OMEPRAZOLE AND SODIUM BICARBONATE
Generic: OMEPRAZOLE AND SODIUM BICARBONATE
ANI PharmaceuticalsManufacturer
ORALRoute
OMEPRAZOLEActive Substance
2025-12-10Original Approval
OMEPRAZOLE AND SODIUM BICARBONATE is FDA application ANDA219161, sponsored by NOVITIUM PHARMA. 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
CHRONIC KIDNEY DISEASE
118 reports
2
DRUG INEFFECTIVE
66 reports
3
ACUTE KIDNEY INJURY
53 reports
4
RENAL FAILURE
53 reports
5
INCORRECT PRODUCT ADMINISTRATION DURATION
39 reports
6
NAUSEA
33 reports
7
HEADACHE
29 reports
8
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION
27 reports
9
DYSPNOEA
23 reports
10
DEATH
22 reports