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Table 4 The list of adverse drug reactions

From: Nalfurafine hydrochloride for refractory pruritus in peritoneal dialysis patients: a phase III, multi-institutional, non-controlled, open-label trial

  2.5-μg administration period 5-μg administration period 5-μg administration period + follow-up period Treatment period + follow-up period
N = 37 N = 35 N = 35 N = 37
Adverse drug reactions Number of patients (%) Number of patients (%) Number of patients (%) Number of patients (%)
Insomnia 3 (8.1) 2 (5.7) 2 (5.7) 5 (13.5)
Dizziness 1 (2.7) 0 (0.0) 0 (0.0) 1 (2.7)
Hypoaesthesia 1 (2.7) 0 (0.0) 0 (0.0) 1 (2.7)
Somnolence 3 (8.1) 0 (0.0) 0 (0.0) 3 (8.1)
Restless legs syndrome 0 (0.0) 1 (2.9) 1 (2.9) 1 (2.7)
Constipation 1 (2.7) 0 (0.0) 0 (0.0) 1 (2.7)
Gastrooesophageal reflux disease 0 (0.0) 1 (2.9) 1 (2.9) 1 (2.7)
Vomiting 1 (2.7) 1 (2.9) 1 (2.9) 2 (5.4)
Hypoaesthesia oral 1 (2.7) 0 (0.0) 0 (0.0) 1 (2.7)
Hepatic function abnormal 1 (2.7) 0 (0.0) 0 (0.0) 1 (2.7)
Drug eruption 1 (2.7) 0 (0.0) 0 (0.0) 1 (2.7)
Pruritus 1 (2.7) 0 (0.0) 0 (0.0) 1 (2.7)
Rash 1 (2.7) 0 (0.0) 0 (0.0) 1 (2.7)
Haematuria 1 (2.7) 0 (0.0) 0 (0.0) 1 (2.7)
Asthenia 1 (2.7) 0 (0.0) 0 (0.0) 1 (2.7)
Feeling hot 1 (2.7) 0 (0.0) 0 (0.0) 1 (2.7)
Aspartate aminotransferase increased 0 (0.0) 0 (0.0) 1 (2.9) 1 (2.7)
Blood prolactin increased 2 (5.4) 2 (5.7) 3 (8.6) 5 (13.5)
Blood testosterone free decreased 2 (5.4) 1 (2.9) 1 (2.9) 3 (8.1)