Skip to content
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.

DICLOFENAC\DICLOFENAC: 3,368 Adverse Event Reports & Safety Profile

Grow Your Own Natural Pharmacy at Home

Medicinal Garden Kit — 10 healing herbs, 4,818 seeds + step-by-step guide.

Get the Kit
3,368
Total FAERS Reports
1,210 (35.9%)
Deaths Reported
1,771
Hospitalizations
3,368
As Primary/Secondary Suspect
1,432
Life-Threatening
1,596
Disabilities

Active Ingredient: DICLOFENAC\DICLOFENAC SODIUM ·

First Report: 19910101 · Latest Report: 20240903

What Are the Most Common DICLOFENAC\DICLOFENAC Side Effects?

#1 Most Reported
Fatigue
1,172 reports (34.8%)
#2 Most Reported
Off label use
1,134 reports (33.7%)
#3 Most Reported
Pain
1,100 reports (32.7%)

All DICLOFENAC\DICLOFENAC Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Fatigue 1,172 34.8% 597 764
Off label use 1,134 33.7% 547 690
Pain 1,100 32.7% 468 617
Rash 1,063 31.6% 544 662
Rheumatoid arthritis 1,056 31.4% 541 679
Drug ineffective 1,015 30.1% 318 493
Joint swelling 1,008 29.9% 562 680
Abdominal discomfort 1,003 29.8% 504 702
Glossodynia 973 28.9% 584 705
Hand deformity 955 28.4% 571 696
Hepatic enzyme increased 951 28.2% 574 680
Systemic lupus erythematosus 947 28.1% 530 691
Hypersensitivity 938 27.9% 529 656
Alopecia 931 27.6% 475 651
Arthropathy 921 27.4% 474 660
Swelling 918 27.3% 517 672
Infusion related reaction 899 26.7% 549 631
General physical health deterioration 889 26.4% 584 693
Pemphigus 882 26.2% 468 615
Arthralgia 877 26.0% 479 631

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

Gender: 91.8% female, 8.2% male. Average age: 46.9 years. Most reports from: CA. View detailed demographics →

Is DICLOFENAC\DICLOFENAC Getting Safer? Reports by Year

YearReportsDeathsHosp.
2003 5 0 3
2006 1 0 1
2007 5 0 0
2008 2 2 2
2010 1 0 0
2011 8 1 2
2012 1 0 0
2014 1 0 0
2015 14 12 13
2016 3 0 1
2017 16 4 11
2018 14 0 3
2019 31 0 17
2020 30 0 5
2021 32 3 17
2022 42 0 6
2023 310 3 70
2024 135 0 47

View full timeline →

What Is DICLOFENAC\DICLOFENAC Used For?

IndicationReports
Product used for unknown indication 2,324
Rheumatoid arthritis 395
Pain 125
Inflammation 122
Osteoarthritis 119
Arthralgia 112
Back pain 69
Arthritis 63
Migraine 37
Analgesic therapy 36

DICLOFENAC\DICLOFENAC vs Alternatives: Which Is Safer?

DICLOFENAC\DICLOFENAC vs DICLOFENAC\MISOPROSTOL DICLOFENAC\DICLOFENAC vs DICLOXACILLIN DICLOFENAC\DICLOFENAC vs DICYCLOMINE DICLOFENAC\DICLOFENAC vs DIDANOSINE DICLOFENAC\DICLOFENAC vs DIENOGEST DICLOFENAC\DICLOFENAC vs DIENOGEST\ESTRADIOL DICLOFENAC\DICLOFENAC vs DIENOGEST\ETHINYL ESTRADIOL DICLOFENAC\DICLOFENAC vs DIETARY SUPPLEMENT DICLOFENAC\DICLOFENAC vs DIETARY SUPPLEMENT\HERBALS DICLOFENAC\DICLOFENAC vs DIETARY SUPPLEMENT\MINERALS\VITAMINS

Official FDA Label for DICLOFENAC\DICLOFENAC

Official prescribing information from the FDA-approved drug label.