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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.

DIPHENHYDRAMINE\NAPROXEN: 1,924 Adverse Event Reports & Safety Profile

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1,924
Total FAERS Reports
39 (2.0%)
Deaths Reported
48
Hospitalizations
1,924
As Primary/Secondary Suspect
8
Life-Threatening
1
Disabilities

Active Ingredient: DIPHENHYDRAMINE HYDROCHLORIDE\NAPROXEN SODIUM ·

First Report: 1933 · Latest Report: 20250908

What Are the Most Common DIPHENHYDRAMINE\NAPROXEN Side Effects?

#1 Most Reported
Product use issue
461 reports (24.0%)
#2 Most Reported
Drug ineffective
442 reports (23.0%)
#3 Most Reported
Insomnia
172 reports (8.9%)

All DIPHENHYDRAMINE\NAPROXEN Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Product use issue 461 24.0% 0 6
Drug ineffective 442 23.0% 0 0
Insomnia 172 8.9% 0 0
Medication error 133 6.9% 0 0
Product use in unapproved indication 112 5.8% 0 2
Somnolence 108 5.6% 0 8
Therapeutic response unexpected 100 5.2% 0 0
Incorrect drug administration duration 97 5.0% 0 4
Incorrect dose administered 75 3.9% 0 0
Drug ineffective for unapproved indication 60 3.1% 0 0
Underdose 60 3.1% 0 0
Expired product administered 56 2.9% 0 2
Feeling abnormal 55 2.9% 0 0
Off label use 43 2.2% 0 0
Wrong technique in product usage process 40 2.1% 0 0
Extra dose administered 39 2.0% 0 0
Abdominal pain upper 38 2.0% 0 1
Poor quality sleep 37 1.9% 0 0
Dizziness 35 1.8% 0 3
Headache 34 1.8% 0 1

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

Gender: 67.5% female, 32.5% male. Average age: 67.6 years. Most reports from: US. View detailed demographics →

Is DIPHENHYDRAMINE\NAPROXEN Getting Safer? Reports by Year

YearReportsDeathsHosp.
2000 1 0 0
2005 1 0 0
2006 1 0 0
2007 1 0 0
2008 2 0 0
2009 1 0 0
2010 3 0 0
2011 4 0 1
2012 4 0 0
2013 7 0 0
2014 191 0 3
2015 246 0 4
2016 140 6 6
2017 90 1 7
2018 93 4 3
2019 47 0 0
2020 28 0 1
2021 14 0 0
2022 7 0 0
2023 5 0 0
2024 4 0 0
2025 2 0 0

View full timeline →

What Is DIPHENHYDRAMINE\NAPROXEN Used For?

IndicationReports
Pain 383
Sleep disorder therapy 339
Analgesic therapy 138
Insomnia 93
Back pain 82
Arthritis 77
Product used for unknown indication 67
Arthralgia 50
Sleep disorder 48
Headache 22

DIPHENHYDRAMINE\NAPROXEN vs Alternatives: Which Is Safer?

DIPHENHYDRAMINE\NAPROXEN vs DIPHENOXYLATE DIPHENHYDRAMINE\NAPROXEN vs DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED AND INACTIVATED POLIOVIRUS VACCINE DIPHENHYDRAMINE\NAPROXEN vs DIPYRIDAMOLE DIPHENHYDRAMINE\NAPROXEN vs DIPYRONE DIPHENHYDRAMINE\NAPROXEN vs DIROXIMEL DIPHENHYDRAMINE\NAPROXEN vs DISOPYRAMIDE DIPHENHYDRAMINE\NAPROXEN vs DISTIGMINE DIPHENHYDRAMINE\NAPROXEN vs DISULFIRAM DIPHENHYDRAMINE\NAPROXEN vs DIVALPROEX DIPHENHYDRAMINE\NAPROXEN vs DOBUTAMINE

Official FDA Label for DIPHENHYDRAMINE\NAPROXEN

Official prescribing information from the FDA-approved drug label.