BEDAQUILINE for Extrapulmonary tuberculosis: Side Effects & Safety Data
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There are 5 adverse event reports in the FDA FAERS database where BEDAQUILINE was used for Extrapulmonary tuberculosis.
Most Reported Side Effects for BEDAQUILINE
| Side Effect | Reports | % | Deaths | Hosp. |
|---|---|---|---|---|
| Electrocardiogram qt prolonged | 593 | 16.2% | 112 | 183 |
| Off label use | 419 | 11.5% | 98 | 153 |
| Anaemia | 359 | 9.8% | 89 | 166 |
| Vomiting | 294 | 8.0% | 92 | 138 |
| Neuropathy peripheral | 259 | 7.1% | 29 | 58 |
| Hepatotoxicity | 254 | 7.0% | 8 | 44 |
| Death | 241 | 6.6% | 241 | 54 |
| Nausea | 236 | 6.5% | 54 | 95 |
| Dyspnoea | 200 | 5.5% | 121 | 121 |
| Intentional product use issue | 181 | 5.0% | 67 | 79 |
| Tuberculosis | 173 | 4.7% | 113 | 44 |
| Aspartate aminotransferase increased | 122 | 3.3% | 31 | 50 |
| Respiratory failure | 116 | 3.2% | 102 | 52 |
| Diarrhoea | 112 | 3.1% | 48 | 45 |
| Hypokalaemia | 112 | 3.1% | 35 | 52 |
Other Indications for BEDAQUILINE
Tuberculosis (2,546)
Pulmonary tuberculosis (615)
Product used for unknown indication (249)
Mycobacterium avium complex infection (43)
Mycobacterial infection (34)
Mycobacterium abscessus infection (32)
Disseminated tuberculosis (30)
Lymph node tuberculosis (20)
Atypical mycobacterial infection (13)
Bone tuberculosis (8)
Other Drugs Used for Extrapulmonary tuberculosis
ISONIAZID (67)
ETHAMBUTOL (54)
PYRAZINAMIDE (52)
RIFAMPIN (45)
LINEZOLID (21)
CLOFAZIMINE (16)
MOXIFLOXACIN (13)
CYCLOSERINE (10)
DELAMANID (10)
LEVOFLOXACIN (8)