Table 3.
Adverse events (AE) associated with anidulafungin use in clinical trials
| Anidulafungin 50 mg (Esophagitis Study) N = 300(%) |
Anidulafungin 100 mg (Candidemia Study) N = 131(%) |
|
|---|---|---|
| Patients with ≥1 treatment-related AE | 43 (14.3) | 32 (24.4) |
| Gastrointestinal system | ||
| Nausea | 3 (1.0) | NR |
| Diarrhea | NR | 4 (3.1) |
| Blood and lymphatic system | ||
| Neutropenia | 3 (1.0) | NRa |
| Leukopenia | 2 (0.7) | NR |
| Investigations | ||
| Elevated γ-glutamyl transferase | 4 (1.3) | NR |
| Elevated alanine aminotransferase | 0 | 3 (2.3) |
| Elevated aspartate aminotransferase | 1 (0.3) | 1 (0.8) |
| Elevated alkaline phosphatase | NR | 2 (1.5) |
| Elevated hepatic enzymes | NR | 2 (1.5) |
| Nervous system | ||
| Headache | 4 (1.3) | NR |
| Skin and subcutaneous tissue | ||
| Rash | 3 (1.0) | NR |
a
NR: Not reported in study population.
Based on studies reported in Krause 2004a, 2004b.