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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.

ATROPINE\HYOSCYAMINE\PHENOBARBITAL\SCOPOLAMINE HYDROBROMIDE: 73 Adverse Event Reports & Safety Profile

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73
Total FAERS Reports
3 (4.1%)
Deaths Reported
7
Hospitalizations
73
As Primary/Secondary Suspect
8
Life-Threatening
1
Disabilities

Active Ingredient: ATROPINE SULFATE\HYOSCYAMINE SULFATE\PHENOBARBITAL\SCOPOLAMINE HYDROBROMIDE ·

First Report: 20070501 · Latest Report: 202011

What Are the Most Common ATROPINE\HYOSCYAMINE\PHENOBARBITAL\SCOPOLAMINE HYDROBROMIDE Side Effects?

#1 Most Reported
Drug hypersensitivity
26 reports (35.6%)
#2 Most Reported
Apparent life threatening event
8 reports (11.0%)
#3 Most Reported
Infantile apnoea
6 reports (8.2%)

All ATROPINE\HYOSCYAMINE\PHENOBARBITAL\SCOPOLAMINE HYDROBROMIDE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Drug hypersensitivity 26 35.6% 0 0
Apparent life threatening event 8 11.0% 0 0
Infantile apnoea 6 8.2% 0 0
Gastrooesophageal reflux disease 5 6.9% 0 0
Headache 5 6.9% 0 1

Who Reports ATROPINE\HYOSCYAMINE\PHENOBARBITAL\SCOPOLAMINE HYDROBROMIDE Side Effects? Age & Gender Data

Gender: 74.5% female, 25.5% male. Average age: 59.1 years. Most reports from: US. View detailed demographics →

Is ATROPINE\HYOSCYAMINE\PHENOBARBITAL\SCOPOLAMINE HYDROBROMIDE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2007 1 0 1
2012 2 0 2
2014 4 0 1
2015 1 0 0
2016 1 0 0
2018 2 0 0
2020 1 0 0

View full timeline →

What Is ATROPINE\HYOSCYAMINE\PHENOBARBITAL\SCOPOLAMINE HYDROBROMIDE Used For?

IndicationReports
Product used for unknown indication 15
Abdominal pain 9
Irritable bowel syndrome 5

Official FDA Label for ATROPINE\HYOSCYAMINE\PHENOBARBITAL\SCOPOLAMINE HYDROBROMIDE

Official prescribing information from the FDA-approved drug label.