ACETAMINOPHEN\CODEINE\DOXYLAMINE: 52 Adverse Event Reports & Safety Profile
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52
Total FAERS Reports
24 (46.2%)
Deaths Reported
14
Hospitalizations
52
As Primary/Secondary Suspect
1
Life-Threatening
1
Disabilities
Active Ingredient: ACETAMINOPHEN\CODEINE PHOSPHATE\DOXYLAMINE SUCCINATE ·
First Report: 200803 · Latest Report: 20230307
What Are the Most Common ACETAMINOPHEN\CODEINE\DOXYLAMINE Side Effects?
#1 Most Reported
Toxicity to various agents
24 reports (46.2%)
#2 Most Reported
Pain
10 reports (19.2%)
#3 Most Reported
Cauda equina syndrome
9 reports (17.3%)
All ACETAMINOPHEN\CODEINE\DOXYLAMINE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Toxicity to various agents | 24 | 46.2% | 20 | 6 |
| Pain | 10 | 19.2% | 4 | 5 |
| Cauda equina syndrome | 9 | 17.3% | 0 | 2 |
| Acute kidney injury | 7 | 13.5% | 0 | 5 |
| Cardio-respiratory arrest | 7 | 13.5% | 7 | 0 |
| Coronary artery stenosis | 7 | 13.5% | 7 | 0 |
| Metabolic acidosis | 7 | 13.5% | 0 | 5 |
| Overdose | 7 | 13.5% | 5 | 5 |
| Pulmonary congestion | 7 | 13.5% | 7 | 0 |
| Pyroglutamic acidosis | 7 | 13.5% | 0 | 5 |
| Accidental overdose | 5 | 9.6% | 4 | 0 |
| Arthralgia | 5 | 9.6% | 0 | 1 |
| Condition aggravated | 5 | 9.6% | 1 | 1 |
| Drug dependence | 5 | 9.6% | 3 | 0 |
| Fall | 5 | 9.6% | 1 | 1 |
| Product prescribing error | 5 | 9.6% | 4 | 0 |
| Urinary incontinence | 5 | 9.6% | 0 | 2 |
Who Reports ACETAMINOPHEN\CODEINE\DOXYLAMINE Side Effects? Age & Gender Data
Gender: 71.4% female, 28.6% male. Average age: 48.8 years. Most reports from: AU. View detailed demographics →
Is ACETAMINOPHEN\CODEINE\DOXYLAMINE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2008 | 1 | 1 | 0 |
| 2013 | 3 | 3 | 0 |
| 2017 | 2 | 2 | 2 |
| 2019 | 7 | 6 | 1 |
| 2022 | 1 | 0 | 0 |
| 2023 | 1 | 0 | 1 |
What Is ACETAMINOPHEN\CODEINE\DOXYLAMINE Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 27 |
| Back pain | 10 |
| Pain | 6 |
Official FDA Label for ACETAMINOPHEN\CODEINE\DOXYLAMINE
Official prescribing information from the FDA-approved drug label.