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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.

ACECLOFENAC: 500 Adverse Event Reports & Safety Profile

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500
Total FAERS Reports
281 (56.2%)
Deaths Reported
119
Hospitalizations
500
As Primary/Secondary Suspect
9
Life-Threatening

First Report: 20010206 · Latest Report: 20250410

What Are the Most Common ACECLOFENAC Side Effects?

#1 Most Reported
Haemorrhagic stroke
216 reports (43.2%)
#2 Most Reported
Tachycardia
215 reports (43.0%)
#3 Most Reported
Fall
213 reports (42.6%)

All ACECLOFENAC Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Haemorrhagic stroke 216 43.2% 216 0
Tachycardia 215 43.0% 211 0
Fall 213 42.6% 205 6
Coma 211 42.2% 200 8
Cardio-respiratory arrest 210 42.0% 210 0
Dyspnoea 210 42.0% 202 5
Pruritus 209 41.8% 202 3
Altered state of consciousness 208 41.6% 206 0
Dizziness 207 41.4% 197 4
Ocular discomfort 207 41.4% 202 0
Ascites 206 41.2% 202 0
Diarrhoea 206 41.2% 203 0
Haematemesis 206 41.2% 201 0
Sepsis 206 41.2% 206 0
Amaurosis fugax 205 41.0% 203 0
Chills 205 41.0% 201 0
Head discomfort 205 41.0% 201 0
Eye pain 204 40.8% 201 0
Blindness 203 40.6% 197 0
Arthralgia 201 40.2% 195 1

Who Reports ACECLOFENAC Side Effects? Age & Gender Data

Gender: 57.6% female, 42.4% male. Average age: 54.5 years. Most reports from: PT. View detailed demographics →

Is ACECLOFENAC Getting Safer? Reports by Year

YearReportsDeathsHosp.
2001 1 0 0
2009 1 0 1
2011 12 0 11
2012 1 0 1
2013 3 0 1
2014 19 0 11
2015 1 1 1
2016 4 0 4
2017 14 0 13
2018 16 1 15
2019 7 0 4
2020 12 0 5
2021 16 5 8
2022 3 0 2
2023 11 4 9
2024 5 1 2
2025 2 1 0

View full timeline →

What Is ACECLOFENAC Used For?

IndicationReports
Product used for unknown indication 341
Pain 33
Arthralgia 17
Antiinflammatory therapy 12
Headache 9
Musculoskeletal pain 7
Back pain 6
Analgesic therapy 5
Rheumatoid arthritis 5
Spinal pain 5

ACECLOFENAC vs Alternatives: Which Is Safer?

ACECLOFENAC vs ACEMETACIN ACECLOFENAC vs ACENOCOUMAROL ACECLOFENAC vs ACEON ACECLOFENAC vs ACETAMINOPHEN ACECLOFENAC vs ACETAMINOPHEN AND OR DEXTROMETHORPHAN AND OR DIPHENHYDRAMINE AND OR GUAIFENESIN AND OR PHENYLEPHRINE AND OR PSEUDOEPHEDRINE ACECLOFENAC vs ACETAMINOPHEN W/HYDROCODONE ACECLOFENAC vs ACETAMINOPHEN\ASPIRIN\CAFFEINE ACECLOFENAC vs ACETAMINOPHEN\ASPIRIN\CAFFEINE\SALICYLAMIDE ACECLOFENAC vs ACETAMINOPHEN\BELLADONNA LEAF\CAFFEINE\OPIUM ACECLOFENAC vs ACETAMINOPHEN\BUTALBITAL

Official FDA Label for ACECLOFENAC

Official prescribing information from the FDA-approved drug label.