CODEINE\DICLOFENAC: 49 Adverse Event Reports & Safety Profile
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49
Total FAERS Reports
3 (6.1%)
Deaths Reported
11
Hospitalizations
49
As Primary/Secondary Suspect
4
Life-Threatening
3
Disabilities
Active Ingredient: CODEINE PHOSPHATE\DICLOFENAC SODIUM ·
First Report: 19980418 · Latest Report: 20190801
What Are the Most Common CODEINE\DICLOFENAC Side Effects?
#1 Most Reported
Pain
14 reports (28.6%)
#2 Most Reported
Malaise
8 reports (16.3%)
#3 Most Reported
Pain in extremity
7 reports (14.3%)
All CODEINE\DICLOFENAC Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Pain | 14 | 28.6% | 0 | 6 |
| Malaise | 8 | 16.3% | 0 | 3 |
| Gait disturbance | 7 | 14.3% | 0 | 0 |
| Pain in extremity | 7 | 14.3% | 0 | 1 |
| Feeling abnormal | 6 | 12.2% | 0 | 0 |
| Nausea | 6 | 12.2% | 0 | 0 |
| Syncope | 6 | 12.2% | 0 | 0 |
| Vomiting | 5 | 10.2% | 0 | 2 |
Who Reports CODEINE\DICLOFENAC Side Effects? Age & Gender Data
Gender: 67.6% female, 32.4% male. Average age: 68.1 years. Most reports from: BR. View detailed demographics →
Is CODEINE\DICLOFENAC Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2008 | 1 | 0 | 0 |
| 2010 | 1 | 0 | 1 |
| 2012 | 1 | 0 | 0 |
| 2014 | 3 | 0 | 1 |
| 2015 | 4 | 0 | 0 |
| 2016 | 2 | 0 | 0 |
| 2017 | 3 | 0 | 1 |
| 2018 | 1 | 0 | 0 |
| 2019 | 2 | 0 | 1 |
What Is CODEINE\DICLOFENAC Used For?
| Indication | Reports |
|---|---|
| Pain | 20 |
| Product used for unknown indication | 11 |
Official FDA Label for CODEINE\DICLOFENAC
Official prescribing information from the FDA-approved drug label.