FOSAPREPITANT
Generic: FOSAPREPITANT
Novadoz Pharmaceuticals LLCManufacturer
INTRAVENOUSRoute
FOSAPREPITANT DIMEGLUMINEActive Substance
2019-09-05Original Approval
FOSAPREPITANT is FDA application ANDA209965, sponsored by MSN. 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 III2020-07-13
Fosaprepitant for Injection, 150 mg / vial in a 10 mL Single-Dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047; Labeling Error: Label Error on Declared Strength: Carton label and product insert incorrectly states
Class II2024-01-10
Fosaprepitant for Injection 150 mg per vial, Sterile lyophilized powder for Intravenous use only after reconstitution anLack of Sterility Assurance: Aseptic process simulation failure.
Top Reported Reactions
1
DYSPNOEA
408 reports
2
INFUSION RELATED REACTION
339 reports
3
ALOPECIA
321 reports
4
FATIGUE
296 reports
5
PYREXIA
290 reports
6
HYPERSENSITIVITY
284 reports
7
NAUSEA
276 reports
8
ARTHRALGIA
263 reports
9
CONFUSIONAL STATE
258 reports
10
DUODENAL ULCER PERFORATION
257 reports