| Parameter, n (%) | Rifaximin (n = 952) | Placebo (n = 942) |
| Any AE | 480 (50.4) | 477 (50.6) |
| Severe AEs | 39 (4.1) | 59 (6.3) |
| Drug-related AEs | 81 (8.5) | 109 (11.6) |
| Serious AEs | 14 (1.5) | 19 (2.0) |
| AEs leading to study discontinuation | 9 (0.9) | 9 (1.0) |
| Upper respiratory tract infection | 47 (4.9) | 47 (5.0) |
| Headache | 42 (4.4) | 51 (5.4) |
| Nausea | 39 (4.1) | 31 (3.3) |
| Diarrhea | 34 (3.6) | 25 (2.7) |
| Abdominal pain | 32 (3.4) | 37 (3.9) |
| Nasopharyngitis | 29 (3.0) | 43 (4.6) |
| Sinusitis | 24 (2.5) | 23 (2.4) |
| Urinary tract infection | 23 (2.4) | 26 (2.8) |
| Bronchitis | 22 (2.3) | 22 (2.3) |
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