A Clinical Overview of Off-label Use of Gabapentinoid Drugs

JAMA Intern Med. 2019 May 1;179(5):695-701. doi: 10.1001/jamainternmed.2019.0086.


Background: The gabapentinoid drugs gabapentin and pregabalin were originally developed as antiseizure drugs but now are prescribed mainly for treatment of pain. For gabapentin, the only pain-related indication approved by the US Food and Drug Administration (FDA) is postherpetic neuralgia. For pregabalin, FDA-approved indications related to pain are limited to postherpetic neuralgia, neuropathic pain associated with diabetic neuropathy or spinal cord injury, and fibromyalgia. Despite these limited indications, gabapentin and pregabalin are widely prescribed off-label for various other pain syndromes. Such use is growing, possibly because clinicians are searching increasingly for alternatives to opioids.

Observations: This report summarizes the limited published evidence to support off-label gabapentinoid uses, describes clinical cases in which off-label use is problematic, and notes how review articles and guidelines tend to overstate gabapentinoid effectiveness.

Conclusions: Clinicians who prescribe gabapentinoids off-label for pain should be aware of the limited evidence and should acknowledge to patients that potential benefits are uncertain for most off-label uses.

Publication types

  • Review

MeSH terms

  • Analgesics / therapeutic use*
  • Diabetic Neuropathies / drug therapy
  • Drug Approval
  • Fibromyalgia / drug therapy
  • Gabapentin / therapeutic use*
  • Humans
  • Low Back Pain / drug therapy
  • Minimal Clinically Important Difference
  • Neuralgia / drug therapy
  • Neuralgia / etiology
  • Neuralgia, Postherpetic / drug therapy
  • Off-Label Use*
  • Pain / drug therapy*
  • Pain Measurement
  • Pregabalin / therapeutic use*
  • Radiculopathy / drug therapy
  • Sciatica / drug therapy
  • Spinal Cord Injuries / complications


  • Analgesics
  • Pregabalin
  • Gabapentin