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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.

NAPHAZOLINE\PHENIRAMINE: 2,037 Adverse Event Reports & Safety Profile

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2,037
Total FAERS Reports
2 (0.1%)
Deaths Reported
8
Hospitalizations
2,037
As Primary/Secondary Suspect
2
Life-Threatening
11
Disabilities

Active Ingredient: NAPHAZOLINE HYDROCHLORIDE\PHENIRAMINE MALEATE ·

First Report: 1995 · Latest Report: 20250919

What Are the Most Common NAPHAZOLINE\PHENIRAMINE Side Effects?

#1 Most Reported
Eye irritation
631 reports (31.0%)
#2 Most Reported
Mydriasis
353 reports (17.3%)
#3 Most Reported
Drug ineffective
324 reports (15.9%)

All NAPHAZOLINE\PHENIRAMINE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Eye irritation 631 31.0% 0 0
Mydriasis 353 17.3% 0 2
Drug ineffective 324 15.9% 0 2
Eye pain 255 12.5% 0 0
Vision blurred 201 9.9% 0 3
Product use in unapproved indication 163 8.0% 0 0
Ocular hyperaemia 135 6.6% 0 0
Therapeutic response unexpected 94 4.6% 0 0
Eye pruritus 90 4.4% 0 1
Expired product administered 80 3.9% 0 1
Lacrimation increased 60 3.0% 0 0
Therapeutic product effect incomplete 57 2.8% 0 1
Visual impairment 57 2.8% 0 0
Dry eye 54 2.7% 0 0
Off label use 53 2.6% 0 0
Eye swelling 51 2.5% 0 1
Instillation site pain 51 2.5% 0 0
Product quality issue 49 2.4% 0 0
Wrong technique in product usage process 45 2.2% 0 0
Condition aggravated 33 1.6% 0 0

Who Reports NAPHAZOLINE\PHENIRAMINE Side Effects? Age & Gender Data

Gender: 71.9% female, 28.1% male. Average age: 57.3 years. Most reports from: US. View detailed demographics →

Is NAPHAZOLINE\PHENIRAMINE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2003 1 0 0
2010 1 0 0
2012 1 0 0
2013 49 0 0
2014 64 0 0
2015 106 0 1
2016 113 0 0
2017 120 0 2
2018 67 0 0
2019 95 0 3
2020 61 0 0
2021 54 0 0
2022 38 0 0
2023 56 0 0
2024 44 0 0
2025 36 0 0

View full timeline →

What Is NAPHAZOLINE\PHENIRAMINE Used For?

IndicationReports
Product used for unknown indication 685
Eye pruritus 368
Eye allergy 320
Ocular hyperaemia 235
Hypersensitivity 192
Dry eye 134
Eye irritation 115
Multiple allergies 78
Lacrimation increased 46
Seasonal allergy 43

NAPHAZOLINE\PHENIRAMINE vs Alternatives: Which Is Safer?

NAPHAZOLINE\PHENIRAMINE vs NAPROXEN NAPHAZOLINE\PHENIRAMINE vs NAPROXEN\NAPROXEN NAPHAZOLINE\PHENIRAMINE vs NAPROXEN\PSEUDOEPHEDRINE NAPHAZOLINE\PHENIRAMINE vs NAPROXEN\SUMATRIPTAN NAPHAZOLINE\PHENIRAMINE vs NARATRIPTAN NAPHAZOLINE\PHENIRAMINE vs NASONEX NAPHAZOLINE\PHENIRAMINE vs NATALIZUMAB NAPHAZOLINE\PHENIRAMINE vs NATALIZUMAB-SZTN NAPHAZOLINE\PHENIRAMINE vs NATAMYCIN NAPHAZOLINE\PHENIRAMINE vs NATEGLINIDE

Official FDA Label for NAPHAZOLINE\PHENIRAMINE

Official prescribing information from the FDA-approved drug label.