MITOXANTRONE

Generic: MITOXANTRONE

HospiraManufacturer
INTRAVENOUSRoute
MITOXANTRONE HYDROCHLORIDEActive Substance
2006-04-11Original Approval

MITOXANTRONE is FDA application ANDA076871, sponsored by HOSPIRA. 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 I2014-12-03
MitoXANTRONE Injection, USP, (concentrate) 2 mg/mL, Rx Only. Hospira, Lake Forest, IL 60045, Product of Australia. Avai

Failed Stability Specifications: Product is subpotent and has out of specification known and unknown

Top Reported Reactions

1
FEBRILE NEUTROPENIA
765 reports
2
OFF LABEL USE
496 reports
3
NEUTROPENIA
465 reports
4
DRUG INEFFECTIVE
460 reports
5
PYREXIA
368 reports
6
THROMBOCYTOPENIA
345 reports
7
SEPSIS
325 reports
8
ACUTE MYELOID LEUKAEMIA
299 reports
9
PNEUMONIA
251 reports
10
PANCYTOPENIA
238 reports