ACETAMINOPHEN\BUTYLSCOPOLAMINE: 60 Adverse Event Reports & Safety Profile
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60
Total FAERS Reports
0
Deaths Reported
14
Hospitalizations
60
As Primary/Secondary Suspect
5
Life-Threatening
Active Ingredient: ACETAMINOPHEN\BUTYLSCOPOLAMINE BROMIDE ·
First Report: 20110730 · Latest Report: 20200602
What Are the Most Common ACETAMINOPHEN\BUTYLSCOPOLAMINE Side Effects?
#1 Most Reported
Headache
48 reports (80.0%)
#2 Most Reported
Swollen tongue
47 reports (78.3%)
#3 Most Reported
Swelling face
47 reports (78.3%)
All ACETAMINOPHEN\BUTYLSCOPOLAMINE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Headache | 48 | 80.0% | 0 | 4 |
| Angioedema | 47 | 78.3% | 0 | 4 |
| Dysphonia | 47 | 78.3% | 0 | 4 |
| Hypersensitivity | 47 | 78.3% | 0 | 4 |
| Swelling face | 47 | 78.3% | 0 | 4 |
| Swollen tongue | 47 | 78.3% | 0 | 4 |
| Drug intolerance | 42 | 70.0% | 0 | 4 |
| Drug ineffective for unapproved indication | 40 | 66.7% | 0 | 4 |
| Off label use | 40 | 66.7% | 0 | 4 |
| Drug ineffective | 38 | 63.3% | 0 | 4 |
| Product use in unapproved indication | 32 | 53.3% | 0 | 4 |
| Suicide attempt | 10 | 16.7% | 0 | 7 |
| Intentional overdose | 9 | 15.0% | 0 | 6 |
| Vomiting | 8 | 13.3% | 0 | 6 |
| Aspiration | 5 | 8.3% | 0 | 5 |
| Hypervigilance | 5 | 8.3% | 0 | 5 |
| Hypotension | 5 | 8.3% | 0 | 5 |
| Hypoxia | 5 | 8.3% | 0 | 5 |
| Mydriasis | 5 | 8.3% | 0 | 5 |
| Poor quality sleep | 5 | 8.3% | 0 | 5 |
Who Reports ACETAMINOPHEN\BUTYLSCOPOLAMINE Side Effects? Age & Gender Data
Gender: 100.0% female, 0.0% male. Average age: 39.7 years. Most reports from: CA. View detailed demographics →
Is ACETAMINOPHEN\BUTYLSCOPOLAMINE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2011 | 5 | 0 | 5 |
| 2019 | 1 | 0 | 1 |
| 2020 | 1 | 0 | 0 |
What Is ACETAMINOPHEN\BUTYLSCOPOLAMINE Used For?
| Indication | Reports |
|---|---|
| Migraine | 28 |
| Product used for unknown indication | 28 |
Official FDA Label for ACETAMINOPHEN\BUTYLSCOPOLAMINE
Official prescribing information from the FDA-approved drug label.