CLONIDINE HYDROCHLORIDE
Generic: CLONIDINE HYDROCHLORIDE
Method PharmaceuticalsManufacturer
ORALRoute
CLONIDINE HYDROCHLORIDEActive Substance
2013-06-13Original Approval
CLONIDINE HYDROCHLORIDE is FDA application ANDA202297, sponsored by YUNG SHIN PHARM. 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.
Recalls
Class III2020-05-26
Clonidine Hydrochloride Tablets, USP 0.1 mg 100-count bottles, Rx only, Manufactured by: Unichem Laboratories LTD. PilerFailed Impurities/Degradation Specifications: potential migration of benzophenone at very low level
Class III2020-01-29
Clonidine Hydrochloride Tablets, USP 0.1mg, Rx Only, 100-count bottle, Manufactured by: Unichem Laboratories Ltd. PilernFailed Impurities/Degredation Specifications: This recall is initiated as a precautionary measure du
Class III2022-09-19
Clonidine Hydrochloride Tablets, USP, 0.3 mg, 100-count bottle, Rx Only, Manufactured by: UNICHEM LABORATORIES LTD. PileProduct mix-up:0.2 mg strength Clonidine Hydrochloride Tablets, USP in a 100-count bottle of 0.3 mg
Top Reported Reactions
1
HYPERTENSION
733 reports
2
HEADACHE
686 reports
3
OFF LABEL USE
618 reports
4
PAIN
605 reports
5
FATIGUE
604 reports
6
HYPERSENSITIVITY
508 reports
7
DRUG INEFFECTIVE
502 reports
8
NAUSEA
450 reports
9
INFUSION RELATED REACTION
425 reports
10
HEPATIC ENZYME INCREASED
417 reports