BACLOFEN for Muscle spasticity: Side Effects & Safety Data
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There are 6,787 adverse event reports in the FDA FAERS database where BACLOFEN was used for Muscle spasticity.
Most Reported Side Effects for BACLOFEN
| Side Effect | Reports | % | Deaths | Hosp. |
|---|---|---|---|---|
| Muscle spasticity | 2,893 | 11.2% | 50 | 872 |
| Drug withdrawal syndrome | 2,284 | 8.9% | 52 | 1,070 |
| Pain | 2,048 | 8.0% | 78 | 612 |
| Toxicity to various agents | 1,868 | 7.3% | 818 | 1,037 |
| Overdose | 1,554 | 6.0% | 118 | 968 |
| Off label use | 1,454 | 5.7% | 134 | 589 |
| Drug ineffective | 1,445 | 5.6% | 33 | 405 |
| Somnolence | 1,433 | 5.6% | 28 | 884 |
| Muscle spasms | 1,279 | 5.0% | 20 | 427 |
| Coma | 1,133 | 4.4% | 49 | 906 |
| Completed suicide | 1,112 | 4.3% | 1,112 | 277 |
| Fall | 1,057 | 4.1% | 51 | 442 |
| Nausea | 943 | 3.7% | 18 | 363 |
| Encephalopathy | 845 | 3.3% | 19 | 326 |
| Vomiting | 828 | 3.2% | 40 | 453 |
Other Indications for BACLOFEN
Product used for unknown indication (6,968)
Pain (1,388)
Cerebral palsy (882)
Muscle spasms (824)
Multiple sclerosis (712)
Spinal cord injury (434)
Alcoholism (383)
Musculoskeletal pain (364)
Back pain (333)
Spinal pain (282)
Other Drugs Used for Muscle spasticity
ONABOTULINUMTOXINA (1,156)
ABOBOTULINUMTOXINA (595)
LIORESAL INTRATHECAL /ML (206)
LIORESAL (153)
TIZANIDINE (135)
INCOBOTULINUMTOXINA (125)
BACLOFEN INTRATHECAL (118)
LIORESAL INTRATHECAL (114)
BOTULINUM TOXIN TYPE A (90)
DIAZEPAM (54)