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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.

DIMETHICONE\LOPERAMIDE: 5,590 Adverse Event Reports & Safety Profile

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5,590
Total FAERS Reports
8 (0.1%)
Deaths Reported
55
Hospitalizations
5,590
As Primary/Secondary Suspect
42
Life-Threatening
1
Disabilities

Active Ingredient: DIMETHICONE\LOPERAMIDE HYDROCHLORIDE ·

First Report: 1989 · Latest Report: 20250903

What Are the Most Common DIMETHICONE\LOPERAMIDE Side Effects?

#1 Most Reported
Drug ineffective
1,380 reports (24.7%)
#2 Most Reported
Incorrect dose administered
892 reports (16.0%)
#3 Most Reported
Dysphagia
549 reports (9.8%)

All DIMETHICONE\LOPERAMIDE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Drug ineffective 1,380 24.7% 3 2
Incorrect dose administered 892 16.0% 3 1
Dysphagia 549 9.8% 0 0
Product size issue 416 7.4% 0 1
Off label use 402 7.2% 0 1
Product packaging issue 348 6.2% 0 0
Wrong technique in product usage process 335 6.0% 0 2
Expired product administered 311 5.6% 0 0
Inappropriate schedule of drug administration 284 5.1% 0 0
Product use issue 259 4.6% 1 1
Choking 247 4.4% 0 0
Wrong technique in drug usage process 235 4.2% 0 0
Foreign body 227 4.1% 0 1
Product difficult to swallow 213 3.8% 0 0
Product use complaint 201 3.6% 0 1
Constipation 195 3.5% 0 0
Intentional product use issue 194 3.5% 0 0
Product quality issue 175 3.1% 0 2
Diarrhoea 157 2.8% 0 0
Product label issue 154 2.8% 0 0

Who Reports DIMETHICONE\LOPERAMIDE Side Effects? Age & Gender Data

Gender: 71.4% female, 28.6% male. Average age: 70.9 years. Most reports from: US. View detailed demographics →

Is DIMETHICONE\LOPERAMIDE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2000 1 0 0
2001 2 0 0
2003 1 0 0
2004 1 0 0
2005 1 0 0
2006 1 0 0
2007 1 0 0
2009 2 0 0
2010 1 0 0
2011 4 0 0
2012 8 0 1
2013 177 0 0
2014 261 0 0
2015 151 0 0
2016 137 0 1
2017 94 2 1
2018 98 0 7
2019 69 0 0
2020 40 0 1
2021 68 0 0
2022 86 0 0
2023 104 0 0
2024 111 1 1
2025 71 0 0

View full timeline →

What Is DIMETHICONE\LOPERAMIDE Used For?

IndicationReports
Diarrhoea 3,543
Product used for unknown indication 1,105
Irritable bowel syndrome 365
Flatulence 187
Antidiarrhoeal supportive care 110
Abdominal distension 98
Muscle spasms 80
Colitis 49
Gastrointestinal disorder 42
Abdominal discomfort 38

DIMETHICONE\LOPERAMIDE vs Alternatives: Which Is Safer?

DIMETHICONE\LOPERAMIDE vs DIMETHINDENE DIMETHICONE\LOPERAMIDE vs DIMETHYL DIMETHICONE\LOPERAMIDE vs DIMETHYL SULFONE DIMETHICONE\LOPERAMIDE vs DINOPROSTONE DIMETHICONE\LOPERAMIDE vs DINUTUXIMAB DIMETHICONE\LOPERAMIDE vs DINUTUXIMAB BETA DIMETHICONE\LOPERAMIDE vs DIOSMIN DIMETHICONE\LOPERAMIDE vs DIOSMIN\HESPERIDIN DIMETHICONE\LOPERAMIDE vs DIOVAN DIMETHICONE\LOPERAMIDE vs DIPHENHYDRAMINE

Official FDA Label for DIMETHICONE\LOPERAMIDE

Official prescribing information from the FDA-approved drug label.