POSACONAZOLE

Generic: POSACONAZOLE

Dr.Reddys Laboratories IncManufacturer
ORALRoute
POSACONAZOLEActive Substance
2022-04-07Original Approval

POSACONAZOLE is FDA application ANDA212500, 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 II2023-01-31
Posaconazole Delayed-Release Tablets, 100 mg, 60-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ

Failed Impurities/Degradation Specifications: High Out Of Specification degradation results.

Top Reported Reactions

1
DRUG INEFFECTIVE
1,312 reports
2
OFF LABEL USE
1,216 reports
3
FEBRILE NEUTROPENIA
894 reports
4
DRUG INTERACTION
817 reports
5
NEUTROPENIA
656 reports
6
PYREXIA
653 reports
7
DEATH
581 reports
8
PRODUCT USE IN UNAPPROVED INDICATION
563 reports
9
PNEUMONIA
488 reports
10
THROMBOCYTOPENIA
421 reports