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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

ISAVUCONAZOLE: 1,413 Adverse Event Reports & Safety Profile

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1,413
Total FAERS Reports
481 (34.0%)
Deaths Reported
580
Hospitalizations
1,413
As Primary/Secondary Suspect
107
Life-Threatening
10
Disabilities

First Report: 20081106 · Latest Report: 20250904

What Are the Most Common ISAVUCONAZOLE Side Effects?

#1 Most Reported
Off label use
342 reports (24.2%)
#2 Most Reported
Drug ineffective
224 reports (15.9%)
#3 Most Reported
Death
155 reports (11.0%)

All ISAVUCONAZOLE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Off label use 342 24.2% 116 121
Drug ineffective 224 15.9% 112 127
Death 155 11.0% 155 21
Product use in unapproved indication 135 9.6% 47 60
Aspergillus infection 58 4.1% 27 38
Condition aggravated 58 4.1% 27 24
Drug interaction 58 4.1% 13 29
Septic shock 56 4.0% 52 27
Nausea 53 3.8% 7 32
Bronchopulmonary aspergillosis 50 3.5% 22 34
Infection 48 3.4% 18 21
Mucormycosis 48 3.4% 21 26
Pyrexia 42 3.0% 9 29
Respiratory failure 42 3.0% 32 27
Drug ineffective for unapproved indication 36 2.6% 16 14
Dyspnoea 36 2.6% 9 16
Febrile neutropenia 36 2.6% 8 25
Vomiting 36 2.6% 3 18
Multiple organ dysfunction syndrome 35 2.5% 35 23
Pneumonia 35 2.5% 7 27

Who Reports ISAVUCONAZOLE Side Effects? Age & Gender Data

Gender: 36.6% female, 63.4% male. Average age: 53.5 years. Most reports from: US. View detailed demographics →

Is ISAVUCONAZOLE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2008 1 0 0
2010 1 0 0
2011 1 0 1
2013 1 0 1
2014 3 2 2
2015 5 4 3
2016 17 5 6
2017 59 20 33
2018 129 54 64
2019 57 19 22
2020 70 38 42
2021 58 10 25
2022 43 4 14
2023 76 11 31
2024 62 12 24
2025 38 2 20

View full timeline →

What Is ISAVUCONAZOLE Used For?

IndicationReports
Aspergillus infection 276
Product used for unknown indication 208
Bronchopulmonary aspergillosis 195
Mucormycosis 159
Fungal infection 115
Antifungal prophylaxis 90
Prophylaxis 76
Antifungal treatment 40
Acute myeloid leukaemia 32
Pulmonary mucormycosis 28

ISAVUCONAZOLE vs Alternatives: Which Is Safer?

ISAVUCONAZOLE vs ISAVUCONAZONIUM ISAVUCONAZOLE vs ISCALIMAB ISAVUCONAZOLE vs ISENTRESS ISAVUCONAZOLE vs ISOFLURANE ISAVUCONAZOLE vs ISONIAZID ISAVUCONAZOLE vs ISONIAZID\PYRAZINAMIDE\RIFAMPIN ISAVUCONAZOLE vs ISONIAZID\PYRIDOXINE\SULFAMETHOXAZOLE\TRIMETHOPRIM ISAVUCONAZOLE vs ISONIAZID\RIFAMPIN ISAVUCONAZOLE vs ISOPROPANOLAMINE ISAVUCONAZOLE vs ISOPROPYL ALCOHOL

Official FDA Label for ISAVUCONAZOLE

Official prescribing information from the FDA-approved drug label.