Table 3

Risk of ADRs that need specific investigations from RCTs and prospective cohort studies

ADRsNo. of eventsNo. of studiesNo. of patientsPooled incidence of ADRs per 100 patients
Hepatobiliary disorders
 Biliary pseudolithiasis89643020.7
 Cholelithiasis62532918.8
 Biliary sludge3264417.3
 Serum bilirubin rise711704.1
 Transient elevation of glutamic oxaloacetic11333.0
 Impaired liver function111060.9
Subtotal 192
Blood and lymphatic disorders
 Thrombocytosis1926131.2
 Neutropaenia1452555.5
 Eosinophilia21345.9
Subtotal 35
Renal and urinary disorders
 Nephrolithiasis or kidney stone523701.4
 Urinary sludge11352.9
 Ureteral calculi11531.9
 Microscopic haematuria111060.9
Subtotal 8
Total 235
  • ADRs, adverse drug reactions; RCTs, randomised controlled trials.