Drug Landscape ›
Fentanyl 100 mcg ›
Regulatory · United States
Marketing authorisation
FDA
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.
Window: 20 April 2025 – 20 April 2026
Total reports: 23
Most-reported reactions
Nausea — 3 reports (13.04%) Oxygen Saturation Decreased — 3 reports (13.04%) Vision Blurred — 3 reports (13.04%) Death — 2 reports (8.7%) Diplopia — 2 reports (8.7%) Drug Effect Decreased — 2 reports (8.7%) Feeling Abnormal — 2 reports (8.7%) Malaise — 2 reports (8.7%) Mental Status Changes — 2 reports (8.7%) Respiratory Failure — 2 reports (8.7%)
Source database →
Fentanyl 100 mcg 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 100 mcg approved in United States?
Yes. FDA has authorised it.
Who is the marketing authorisation holder for Fentanyl 100 mcg in United States?
Ohio State University is the originator. The local marketing authorisation holder may differ — check the official source linked above.