Table 4.
Review of major studies reporting on adverse events associated with posaconazole
| Study | n | Patient population | Dose | Nausea | Vomiting | Headache | Dizziness | QT prolongation | Rash | Liver enzymes | AST | ALT | ALP |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 97 | 448 | Healthy volunteers | 50–1200 mg/d | NR | NR | 17% | 6% | None | NR | NR | 6% | 11% | NR |
| 87 | 330 | Cancer, HSCT | 800 mg/d | 14% | 6% | 5% | 5% | 5% | NR | NR | 5% | NR | 5% |
| 86 | 23 | SOT | 800 mg/d | 17.4% | 8.7% | NR | NR | NR | NR | NR | 8.7% | 4.3% | NR |
| 98 | 53 | Heme, HSCT | 800 mg/d | NR | NR | NR | NR | NR | NR | NR | 0 | NR | 0 |
| 88 | 107 | Cancer, HSCT/SOT, other1 | 800 mg/d | 12% | 5% | <3% | <3% | 0 | 4% | 3% | NR | 2% | NR |
| 99 | 304 | AML/MDS | 600 mg/d | NR | NR | NR | NR | <1% | NR | <1% | NR | <1% | NR |
| 45 | 301 | HSCT | 600 mg/d | 7% | 4% | 1% | NR | NR | NR | 3% | 3% | 3% | NR |
| 100 | 428 | Cancer, HSCT/SOT, other2 | 800–1200 mg/d | 8% | 7% | 9% | 2% | 2% | 3% | 2% | 3% | 5% | NR |
| 101 | 21 | Cancer, HSCT/SOT, DM | 800 mg/d | 5% | 5% | NR | NR | 0 | 5% | NR | 5% | NR | NR |
Notes:
1
Other, diabetes mellitus, HIV/AIDS;
2
Other, acquired immunocompromising conditions, no known underlying immunocompromising conditions.
Abbreviations: n, number of patients; AST, aspartate aminotransferase; ALT, alanine aminotransferase; ALP, alkaline phosphatase; d, day; NR, not reported; heme, hematologic malignancy; HSCT, hematopoietic stem cell transplant; SOT, solid organ transplant; AML, acute myelogenous leukemia; MDS, myelodysplastic syndrome; DM, diabetes mellitus.