Does BEDAQUILINE Cause Ototoxicity? 27 Reports in FDA Database
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According to the FDA Adverse Event Reporting System (FAERS), 27 reports of Ototoxicity have been filed in association with BEDAQUILINE (SIRTURO). This represents 0.7% of all adverse event reports for BEDAQUILINE.
27
Reports of Ototoxicity with BEDAQUILINE
0.7%
of all BEDAQUILINE reports
1
Deaths
8
Hospitalizations
How Dangerous Is Ototoxicity From BEDAQUILINE?
Of the 27 reports, 1 (3.7%) resulted in death, 8 (29.6%) required hospitalization, and 1 (3.7%) were considered life-threatening.
Is Ototoxicity Listed in the Official Label?
This adverse event is not currently listed in the official FDA drug label for BEDAQUILINE. However, 27 reports have been filed with the FAERS database.
What Other Side Effects Does BEDAQUILINE Cause?
Electrocardiogram qt prolonged (593)
Off label use (419)
Anaemia (359)
Vomiting (294)
Neuropathy peripheral (259)
Hepatotoxicity (254)
Death (241)
Nausea (236)
Dyspnoea (200)
Intentional product use issue (181)
What Other Drugs Cause Ototoxicity?
CISPLATIN (273)
CARBOPLATIN (208)
VINCRISTINE (194)
AMIKACIN (158)
ETOPOSIDE (121)
GENTAMICIN (108)
CYCLOSPORINE (105)
VANCOMYCIN (87)
LINEZOLID (82)
TOBRAMYCIN (78)
Which BEDAQUILINE Alternatives Have Lower Ototoxicity Risk?
BEDAQUILINE vs BELANTAMAB MAFODOTIN
BEDAQUILINE vs BELANTAMAB MAFODOTIN-BLMF
BEDAQUILINE vs BELATACEPT
BEDAQUILINE vs BELIMUMAB
BEDAQUILINE vs BELINOSTAT