isavuconazonium Side Effects
Also known as: Cresemba
Analysis of 3,219 adverse event reports submitted to the FDA from 2015 to 2025.
Total Reports
3,219
Death-Related
674
20.9% of reports
Hospitalizations
1,032
32.1% of reports
Top Indication
Product Used For Unknown Indication
Most Reported Adverse Reactions
Who Reports Side Effects
Gender Distribution
Age Distribution
Reporting Trend by Year
Reactions in Death Reports
Top reactions reported in 674 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| DEATH | 310 |
| OFF LABEL USE | 126 |
| DRUG INEFFECTIVE | 51 |
| ACUTE MYELOID LEUKAEMIA | 33 |
| SEPTIC SHOCK | 33 |
| CONDITION AGGRAVATED | 32 |
| ACUTE KIDNEY INJURY | 31 |
| MULTIPLE ORGAN DYSFUNCTION SYNDROME | 31 |
| ASPERGILLUS INFECTION | 25 |
| RESPIRATORY FAILURE | 25 |
| DISEASE PROGRESSION | 23 |
| SEPSIS | 23 |
| FEBRILE NEUTROPENIA | 20 |
| PNEUMONIA | 20 |
| BRONCHOPULMONARY ASPERGILLOSIS | 19 |
| COVID-19 | 17 |
| BLOOD ALKALINE PHOSPHATASE INCREASED | 14 |
| DYSPNOEA | 14 |
| HYPOTENSION | 14 |
| BLOOD BILIRUBIN INCREASED | 13 |
Reactions in Hospitalization Reports
Top reactions in 1,032 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| OFF LABEL USE | 155 |
| PNEUMONIA | 90 |
| FEBRILE NEUTROPENIA | 89 |
| PYREXIA | 86 |
| NAUSEA | 62 |
| DYSPNOEA | 55 |
| ACUTE KIDNEY INJURY | 53 |
| DIARRHOEA | 50 |
| DRUG INTERACTION | 49 |
| SEPSIS | 45 |
| VOMITING | 45 |
| DEATH | 44 |
| FATIGUE | 44 |
| HOSPITALISATION | 42 |
| DRUG INEFFECTIVE | 39 |
| PLATELET COUNT DECREASED | 38 |
| CONDITION AGGRAVATED | 33 |
| INFECTION | 32 |
| COVID-19 | 29 |
| HAEMOGLOBIN DECREASED | 27 |
Nearby — Related Medications
What the FAERS Data Reveals About isavuconazonium Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 3,219 voluntary reports linked to isavuconazonium and its brand equivalents (Cresemba), spanning 2015 through 2025. Of those, 674 (20.9%) listed death as an outcome and 1,032 (32.1%) involved hospitalization. The most common indication reported alongside adverse events was Product Used For Unknown Indication.
Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 41% were female and 59% male; age distribution skews toward 45-64, with 634 reports in that bracket. The single most reported reaction is off label use with 926 submissions, followed by death and nausea.
FAERS is a signal-detection tool, not a scorecard. Reports are voluntary, and a single case may list multiple suspect drugs, so numbers above should not be read as incidence rates or per-patient risk. Widely prescribed drugs naturally accumulate more reports than niche therapies even when individual risk is low. These aggregates are useful for spotting patterns that merit further pharmacovigilance, not for choosing between medications. This page is for educational reference only and is not medical advice — speak with a licensed clinician about any side-effect concerns.
Read our methodology — how this data is sourced, computed, and verified.