🇺🇸 Fentanyl sublingual spray in United States

11 US adverse-event reports

Marketing authorisation

FDA

  • Status: approved

Safety signals — FAERS

Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.

Most-reported reactions

  1. Death — 2 reports (18.18%)
  2. Abdominal Pain — 1 report (9.09%)
  3. Application Site Pain — 1 report (9.09%)
  4. Arthralgia — 1 report (9.09%)
  5. Cardiac Arrest — 1 report (9.09%)
  6. Craniocerebral Injury — 1 report (9.09%)
  7. Hospice Care — 1 report (9.09%)
  8. Ill-Defined Disorder — 1 report (9.09%)
  9. Investigation — 1 report (9.09%)
  10. Loss Of Consciousness — 1 report (9.09%)

Source database →

Fentanyl sublingual spray in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Frequently asked questions

Is Fentanyl sublingual spray approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for Fentanyl sublingual spray in United States?

INSYS Therapeutics Inc is the originator. The local marketing authorisation holder may differ — check the official source linked above.