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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.

DEXKETOPROFEN TROMETAMOL: 221 Adverse Event Reports & Safety Profile

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221
Total FAERS Reports
23 (10.4%)
Deaths Reported
110
Hospitalizations
221
As Primary/Secondary Suspect
30
Life-Threatening
6
Disabilities

First Report: 20021010 · Latest Report: 20250326

What Are the Most Common DEXKETOPROFEN TROMETAMOL Side Effects?

#1 Most Reported
Acute kidney injury
21 reports (9.5%)
#2 Most Reported
Sopor
15 reports (6.8%)
#3 Most Reported
Drug abuse
15 reports (6.8%)

All DEXKETOPROFEN TROMETAMOL Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Acute kidney injury 21 9.5% 2 19
Drug abuse 15 6.8% 0 1
Sopor 15 6.8% 0 0
Dyspnoea 13 5.9% 0 1
Dizziness 12 5.4% 0 10
Toxic epidermal necrolysis 12 5.4% 10 2
Upper gastrointestinal haemorrhage 12 5.4% 10 2
Intentional overdose 10 4.5% 0 5
Anaphylactic reaction 9 4.1% 0 2
Hepatic cytolysis 9 4.1% 2 7
Hyperbilirubinaemia 9 4.1% 0 4
Pruritus 9 4.1% 0 2
Tubulointerstitial nephritis 9 4.1% 0 8
Vomiting 9 4.1% 0 3
Back pain 8 3.6% 0 3
Pain 8 3.6% 0 4
Angioedema 7 3.2% 0 0
Contraindicated product administered 7 3.2% 0 1
Face oedema 7 3.2% 0 0
Headache 7 3.2% 0 6

Who Reports DEXKETOPROFEN TROMETAMOL Side Effects? Age & Gender Data

Gender: 67.5% female, 32.5% male. Average age: 49.6 years. Most reports from: ES. View detailed demographics →

Is DEXKETOPROFEN TROMETAMOL Getting Safer? Reports by Year

YearReportsDeathsHosp.
2002 1 0 1
2008 1 0 0
2012 1 0 0
2013 4 0 3
2014 4 0 4
2015 1 0 1
2016 8 0 8
2017 10 0 7
2018 34 0 20
2019 15 0 7
2020 25 1 11
2021 29 5 9
2022 9 2 3
2023 24 10 12
2024 8 0 6
2025 7 0 5

View full timeline →

What Is DEXKETOPROFEN TROMETAMOL Used For?

IndicationReports
Product used for unknown indication 78
Pain 42
Back pain 19
Analgesic therapy 8
Procedural pain 5

DEXKETOPROFEN TROMETAMOL vs Alternatives: Which Is Safer?

DEXKETOPROFEN TROMETAMOL vs DEXLANSOPRAZOLE DEXKETOPROFEN TROMETAMOL vs DEXMEDETOMIDINE DEXKETOPROFEN TROMETAMOL vs DEXMETHYLPHENIDATE DEXKETOPROFEN TROMETAMOL vs DEXMETHYLPHENIDATE\SERDEXMETHYLPHENIDATE DEXKETOPROFEN TROMETAMOL vs DEXPANTHENOL DEXKETOPROFEN TROMETAMOL vs DEXRAZOXANE DEXKETOPROFEN TROMETAMOL vs DEXTRAN 70\HYPROMELLOSE 2910 DEXKETOPROFEN TROMETAMOL vs DEXTROAMPHETAMINE DEXKETOPROFEN TROMETAMOL vs DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE AND AMPHETAMINE DEXKETOPROFEN TROMETAMOL vs DEXTROMETHORPHAN

Official FDA Label for DEXKETOPROFEN TROMETAMOL

Official prescribing information from the FDA-approved drug label.