NIZATIDINE

Generic: NIZATIDINE

Amneal Pharmaceuticals LLCManufacturer
ORALRoute
NIZATIDINEActive Substance
2009-11-18Original Approval

NIZATIDINE is FDA application ANDA090576, sponsored by AMNEAL 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 II2020-04-15
Nizatidine Oral Solution, 15 mg/mL (75 mg/5mL) USP 480 mL bottles, Rx Only Distributed by: Gemini Laboratories, LLC Brid

CGMP Deviations: potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA

Top Reported Reactions

1
CHRONIC KIDNEY DISEASE
264 reports
2
ACUTE KIDNEY INJURY
161 reports
3
RENAL FAILURE
135 reports
4
NAUSEA
73 reports
5
END STAGE RENAL DISEASE
72 reports
6
VOMITING
66 reports
7
RENAL INJURY
59 reports
8
DRUG INEFFECTIVE
56 reports
9
DYSPNOEA
56 reports
10
GASTROOESOPHAGEAL REFLUX DISEASE
56 reports