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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\DIPHENOXYLATE: 1,871 Adverse Event Reports & Safety Profile

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1,871
Total FAERS Reports
100 (5.3%)
Deaths Reported
450
Hospitalizations
1,871
As Primary/Secondary Suspect
15
Life-Threatening
15
Disabilities

Active Ingredient: ATROPINE SULFATE\DIPHENOXYLATE HYDROCHLORIDE ·

First Report: 1961 · Latest Report: 20250201

What Are the Most Common ATROPINE\DIPHENOXYLATE Side Effects?

#1 Most Reported
Drug ineffective
935 reports (50.0%)
#2 Most Reported
Macular degeneration
484 reports (25.9%)
#3 Most Reported
Product use issue
276 reports (14.8%)

All ATROPINE\DIPHENOXYLATE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Drug ineffective 935 50.0% 10 277
Macular degeneration 484 25.9% 0 205
Product use issue 276 14.8% 10 44
Weight decreased 270 14.4% 3 227
Nausea 268 14.3% 0 206
Malaise 262 14.0% 0 204
Constipation 241 12.9% 2 168
Off label use 235 12.6% 2 193
Pain 226 12.1% 1 204
Diarrhoea 218 11.7% 12 72
Pyrexia 217 11.6% 0 207
Therapeutic product effect incomplete 209 11.2% 0 191
Abdominal pain 205 11.0% 0 176
Headache 196 10.5% 0 160
Chronic sinusitis 192 10.3% 0 189
Paraesthesia oral 192 10.3% 0 189
Dyspepsia 187 10.0% 0 170
Frequent bowel movements 187 10.0% 0 170
Anaemia 179 9.6% 2 172
Infusion related reaction 178 9.5% 0 175

Who Reports ATROPINE\DIPHENOXYLATE Side Effects? Age & Gender Data

Gender: 77.5% female, 22.5% male. Average age: 64.9 years. Most reports from: US. View detailed demographics →

Is ATROPINE\DIPHENOXYLATE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2000 1 0 0
2001 1 0 1
2002 3 0 2
2004 3 0 1
2007 4 1 0
2008 1 0 1
2009 1 0 0
2010 1 0 1
2011 5 0 0
2012 7 2 4
2013 9 5 3
2014 25 0 4
2015 30 1 6
2016 44 3 12
2017 246 22 65
2018 21 1 12
2019 19 6 5
2020 17 0 2
2021 14 0 1
2022 13 0 3
2023 6 0 2
2024 12 0 2
2025 2 0 2

View full timeline →

What Is ATROPINE\DIPHENOXYLATE Used For?

IndicationReports
Product used for unknown indication 629
Diarrhoea 588
Irritable bowel syndrome 70
Colitis microscopic 27
Colitis ulcerative 17
Crohn's disease 16
Colitis 11
Abdominal discomfort 6
Bowel movement irregularity 6
Gastrointestinal disorder 6

ATROPINE\DIPHENOXYLATE vs Alternatives: Which Is Safer?

ATROPINE\DIPHENOXYLATE vs AUBAGIO ATROPINE\DIPHENOXYLATE vs AUGMENTIN ATROPINE\DIPHENOXYLATE vs AUTOLOGOUS CULTURED CHONDROCYTES ATROPINE\DIPHENOXYLATE vs AUTOLOGOUS CULTURED CHONDROCYTES\SUS SCROFA COLLAGEN ATROPINE\DIPHENOXYLATE vs AVACINCAPTAD PEGOL ATROPINE\DIPHENOXYLATE vs AVACOPAN ATROPINE\DIPHENOXYLATE vs AVALGLUCOSIDASE ALFA-NGPT ATROPINE\DIPHENOXYLATE vs AVANAFIL ATROPINE\DIPHENOXYLATE vs AVANDAMET ATROPINE\DIPHENOXYLATE vs AVANDIA

Official FDA Label for ATROPINE\DIPHENOXYLATE

Official prescribing information from the FDA-approved drug label.