ACETAMINOPHEN\ASPIRIN\DIPHENHYDRAMINE: 37 Adverse Event Reports & Safety Profile
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37
Total FAERS Reports
2 (5.4%)
Deaths Reported
2
Hospitalizations
37
As Primary/Secondary Suspect
Active Ingredient: ACETAMINOPHEN\ASPIRIN\DIPHENHYDRAMINE CITRATE ·
First Report: 20030803 · Latest Report: 2019
What Are the Most Common ACETAMINOPHEN\ASPIRIN\DIPHENHYDRAMINE Side Effects?
#1 Most Reported
Drug ineffective
13 reports (35.1%)
#2 Most Reported
Somnolence
12 reports (32.4%)
#3 Most Reported
Product use in unapproved indication
12 reports (32.4%)
All ACETAMINOPHEN\ASPIRIN\DIPHENHYDRAMINE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Drug ineffective | 13 | 35.1% | 0 | 0 |
| Product use in unapproved indication | 12 | 32.4% | 0 | 0 |
| Somnolence | 12 | 32.4% | 0 | 0 |
| Drug effective for unapproved indication | 7 | 18.9% | 0 | 0 |
| Vomiting | 5 | 13.5% | 1 | 1 |
Who Reports ACETAMINOPHEN\ASPIRIN\DIPHENHYDRAMINE Side Effects? Age & Gender Data
Gender: 58.3% female, 41.7% male. Average age: 54.4 years. Most reports from: US. View detailed demographics →
Is ACETAMINOPHEN\ASPIRIN\DIPHENHYDRAMINE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2003 | 1 | 1 | 1 |
| 2006 | 1 | 0 | 0 |
| 2016 | 1 | 0 | 0 |
| 2017 | 1 | 1 | 1 |
| 2019 | 1 | 0 | 0 |
What Is ACETAMINOPHEN\ASPIRIN\DIPHENHYDRAMINE Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 11 |
| Headache | 9 |
| Migraine | 6 |
Official FDA Label for ACETAMINOPHEN\ASPIRIN\DIPHENHYDRAMINE
Official prescribing information from the FDA-approved drug label.