Nitazoxanide (n=194) | Placebo (n=198) | p value | |
Number of participants with at least one adverse event | 60 (30.9%) | 60 (30.4%) | 0.913 |
Number of participants with two adverse events | 22 (11.3%) | 18 (9.1%) | 0.507 |
Number of participants with three or more adverse events | 16 (8.2%) | 12 (6.1%) | 0.438 |
Number of participants with severe adverse event | 1 (0.5%) | 1 (0.5%) | 0.999 |
Number of participants discontinuing treatment because of moderate adverse events | 6 (3.1%) | 1 (0.5%) | 0.065 |
Detailed adverse events | |||
Diarrhea | 57 (29.4%) | 49 (24.7%) | 0.309 |
Headache | 34 (17.5%) | 32 (16.1%) | 0.787 |
Nausea | 28 (14.4%) | 29 (14.6%) | 0.999 |
Abdominal pain | 10 (5.2%) | 5 (2.5%) | 0.197 |
Abnormal color of urine | 11 (5.6%) | 3 (1.5%) | 0.031 |
Vomiting | 9 (4.6%) | 3 (1.5%) | 0.085 |
Pruritus | 4 (2.1%) | 1 (0.5%) | 0.212 |
Urticaria | 1 (0.5%) | 3 (1.5%) | 0.623 |
Data are n (%) and include all adverse events reported after nitazoxanide or placebo.