TABLE 3

Adverse Events

Nitazoxanide (n=194)Placebo (n=198)p value
Number of participants with at least one adverse event60 (30.9%)60 (30.4%)0.913
Number of participants with two adverse events22 (11.3%)18 (9.1%)0.507
Number of participants with three or more adverse events16 (8.2%)12 (6.1%)0.438
Number of participants with severe adverse event1 (0.5%)1 (0.5%)0.999
Number of participants discontinuing treatment because of moderate adverse events6 (3.1%)1 (0.5%)0.065
Detailed adverse events
 Diarrhea57 (29.4%)49 (24.7%)0.309
 Headache34 (17.5%)32 (16.1%)0.787
 Nausea28 (14.4%)29 (14.6%)0.999
 Abdominal pain10 (5.2%)5 (2.5%)0.197
 Abnormal color of urine11 (5.6%)3 (1.5%)0.031
 Vomiting9 (4.6%)3 (1.5%)0.085
 Pruritus4 (2.1%)1 (0.5%)0.212
 Urticaria1 (0.5%)3 (1.5%)0.623

Data are n (%) and include all adverse events reported after nitazoxanide or placebo.