BUTYROLACTONE: 69 Adverse Event Reports & Safety Profile
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69
Total FAERS Reports
8 (11.6%)
Deaths Reported
27
Hospitalizations
69
As Primary/Secondary Suspect
11
Life-Threatening
First Report: 20060101 · Latest Report: 20250424
What Are the Most Common BUTYROLACTONE Side Effects?
#1 Most Reported
Drug abuse
27 reports (39.1%)
#2 Most Reported
Intentional product misuse
19 reports (27.5%)
#3 Most Reported
Miosis
14 reports (20.3%)
All BUTYROLACTONE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Drug abuse | 27 | 39.1% | 0 | 16 |
| Intentional product misuse | 19 | 27.5% | 0 | 6 |
| Coma | 14 | 20.3% | 0 | 9 |
| Miosis | 14 | 20.3% | 0 | 7 |
| Drug dependence | 11 | 15.9% | 0 | 3 |
| Agitation | 10 | 14.5% | 0 | 8 |
| Toxicity to various agents | 10 | 14.5% | 5 | 5 |
| Substance use disorder | 8 | 11.6% | 0 | 1 |
| Unresponsive to stimuli | 7 | 10.1% | 0 | 7 |
| Altered state of consciousness | 5 | 7.3% | 0 | 1 |
| Dyskinesia | 5 | 7.3% | 0 | 5 |
| Mydriasis | 5 | 7.3% | 0 | 3 |
| Overdose | 5 | 7.3% | 0 | 4 |
| Substance abuse | 5 | 7.3% | 3 | 1 |
Who Reports BUTYROLACTONE Side Effects? Age & Gender Data
Gender: 7.6% female, 92.4% male. Average age: 35.1 years. Most reports from: FR. View detailed demographics →
Is BUTYROLACTONE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2006 | 1 | 0 | 0 |
| 2015 | 1 | 0 | 0 |
| 2017 | 3 | 0 | 2 |
| 2021 | 3 | 3 | 0 |
| 2022 | 7 | 0 | 5 |
| 2023 | 2 | 0 | 0 |
| 2024 | 4 | 0 | 0 |
| 2025 | 5 | 0 | 4 |
What Is BUTYROLACTONE Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 51 |
Official FDA Label for BUTYROLACTONE
Official prescribing information from the FDA-approved drug label.