ONDANSETRON HYDROCHLORIDE

Generic: ONDANSETRON HYDROCHLORIDE

Ipca Laboratories LimitedManufacturer
ORALRoute
ONDANSETRON HYDROCHLORIDEActive Substance
2014-01-23Original Approval

ONDANSETRON HYDROCHLORIDE is FDA application ANDA203761, sponsored by IPCA LABS LTD. 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 II2022-04-13
Ondansetron HCL, Tab 8 mg filmcoated, 30-count bottle, Rx only, MFG: Sandoz Pharma, NDC 65862-188-30

cGMP deviations: Temperature abuse

Class II2023-11-14
Ondansetron Injection, USP, 4 mg/2 mL (2 mg/mL), 2 mL per vial, Rx only, Manufactured for: Baxter Healthcare Corporation

Failed pH Specifications

Top Reported Reactions

1
NAUSEA
2,394 reports
2
FATIGUE
1,514 reports
3
OFF LABEL USE
1,334 reports
4
HEADACHE
1,316 reports
5
DIARRHOEA
1,293 reports
6
VOMITING
1,195 reports
7
PAIN
1,070 reports
8
DYSPNOEA
1,037 reports
9
DRUG INEFFECTIVE
907 reports
10
PYREXIA
774 reports