Floxin Otic (Ofloxacin Otic) - Side Effects and Adverse Reactions

ADVERSE REACTIONS

Subjects with Otitis Externa

In a 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 2 or more of the subjects:

	Incidence Rate
Adverse Event	Studies 002/003† BID (N=229)	Studies 016/017† QD (N=3109)	Studies 002† QD (N=489)
†Studies 002/003 (BID) and 016/017 (QD) were active-controlled and comparative.
Application Site	3%	16.8%	0.6%
Reaction
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%

Study 020 (QD) was open and non-comparative.

An unexpected increased incidence of application site reaction was seen in studies 016/017 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 neurospsychiatric disturbances have been included in spontaneous post-marketing reports. A casual relationship with ofloxacin otic solution 0.3% is unknown.

REPORTS OF SIDE EFFECTS / ADVERSE REACTIONS RELATED TO FLOXIN OTIC

Possible Floxin Otic side effects / adverse reactions in 51 year old female

Reported by a physician from United States on 2007-04-30

Patient: 51 year old female

Reactions: Tendon Injury, Tendon Rupture, Pain, NO Therapeutic Response, Inadequate Analgesia, Asthenia, Eye Disorder

Adverse event resulted in: hospitalization

Suspect drug(s):
Floxin Otic

Other drugs received by patient: Multivitamin

Possible Floxin Otic side effects / adverse reactions in 57 year old male

Reported by a physician from United States on 2007-10-19

Patient: 57 year old male weighing 102.1 kg (224.5 pounds)

Reactions: Sudden Hearing Loss, Middle Ear Effusion, Vertigo, Middle Ear Disorder, Deafness Neurosensory, Drug Interaction, Treatment Failure

Suspect drug(s):
Floxin Otic

Other drugs received by patient: Lipitor(atorvastatin Calcium)( 20 Milligram) (Atorvastatin Calcium); Aspirin (Acetylsalicylic Acid) (81 Milliaram)(acetylsalicylic Acid)