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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.

DICLOFENAC\MISOPROSTOL: 1,567 Adverse Event Reports & Safety Profile

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1,567
Total FAERS Reports
30 (1.9%)
Deaths Reported
232
Hospitalizations
1,567
As Primary/Secondary Suspect
28
Life-Threatening
97
Disabilities

Active Ingredient: DICLOFENAC SODIUM\MISOPROSTOL ·

First Report: 19950901 · Latest Report: 20250501

What Are the Most Common DICLOFENAC\MISOPROSTOL Side Effects?

#1 Most Reported
Drug ineffective
478 reports (30.5%)
#2 Most Reported
Drug hypersensitivity
384 reports (24.5%)
#3 Most Reported
Rheumatoid arthritis
271 reports (17.3%)

All DICLOFENAC\MISOPROSTOL Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Drug ineffective 478 30.5% 0 48
Drug hypersensitivity 384 24.5% 0 45
Rheumatoid arthritis 271 17.3% 0 4
Pain 220 14.0% 5 9
Drug intolerance 194 12.4% 0 42
Infection 189 12.1% 0 43
Nausea 180 11.5% 0 48
Condition aggravated 174 11.1% 0 3
Arthralgia 147 9.4% 0 6
International normalised ratio fluctuation 144 9.2% 0 41
Malaise 139 8.9% 5 46
Fatigue 129 8.2% 0 44
Abdominal discomfort 115 7.3% 0 2
Therapeutic product effect incomplete 113 7.2% 0 40
Off label use 107 6.8% 2 11
Pain in extremity 102 6.5% 0 42
Vomiting 101 6.5% 0 47
Muscle spasms 94 6.0% 0 1
Bloody discharge 92 5.9% 0 40
Treatment failure 88 5.6% 0 1

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

Gender: 83.2% female, 16.8% male. Average age: 61.9 years. Most reports from: US. View detailed demographics →

Is DICLOFENAC\MISOPROSTOL Getting Safer? Reports by Year

YearReportsDeathsHosp.
2000 5 0 1
2001 3 0 1
2002 1 0 0
2003 2 0 0
2004 3 0 2
2005 1 0 1
2006 5 0 0
2007 4 0 0
2008 4 0 2
2009 1 0 0
2010 9 0 0
2011 15 0 2
2012 9 0 2
2013 26 2 6
2014 55 1 20
2015 55 1 23
2016 25 0 9
2017 33 1 13
2018 34 4 13
2019 16 0 2
2020 19 2 4
2021 9 0 3
2022 13 0 3
2023 9 0 2
2024 5 0 0
2025 2 0 1

View full timeline →

What Is DICLOFENAC\MISOPROSTOL Used For?

IndicationReports
Rheumatoid arthritis 447
Product used for unknown indication 246
Arthritis 174
Osteoarthritis 75
Pain 63
Arthralgia 45
Back pain 30
Inflammation 18
Lichen planus 12
Fibromyalgia 10

DICLOFENAC\MISOPROSTOL vs Alternatives: Which Is Safer?

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

Official FDA Label for DICLOFENAC\MISOPROSTOL

Official prescribing information from the FDA-approved drug label.