FORMOTEROL FUMARATE INHALATION SOLUTION

Generic: FORMOTEROL FUMARATE DIHYDRATE

Ritedose PharmaceuticalsManufacturer
RESPIRATORY (INHALATION)Route
FORMOTEROL FUMARATEActive Substance
2022-11-25Original Approval

FORMOTEROL FUMARATE INHALATION SOLUTION is FDA application ANDA216486, sponsored by RITEDOSE CORP. 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 II2021-03-15
Budesonide and Formoterol Fumarate Dihydrate Inhalation Aerosol 80/4.5 budesonide 80 mcg/formoterol fumarate dihydrate 4

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Top Reported Reactions

1
DYSPNOEA
1,134 reports
2
ASTHMA
1,092 reports
3
COUGH
636 reports
4
WHEEZING
567 reports
5
THERAPEUTIC PRODUCT EFFECT INCOMPLETE
445 reports
6
PNEUMONIA
437 reports
7
OBSTRUCTIVE AIRWAYS DISORDER
418 reports
8
DRUG INEFFECTIVE
400 reports
9
GASTROOESOPHAGEAL REFLUX DISEASE
386 reports
10
HEADACHE
345 reports