CYCLOSPORINE
Generic: CYCLOSPORINE
Apotex Corp.Manufacturer
ORALRoute
CYCLOSPORINEActive Substance
2002-05-09Original Approval
CYCLOSPORINE is FDA application ANDA065040, sponsored by APOTEX. 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 II2017-02-08
CycloSPORINE Capsules, USP, 100 mg, 30 count (5x6) blister cartons, Rx only, Distributed by American Health Packaging, CFailed Impurities/Degradations Specifications; out of specification results for Maximum Unknown Impu
Class II2017-02-03
CycloSPORINE Capsules, USP, 100 mg, 30 count bottle, Rx Only, Manufactured by Apotex, Inc., Toronto, Ontario, Canada, MaFailed Impurities/Degradations Specifications; out of specification results for Maximum Unknown Impu
Top Reported Reactions
1
DRUG INEFFECTIVE
7,603 reports
2
OFF LABEL USE
7,540 reports
3
PRODUCT USE IN UNAPPROVED INDICATION
3,577 reports
4
PYREXIA
2,752 reports
5
DIARRHOEA
2,199 reports
6
CONDITION AGGRAVATED
2,053 reports
7
NAUSEA
2,011 reports
8
PNEUMONIA
1,965 reports
9
CYTOMEGALOVIRUS INFECTION
1,910 reports
10
HYPERTENSION
1,698 reports