Baclofen: Side Effects, Uses & Monitoring
Facts extracted from current FDA product labeling for Baclofen. Educational only — not medical advice.
Reported adverse reactions
| Reaction | Highest frequency reported* |
|---|---|
| Vomiting | 6.2% |
| Somnolence | 5.7% |
| Hypotonia | 5.4% |
| Paresthesia | 2.4% |
| Dizziness | 1.7% |
| Nausea and vomiting | 1.6% |
| Headache | 1.6% |
| Nausea | 1.4% |
| Hypotension | 1% |
| Back pain | 0.9% |
| Urinary retention | 0.7% |
| Asthenia | 0.7% |
| Convulsion | 0.5% |
| Confusion | 0.5% |
| Ambylopia | 0.5% |
| Fever | 0.5% |
| Thinking abnormal | 0.5% |
| Agitation | 0.5% |
| Chills | 0.5% |
| Tremor | 0.5% |
*Highest percentage across placebo-controlled trial tables summarized in current labeling.
Labeled uses
Baclofen injection (intrathecal) is indicated for use in the management of severe spasticity. Patients should first respond to a screening dose of intrathecal baclofen prior to consideration for long term infusion via an implantable pump. For spasticity of spinal cord origin, chronic infusion of baclofen injection (intrathecal) via an implantable pump should be reserved for patients unresponsive to oral baclofen therapy, or those who experience intolerable CNS side effects at effective doses. Patients with spasticity due to traumatic brain injury should wait at least one year after the injury before consideration of long term intrathecal baclofen therapy. Baclofen injection (intrathecal) is intended for use by the intrathecal route in single bolus test doses (via spinal catheter or lumbar puncture) and, for chronic use, only in implantable pumps approved by the FDA specifically for the administration of baclofen injection (intrathecal) into the intrathecal space. Spasticity of Spinal Cord Origin: Evidence supporting the efficacy of baclofen injection (intrathecal) was obtained in randomized, controlled investigations that compared the effects of either a single intrathecal dose or …
Medical disclaimer: Always consult a qualified healthcare professional about any medication.