BEDAQUILINE for Disseminated tuberculosis: Side Effects & Safety Data
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There are 30 adverse event reports in the FDA FAERS database where BEDAQUILINE was used for Disseminated 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)
Lymph node tuberculosis (20)
Atypical mycobacterial infection (13)
Bone tuberculosis (8)
Lung infection (7)
Other Drugs Used for Disseminated tuberculosis
RIFAMPIN (438)
ETHAMBUTOL (402)
ISONIAZID (399)
PYRAZINAMIDE (396)
MOXIFLOXACIN (129)
LEVOFLOXACIN (98)
LINEZOLID (87)
RIFABUTIN (64)
DEXAMETHASONE (53)
LEVETIRACETAM (26)