Skip to site content

Serious Breathing Difficulty Risk with Gabapentinoids

December 19, 2019

The Issue

The FDA issued a Drug Safety Communication (DSC) that highlights a new warning for gabapentinoid medications. Reports to the FDA through the MedWatch Adverse Drug Event reporting program and clinical trials show that gabapentinoids can cause serious breathing difficulties (e.g., respiratory depression) in patients who have respiratory risk factors. Respiratory risk factors include:

  • Co-administration with an opioid
  • Co-administration with other central nervous system depressants (e.g., benzodiazepines, antihistamines, anti-anxiety medications, and antidepressants)
  • Underlying respiratory disease
  • Elderly patients


Gabapentinoids include the medications:

  • Gabapentin (Neurontin®, Galise®, Horizant®)
  • Pregabalin (Lyrica®, Lyrica CR®)

Report adverse events involving this or other medicines to the MedWatch program as recommended in the Indian Health Manual and include “IHS” in the reporter section (section G).

Instructions for reporting can be found online at the NPTC Pharmacovigilance website.