DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE
Generic: DEXMEDETOMIDINE HYDROCHLORIDE
Sagent PharmaceuticalsManufacturer
INTRAVENOUSRoute
DEXMEDETOMIDINE HYDROCHLORIDEActive Substance
2023-06-07Original Approval
DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE is FDA application ANDA217308, sponsored by MILLA PHARMS. 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
BRADYCARDIA
181 reports
2
OFF LABEL USE
156 reports
3
CARDIAC ARREST
109 reports
4
HYPOTENSION
92 reports
5
PRODUCT USE IN UNAPPROVED INDICATION
86 reports
6
PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE
72 reports
7
DRUG INTERACTION
71 reports
8
PYREXIA
69 reports
9
DRUG INEFFECTIVE
58 reports
10
OXYGEN SATURATION DECREASED
58 reports