Safety Information

The most common reported adverse reactions in 3 clinical trials (n=799) in OE patients treated once daily with FLOXIN Otic were application site reaction (0.6%-16.8%), pruritus (1%-1.2%), earache (0.6%-0.8%), dizziness (0.0%-0.6%), and headache (0.2%-0.3%). In 2 of these clinical studies (n=310), the higher application site reaction rate resulted from the specific questioning of subjects.

The most common reported adverse reactions in clinical trials in AOM patients with TT and CSOM patients treated twice daily with FLOXIN Otic (n=656) were taste perversion (7%); earache (1%), pruritus (1%), paraesthesia (1%), rash (1%) and dizziness (1%).

FLOXIN Otic is contraindicated in patients with a history of hypersensitivity to ofloxacin, other quinolones, or other ingredients of the medication. Serious and occasionally fatal hypersensitivity (anaphylactic)  reactions have been reported in patients receiving systemic quinolones. At the first sign of allergic reaction, stop taking the drug. Patients who have not improved after one week of treatment should be evaluated by their healthcare provider.