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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.

FEXOFENADINE\FEXOFENADINE: 1,118 Adverse Event Reports & Safety Profile

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1,118
Total FAERS Reports
60 (5.4%)
Deaths Reported
101
Hospitalizations
1,118
As Primary/Secondary Suspect
18
Life-Threatening
20
Disabilities

Active Ingredient: FEXOFENADINE\FEXOFENADINE HYDROCHLORIDE ·

First Report: 200306 · Latest Report: 20190601

What Are the Most Common FEXOFENADINE\FEXOFENADINE Side Effects?

#1 Most Reported
Drug ineffective
283 reports (25.3%)
#2 Most Reported
Drug administered to patient of inappropriate age
194 reports (17.4%)
#3 Most Reported
Off label use
100 reports (8.9%)

All FEXOFENADINE\FEXOFENADINE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Drug ineffective 283 25.3% 0 6
Drug administered to patient of inappropriate age 194 17.4% 0 0
Off label use 100 8.9% 0 4
Dizziness 69 6.2% 0 18
Insomnia 52 4.7% 0 5
Somnolence 49 4.4% 0 4
Completed suicide 47 4.2% 47 15
Urticaria 45 4.0% 0 13
Headache 44 3.9% 0 6
Nausea 41 3.7% 0 13
Palpitations 39 3.5% 0 9
Pruritus 35 3.1% 0 5
Dyspnoea 34 3.0% 0 12
Wrong technique in product usage process 34 3.0% 0 0
Expired product administered 33 3.0% 0 0
Rash 31 2.8% 0 10
Condition aggravated 30 2.7% 0 2
Product use issue 30 2.7% 0 1
Diarrhoea 28 2.5% 0 6
Drug ineffective for unapproved indication 28 2.5% 0 0

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

Gender: 69.1% female, 30.9% male. Average age: 55.2 years. Most reports from: US. View detailed demographics →

Is FEXOFENADINE\FEXOFENADINE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2003 1 0 0
2007 1 1 0
2008 2 0 1
2011 8 0 0
2012 9 0 1
2013 16 0 6
2014 86 0 10
2015 201 8 18
2016 165 12 8
2017 113 0 4
2018 110 0 6
2019 33 0 5

View full timeline →

What Is FEXOFENADINE\FEXOFENADINE Used For?

IndicationReports
Product used for unknown indication 213
Hypersensitivity 206
Seasonal allergy 187
Rhinorrhoea 116
Sneezing 68
Urticaria 52
Eye pruritus 45
Lacrimation increased 43
Perennial allergy 39
Throat irritation 31

FEXOFENADINE\FEXOFENADINE vs Alternatives: Which Is Safer?

FEXOFENADINE\FEXOFENADINE vs FEXOFENADINE\PSEUDOEPHEDRINE FEXOFENADINE\FEXOFENADINE vs FEZOLINETANT FEXOFENADINE\FEXOFENADINE vs FIBRINOGEN HUMAN FEXOFENADINE\FEXOFENADINE vs FIBRINOGEN HUMAN\HUMAN THROMBIN FEXOFENADINE\FEXOFENADINE vs FIBRINOGEN HUMAN\THROMBIN HUMAN FEXOFENADINE\FEXOFENADINE vs FIDAXOMICIN FEXOFENADINE\FEXOFENADINE vs FILGOTINIB FEXOFENADINE\FEXOFENADINE vs FILGRASTIM FEXOFENADINE\FEXOFENADINE vs FILGRASTIM-AAFI FEXOFENADINE\FEXOFENADINE vs FILGRASTIM-SNDZ

Official FDA Label for FEXOFENADINE\FEXOFENADINE

Official prescribing information from the FDA-approved drug label.