SPIRONOLACTONE
Generic: SPIRONOLACTONE
Zydus Lifesciences LimitedManufacturer
ORALRoute
SPIRONOLACTONEActive Substance
2018-07-18Original Approval
SPIRONOLACTONE is FDA application ANDA205936, sponsored by ZYDUS 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
Top Reported Reactions
1
DYSPNOEA
8,911 reports
2
FATIGUE
7,272 reports
3
NAUSEA
6,785 reports
4
DIARRHOEA
6,415 reports
5
ACUTE KIDNEY INJURY
5,590 reports
6
DIZZINESS
5,551 reports
7
HEADACHE
5,417 reports
8
OFF LABEL USE
5,054 reports
9
DRUG INEFFECTIVE
4,808 reports
10
HYPOTENSION
4,773 reports