distension (9)
Vomiting (9)
Blood uric acid increased (8)
Dyspnoea (8)
Product use in unapproved indication (7)
Stress (7)
Abdominal pain (6)
Anaemia (6)
Appendicitis (6)
Appendicolith (6)
What Other Drugs Cause Off label use?
RITUXIMAB (39,751)
INFLIXIMAB (34,801)
DENOSUMAB (34,612)
METHOTREXATE (24,020)
VEDOLIZUMAB (21,017)
ETANERCEPT (20,178)
TOCILIZUMAB (18,256)
PREDNISONE (17,867)
LENALIDOMIDE (17,017)
ADALIMUMAB (16,417)