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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.

NIMESULIDE: 996 Adverse Event Reports & Safety Profile

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996
Total FAERS Reports
244 (24.5%)
Deaths Reported
408
Hospitalizations
996
As Primary/Secondary Suspect
102
Life-Threatening
10
Disabilities

First Report: 19980101 · Latest Report: 20250711

What Are the Most Common NIMESULIDE Side Effects?

#1 Most Reported
Dyspnoea
217 reports (21.8%)
#2 Most Reported
Headache
216 reports (21.7%)
#3 Most Reported
Pruritus
215 reports (21.6%)

All NIMESULIDE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Dyspnoea 217 21.8% 182 14
Headache 216 21.7% 168 23
Pruritus 215 21.6% 188 5
Arthralgia 208 20.9% 183 13
Diarrhoea 207 20.8% 188 12
Dizziness 204 20.5% 183 8
Haematemesis 203 20.4% 187 6
Altered state of consciousness 199 20.0% 195 2
Fall 199 20.0% 193 4
Cardio-respiratory arrest 197 19.8% 195 0
Coma 197 19.8% 187 2
Vomiting 197 19.8% 137 36
Somnolence 196 19.7% 164 17
Haemorrhagic stroke 195 19.6% 195 0
Amaurosis fugax 193 19.4% 191 0
Head discomfort 193 19.4% 188 0
Sepsis 193 19.4% 191 2
Tachycardia 193 19.4% 182 6
Blindness 192 19.3% 185 0
Chills 192 19.3% 186 1

Who Reports NIMESULIDE Side Effects? Age & Gender Data

Gender: 66.5% female, 33.5% male. Average age: 49.7 years. Most reports from: IT. View detailed demographics →

Is NIMESULIDE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2003 1 0 0
2004 1 0 1
2005 3 0 3
2006 2 1 1
2007 1 0 1
2008 2 0 2
2009 1 0 1
2011 2 0 0
2012 2 0 0
2013 18 0 3
2014 32 0 17
2015 33 0 20
2016 54 0 29
2017 29 0 10
2018 65 0 36
2019 36 1 16
2020 33 2 21
2021 57 0 27
2022 25 0 19
2023 11 0 6
2024 10 0 6
2025 5 0 3

View full timeline →

What Is NIMESULIDE Used For?

IndicationReports
Product used for unknown indication 484
Pain 64
Back pain 38
Headache 30
Arthralgia 25
Toothache 25
Drug abuse 19
Intentional self-injury 15
Analgesic therapy 14
Neuritis 14

NIMESULIDE vs Alternatives: Which Is Safer?

NIMESULIDE vs NIMODIPINE NIMESULIDE vs NINTEDANIB NIMESULIDE vs NINTEDANIB ESYLATE NIMESULIDE vs NIRAPARIB NIMESULIDE vs NIRMATRELVIR\RITONAVIR NIMESULIDE vs NIROGACESTAT NIMESULIDE vs NIROGACESTAT HYDROBROMIDE NIMESULIDE vs NIRSEVIMAB NIMESULIDE vs NIRSEVIMAB-ALIP NIMESULIDE vs NITAZOXANIDE

Official FDA Label for NIMESULIDE

Official prescribing information from the FDA-approved drug label.