Table 3. Most frequent adverse reactions reported in patients treated for complicated urinary tract infections, including pyelonephritis, in the phase 3 clinical trials 1.
| Adverse reaction | Ceftolozane/tazobactama (n = 533) | Levofloxacin (n = 535) |
| Headache | 5.8% | 4.9% |
| Constipation | 3.9% | 3.2% |
| Nausea | 2.8% | 1.7% |
| Diarrhea | 1.9% | 4.3% |
| Pyrexia | 1.7% | 0.9% |
| ALT increased | 1.7% | 0.9% |
| AST increased | 1.7% | 0.9% |
| Insomnia | 1.3% | 2.6% |
| Vomiting | 1.1% | 1.1% |
| Dizziness | 1.1% | 0.2% |
| Rash | 0.9% | 0.4% |
| Hypokalemia | 0.8% | 0.4% |
| Abdominal pain | 0.8% | 0.4% |
| Anemia | 0.4% | 0.9% |
| Thrombocytosis | 0.4% | 0.4% |
| Hypotension | 0.4% | 0.2% |
| Anxiety | 0.2% | 0.7% |
| Atrial fibrillation | 0.2% | 0 |
Note: ALT = alanine transaminase; AST = aspartate aminotransferase.
a
Ceftolozane 1 g/tazobactam 0.5 g IV every 8 hours, adjusted for decreased renal function if necessary.