BACLOFEN INTRATHECAL /ML: 52 Adverse Event Reports & Safety Profile
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52
Total FAERS Reports
1 (1.9%)
Deaths Reported
23
Hospitalizations
52
As Primary/Secondary Suspect
2
Life-Threatening
First Report: 20090310 · Latest Report: 20130315
What Are the Most Common BACLOFEN INTRATHECAL /ML Side Effects?
#1 Most Reported
Muscle spasticity
15 reports (28.8%)
#2 Most Reported
Pain
14 reports (26.9%)
#3 Most Reported
Drug withdrawal syndrome
13 reports (25.0%)
All BACLOFEN INTRATHECAL /ML Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Muscle spasticity | 15 | 28.9% | 0 | 9 |
| Pain | 14 | 26.9% | 0 | 7 |
| Drug withdrawal syndrome | 13 | 25.0% | 0 | 7 |
| Therapeutic response decreased | 8 | 15.4% | 0 | 4 |
| Muscle spasms | 6 | 11.5% | 0 | 4 |
| Pyrexia | 6 | 11.5% | 0 | 4 |
Who Reports BACLOFEN INTRATHECAL /ML Side Effects? Age & Gender Data
Average age: 43.2 years. Most reports from: US. View detailed demographics →
Is BACLOFEN INTRATHECAL /ML Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2009 | 1 | 0 | 0 |
| 2011 | 1 | 0 | 0 |
| 2012 | 8 | 0 | 3 |
| 2013 | 4 | 0 | 4 |
What Is BACLOFEN INTRATHECAL /ML Used For?
| Indication | Reports |
|---|---|
| Muscle spasticity | 33 |
| Pain | 9 |
Official FDA Label for BACLOFEN INTRATHECAL /ML
Official prescribing information from the FDA-approved drug label.