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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.

KETOPROFEN LYSINE: 380 Adverse Event Reports & Safety Profile

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380
Total FAERS Reports
1 (0.3%)
Deaths Reported
177
Hospitalizations
380
As Primary/Secondary Suspect
7
Life-Threatening

First Report: 20110511 · Latest Report: 20250308

What Are the Most Common KETOPROFEN LYSINE Side Effects?

#1 Most Reported
Drug abuse
112 reports (29.5%)
#2 Most Reported
Intentional self-injury
71 reports (18.7%)
#3 Most Reported
Abdominal pain upper
52 reports (13.7%)

All KETOPROFEN LYSINE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Drug abuse 112 29.5% 0 64
Intentional self-injury 71 18.7% 0 27
Abdominal pain upper 52 13.7% 0 36
Vomiting 36 9.5% 0 17
Sopor 32 8.4% 0 12
Asthenia 26 6.8% 0 13
Pruritus 26 6.8% 0 9
Urticaria 25 6.6% 0 6
Erythema 24 6.3% 0 13
Nausea 23 6.1% 0 8
Dyspnoea 20 5.3% 0 9
Face oedema 20 5.3% 0 6
Abdominal pain 18 4.7% 0 5
Headache 18 4.7% 0 2
Intentional overdose 18 4.7% 0 9
Agitation 16 4.2% 0 9
Melaena 15 4.0% 0 12
Angioedema 14 3.7% 0 4
Haematemesis 14 3.7% 0 11
Rash 14 3.7% 0 8

Who Reports KETOPROFEN LYSINE Side Effects? Age & Gender Data

Gender: 55.3% female, 44.7% male. Average age: 40.8 years. Most reports from: IT. View detailed demographics →

Is KETOPROFEN LYSINE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2011 3 0 0
2012 1 0 1
2013 2 0 2
2014 22 0 11
2015 24 0 10
2016 35 0 11
2017 47 0 36
2018 40 0 18
2019 51 0 31
2020 26 0 3
2021 21 0 5
2022 18 1 10
2023 44 0 27
2024 4 0 3
2025 1 0 0

View full timeline →

What Is KETOPROFEN LYSINE Used For?

IndicationReports
Product used for unknown indication 123
Toothache 33
Pain 27
Intentional self-injury 26
Headache 24
Back pain 15
Drug abuse 13
Sciatica 10
Arthralgia 9
Inflammation 9

KETOPROFEN LYSINE vs Alternatives: Which Is Safer?

KETOPROFEN LYSINE vs KETOROLAC TROMETHAMINE KETOPROFEN LYSINE vs KETOROLAC\KETOROLAC TROMETHAMINE KETOPROFEN LYSINE vs KETOTIFEN KETOPROFEN LYSINE vs KLONOPIN KETOPROFEN LYSINE vs L-ASPARAGINASE KETOPROFEN LYSINE vs LABETALOL KETOPROFEN LYSINE vs LABETALOL\LABETALOL KETOPROFEN LYSINE vs LACIDIPINE KETOPROFEN LYSINE vs LACOSAMIDE KETOPROFEN LYSINE vs LACTOBACILLUS ACIDOPHILUS

Official FDA Label for KETOPROFEN LYSINE

Official prescribing information from the FDA-approved drug label.