CYCLOPHOSPHAMIDE

Generic: CYCLOPHOSPHAMIDE

Dr. Reddy's Labratories Inc.Manufacturer
INTRAVENOUSRoute
CYCLOPHOSPHAMIDE ANHYDROUSActive Substance
2020-07-30Original Approval

CYCLOPHOSPHAMIDE is FDA application NDA212501, sponsored by DR REDDYS. 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 II2025-09-05
Cyclophosphamide Injection 500 mg/5 mL (100 mg/mL), Hazardous Drug, Rx Only, Sterile, 5mL Multiple Dose Vial, Manufactur

cGMP deviations: Temperature excursion during transportation.

Top Reported Reactions

1
OFF LABEL USE
16,346 reports
2
FEBRILE NEUTROPENIA
14,530 reports
3
NEUTROPENIA
10,581 reports
4
DRUG INEFFECTIVE
10,572 reports
5
PYREXIA
9,242 reports
6
DISEASE PROGRESSION
8,095 reports
7
PNEUMONIA
6,668 reports
8
THROMBOCYTOPENIA
6,523 reports
9
PRODUCT USE IN UNAPPROVED INDICATION
6,513 reports
10
NAUSEA
6,251 reports