DIFENOXIN: 50 Adverse Event Reports & Safety Profile
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50
Total FAERS Reports
0
Deaths Reported
37
Hospitalizations
50
As Primary/Secondary Suspect
Active Ingredient: DIFENOXIN HYDROCHLORIDE ·
First Report: 20180101 · Latest Report: 20180101
What Are the Most Common DIFENOXIN Side Effects?
#1 Most Reported
Macular degeneration
49 reports (98.0%)
#2 Most Reported
Drug ineffective
48 reports (96.0%)
#3 Most Reported
Therapeutic product effect incomplete
34 reports (68.0%)
All DIFENOXIN Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Macular degeneration | 49 | 98.0% | 0 | 36 |
| Drug ineffective | 48 | 96.0% | 0 | 35 |
| Therapeutic product effect incomplete | 34 | 68.0% | 0 | 34 |
| Chronic sinusitis | 33 | 66.0% | 0 | 33 |
| Nausea | 33 | 66.0% | 0 | 33 |
| Off label use | 33 | 66.0% | 0 | 33 |
| Paraesthesia oral | 33 | 66.0% | 0 | 33 |
| Pyrexia | 33 | 66.0% | 0 | 33 |
| Weight decreased | 33 | 66.0% | 0 | 33 |
| Dyspepsia | 32 | 64.0% | 0 | 32 |
| Colitis ulcerative | 31 | 62.0% | 0 | 31 |
| Constipation | 31 | 62.0% | 0 | 31 |
| Erythema | 31 | 62.0% | 0 | 31 |
| Female genital tract fistula | 31 | 62.0% | 0 | 31 |
| Frequent bowel movements | 31 | 62.0% | 0 | 31 |
| Haematochezia | 31 | 62.0% | 0 | 31 |
| Headache | 31 | 62.0% | 0 | 31 |
| Infusion related reaction | 31 | 62.0% | 0 | 31 |
| Malaise | 31 | 62.0% | 0 | 31 |
| Pain | 31 | 62.0% | 0 | 31 |
Who Reports DIFENOXIN Side Effects? Age & Gender Data
Gender: 100.0% female, 0.0% male. Average age: 68.9 years. Most reports from: CA. View detailed demographics →
Is DIFENOXIN Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2018 | 10 | 0 | 10 |
What Is DIFENOXIN Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 43 |
Official FDA Label for DIFENOXIN
Official prescribing information from the FDA-approved drug label.