SODIUM PHENYLBUTYRATE
Generic: SODIUM PHENYLBUTYRATE
Zydus Pharmaceuticals USA Inc.Manufacturer
ORALRoute
SODIUM PHENYLBUTYRATEActive Substance
2026-02-17Original Approval
SODIUM PHENYLBUTYRATE is FDA application ANDA220418, sponsored by NAVINTA LLC. 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
DEATH
23 reports
2
OFF LABEL USE
20 reports
3
DIARRHOEA
17 reports
4
HYPERAMMONAEMIA
16 reports
5
AMMONIA INCREASED
9 reports
6
DRUG INEFFECTIVE
9 reports
7
NAUSEA
9 reports
8
FATIGUE
8 reports
9
ADVERSE EVENT
7 reports
10
DECREASED APPETITE
7 reports