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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.

EBASTINE: 775 Adverse Event Reports & Safety Profile

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775
Total FAERS Reports
10 (1.3%)
Deaths Reported
407
Hospitalizations
775
As Primary/Secondary Suspect
103
Life-Threatening
20
Disabilities

First Report: 20040328 · Latest Report: 20250821

What Are the Most Common EBASTINE Side Effects?

#1 Most Reported
Vomiting
57 reports (7.4%)
#2 Most Reported
Urticaria
51 reports (6.6%)
#3 Most Reported
Drug reaction with eosinophilia and systemic symptoms
50 reports (6.5%)

All EBASTINE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Vomiting 57 7.4% 0 51
Urticaria 51 6.6% 0 18
Drug reaction with eosinophilia and systemic symptoms 50 6.5% 0 37
Somnolence 44 5.7% 0 22
Diarrhoea 41 5.3% 0 26
Intentional overdose 38 4.9% 0 26
Suicide attempt 37 4.8% 0 31
Angioedema 35 4.5% 0 16
Drug abuse 34 4.4% 0 22
Abdominal pain upper 32 4.1% 0 28
Product use in unapproved indication 31 4.0% 3 18
Pruritus 31 4.0% 1 13
Pyrexia 31 4.0% 0 26
Dyspnoea 30 3.9% 0 21
Fall 30 3.9% 1 24
Hallucination, auditory 30 3.9% 0 28
Coma 29 3.7% 0 5
Paranoia 29 3.7% 0 28
Psychotic disorder 29 3.7% 0 28
Cough 27 3.5% 0 22

Who Reports EBASTINE Side Effects? Age & Gender Data

Gender: 68.4% female, 31.6% male. Average age: 46.1 years. Most reports from: FR. View detailed demographics →

Is EBASTINE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2004 1 0 1
2008 3 0 3
2009 7 0 7
2010 2 0 1
2011 7 0 7
2012 6 0 2
2013 6 0 2
2014 10 0 7
2015 23 0 17
2016 29 0 14
2017 16 0 13
2018 34 1 19
2019 40 0 26
2020 81 1 29
2021 69 0 35
2022 50 0 31
2023 64 1 40
2024 72 5 19
2025 29 0 19

View full timeline →

What Is EBASTINE Used For?

IndicationReports
Product used for unknown indication 298
Hypersensitivity 73
Asthma 42
Pruritus 29
Urticaria chronic 27
Urticaria 24
Influenza 22
Chronic spontaneous urticaria 19
Rash 16
Antiallergic therapy 15

EBASTINE vs Alternatives: Which Is Safer?

EBASTINE vs ECALLANTIDE EBASTINE vs ECONAZOLE EBASTINE vs ECULIZUMAB EBASTINE vs EDARAVONE EBASTINE vs EDETATE EBASTINE vs EDOXABAN EBASTINE vs EDOXABAN TOSILATE EBASTINE vs EFALIZUMAB EBASTINE vs EFANESOCTOCOG ALFA EBASTINE vs EFAVIRENZ

Official FDA Label for EBASTINE

Official prescribing information from the FDA-approved drug label.