NAPROXEN SODIUM
Generic: NAPROXEN SODIUM, NAPROXEN SODIUM TABLET, FILM COATED
Rite Aid CorporationManufacturer
ORALRoute
NAPROXEN SODIUMActive Substance
2017-01-23Original Approval
NAPROXEN SODIUM is FDA application ANDA204872, sponsored by LNK INTL INC. 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 II2024-10-24
THERACARE MAXIMUM STRENGTH PAIN RELIEF 4% LIDOCAINE PATCH, a) 1 patch (NDC 71101-001-24, UPC 8 45717 00878 5) and b) 6 pcGMP Deviations
Class III2020-07-31
Red Cross Oral Pain (Oral Anesthetic benzocaine 20%), Maximum Strength, 1/8 Fl. Oz. (3.7 mL) bottle with Cotton Pellets Labeling; Not Elsewhere Classified: The Mentholatum Company is initiating a voluntary recall due to
Class II2024-10-24
HealthWise PERIOD PATCH Menstrual Pain Relief, Menthol 10%, 10 patches per box, Manufactured for Veridian Healthcare, LLcGMP Deviations
Top Reported Reactions
1
DRUG INEFFECTIVE
65,978 reports
2
FATIGUE
64,616 reports
3
NAUSEA
56,188 reports
4
OFF LABEL USE
51,627 reports
5
PAIN
50,605 reports
6
DYSPNOEA
49,504 reports
7
DIARRHOEA
47,676 reports
8
HEADACHE
46,600 reports
9
DIZZINESS
39,829 reports
10
VOMITING
38,510 reports