ATROPINE\DIFENOXIN: 70 Adverse Event Reports & Safety Profile
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70
Total FAERS Reports
0
Deaths Reported
21
Hospitalizations
70
As Primary/Secondary Suspect
1
Disabilities
Active Ingredient: ATROPINE SULFATE\DIFENOXIN HYDROCHLORIDE ·
First Report: 2012 · Latest Report: 20191006
What Are the Most Common ATROPINE\DIFENOXIN Side Effects?
#1 Most Reported
Drug ineffective
45 reports (64.3%)
#2 Most Reported
Macular degeneration
44 reports (62.9%)
#3 Most Reported
Product use in unapproved indication
16 reports (22.9%)
All ATROPINE\DIFENOXIN Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Drug ineffective | 45 | 64.3% | 0 | 3 |
| Macular degeneration | 44 | 62.9% | 0 | 3 |
| Product use in unapproved indication | 16 | 22.9% | 0 | 16 |
| Agitation | 12 | 17.1% | 0 | 12 |
| Substance-induced psychotic disorder | 12 | 17.1% | 0 | 12 |
| Hallucinations, mixed | 6 | 8.6% | 0 | 6 |
| Mydriasis | 6 | 8.6% | 0 | 6 |
| Delirium | 5 | 7.1% | 0 | 5 |
| Dry mouth | 5 | 7.1% | 0 | 4 |
| Hallucination | 5 | 7.1% | 0 | 5 |
| Tachycardia | 5 | 7.1% | 0 | 5 |
Who Reports ATROPINE\DIFENOXIN Side Effects? Age & Gender Data
Gender: 72.7% female, 27.3% male. Average age: 38.6 years. Most reports from: CA. View detailed demographics →
Is ATROPINE\DIFENOXIN Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2012 | 1 | 0 | 0 |
| 2017 | 1 | 0 | 0 |
| 2019 | 1 | 0 | 0 |
What Is ATROPINE\DIFENOXIN Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 41 |
| Chemical poisoning | 15 |
Official FDA Label for ATROPINE\DIFENOXIN
Official prescribing information from the FDA-approved drug label.