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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.

ESOMEPRAZOLE\NAPROXEN: 5,684 Adverse Event Reports & Safety Profile

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5,684
Total FAERS Reports
1,083 (19.1%)
Deaths Reported
352
Hospitalizations
5,684
As Primary/Secondary Suspect
161
Life-Threatening
120
Disabilities

Active Ingredient: ESOMEPRAZOLE MAGNESIUM\NAPROXEN ·

First Report: 1976 · Latest Report: 20250513

What Are the Most Common ESOMEPRAZOLE\NAPROXEN Side Effects?

#1 Most Reported
Chronic kidney disease
2,714 reports (47.7%)
#2 Most Reported
Renal failure
2,374 reports (41.8%)
#3 Most Reported
Acute kidney injury
1,120 reports (19.7%)

All ESOMEPRAZOLE\NAPROXEN Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Chronic kidney disease 2,714 47.8% 412 89
Renal failure 2,374 41.8% 830 84
Acute kidney injury 1,120 19.7% 234 78
Death 705 12.4% 703 7
Drug ineffective 459 8.1% 16 32
Off label use 440 7.7% 18 43
Nausea 431 7.6% 16 96
End stage renal disease 349 6.1% 123 23
Tubulointerstitial nephritis 315 5.5% 56 19
Hyperhidrosis 308 5.4% 0 5
Pain 283 5.0% 18 101
Nightmare 247 4.4% 0 0
Sedation 244 4.3% 0 0
Rheumatoid arthritis 235 4.1% 18 95
Fatigue 200 3.5% 18 95
Arthralgia 195 3.4% 14 28
Product use in unapproved indication 186 3.3% 2 4
Nephrolithiasis 174 3.1% 0 0
Cough 172 3.0% 0 69
Dyspnoea 165 2.9% 17 33

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

Gender: 48.7% female, 51.3% male. Average age: 55.7 years. Most reports from: US. View detailed demographics →

Is ESOMEPRAZOLE\NAPROXEN Getting Safer? Reports by Year

YearReportsDeathsHosp.
2000 2 0 1
2001 7 3 0
2002 2 0 1
2003 13 6 2
2004 12 4 4
2005 16 8 2
2006 23 13 0
2007 29 7 4
2008 34 9 11
2009 32 10 5
2010 35 8 1
2011 98 39 16
2012 76 13 9
2013 85 9 10
2014 111 7 18
2015 172 10 30
2016 147 8 26
2017 77 4 14
2018 75 0 10
2019 55 1 8
2020 23 0 8
2021 9 3 2
2022 4 0 2
2023 12 1 7
2024 2 0 1
2025 2 0 2

View full timeline →

What Is ESOMEPRAZOLE\NAPROXEN Used For?

IndicationReports
Product used for unknown indication 3,129
Arthritis 77
Pain 74
Arthralgia 63
Osteoarthritis 63
Rheumatoid arthritis 46
Gastrooesophageal reflux disease 36
Back pain 34
Inflammation 27
Pain in extremity 18

ESOMEPRAZOLE\NAPROXEN vs Alternatives: Which Is Safer?

ESOMEPRAZOLE\NAPROXEN vs ESTAZOLAM ESOMEPRAZOLE\NAPROXEN vs ESTRADIOL ESOMEPRAZOLE\NAPROXEN vs ESTRADIOL CYPIONATE ESOMEPRAZOLE\NAPROXEN vs ESTRADIOL\LEVONORGESTREL ESOMEPRAZOLE\NAPROXEN vs ESTRADIOL\NORETHINDRONE ESOMEPRAZOLE\NAPROXEN vs ESTRADIOL\NORETHINDRONE\RELUGOLIX ESOMEPRAZOLE\NAPROXEN vs ESTRADIOL\PROGESTERONE ESOMEPRAZOLE\NAPROXEN vs ESTRAMUSTINE ESOMEPRAZOLE\NAPROXEN vs ESTRING ESOMEPRAZOLE\NAPROXEN vs ESTRIOL

Official FDA Label for ESOMEPRAZOLE\NAPROXEN

Official prescribing information from the FDA-approved drug label.