Drug Landscape ›
dexmedetomidine hydrochloride for injection ›
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: 10
Most-reported reactions
Altered State Of Consciousness — 1 report (10%) Anuria — 1 report (10%) Blindness — 1 report (10%) Blindness Cortical — 1 report (10%) Cardiogenic Shock — 1 report (10%) Cerebral Infarction — 1 report (10%) Circulatory Collapse — 1 report (10%) Colour Blindness — 1 report (10%) Condition Aggravated — 1 report (10%) Csf Pressure Increased — 1 report (10%)
Source database →
dexmedetomidine hydrochloride for injection 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 dexmedetomidine hydrochloride for injection approved in United States?
Yes. FDA has authorised it.
Who is the marketing authorisation holder for dexmedetomidine hydrochloride for injection in United States?
Peking University First Hospital is the originator. The local marketing authorisation holder may differ — check the official source linked above.