Table 2. Most frequent adverse reactions reported in patients with complicated intra-abdominal infections treated in the phase 3 clinical trials 1.
Adverse reaction | Ceftolozane/tazobactama (n = 482) | Meropenem (n = 497) |
Nausea | 7.9% | 5.8% |
Diarrhea | 6.2% | 5% |
Pyrexia | 5.6% | 4% |
Insomnia | 3.5% | 2.2% |
Vomiting | 3.3% | 4% |
Hypokalemia | 3.3% | 2% |
Headache | 2.5% | 1.8% |
Constipation | 1.9% | 1.2% |
Thrombocytosis | 1.9% | 1% |
Anxiety | 1.9% | 1.4% |
Hypotension | 1.7% | 0.8% |
Rash | 1.7% | 1.4% |
ALT increased | 1.5% | 1% |
Anemia | 1.5% | 1% |
Abdominal pain | 1.2% | 0.4% |
Atrial fibrillation | 1.2% | 0.6% |
AST increased | 1% | 0.6% |
Dizziness | 0.8% | 1% |
Note: ALT = alanine transaminase; AST = aspartate aminotransferase.
Ceftolozane/tazobactam 1 g/0.5 g IV every 8 hours, adjusted for decreased renal function if necessary. The ceftolozane/tazobactam was given in conjunction with metronidazole.