BUCLIZINE: 36 Adverse Event Reports & Safety Profile
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36
Total FAERS Reports
6 (16.7%)
Deaths Reported
23
Hospitalizations
36
As Primary/Secondary Suspect
10
Life-Threatening
Approved Prior to Jan 1, 1982
FDA Approved
Discontinued
Status
FDA Application: 010911 ·
First Report: 20130630 · Latest Report: 20240326
What Are the Most Common BUCLIZINE Side Effects?
#1 Most Reported
Toxicity to various agents
14 reports (38.9%)
#2 Most Reported
Depressed level of consciousness
10 reports (27.8%)
#3 Most Reported
Intentional overdose
9 reports (25.0%)
All BUCLIZINE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Toxicity to various agents | 14 | 38.9% | 4 | 8 |
| Depressed level of consciousness | 10 | 27.8% | 4 | 4 |
| Intentional overdose | 9 | 25.0% | 0 | 8 |
| Anticholinergic syndrome | 8 | 22.2% | 0 | 5 |
| Drug abuse | 8 | 22.2% | 0 | 5 |
| Suicidal ideation | 8 | 22.2% | 0 | 7 |
| Dystonia | 7 | 19.4% | 0 | 5 |
| Overdose | 7 | 19.4% | 0 | 5 |
| Drug interaction | 6 | 16.7% | 0 | 4 |
| Electrocardiogram abnormal | 6 | 16.7% | 0 | 4 |
| Intentional self-injury | 6 | 16.7% | 0 | 6 |
| Confusional state | 5 | 13.9% | 1 | 1 |
| Delirium | 5 | 13.9% | 0 | 2 |
| Muscle twitching | 5 | 13.9% | 0 | 3 |
| Somnolence | 5 | 13.9% | 0 | 3 |
Who Reports BUCLIZINE Side Effects? Age & Gender Data
Gender: 78.1% female, 21.9% male. Average age: 31.8 years. Most reports from: US. View detailed demographics →
Is BUCLIZINE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2013 | 3 | 0 | 3 |
| 2014 | 1 | 0 | 1 |
| 2015 | 4 | 0 | 4 |
| 2017 | 1 | 0 | 0 |
| 2018 | 1 | 0 | 1 |
| 2019 | 3 | 0 | 3 |
| 2021 | 1 | 1 | 0 |
| 2024 | 1 | 0 | 1 |
What Is BUCLIZINE Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 25 |
Official FDA Label for BUCLIZINE
Official prescribing information from the FDA-approved drug label.