Floxin Otic

Floxin Otic

SIDE EFFECTS

Subjects with Otitis Externa

In the phase III clinical trials performed in support of once-daily dosing, 799 subjects with otitis externa and intact tympanic membranes were treated with ofloxacin otic solution. The studies, which served as the basis for approval, were 020 (pediatric, adolescents and adults), 016 (adolescents and adults) and 017 (pediatric). The following treatment-related adverse events occurred in two or more of the subjects.

  Incidence Rate
Adverse Event Studies 002/003†
BID
(N=229)
Studies 016/017†
QD
(N=310)
Study 020†
QD
(N=489)
Application Site Reaction 3% 16.8% 0.6%
Pruritus 4% 1.2% 1.0%
Earache 1% 0.6% 0.8%
Dizziness 1% 0.0% 0.6%
Headache 0% 0.3% 0.2%
Vertigo 1% 0.0 0.0%
† Studies 002/003 (BID) and 016/017 (QD) were active-controlled and comparative. Study 020 (QD) was open and non-comparative.

An unexpected increased incidence of application site reaction was seen in studies and was similar for both ofloxacin and the active control drug (neomycin-polymyxin B sulfate-hydrocortisone). This finding is believed to be the result of specific questioning of the subjects regarding the incidence of application site reactions.

In once daily dosing studies, there were also single reports of nausea, seborrhea, transient loss of hearing, tinnitus, otitis externa, otitis media, tremor, hypertension and fungal infection.

In twice daily dosing studies, the following treatment-related adverse events were each reported in a single subject: dermatitis, eczema, erythematous rash, follicular rash, hypoaesthesia, tinnitus, dyspepsia, hot flushes, flushing and otorrhagia.

Subjects with Acute Otitis Media with Tympanostomy Tubes (AOM TT) and Subjects with Chronic Suppurative Otitis Media (CSOM) with Perforated Tympanic Membranes

In phase III clinical trials which formed the basis for approval, the following treatment-related adverse events occurred in 1% or more of the 656 subjects with non-intact tympanic membranes in AOM TT or CSOM treated twice-daily with ofloxacin otic solution:

Adverse Event Incidence
(N=656)
Taste Perversion 7%
Earache 1%
Pruritus 1%
Paraesthesia 1%
Rash 1%
Dizziness 1%

Other treatment-related adverse reactions reported in subjects with non-intact tympanic membranes included: diarrhea (0.6%), nausea (0.3%), vomiting (0.3%), dry mouth (0.5%), headache (0.3%), vertigo (0.5%), otorrhagia (0.6%), tinnitus (0.3%), fever (0.3%). The following treatment-related adverse events were each reported in a single subject: application site reaction, otitis externa, urticaria, abdominal pain, dysaesthesia, hyperkinesia, halitosis, inflammation, pain, insomnia, coughing, pharyngitis, rhinitis, sinusitis, and tachycardia.

Post-Marketing Adverse Events

Cases of uncommon transient neuropsychiatric disturbances have been included in spontaneous post-marketing reports. A causal relationship with ofloxacin otic solution 0.3% is unknown.

Read the Floxin Otic (ofloxacin otic solution) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

Specific drug interaction studies have not been conducted with FLOXIN® Otic (ofloxacin otic solution) .

Last reviewed on RxList: 1/15/2008
This monograph has been modified to include the generic and brand name in many instances.

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Floxin Otic Singles - User Reviews

Floxin Otic Singles User Reviews

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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