Table 5.

Safety of azathioprine for all patients with ITP

Adverse events∗All grades, n (%)Grade 3 or higher, n (%)
Any side effects 68 (73.9%) 20 (21.7%) 
Nausea/vomiting 28 (30.4%) 5 (5.4%) 
Infections 19 (20.7%) 3 (3.3%) 
Fatigue 19 (20.7%) 2 (2.2%) 
Myelosuppression  14 (15.2%) 6 (6.5%) 
Diarrhea 13 (14.1%) 3 (3.3%) 
Abdominal pain 12 (13.0%) 1 (1.1%) 
Weight loss 8 (8.7%) 1 (1.1%) 
Hepatotoxicity  7 (7.6%) 3 (3.3%) 
Fevers 4 (4.3%) 0 (0.0%) 
Night sweats 3 (3.3%) 0 (0.0%) 
Rash 3 (3.3%) 0 (0.0%) 
Malignancy 1 (1.1%) 1 (1.1%) 
Others 25 (27.2%) 5 (5.4%) 
Pancreatitis  
Acute kidney injury  
Arrhythmia  
Management of side effects  n (%) 
Dose reduction  9 (13.2%) 
Treatment of side effects  1 (1.5%) 
Discontinuation  31 (45.6%) 
Adverse events∗All grades, n (%)Grade 3 or higher, n (%)
Any side effects 68 (73.9%) 20 (21.7%) 
Nausea/vomiting 28 (30.4%) 5 (5.4%) 
Infections 19 (20.7%) 3 (3.3%) 
Fatigue 19 (20.7%) 2 (2.2%) 
Myelosuppression  14 (15.2%) 6 (6.5%) 
Diarrhea 13 (14.1%) 3 (3.3%) 
Abdominal pain 12 (13.0%) 1 (1.1%) 
Weight loss 8 (8.7%) 1 (1.1%) 
Hepatotoxicity  7 (7.6%) 3 (3.3%) 
Fevers 4 (4.3%) 0 (0.0%) 
Night sweats 3 (3.3%) 0 (0.0%) 
Rash 3 (3.3%) 0 (0.0%) 
Malignancy 1 (1.1%) 1 (1.1%) 
Others 25 (27.2%) 5 (5.4%) 
Pancreatitis  
Acute kidney injury  
Arrhythmia  
Management of side effects  n (%) 
Dose reduction  9 (13.2%) 
Treatment of side effects  1 (1.5%) 
Discontinuation  31 (45.6%) 

∗As per the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0.

Defined as any increase in aspartate aminotransferase or alanine aminotransferase above the upper limits of the reference range at our institution, which were 33 U/L and 32 U/L, respectively.

Defined as any decrease in hemoglobin levels, neutrophil count, or lymphocyte count below the lower limits of the reference range at our institution, which were 115 g/L, 2.0 × 109/L, and 1.0 × 109/L, respectively; patients who had established cytopenias before azathioprine initiation were omitted.

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