BUTRANS: 112 Adverse Event Reports & Safety Profile
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112
Total FAERS Reports
22 (19.6%)
Deaths Reported
24
Hospitalizations
112
As Primary/Secondary Suspect
2
Life-Threatening
9
Disabilities
First Report: 2004 · Latest Report: 20140524
What Are the Most Common BUTRANS Side Effects?
#1 Most Reported
Death
12 reports (10.7%)
#2 Most Reported
Drug ineffective
11 reports (9.8%)
#3 Most Reported
Delirium
11 reports (9.8%)
All BUTRANS Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Death | 12 | 10.7% | 12 | 0 |
| Delirium | 11 | 9.8% | 0 | 6 |
| Drug ineffective | 11 | 9.8% | 0 | 3 |
| Tremor | 10 | 8.9% | 0 | 6 |
| Pain | 9 | 8.0% | 0 | 3 |
| Hallucination | 8 | 7.1% | 0 | 2 |
| Nausea | 8 | 7.1% | 1 | 2 |
| Application site pain | 6 | 5.4% | 0 | 0 |
| Application site pruritus | 6 | 5.4% | 0 | 0 |
| Dizziness | 6 | 5.4% | 1 | 2 |
| Dyspnoea | 6 | 5.4% | 0 | 2 |
| Headache | 6 | 5.4% | 0 | 0 |
| Confusional state | 5 | 4.5% | 1 | 3 |
| Drug withdrawal syndrome | 5 | 4.5% | 0 | 1 |
| Product adhesion issue | 5 | 4.5% | 0 | 0 |
| Vomiting | 5 | 4.5% | 0 | 2 |
Who Reports BUTRANS Side Effects? Age & Gender Data
Average age: 60.7 years. Most reports from: US. View detailed demographics →
Is BUTRANS Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2004 | 1 | 0 | 0 |
| 2011 | 3 | 0 | 1 |
| 2012 | 3 | 0 | 1 |
| 2013 | 16 | 2 | 4 |
| 2014 | 35 | 2 | 11 |
What Is BUTRANS Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 38 |
| Pain | 32 |
| Back pain | 23 |
BUTRANS vs Alternatives: Which Is Safer?
BUTRANS vs BUTYLSCOPOLAMINE
BUTRANS vs BYETTA
BUTRANS vs BYETTA PEN DISPOSABLE
BUTRANS vs CABAZITAXEL
BUTRANS vs CABERGOLINE
BUTRANS vs CABOTEGRAVIR
BUTRANS vs CABOTEGRAVIR\RILPIVIRINE
BUTRANS vs CABOZANTINIB
BUTRANS vs CABOZANTINIB S-MALATE
BUTRANS vs CAFFEINE
Official FDA Label for BUTRANS
Official prescribing information from the FDA-approved drug label.