CYCLOBENZAPRINE HYDROCHLORIDE

Generic: CYCLOBENZAPRINE HYDROCHLORIDE

Amneal Pharmaceuticals of New York LLCManufacturer
ORALRoute
CYCLOBENZAPRINE HYDROCHLORIDEActive Substance
2007-02-01Original Approval

CYCLOBENZAPRINE HYDROCHLORIDE is FDA application NDA021777, sponsored by TEVA PHARMS INTL. 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 I2025-08-27
Cyclobenzaprine Hydrochloride Tablets, USP, 10 mg, 90-count bottle, RX only, Manufactured by: Unichem Laboratories, L

Labeling: Label Mix Up; Bottles of Meloxicam USP, 7.5mg, 90-count tablets (yellow in color), were la

Top Reported Reactions

1
PAIN
5,097 reports
2
FATIGUE
4,026 reports
3
DRUG INEFFECTIVE
3,602 reports
4
NAUSEA
3,540 reports
5
HEADACHE
3,517 reports
6
OFF LABEL USE
2,975 reports
7
CHRONIC KIDNEY DISEASE
2,750 reports
8
DIARRHOEA
2,632 reports
9
ARTHRALGIA
2,463 reports
10
FALL
2,430 reports