CAPECITABINE

Generic: CAPECITABINE

BluePoint LaboratoriesManufacturer
ORALRoute
CAPECITABINEActive Substance
2015-04-23Original Approval

CAPECITABINE is FDA application ANDA202593, sponsored by ACCORD HLTHCARE. 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 II2015-12-21
Capecitabine tablets USP 500 mg, Cytotoxic Agent, Rx Only, 120 tablets per bottle, Manufactured in Czech Republic by: Te

Failed Dissolution Specifications: low test results at the 18 month time-point

Top Reported Reactions

1
DIARRHOEA
7,683 reports
2
NAUSEA
4,688 reports
3
DEATH
4,435 reports
4
DISEASE PROGRESSION
3,846 reports
5
VOMITING
3,791 reports
6
PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME
3,745 reports
7
FATIGUE
3,512 reports
8
MALIGNANT NEOPLASM PROGRESSION
2,798 reports
9
NEUTROPENIA
2,453 reports
10
OFF LABEL USE
2,288 reports