DEXMEDETOMIDINE HYDROCHLORIDE
Generic: DEXMEDETOMIDINE HYDROCHLORIDE, DEXMEDETOMIDINE
Sun Pharmaceuticals IndustriesManufacturer
INTRAVENOUSRoute
DEXMEDETOMIDINE HYDROCHLORIDEActive Substance
2015-08-20Original Approval
DEXMEDETOMIDINE HYDROCHLORIDE is FDA application ANDA202126, sponsored by GLAND. Any recalls listed below come from FDA drug enforcement reports, and reaction counts are the number of FAERS adverse event reports that mention the drug and that reaction; a report does not prove the drug caused it.
Top Reported Reactions
1
OFF LABEL USE
592 reports
2
DRUG INEFFECTIVE
436 reports
3
BRADYCARDIA
403 reports
4
HYPOTENSION
299 reports
5
CARDIAC ARREST
255 reports
6
DRUG INTERACTION
242 reports
7
AGITATION
200 reports
8
RESPIRATORY FAILURE
167 reports
9
PRODUCT USE IN UNAPPROVED INDICATION
163 reports
10
DELIRIUM
152 reports