IMATINIB MESYLATE
Generic: IMATINIB MESYLATE
BluePoint LaboratoriesManufacturer
ORALRoute
IMATINIB MESYLATEActive Substance
2015-12-03Original Approval
IMATINIB MESYLATE is FDA application ANDA078340, sponsored by SUN 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 II2020-12-08
Imatinib Mesylate Tablets 400 mg, Rx Only, 30-count Bottle, Manufactured by: Shilpa Medicare Limited, India, DistributedCGMP Deviations
Class II2020-12-08
Imatinib Mesylate Tablets 100 mg, Rx Only, 90-count Bottle, Manufactured by: Shilpa Medicare Limited, India, DistributedCGMP Deviations
Top Reported Reactions
1
DRUG INEFFECTIVE
1,645 reports
2
DRUG RESISTANCE
1,047 reports
3
DEATH
1,040 reports
4
NAUSEA
1,020 reports
5
DIARRHOEA
1,018 reports
6
DRUG INTOLERANCE
899 reports
7
MALIGNANT NEOPLASM PROGRESSION
822 reports
8
FATIGUE
819 reports
9
OFF LABEL USE
758 reports
10
VOMITING
693 reports