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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.

ITRACONAZOLE\SODIUM: 126 Adverse Event Reports & Safety Profile

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126
Total FAERS Reports
4 (3.2%)
Deaths Reported
33
Hospitalizations
126
As Primary/Secondary Suspect
7
Life-Threatening
2
Disabilities

Active Ingredient: ITRACONAZOLE\SODIUM CHLORIDE ·

First Report: 1990 · Latest Report: 20150627

What Are the Most Common ITRACONAZOLE\SODIUM Side Effects?

#1 Most Reported
Drug dose omission
12 reports (9.5%)
#2 Most Reported
Drug interaction
11 reports (8.7%)
#3 Most Reported
Nausea
8 reports (6.3%)

All ITRACONAZOLE\SODIUM Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Drug dose omission 12 9.5% 0 0
Drug interaction 11 8.7% 0 6
Nausea 8 6.4% 0 1
Diarrhoea 7 5.6% 0 0
Drug ineffective 7 5.6% 0 0
Cushing's syndrome 5 4.0% 0 4
Foetal exposure during pregnancy 5 4.0% 0 3

Who Reports ITRACONAZOLE\SODIUM Side Effects? Age & Gender Data

Gender: 48.6% female, 51.4% male. Average age: 52.8 years. Most reports from: US. View detailed demographics →

Is ITRACONAZOLE\SODIUM Getting Safer? Reports by Year

YearReportsDeathsHosp.
2002 2 0 1
2004 3 0 0
2005 2 0 0
2008 1 0 0
2010 1 0 0
2012 7 1 5
2013 20 1 8
2014 33 0 7
2015 21 1 8

View full timeline →

What Is ITRACONAZOLE\SODIUM Used For?

IndicationReports
Product used for unknown indication 33
Histoplasmosis 11
Fungal infection 10
Onychomycosis 9
Aspergillus infection 7
Bronchopulmonary aspergillosis 6
Bronchopulmonary aspergillosis allergic 5

ITRACONAZOLE\SODIUM vs Alternatives: Which Is Safer?

ITRACONAZOLE\SODIUM vs IVABRADINE ITRACONAZOLE\SODIUM vs IVACAFTOR ITRACONAZOLE\SODIUM vs IVACAFTOR\LUMACAFTOR ITRACONAZOLE\SODIUM vs IVACAFTOR\TEZACAFTOR ITRACONAZOLE\SODIUM vs IVERMECTIN ITRACONAZOLE\SODIUM vs IVOSIDENIB ITRACONAZOLE\SODIUM vs IXABEPILONE ITRACONAZOLE\SODIUM vs IXAZOMIB ITRACONAZOLE\SODIUM vs IXEKIZUMAB ITRACONAZOLE\SODIUM vs JAKAFI

Official FDA Label for ITRACONAZOLE\SODIUM

Official prescribing information from the FDA-approved drug label.