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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\PSEUDOEPHEDRINE: 3,409 Adverse Event Reports & Safety Profile

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3,409
Total FAERS Reports
8 (0.2%)
Deaths Reported
71
Hospitalizations
3,409
As Primary/Secondary Suspect
14
Life-Threatening
10
Disabilities

Active Ingredient: FEXOFENADINE HYDROCHLORIDE\PSEUDOEPHEDRINE HYDROCHLORIDE ·

First Report: 199509 · Latest Report: 20250830

What Are the Most Common FEXOFENADINE\PSEUDOEPHEDRINE Side Effects?

#1 Most Reported
Drug ineffective
872 reports (25.6%)
#2 Most Reported
Insomnia
417 reports (12.2%)
#3 Most Reported
Medication residue present
208 reports (6.1%)

All FEXOFENADINE\PSEUDOEPHEDRINE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Drug ineffective 872 25.6% 1 1
Insomnia 417 12.2% 0 3
Medication residue present 208 6.1% 0 1
Feeling abnormal 171 5.0% 0 0
Product residue present 149 4.4% 0 2
Extra dose administered 122 3.6% 0 0
Headache 118 3.5% 0 1
Therapeutic response decreased 102 3.0% 0 0
Somnolence 93 2.7% 0 2
Nausea 92 2.7% 0 5
Dizziness 90 2.6% 0 1
Product quality issue 77 2.3% 0 3
Malaise 76 2.2% 0 5
Dyspnoea 74 2.2% 0 5
Dry mouth 70 2.1% 0 0
Wrong technique in product usage process 69 2.0% 0 1
Fatigue 63 1.9% 0 2
No adverse event 63 1.9% 1 0
Palpitations 61 1.8% 0 3
Condition aggravated 60 1.8% 0 3

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

Gender: 67.2% female, 32.8% male. Average age: 57.5 years. Most reports from: US. View detailed demographics →

Is FEXOFENADINE\PSEUDOEPHEDRINE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2001 1 0 0
2005 2 0 0
2009 2 0 2
2010 1 0 1
2011 1 0 0
2013 4 0 1
2014 53 0 3
2015 64 0 9
2016 67 2 1
2017 41 0 4
2018 30 0 2
2019 33 0 4
2020 27 0 0
2021 19 0 1
2022 11 0 1
2023 36 0 3
2024 22 0 3
2025 10 0 0

View full timeline →

What Is FEXOFENADINE\PSEUDOEPHEDRINE Used For?

IndicationReports
Hypersensitivity 523
Product used for unknown indication 421
Multiple allergies 348
Nasal congestion 163
Seasonal allergy 98
Rhinorrhoea 86
Rhinitis allergic 62
Sinus disorder 62
Sinusitis 58
Sinus congestion 40

FEXOFENADINE\PSEUDOEPHEDRINE vs Alternatives: Which Is Safer?

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

Official FDA Label for FEXOFENADINE\PSEUDOEPHEDRINE

Official prescribing information from the FDA-approved drug label.