MOMETASONE FUROATE
Generic: MOMETASONE FUROATE
Padagis Israel Pharmaceuticals LtdManufacturer
TOPICALRoute
MOMETASONE FUROATEActive Substance
2002-03-18Original Approval
MOMETASONE FUROATE is FDA application ANDA076067, sponsored by PADAGIS US. 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 II2019-07-23
Mometasone Furoate Cream USP, 0.1%, packaged in a) 15gram tubes (NDC 68462-192-17) and b) 45 gram tubes (NDC 68462-192-5GMP Deviations: Glenmark received complaints stating that mometasone fuorate cream was gritty.
Class III2022-06-16
Mometasone Furoate, Topical Solution USP, 0.1 % Lotion, a) 30 ml-bottle (NDC 68462-385-37), b) 60 ml-bottle (NDC 68462-3Defective Container
Top Reported Reactions
1
DYSPNOEA
966 reports
2
DRUG INEFFECTIVE
900 reports
3
ASTHMA
882 reports
4
HEADACHE
882 reports
5
OFF LABEL USE
745 reports
6
COUGH
729 reports
7
FATIGUE
668 reports
8
PRURITUS
617 reports
9
GASTROOESOPHAGEAL REFLUX DISEASE
582 reports
10
NAUSEA
550 reports