Table 2 Confirmed ADRs
Organ system | ADR | Number of reports | Number of patients who died in whom ADR occurred (number of deaths in which ADR was implicated) | Implicated drugsa (number of reports in which drug implicated) |
|---|---|---|---|---|
Cardiovascular | Sudden death -suspected arrhythmia | 4 | 4 (4) | Bedaquiline (4) |
Clofazimine (4) | ||||
Levofloxacin (4) | ||||
QTcF prolongation | 8 | 1 (0) | Bedaquiline (8) | |
Clofazimine (7) | ||||
Levofloxacin (6) | ||||
Moxifloxacin (1) | ||||
Skin | Acneiform rash | 2 | 0 | Bedaquiline (2) |
Clofazimine (2) | ||||
Emtricitabine (1) | ||||
Ethionamide (1) | ||||
Isoniazid (1) | ||||
Levofloxacin (2) | ||||
Linezolid (2) | ||||
Lopinavir/ritonavir (1) | ||||
Para-aminosalicylic acid (2) | ||||
Pyrazinamide (2) | ||||
Tenofovir (1) | ||||
Terizidone (2) | ||||
Itchy rash | 1 | 0 | Bedaquiline (1) | |
Clofazimine (1) | ||||
Linezolid (1) | ||||
Para-aminosalicylic acid (1) | ||||
Pustular facial rash | 3 | 0 | Bedaquiline (3) | |
Clofazimine (3) | ||||
Ethionamide (1) | ||||
Isoniazid (1) | ||||
Lamivudine (1) | ||||
Levofloxacin (3) | ||||
Linezolid (3) | ||||
Nevirapine (1) | ||||
Para-aminosalicylic acid (3) | ||||
Pyrazinamide (3) | ||||
Tenofovir (1) | ||||
Terizidone (3) | ||||
Rash | 1 | 0 | Bedaquiline (1) | |
Clofazimine (1) | ||||
Isoniazid (1) | ||||
Levofloxacin (1) | ||||
Linezolid (1) | ||||
Para-aminosalicylic acid (1) | ||||
Pyrazinamide (1) | ||||
Terizidone (1) | ||||
Gastrointestinal | Antibiotic-associated diarrhoea | 2 | 2 (2) | Levofloxacin (1) |
Moxifloxacin (1) | ||||
Musculoskeletal | Arthralgia | 3 | 0 | Bedaquiline (3) |
Levofloxacin (1) | ||||
Para-aminosalicylic acid (3) | ||||
Pyrazinamide (2) | ||||
Haematological | Increased bleeding risk | 1 | 1 (1) | Warfarin (1) |
Pancytopenia | 1 | 1 (1) | Linezolid (1) | |
Neurologic | Psychosis | 1 | 0 | Levofloxacin (1) |
Terizidone (1) | ||||
Seizure | 1 | 1 (1) | Moxifloxacin (1) | |
Renal | Renal failure | 2 | 2 (2) | Kanamycin (2) |