Is baclofen safe for treating back pain?

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Last updated: October 17, 2025View editorial policy

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Safety of Baclofen for Back Pain

Baclofen is not recommended for treating back pain as it lacks FDA approval for this indication and has limited evidence supporting its efficacy compared to other muscle relaxants with better safety profiles. 1, 2

Evidence Against Baclofen Use in Back Pain

  • Baclofen is FDA-approved only for spasticity resulting from multiple sclerosis and spinal cord diseases, not for back pain or skeletal muscle spasm from rheumatic disorders 1
  • Among skeletal muscle relaxants, there is sparse evidence on the efficacy of baclofen specifically for low back pain 2
  • The American College of Physicians guidelines do not recommend baclofen as a preferred option for muscle relaxant therapy in low back pain 3
  • Tizanidine is considered the most effective muscle relaxant option for lumbar radiculopathy with a better safety profile 3

Safety Concerns with Baclofen

  • Baclofen carries significant central nervous system side effects including sedation, excessive weakness, dizziness, mental confusion, and somnolence 1
  • Patients should be cautioned about operating machinery or driving due to decreased alertness 1
  • CNS effects of baclofen may be additive to those of alcohol and other CNS depressants 1
  • Special caution is needed in patients with epilepsy, as deterioration in seizure control has been reported 1

Alternative Treatment Options for Back Pain

  • NSAIDs have good evidence for effectiveness in both acute and chronic low back pain with moderate pain relief 2
  • Skeletal muscle relaxants like tizanidine are effective for short-term pain relief in acute low back pain 2
  • For chronic low back pain, tricyclic antidepressants show small to moderate effects for pain relief 2, 4
  • Gabapentin has demonstrated small, short-term benefits specifically in patients with radiculopathy 2, 3

Recent Research on Baclofen for Back Pain

  • A 2019 randomized controlled trial found that adding baclofen to ibuprofen did not improve functioning or pain any more than placebo plus ibuprofen for acute low back pain 5
  • A 2021 systematic review noted that while baclofen showed some improvement in pain and disability levels, results must be interpreted with caution due to heterogeneous patient demographics and potential adverse events 6
  • A 2010 study suggested that combined treatment of acupuncture and baclofen may be more effective than baclofen alone, but this is not sufficient evidence to recommend baclofen as first-line therapy 7

Treatment Algorithm for Back Pain

  • For acute low back pain: NSAIDs as first-line pharmacological treatment 2
  • If additional pain relief is needed, consider tizanidine (preferred muscle relaxant) rather than baclofen 3
  • For chronic low back pain: NSAIDs or tricyclic antidepressants as first-line pharmacological options 2, 4
  • For low back pain with radiculopathy: consider gabapentin which has demonstrated benefits specifically for radicular symptoms 2, 3

Important Clinical Considerations

  • Time-limited courses of therapy are recommended for all muscle relaxants due to limited evidence on benefits and risks associated with long-term use 2
  • All skeletal muscle relaxants, including baclofen, are associated with central nervous system adverse effects, primarily sedation 2, 1
  • Systemic corticosteroids are not recommended for treatment of low back pain with or without sciatica 2, 3

References

Guideline

Guideline Directed Topic Overview

Dr.Oracle Medical Advisory Board & Editors, 2025

Guideline

Medication Selection for Lumbar Radiculopathy

Praxis Medical Insights: Practical Summaries of Clinical Guidelines, 2025

Guideline

Treatment of Chronic Low Back Pain with Amitriptyline

Praxis Medical Insights: Practical Summaries of Clinical Guidelines, 2025

Research

The pharmacological management of chronic lower back pain.

Expert opinion on pharmacotherapy, 2021

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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