VALDECOXIB: 199 Adverse Event Reports & Safety Profile
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199
Total FAERS Reports
27 (13.6%)
Deaths Reported
45
Hospitalizations
199
As Primary/Secondary Suspect
2
Life-Threatening
4
Disabilities
Nov 16, 2001
FDA Approved
Discontinued
Status
FDA Application: 021341 ·
First Report: 2000 · Latest Report: 20220927
What Are the Most Common VALDECOXIB Side Effects?
#1 Most Reported
Drug hypersensitivity
82 reports (41.2%)
#2 Most Reported
Ischaemic stroke
62 reports (31.2%)
#3 Most Reported
Depression
17 reports (8.5%)
All VALDECOXIB Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Drug hypersensitivity | 82 | 41.2% | 1 | 1 |
| Ischaemic stroke | 62 | 31.2% | 12 | 24 |
| Depression | 17 | 8.5% | 1 | 8 |
| Myocardial infarction | 15 | 7.5% | 2 | 7 |
| Drug ineffective | 11 | 5.5% | 0 | 0 |
| Hypertension | 11 | 5.5% | 9 | 10 |
| Cardiovascular disorder | 9 | 4.5% | 1 | 5 |
| Muscle spasms | 9 | 4.5% | 1 | 1 |
| Renal failure | 9 | 4.5% | 9 | 9 |
| Arthralgia | 8 | 4.0% | 0 | 1 |
| Insomnia | 8 | 4.0% | 0 | 1 |
| Asthenia | 7 | 3.5% | 0 | 1 |
| Back pain | 7 | 3.5% | 0 | 0 |
| Coma | 7 | 3.5% | 7 | 7 |
| Diabetes mellitus | 7 | 3.5% | 6 | 7 |
| Atrophy | 6 | 3.0% | 0 | 0 |
| Bursitis | 6 | 3.0% | 0 | 0 |
| Fall | 6 | 3.0% | 0 | 0 |
| Joint effusion | 6 | 3.0% | 0 | 0 |
| Myofascial pain syndrome | 6 | 3.0% | 0 | 0 |
Who Reports VALDECOXIB Side Effects? Age & Gender Data
Gender: 76.0% female, 24.0% male. Average age: 59.4 years. Most reports from: US. View detailed demographics →
Is VALDECOXIB Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2000 | 8 | 1 | 1 |
| 2001 | 10 | 2 | 5 |
| 2002 | 12 | 3 | 4 |
| 2003 | 15 | 3 | 7 |
| 2004 | 26 | 5 | 11 |
| 2005 | 2 | 0 | 0 |
| 2007 | 1 | 0 | 0 |
| 2008 | 1 | 0 | 0 |
| 2011 | 4 | 0 | 0 |
| 2013 | 3 | 0 | 0 |
| 2014 | 2 | 0 | 1 |
| 2015 | 1 | 0 | 0 |
| 2016 | 1 | 0 | 0 |
| 2017 | 1 | 0 | 1 |
| 2022 | 1 | 1 | 1 |
What Is VALDECOXIB Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 24 |
| Arthritis | 12 |
| Pain | 11 |
| Rheumatoid arthritis | 8 |
| Contusion | 5 |
| Pain management | 5 |
VALDECOXIB vs Alternatives: Which Is Safer?
VALDECOXIB vs VALERIAN
VALDECOXIB vs VALGANCICLOVIR
VALDECOXIB vs VALIUM
VALDECOXIB vs VALPROATE
VALDECOXIB vs VALPROIC ACID
VALDECOXIB vs VALPROMIDE
VALDECOXIB vs VALSARTAN
VALDECOXIB vs VALTREX
VALDECOXIB vs VAMOROLONE
VALDECOXIB vs VANCOMYCIN
Official FDA Label for VALDECOXIB
Official prescribing information from the FDA-approved drug label.