HYDROXYUREA
Generic: HYDROXYUREA
Par Health USAManufacturer
ORALRoute
HYDROXYUREAActive Substance
1999-02-24Original Approval
HYDROXYUREA is FDA application ANDA075340, sponsored by PH HEALTH. 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.
Top Reported Reactions
1
OFF LABEL USE
1,726 reports
2
SICKLE CELL ANAEMIA WITH CRISIS
1,231 reports
3
FATIGUE
1,150 reports
4
DIARRHOEA
1,104 reports
5
NAUSEA
994 reports
6
HEADACHE
830 reports
7
DEATH
774 reports
8
PRODUCT DOSE OMISSION ISSUE
757 reports
9
DRUG INEFFECTIVE
730 reports
10
HAEMOGLOBIN DECREASED
674 reports