ACETAMINOPHEN\CAFFEINE\SALICYLIC ACID: 75 Adverse Event Reports & Safety Profile
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75
Total FAERS Reports
34 (45.3%)
Deaths Reported
14
Hospitalizations
75
As Primary/Secondary Suspect
First Report: 2012 · Latest Report: 20230101
What Are the Most Common ACETAMINOPHEN\CAFFEINE\SALICYLIC ACID Side Effects?
#1 Most Reported
Completed suicide
22 reports (29.3%)
#2 Most Reported
No adverse event
12 reports (16.0%)
#3 Most Reported
Toxicity to various agents
11 reports (14.7%)
All ACETAMINOPHEN\CAFFEINE\SALICYLIC ACID Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Completed suicide | 22 | 29.3% | 22 | 10 |
| No adverse event | 12 | 16.0% | 0 | 0 |
| Off label use | 11 | 14.7% | 0 | 0 |
| Toxicity to various agents | 11 | 14.7% | 11 | 7 |
| Cardio-respiratory arrest | 9 | 12.0% | 9 | 1 |
| Drug ineffective | 6 | 8.0% | 0 | 0 |
| Suspected suicide | 6 | 8.0% | 6 | 3 |
| Death | 5 | 6.7% | 5 | 0 |
| Expired product administered | 5 | 6.7% | 0 | 0 |
| Incorrect dose administered | 5 | 6.7% | 0 | 0 |
Who Reports ACETAMINOPHEN\CAFFEINE\SALICYLIC ACID Side Effects? Age & Gender Data
Gender: 71.8% female, 28.2% male. Average age: 48.2 years. Most reports from: US. View detailed demographics →
Is ACETAMINOPHEN\CAFFEINE\SALICYLIC ACID Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2012 | 1 | 0 | 0 |
| 2013 | 1 | 0 | 0 |
| 2014 | 7 | 0 | 0 |
| 2015 | 32 | 0 | 1 |
| 2017 | 1 | 1 | 0 |
| 2018 | 1 | 1 | 0 |
| 2019 | 1 | 1 | 0 |
| 2023 | 4 | 4 | 0 |
What Is ACETAMINOPHEN\CAFFEINE\SALICYLIC ACID Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 29 |
| Migraine | 23 |
| Suicide attempt | 5 |
Official FDA Label for ACETAMINOPHEN\CAFFEINE\SALICYLIC ACID
Official prescribing information from the FDA-approved drug label.