Important Safety Information

gammaCore® (non-invasive vagus nerve stimulator) is indicated for the acute treatment of pain associated with episodic cluster headache and migraine headache in adult patients

  • The safety and effectiveness of gammaCore (nVNS) have not been established in the acute treatment of chronic cluster headache
  • gammaCore has not been shown to be effective for the prophylactic treatment of migraine headache, chronic cluster headache, or episodic cluster headache
  • The long-term effects of the chronic use of gammaCore have not been evaluated
  • Safety and efficacy of gammaCore have not been evaluated in the following patients, and therefore it is NOT indicated for:
    • Patients with an active implantable medical device, such as a pacemaker, hearing aid implant, or any implanted electronic device
    • Patients diagnosed with narrowing of the arteries (carotid atherosclerosis)
    • Patients who have had surgery to cut the vagus nerve in the neck (cervical vagotomy)
    • Pediatric patients
    • Pregnant women
    • Patients with clinically significant hypertension, hypotension, bradycardia, or tachycardia
  • Patients should not use gammaCore if they:
    • Have a metallic device such as a stent, bone plate, or bone screw implanted at or near their neck
    • Are using another device at the same time (e.g., TENS Unit, muscle stimulator) or any portable electronic device (e.g., mobile phone)