Skip to content
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\BUTYLSCOPOLAMINE: 60 Adverse Event Reports & Safety Profile

Grow Your Own Natural Pharmacy at Home

Medicinal Garden Kit — 10 healing herbs, 4,818 seeds + step-by-step guide.

Get the Kit
60
Total FAERS Reports
0
Deaths Reported
14
Hospitalizations
60
As Primary/Secondary Suspect
5
Life-Threatening

Active Ingredient: ACETAMINOPHEN\BUTYLSCOPOLAMINE BROMIDE ·

First Report: 20110730 · Latest Report: 20200602

What Are the Most Common ACETAMINOPHEN\BUTYLSCOPOLAMINE Side Effects?

#1 Most Reported
Headache
48 reports (80.0%)
#2 Most Reported
Swollen tongue
47 reports (78.3%)
#3 Most Reported
Swelling face
47 reports (78.3%)

All ACETAMINOPHEN\BUTYLSCOPOLAMINE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Headache 48 80.0% 0 4
Angioedema 47 78.3% 0 4
Dysphonia 47 78.3% 0 4
Hypersensitivity 47 78.3% 0 4
Swelling face 47 78.3% 0 4
Swollen tongue 47 78.3% 0 4
Drug intolerance 42 70.0% 0 4
Drug ineffective for unapproved indication 40 66.7% 0 4
Off label use 40 66.7% 0 4
Drug ineffective 38 63.3% 0 4
Product use in unapproved indication 32 53.3% 0 4
Suicide attempt 10 16.7% 0 7
Intentional overdose 9 15.0% 0 6
Vomiting 8 13.3% 0 6
Aspiration 5 8.3% 0 5
Hypervigilance 5 8.3% 0 5
Hypotension 5 8.3% 0 5
Hypoxia 5 8.3% 0 5
Mydriasis 5 8.3% 0 5
Poor quality sleep 5 8.3% 0 5

Who Reports ACETAMINOPHEN\BUTYLSCOPOLAMINE Side Effects? Age & Gender Data

Gender: 100.0% female, 0.0% male. Average age: 39.7 years. Most reports from: CA. View detailed demographics →

Is ACETAMINOPHEN\BUTYLSCOPOLAMINE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2011 5 0 5
2019 1 0 1
2020 1 0 0

View full timeline →

What Is ACETAMINOPHEN\BUTYLSCOPOLAMINE Used For?

IndicationReports
Migraine 28
Product used for unknown indication 28

Official FDA Label for ACETAMINOPHEN\BUTYLSCOPOLAMINE

Official prescribing information from the FDA-approved drug label.