FDA — authorised 18 September 2015
- Application: ANDA201072
- Marketing authorisation holder: FRESENIUS KABI USA
- Status: supplemented
🇺🇸 DEXMEDETOMIDINE in United States
FDA authorised DEXMEDETOMIDINE on 18 September 2015 · 2,884 US adverse-event reports
Marketing authorisations
FDA — authorised 21 October 2015
- Application: NDA206628
- Marketing authorisation holder: HQ SPCLT PHARMA
- Status: supplemented
FDA — authorised 21 August 2018
- Application: ANDA208532
- Marketing authorisation holder: BAXTER HLTHCARE CORP
- Status: supplemented
FDA — authorised 29 November 2018
- Application: ANDA208129
- Marketing authorisation holder: FRESENIUS KABI USA
- Status: supplemented
FDA — authorised 24 September 2024
- Application: ANDA218112
- Marketing authorisation holder: SOMERSET
- Status: approved
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.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 2,884
Most-reported reactions
- Off Label Use — 573 reports (19.87%)
- Drug Ineffective — 412 reports (14.29%)
- Bradycardia — 409 reports (14.18%)
- Hypotension — 295 reports (10.23%)
- Cardiac Arrest — 256 reports (8.88%)
- Drug Interaction — 237 reports (8.22%)
- Agitation — 204 reports (7.07%)
- Respiratory Failure — 176 reports (6.1%)
- Product Use In Unapproved Indication — 165 reports (5.72%)
- Delirium — 157 reports (5.44%)
DEXMEDETOMIDINE 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 approved in United States?
Yes. FDA authorised it on 18 September 2015; FDA authorised it on 21 October 2015; FDA authorised it on 21 August 2018.
Who is the marketing authorisation holder for DEXMEDETOMIDINE in United States?
FRESENIUS KABI USA holds the US marketing authorisation.