Table 7.

Occurrence of adverse drug reactions by safety specification category

Safety specifications	Number of patients
Preferred term
Acute hepatic failure and hepatic function disorder	226
Acute hepatic failure	1
Alanine aminotransferase abnormal	1
Alanine aminotransferase increased	9
Aspartate aminotransferase abnormal	1
Aspartate aminotransferase increased	11
Gamma-glutamyltransferase increased	15
Hepatic function abnormal	136
Hepatic steatosis	1
Hepatitis acute	1
Hyperbilirubinaemia	2
Liver disorder	50
Liver function test abnormal	2
Transaminases increased	1
Hepatic enzyme increased	11
Drug-induced liver injury	5
Hepatic cancer	1
Liver function test increased	3
Thirst	133
Lip dry	1
Thirst	133
Hypernatraemia	81
Blood sodium increased	7
Hypernatraemia	74
Renal failure and impairment	80
Azotaemia	0
Blood creatinine increased	18
Blood urea increased	14
Glomerular filtration rate decreased	2
Renal disorder	2
Renal failure	11
Protein urine present	1
Postrenal failure	1
Renal impairment	36
Chronic kidney disease	3
Acute kidney injury	3
Prerenal failure	2
End stage renal disease	1
Hyperkalaemia	23
Blood potassium increased	4
Hyperkalaemia	13
Muscle spasms	6
Dehydration	17
Dehydration	16
Weight decreased	2
Thrombosis and thromboembolism	7
Cerebellar infarction	1
Cerebral infarction	2
Disseminated intravascular coagulation	1
Pulmonary embolism	2
Retinal artery occlusion	1