ACETAMINOPHEN\CAFFEINE\PROMETHAZINE\SALICYLAMIDE: 55 Adverse Event Reports & Safety Profile
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55
Total FAERS Reports
3 (5.5%)
Deaths Reported
23
Hospitalizations
55
As Primary/Secondary Suspect
3
Life-Threatening
1
Disabilities
First Report: 20000222 · Latest Report: 20250510
What Are the Most Common ACETAMINOPHEN\CAFFEINE\PROMETHAZINE\SALICYLAMIDE Side Effects?
#1 Most Reported
Urinary retention
7 reports (12.7%)
#2 Most Reported
Vomiting
6 reports (10.9%)
#3 Most Reported
Nasopharyngitis
6 reports (10.9%)
All ACETAMINOPHEN\CAFFEINE\PROMETHAZINE\SALICYLAMIDE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Urinary retention | 7 | 12.7% | 0 | 5 |
| Nasopharyngitis | 6 | 10.9% | 1 | 3 |
| Vomiting | 6 | 10.9% | 0 | 4 |
| Dizziness | 5 | 9.1% | 0 | 5 |
| Malaise | 5 | 9.1% | 0 | 5 |
| Pyrexia | 5 | 9.1% | 1 | 3 |
| Rash | 5 | 9.1% | 0 | 3 |
Who Reports ACETAMINOPHEN\CAFFEINE\PROMETHAZINE\SALICYLAMIDE Side Effects? Age & Gender Data
Gender: 60.0% female, 40.0% male. Average age: 56.9 years. Most reports from: JP. View detailed demographics →
Is ACETAMINOPHEN\CAFFEINE\PROMETHAZINE\SALICYLAMIDE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2000 | 1 | 0 | 1 |
| 2007 | 1 | 0 | 0 |
| 2012 | 1 | 0 | 0 |
| 2013 | 2 | 0 | 1 |
| 2014 | 1 | 0 | 0 |
| 2015 | 7 | 1 | 5 |
| 2016 | 3 | 0 | 2 |
| 2017 | 4 | 0 | 3 |
| 2018 | 3 | 0 | 1 |
| 2019 | 3 | 0 | 0 |
| 2020 | 3 | 1 | 2 |
| 2021 | 1 | 0 | 1 |
| 2022 | 5 | 0 | 0 |
| 2023 | 2 | 0 | 1 |
| 2025 | 1 | 0 | 0 |
What Is ACETAMINOPHEN\CAFFEINE\PROMETHAZINE\SALICYLAMIDE Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 18 |
| Nasopharyngitis | 13 |
| Pyrexia | 5 |
Official FDA Label for ACETAMINOPHEN\CAFFEINE\PROMETHAZINE\SALICYLAMIDE
Official prescribing information from the FDA-approved drug label.