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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

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

YearReportsDeathsHosp.
2003 1 1 1
2006 1 0 0
2016 1 0 0
2017 1 1 1
2019 1 0 0

View full timeline →

What Is ACETAMINOPHEN\ASPIRIN\DIPHENHYDRAMINE Used For?

IndicationReports
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.