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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.

NAPROXEN\PSEUDOEPHEDRINE: 383 Adverse Event Reports & Safety Profile

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383
Total FAERS Reports
2 (0.5%)
Deaths Reported
4
Hospitalizations
383
As Primary/Secondary Suspect
2
Life-Threatening
2
Disabilities

Active Ingredient: NAPROXEN SODIUM\PSEUDOEPHEDRINE HYDROCHLORIDE ·

First Report: 2007 · Latest Report: 20250201

What Are the Most Common NAPROXEN\PSEUDOEPHEDRINE Side Effects?

#1 Most Reported
Drug ineffective
119 reports (31.1%)
#2 Most Reported
Off label use
42 reports (11.0%)
#3 Most Reported
Incorrect dose administered
34 reports (8.9%)

All NAPROXEN\PSEUDOEPHEDRINE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Drug ineffective 119 31.1% 0 0
Off label use 42 11.0% 1 1
Incorrect dose administered 34 8.9% 0 0
Drug effective for unapproved indication 28 7.3% 0 0
Insomnia 28 7.3% 0 0
Expired product administered 17 4.4% 0 0
Therapeutic response unexpected 15 3.9% 0 0
Wrong technique in product usage process 15 3.9% 0 0
Dizziness 13 3.4% 0 0
Feeling abnormal 13 3.4% 0 0
Incorrect drug administration duration 12 3.1% 0 0
Drug effect incomplete 8 2.1% 0 0
Heart rate increased 8 2.1% 0 0
Inappropriate schedule of product administration 8 2.1% 0 0
Incorrect product administration duration 8 2.1% 0 0
Nausea 8 2.1% 0 0
Drug ineffective for unapproved indication 7 1.8% 0 0
No adverse event 7 1.8% 0 0
Pruritus 7 1.8% 1 1
Abdominal pain upper 6 1.6% 0 0

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

Gender: 70.3% female, 29.7% male. Average age: 51.5 years. Most reports from: US. View detailed demographics →

Is NAPROXEN\PSEUDOEPHEDRINE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2007 2 0 0
2011 3 0 0
2012 3 0 0
2013 2 0 0
2014 1 0 0
2015 49 0 0
2016 57 0 0
2017 47 0 0
2018 42 0 0
2019 46 0 0
2020 15 0 0
2021 17 0 0
2022 20 0 0
2023 14 0 1
2024 10 0 0
2025 1 0 0

View full timeline →

What Is NAPROXEN\PSEUDOEPHEDRINE Used For?

IndicationReports
Product used for unknown indication 95
Hypersensitivity 60
Nasopharyngitis 52
Sinus headache 44
Headache 41
Sinus congestion 35
Viral upper respiratory tract infection 35
Paranasal sinus discomfort 34
Nasal congestion 29
Sinus disorder 16

NAPROXEN\PSEUDOEPHEDRINE vs Alternatives: Which Is Safer?

NAPROXEN\PSEUDOEPHEDRINE vs NAPROXEN\SUMATRIPTAN NAPROXEN\PSEUDOEPHEDRINE vs NARATRIPTAN NAPROXEN\PSEUDOEPHEDRINE vs NASONEX NAPROXEN\PSEUDOEPHEDRINE vs NATALIZUMAB NAPROXEN\PSEUDOEPHEDRINE vs NATALIZUMAB-SZTN NAPROXEN\PSEUDOEPHEDRINE vs NATAMYCIN NAPROXEN\PSEUDOEPHEDRINE vs NATEGLINIDE NAPROXEN\PSEUDOEPHEDRINE vs NAVITOCLAX NAPROXEN\PSEUDOEPHEDRINE vs NAXITAMAB-GQGK NAPROXEN\PSEUDOEPHEDRINE vs NEBIVOLOL

Official FDA Label for NAPROXEN\PSEUDOEPHEDRINE

Official prescribing information from the FDA-approved drug label.