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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.

DIPHENOXYLATE: 140 Adverse Event Reports & Safety Profile

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140
Total FAERS Reports
27 (19.3%)
Deaths Reported
61
Hospitalizations
140
As Primary/Secondary Suspect
1
Life-Threatening

First Report: 20140222 · Latest Report: 20250101

What Are the Most Common DIPHENOXYLATE Side Effects?

#1 Most Reported
Drug ineffective
88 reports (62.9%)
#2 Most Reported
Macular degeneration
72 reports (51.4%)
#3 Most Reported
Therapeutic product effect incomplete
41 reports (29.3%)

All DIPHENOXYLATE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Drug ineffective 88 62.9% 0 47
Macular degeneration 72 51.4% 0 39
Pyrexia 41 29.3% 0 39
Therapeutic product effect incomplete 41 29.3% 0 39
Off label use 40 28.6% 0 40
Weight decreased 40 28.6% 0 39
Nausea 39 27.9% 0 39
Paraesthesia oral 39 27.9% 0 39
Chronic sinusitis 38 27.1% 0 38
Dyspepsia 38 27.1% 0 38
Infusion related reaction 37 26.4% 0 37
Malaise 37 26.4% 0 37
Pain 37 26.4% 0 37
Procedural pain 37 26.4% 0 37
Frequent bowel movements 29 20.7% 0 26
Haematochezia 29 20.7% 0 26
Constipation 28 20.0% 0 27
Abdominal pain 27 19.3% 0 27
Erythema 27 19.3% 0 27
Headache 27 19.3% 0 26

Who Reports DIPHENOXYLATE Side Effects? Age & Gender Data

Gender: 73.3% female, 26.7% male. Average age: 57.4 years. Most reports from: CA. View detailed demographics →

Is DIPHENOXYLATE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2014 3 0 0
2017 4 1 0
2018 9 0 9
2020 1 0 0
2024 1 0 1
2025 1 0 0

View full timeline →

What Is DIPHENOXYLATE Used For?

IndicationReports
Product used for unknown indication 102
Diarrhoea 15

DIPHENOXYLATE vs Alternatives: Which Is Safer?

DIPHENOXYLATE vs DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED AND INACTIVATED POLIOVIRUS VACCINE DIPHENOXYLATE vs DIPYRIDAMOLE DIPHENOXYLATE vs DIPYRONE DIPHENOXYLATE vs DIROXIMEL DIPHENOXYLATE vs DISOPYRAMIDE DIPHENOXYLATE vs DISTIGMINE DIPHENOXYLATE vs DISULFIRAM DIPHENOXYLATE vs DIVALPROEX DIPHENOXYLATE vs DOBUTAMINE DIPHENOXYLATE vs DOBUTAMINE\DOBUTAMINE

Official FDA Label for DIPHENOXYLATE

Official prescribing information from the FDA-approved drug label.