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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.

ASTEMIZOLE: 41 Adverse Event Reports & Safety Profile

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41
Total FAERS Reports
5 (12.2%)
Deaths Reported
20
Hospitalizations
41
As Primary/Secondary Suspect
2
Life-Threatening
3
Disabilities

First Report: 1976 · Latest Report: 20250901

What Are the Most Common ASTEMIZOLE Side Effects?

#1 Most Reported
Coma
6 reports (14.6%)
#2 Most Reported
Somnolence
5 reports (12.2%)
#3 Most Reported
Intentional overdose
4 reports (9.8%)

All ASTEMIZOLE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Coma 6 14.6% 0 4
Somnolence 5 12.2% 0 2

Who Reports ASTEMIZOLE Side Effects? Age & Gender Data

Gender: 80.0% female, 20.0% male. Average age: 58.1 years. Most reports from: FR. View detailed demographics →

Is ASTEMIZOLE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2006 1 0 1
2015 1 0 1
2019 2 0 2
2020 1 1 1
2021 4 0 1
2022 8 0 5
2023 1 0 0
2024 3 2 1
2025 4 1 2

View full timeline →

What Is ASTEMIZOLE Used For?

IndicationReports
Product used for unknown indication 16
Anxiety 5

Official FDA Label for ASTEMIZOLE

Official prescribing information from the FDA-approved drug label.