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Table 2 Confirmed ADRs

From: Adverse drug reactions in South African patients receiving bedaquiline-containing tuberculosis treatment: an evaluation of spontaneously reported cases

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)
  1. a Multiple drug suspects may be implicated in an ADR