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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\NAPROXEN: 1,157 Adverse Event Reports & Safety Profile

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1,157
Total FAERS Reports
662 (57.2%)
Deaths Reported
839
Hospitalizations
1,157
As Primary/Secondary Suspect
773
Life-Threatening
776
Disabilities

Active Ingredient: NAPROXEN\NAPROXEN SODIUM ·

First Report: 19910101 · Latest Report: 20240917

What Are the Most Common NAPROXEN\NAPROXEN Side Effects?

#1 Most Reported
Fatigue
502 reports (43.4%)
#2 Most Reported
Mobility decreased
467 reports (40.4%)
#3 Most Reported
Off label use
462 reports (39.9%)

All NAPROXEN\NAPROXEN Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Fatigue 502 43.4% 355 426
Mobility decreased 467 40.4% 353 395
Off label use 462 39.9% 299 400
Fibromyalgia 456 39.4% 354 396
Folliculitis 449 38.8% 380 397
Joint swelling 448 38.7% 338 368
Psoriatic arthropathy 445 38.5% 328 368
Glossodynia 434 37.5% 356 384
General physical health deterioration 433 37.4% 358 379
Hand deformity 431 37.3% 351 380
Duodenal ulcer perforation 424 36.7% 336 368
Abdominal discomfort 423 36.6% 315 368
Vomiting 419 36.2% 312 357
Hypoaesthesia 417 36.0% 366 360
Arthropathy 415 35.9% 282 358
Hepatic enzyme increased 414 35.8% 338 369
Urticaria 411 35.5% 311 325
Helicobacter infection 410 35.4% 345 362
Type 2 diabetes mellitus 410 35.4% 328 342
Irritable bowel syndrome 409 35.4% 350 355

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

Gender: 93.6% female, 6.4% male. Average age: 46.2 years. Most reports from: CA. View detailed demographics →

Is NAPROXEN\NAPROXEN Getting Safer? Reports by Year

YearReportsDeathsHosp.
2005 2 0 2
2006 1 0 0
2014 1 0 1
2015 5 5 5
2018 4 3 3
2019 2 0 0
2020 3 0 2
2021 3 0 2
2022 9 4 2
2023 41 5 9
2024 30 0 5

View full timeline →

What Is NAPROXEN\NAPROXEN Used For?

IndicationReports
Rheumatoid arthritis 687
Product used for unknown indication 351
Headache 45
Pain 31
Juvenile idiopathic arthritis 15
Back pain 13
Arthralgia 10
Fasciitis 6
Pruritus 6
Peripheral swelling 5

NAPROXEN\NAPROXEN vs Alternatives: Which Is Safer?

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

Official FDA Label for NAPROXEN\NAPROXEN

Official prescribing information from the FDA-approved drug label.