BUMEX

Generic: BUMETANIDE

Validus Pharmaceuticals LLCManufacturer
ORALRoute
BUMETANIDEActive Substance
1983-02-28Original Approval

BUMEX is FDA application NDA018225, sponsored by VALIDUS PHARMS. 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 III2013-11-06
Bumetanide Tablets USP 0.5 mg. Rx Only, a) 100-count Bottle, b) 500-count Bottle, Sandoz Inc., Princeton, NJ 08540, NDC

Failed Moisture Limit; Out of Specification (OOS) results were obtained for moisture content during

Top Reported Reactions

1
DYSPNOEA
1,919 reports
2
ACUTE KIDNEY INJURY
1,396 reports
3
FATIGUE
1,299 reports
4
DEATH
1,257 reports
5
DIARRHOEA
1,206 reports
6
NAUSEA
1,114 reports
7
DIZZINESS
974 reports
8
HEADACHE
933 reports
9
PNEUMONIA
831 reports
10
RENAL FAILURE
742 reports