Table 6.
Most frequently (≥2%) occurring adverse events from pooled phase 3 clinical studies of third-generation tetracycline-class drugs [10,12,77].
| Indication | Adverse event | Tetracycline-class agent | Comparator |
|---|---|---|---|
| Omadacycline | |||
| ABSSSI, CABP | N = 1073 | N = 1077a | |
| Nausea | 15% | 8% | |
| Vomiting | 8% | 3% | |
| ALT increased | 4% | 4% | |
| AST increased | 3% | 4% | |
| Headache | 3% | 2% | |
| Infusion-site extravasation | 3% | 2% | |
| Wound infection | 3% | 2% | |
| Cellulitis | 3% | 2% | |
| Diarrhoea | 2% | 5% | |
| Subcutaneous abscess | 2% | 3% | |
| Hypertension | 2% | 1% | |
| Tigecycline | |||
| CABP, cSSSI, cIAI | N = 2514 | N = 2307b | |
| Nausea | 26% | 13% | |
| Vomiting | 18% | 9% | |
| Diarrhoea | 12% | 11% | |
| Infection | 7% | 5% | |
| Abdominal pain | 6% | 4% | |
| Headache | 6% | 7% | |
| SGPT increased | 5% | 5% | |
| Anemia | 5% | 6% | |
| Hypoproteinemia | 5% | 3% | |
| SGOT increased | 4% | 5% | |
| Phlebitis | 3% | 4% | |
| Rash | 3% | 4% | |
| Alkaline phosphatase increased | 3% | 3% | |
| Dizziness | 3% | 3% | |
| Asthenia | 3% | 2% | |
| Amylase increased | 3% | 2% | |
| Abnormal healing | 3% | 2% | |
| BUN increased | 3% | 1% | |
| Abscess | 2% | 2% | |
| Dyspepsia | 2% | 2% | |
| Pneumonia | 2% | 2% | |
| Bilirubinemia | 2% | 1% | |
| Hyponatremia | 2% | 1% | |
| Eravacycline | |||
| cIAI | N = 520 | N = 517c | |
| Infusion-site reactions | 8% | 2% | |
| Nausea | 7% | 0.6% | |
| Vomiting | 4% | 3% | |
| Diarrhoea | 2% | 2% | |
a
Comparators: linezolid, moxifloxacin.
b
Comparators: vancomycin–aztreonam, imipenem–cilastatin, levofloxacin, linezolid.
c
Comparators: ertapenem, meropenem.
ABSSSI: acute bacterial skin and skin structure infection; ALT: alanine aminotransferase; AST: aspartate aminotransferase; BUN: blood urea nitrogen; CABP: community-acquired bacterial pneumonia; cIAI: complicated intra-abdominal infection; cSSSI: complication skin and skin structure infection; SGOT: serum glutamic oxaloacetic transaminase; SGPT: serum glutamic pyruvic transaminase.