FLUTICASONE PROPIONATE

Generic: FLUTICASONE PROPIONATE

Padagis Israel Pharmaceuticals LtdManufacturer
TOPICALRoute
FLUTICASONE PROPIONATEActive Substance
2013-07-30Original Approval

FLUTICASONE PROPIONATE is FDA application ANDA091553, sponsored by PADAGIS ISRAEL. 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 II2024-02-14
Fluticasone Propionate Nasal Spray USP, 50 mcg per spray, 120 metered sprays, 16 g net fill, Rx only, Manufactured by: A

CGMP Deviations:Suspected potential presence of Burkholderia cepacia complex

Top Reported Reactions

1
PRODUCT DOSE OMISSION ISSUE
3,033 reports
2
DYSPNOEA
2,621 reports
3
DRUG INEFFECTIVE
2,606 reports
4
HEADACHE
2,340 reports
5
FATIGUE
2,170 reports
6
OFF LABEL USE
2,169 reports
7
PAIN
1,910 reports
8
NAUSEA
1,882 reports
9
COUGH
1,838 reports
10
ASTHMA
1,752 reports