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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.

AZELASTINE\AZELASTINE: 29 Adverse Event Reports & Safety Profile

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29
Total FAERS Reports
6 (20.7%)
Deaths Reported
6
Hospitalizations
29
As Primary/Secondary Suspect
5
Life-Threatening

Active Ingredient: AZELASTINE\AZELASTINE HYDROCHLORIDE ·

First Report: 20000101 · Latest Report: 20240726

What Are the Most Common AZELASTINE\AZELASTINE Side Effects?

#1 Most Reported
Capnocytophaga sepsis
5 reports (17.2%)
#2 Most Reported
Product dose omission issue
3 reports (10.3%)
#3 Most Reported
Product delivery mechanism issue
3 reports (10.3%)

All AZELASTINE\AZELASTINE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Capnocytophaga sepsis 5 17.2% 5 0

Who Reports AZELASTINE\AZELASTINE Side Effects? Age & Gender Data

Gender: 56.0% female, 44.0% male. Average age: 63.3 years. Most reports from: US. View detailed demographics →

Is AZELASTINE\AZELASTINE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2000 1 0 1
2008 2 0 2
2021 1 0 1
2022 2 1 1
2023 3 0 1
2024 8 5 0

View full timeline →

What Is AZELASTINE\AZELASTINE Used For?

IndicationReports
Product used for unknown indication 13
Asthma 6

Official FDA Label for AZELASTINE\AZELASTINE

Official prescribing information from the FDA-approved drug label.