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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.

ROFECOXIB: 1,238 Adverse Event Reports & Safety Profile

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1,238
Total FAERS Reports
56 (4.5%)
Deaths Reported
176
Hospitalizations
1,238
As Primary/Secondary Suspect
52
Life-Threatening
29
Disabilities
Feb 25, 2000
FDA Approved
Discontinued
Status

FDA Application: 021042 ·

First Report: 1989 · Latest Report: 20240401

What Are the Most Common ROFECOXIB Side Effects?

#1 Most Reported
Drug hypersensitivity
404 reports (32.6%)
#2 Most Reported
Drug ineffective
319 reports (25.8%)
#3 Most Reported
Depression
198 reports (16.0%)

All ROFECOXIB Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Drug hypersensitivity 404 32.6% 0 14
Drug ineffective 319 25.8% 0 15
Depression 198 16.0% 9 40
Fatigue 194 15.7% 1 11
Rheumatoid arthritis 188 15.2% 0 11
Anxiety 187 15.1% 6 25
Diarrhoea 179 14.5% 2 12
Dizziness 172 13.9% 1 9
Abdominal pain 170 13.7% 1 3
Malaise 166 13.4% 0 5
Myocardial infarction 165 13.3% 15 28
Migraine 163 13.2% 1 3
Feeling abnormal 161 13.0% 0 4
Bronchitis 160 12.9% 0 2
Fibromyalgia 160 12.9% 0 2
Agitation 159 12.8% 0 0
Cystitis 158 12.8% 0 0
Hallucination 158 12.8% 0 0
Hyperhidrosis 158 12.8% 0 1
Abdominal pain upper 157 12.7% 0 2

Who Reports ROFECOXIB Side Effects? Age & Gender Data

Gender: 77.9% female, 22.1% male. Average age: 63.1 years. Most reports from: US. View detailed demographics →

Is ROFECOXIB Getting Safer? Reports by Year

YearReportsDeathsHosp.
2000 54 9 18
2001 32 6 26
2002 27 6 17
2003 29 8 21
2004 60 15 41
2005 4 2 3
2006 3 2 1
2007 1 0 0
2008 1 0 0
2010 1 0 0
2011 5 0 5
2012 4 0 0
2013 4 0 0
2014 3 0 1
2015 11 0 2
2016 1 0 0
2017 8 0 1
2018 1 0 0
2019 3 0 0
2020 5 0 2
2021 1 0 1
2023 1 0 0
2024 2 0 0

View full timeline →

What Is ROFECOXIB Used For?

IndicationReports
Rheumatoid arthritis 264
Product used for unknown indication 184
Urticaria 154
Arthritis 47
Rheumatic disorder 27
Back pain 12
Osteoarthritis 8
Pain management 8
Arthralgia 7
Pain 6

ROFECOXIB vs Alternatives: Which Is Safer?

ROFECOXIB vs ROFLUMILAST ROFECOXIB vs ROLAPITANT ROFECOXIB vs ROMIDEPSIN ROFECOXIB vs ROMIPLOSTIM ROFECOXIB vs ROMOSOZUMAB ROFECOXIB vs ROMOSOZUMAB-AQQG ROFECOXIB vs ROPEGINTERFERON ALFA-2B-NJFT ROFECOXIB vs ROPINIROLE ROFECOXIB vs ROPIVACAINE ROFECOXIB vs ROSIGLITAZONE

Official FDA Label for ROFECOXIB

Official prescribing information from the FDA-approved drug label.