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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.

BILASTINE: 774 Adverse Event Reports & Safety Profile

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774
Total FAERS Reports
11 (1.4%)
Deaths Reported
290
Hospitalizations
774
As Primary/Secondary Suspect
39
Life-Threatening
6
Disabilities

First Report: 20100831 · Latest Report: 20250522

What Are the Most Common BILASTINE Side Effects?

#1 Most Reported
Urticaria
132 reports (17.1%)
#2 Most Reported
Drug ineffective
127 reports (16.4%)
#3 Most Reported
Pruritus
103 reports (13.3%)

All BILASTINE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Urticaria 132 17.1% 0 32
Drug ineffective 127 16.4% 3 23
Pruritus 103 13.3% 0 35
Dyspnoea 93 12.0% 2 38
Malaise 76 9.8% 2 52
Headache 75 9.7% 0 25
Arthralgia 74 9.6% 0 19
Off label use 72 9.3% 2 20
Fatigue 68 8.8% 0 28
Cough 62 8.0% 0 33
Product use in unapproved indication 58 7.5% 3 9
Hypertension 54 7.0% 0 38
Vomiting 54 7.0% 0 28
Asthma 53 6.9% 2 39
Angioedema 52 6.7% 0 17
Myalgia 52 6.7% 0 7
Wheezing 50 6.5% 0 31
Erythema 48 6.2% 0 5
Diarrhoea 43 5.6% 0 11
Chronic spontaneous urticaria 42 5.4% 0 4

Who Reports BILASTINE Side Effects? Age & Gender Data

Gender: 66.4% female, 33.6% male. Average age: 50.6 years. Most reports from: CA. View detailed demographics →

Is BILASTINE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2010 1 0 0
2013 6 2 3
2014 6 0 2
2015 16 0 2
2016 16 0 13
2017 33 0 10
2018 69 0 60
2019 62 3 12
2020 35 0 12
2021 54 1 16
2022 48 2 27
2023 42 1 15
2024 21 0 14
2025 14 0 2

View full timeline →

What Is BILASTINE Used For?

IndicationReports
Product used for unknown indication 388
Chronic spontaneous urticaria 106
Hypersensitivity 32
Antiallergic therapy 24
Rhinitis allergic 21
Asthma 16
Pruritus 15
Urticaria 14
Seasonal allergy 13
Urticaria chronic 10

BILASTINE vs Alternatives: Which Is Safer?

BILASTINE vs BIMATOPROST BILASTINE vs BIMATOPROST\TIMOLOL BILASTINE vs BIMEKIZUMAB BILASTINE vs BIMEKIZUMAB-BKZX BILASTINE vs BINIMETINIB BILASTINE vs BIOFLAVONOIDS BILASTINE vs BIOTIN BILASTINE vs BIPERIDEN BILASTINE vs BIRCH TRITERPENES BILASTINE vs BISACODYL

Official FDA Label for BILASTINE

Official prescribing information from the FDA-approved drug label.