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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.

LOXOPROFEN: 1,359 Adverse Event Reports & Safety Profile

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1,359
Total FAERS Reports
184 (13.5%)
Deaths Reported
819
Hospitalizations
1,359
As Primary/Secondary Suspect
155
Life-Threatening
31
Disabilities

Active Ingredient: LOXOPROFEN SODIUM ·

First Report: 19961014 · Latest Report: 20250727

What Are the Most Common LOXOPROFEN Side Effects?

#1 Most Reported
Pyrexia
103 reports (7.6%)
#2 Most Reported
Acute kidney injury
94 reports (6.9%)
#3 Most Reported
Anaemia
75 reports (5.5%)

All LOXOPROFEN Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Pyrexia 103 7.6% 16 72
Acute kidney injury 94 6.9% 8 78
Anaemia 75 5.5% 9 52
Renal impairment 74 5.5% 9 52
Decreased appetite 70 5.2% 14 53
Malaise 68 5.0% 19 55
Hepatic function abnormal 64 4.7% 8 44
Interstitial lung disease 61 4.5% 22 43
Rash 59 4.3% 11 38
Nausea 57 4.2% 5 31
Diarrhoea 56 4.1% 9 34
Vomiting 56 4.1% 9 31
Off label use 53 3.9% 3 30
Platelet count decreased 51 3.8% 4 33
Dizziness 42 3.1% 4 25
Altered state of consciousness 41 3.0% 2 38
Drug eruption 40 2.9% 3 21
Drug ineffective 40 2.9% 3 19
Gastric ulcer 39 2.9% 3 26
Gastrointestinal haemorrhage 38 2.8% 7 22

Who Reports LOXOPROFEN Side Effects? Age & Gender Data

Gender: 49.7% female, 50.3% male. Average age: 60.7 years. Most reports from: JP. View detailed demographics →

Is LOXOPROFEN Getting Safer? Reports by Year

YearReportsDeathsHosp.
2000 2 0 2
2001 1 0 1
2003 3 0 2
2006 1 1 0
2007 5 1 2
2008 3 0 2
2009 5 0 5
2010 13 3 8
2011 7 1 6
2012 14 4 8
2013 48 14 26
2014 80 11 55
2015 93 13 77
2016 114 13 78
2017 112 28 72
2018 96 15 64
2019 79 11 54
2020 61 10 31
2021 55 5 39
2022 65 10 36
2023 60 9 37
2024 41 5 22
2025 16 1 7

View full timeline →

What Is LOXOPROFEN Used For?

IndicationReports
Product used for unknown indication 387
Pain 121
Back pain 66
Pyrexia 65
Cancer pain 49
Analgesic therapy 48
Rheumatoid arthritis 42
Headache 37
Hypertension 31
Arthralgia 30

LOXOPROFEN vs Alternatives: Which Is Safer?

LOXOPROFEN vs LUBIPROSTONE LOXOPROFEN vs LUCENTIS LOXOPROFEN vs LUCRIN DEPOT LOXOPROFEN vs LUMASIRAN LOXOPROFEN vs LUMATEPERONE LOXOPROFEN vs LUMIGAN LOXOPROFEN vs LUPRON DEPOT LOXOPROFEN vs LUPRON DEPOT-PED LOXOPROFEN vs LURASIDONE LOXOPROFEN vs LURBINECTEDIN

Official FDA Label for LOXOPROFEN

Official prescribing information from the FDA-approved drug label.