Drug Landscape ›
Fentanyl infusion ›
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: 60
Most-reported reactions
Blood Creatinine Increased — 10 reports (16.67%) Alanine Aminotransferase Increased — 9 reports (15%) Aspartate Aminotransferase Increased — 9 reports (15%) Hypotension — 7 reports (11.67%) Acute Kidney Injury — 6 reports (10%) Glomerular Filtration Rate Decreased — 4 reports (6.67%) Hypoxia — 4 reports (6.67%) Shock — 4 reports (6.67%) Therapy Cessation — 4 reports (6.67%) Acute Respiratory Distress Syndrome — 3 reports (5%)
Source database →
Fentanyl infusion 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 infusion approved in United States?
Yes. FDA has authorised it.
Who is the marketing authorisation holder for Fentanyl infusion in United States?
Ain Shams University is the originator. The local marketing authorisation holder may differ — check the official source linked above.