FDA — authorised 28 September 2013
- Application: NDA021038
- Marketing authorisation holder: HOSPIRA
- Indication: Manufacturing (CMC)
- Status: approved
🇺🇸 DEXMEDETOMIDINE HYDROCHLORIDE in United States
FDA authorised DEXMEDETOMIDINE HYDROCHLORIDE on 28 September 2013 · 959 US adverse-event reports
Marketing authorisations
FDA — authorised 29 November 2018
- Application: ANDA208129
- Marketing authorisation holder: FRESENIUS KABI USA
- Status: approved
FDA — authorised 27 August 2020
- Application: ANDA212571
- Marketing authorisation holder: MYLAN LABS LTD
- Status: approved
FDA — authorised 28 November 2023
- Application: ANDA201072
- Marketing authorisation holder: FRESENIUS KABI USA
- Indication: Labeling
- Status: approved
FDA — authorised 24 September 2024
- Application: ANDA218112
- Marketing authorisation holder: SOMERSET
- 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: 959
Most-reported reactions
- Bradycardia — 184 reports (19.19%)
- Off Label Use — 157 reports (16.37%)
- Cardiac Arrest — 108 reports (11.26%)
- Hypotension — 92 reports (9.59%)
- Product Use In Unapproved Indication — 87 reports (9.07%)
- Drug Interaction — 74 reports (7.72%)
- Product Administered To Patient Of Inappropriate Age — 70 reports (7.3%)
- Pyrexia — 67 reports (6.99%)
- Product Use Issue — 63 reports (6.57%)
- Oxygen Saturation Decreased — 57 reports (5.94%)
DEXMEDETOMIDINE HYDROCHLORIDE 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 approved in United States?
Yes. FDA authorised it on 28 September 2013; FDA authorised it on 29 November 2018; FDA authorised it on 27 August 2020.
Who is the marketing authorisation holder for DEXMEDETOMIDINE HYDROCHLORIDE in United States?
HOSPIRA holds the US marketing authorisation.