NIFEDIPINE

Generic: NIFEDIPINE

Ingenus PharmaceuticalsManufacturer
ORALRoute
NIFEDIPINEActive Substance
2016-08-25Original Approval

NIFEDIPINE is FDA application ANDA202987, sponsored by NOVAST LABS. 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 II2021-07-02
NIFEdipine EXTENDED-RELEASE TABLETS, USP 30 mg Rx only packaged as a) 100 count unit dose carton, NDC 0904-7080-61; b) 5

Failed Dissolution Specification: Out of specification for dissolution during routine stability test

Top Reported Reactions

1
DRUG INEFFECTIVE
2,309 reports
2
DYSPNOEA
2,178 reports
3
DIARRHOEA
2,119 reports
4
FATIGUE
2,068 reports
5
OFF LABEL USE
1,958 reports
6
NAUSEA
1,945 reports
7
HEADACHE
1,751 reports
8
HYPERTENSION
1,557 reports
9
DIZZINESS
1,544 reports
10
PAIN
1,402 reports