Does BEDAQUILINE Cause Off label use? 419 Reports in FDA Database
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According to the FDA Adverse Event Reporting System (FAERS), 419 reports of Off label use have been filed in association with BEDAQUILINE (SIRTURO). This represents 11.5% of all adverse event reports for BEDAQUILINE.
419
Reports of Off label use with BEDAQUILINE
11.5%
of all BEDAQUILINE reports
98
Deaths
153
Hospitalizations
How Dangerous Is Off label use From BEDAQUILINE?
Of the 419 reports, 98 (23.4%) resulted in death, 153 (36.5%) required hospitalization, and 36 (8.6%) 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 BEDAQUILINE. However, 419 reports have been filed with the FAERS database.
What Other Side Effects Does BEDAQUILINE Cause?
Electrocardiogram qt prolonged (593)
Anaemia (359)
Vomiting (294)
Neuropathy peripheral (259)
Hepatotoxicity (254)
Death (241)
Nausea (236)
Dyspnoea (200)
Intentional product use issue (181)
Tuberculosis (173)
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)
Which BEDAQUILINE Alternatives Have Lower Off label use Risk?
BEDAQUILINE vs BELANTAMAB MAFODOTIN
BEDAQUILINE vs BELANTAMAB MAFODOTIN-BLMF
BEDAQUILINE vs BELATACEPT
BEDAQUILINE vs BELIMUMAB
BEDAQUILINE vs BELINOSTAT