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Drug side effects

isavuconazonium Side Effects

The reactions most often reported to the FDA for isavuconazonium (also sold as Cresemba), with demographics, serious outcomes, and reporting trends.

Data updated 2026-05-15

3,219
FAERS reports

Data from the FDA Adverse Event Reporting System (FAERS), 2015 to 2025. A FAERS report records a temporal association, not proof of cause. See our methodology for how figures are compiled and de-duplicated.

The most commonly reported side effects of isavuconazonium come from 3,219 reports to the FDA, broken down here by frequency, patient demographics, and serious outcomes.

This page analyzes 3,219 reports to the FDA Adverse Event Reporting System (FAERS) for isavuconazonium (Cresemba): the reactions reported most often, who reported them, serious outcomes such as hospitalization, and year-over-year trends. A FAERS report does not prove the drug caused the effect, and report volume tracks how widely a drug is used, not how likely an effect is for any one person. Educational information, not medical advice.

Total Reports

3,219

Reports Mentioning Death

674

20.9% of reports — not proof the medicine caused the death

Hospitalizations

1,032

32.1% of reports

Top Indication

Product Used For Unknown Indication

Most Reported Adverse Reactions

DEATH
310
NAUSEA
143
FEBRILE NEUTROPENIA
135
PYREXIA
125
PNEUMONIA
114
CONDITION AGGRAVATED
106
FATIGUE
101
DIARRHOEA
91
DYSPNOEA
87
DRUG INTERACTION
84
VOMITING
81
ACUTE KIDNEY INJURY
70
SEPSIS
63
PLATELET COUNT DECREASED
59
ASPERGILLUS INFECTION
56
INFECTION
55
DECREASED APPETITE
53

Who Reports Side Effects

Gender Distribution

Female 1,166 (41%)
Male 1,709 (59%)
Unknown 1

Age Distribution

0-17 130 (7%)
18-44 330 (18%)
45-64 634 (34%)
65-74 522 (28%)
75+ 244 (13%)

Reporting Trend by Year

15
16
17
18
19
20
21
22
23
24
25

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
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
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
PLATELET COUNT DECREASED 38
CONDITION AGGRAVATED 33
INFECTION 32
COVID-19 29
HAEMOGLOBIN DECREASED 27

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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 death with 310 submissions, followed by nausea and febrile neutropenia.

How to read these numbers

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.

Drugs With a Similar FAERS Report Volume

Other medications with a total FDA adverse-event report count closest to isavuconazonium's 3,219.