Ofloxacin: Side Effects, Uses & Monitoring
Ofloxacin otic solution 0.3% is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the specific conditions listed below Otitis Externa in adults and pediatric pat
- Data source
- FDA labeling via NIH DailyMed (label d02d88ba…)
- Label version
- current
- Last reviewed
- 2026
Reported adverse reactions
Reactions listed in current FDA labeling, with the highest frequency reported across summarized placebo-controlled trials.
| Adverse reaction (as reported in labeling) | Reported frequency* |
|---|---|
| Application site reaction | 16.8% |
| Taste perversion | 7% |
| Pruritus | 4% |
| Earache | 1% |
| Dizziness | 1% |
| Vertigo | 1% |
| Paraesthesia | 1% |
| Rash | 1% |
| Headache | 0.3% |
*Highest percentage reported for the active moiety across placebo-controlled trial tables in current FDA labeling. Values reflect trial reporting, not your individual risk.
Labeled uses (from FDA prescribing information)
Ofloxacin otic solution 0.3% is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the specific conditions listed below Otitis Externa in adults and pediatric patients, 6 months and older, due to Escherichia coli , Pseudomonas aeruginosa and Staphylococcus aureus . Chronic Suppurative Otitis Media in patients 12 years and older with perforated tympanic membranes due to Proteus mirabilis , Pseudomonas aeruginosa and Staphylococcus aureus . Acute Otitis Media in pediatric patients one year and older with tympanostomy tubes due to Haemophilus influenzae , Moraxella catarrhalis , Pseudomonas aeruginosa , Staphylococcus aureus and Streptococcus pneumoniae .
Conditions associated with Ofloxacin in labeling
Ear Infection (Otitis Media)
Infection or inflammation of the middle ear, common in children, causing ear pain, fever, and sometimes fluid ...
Otitis Media
Infection or inflammation of the middle ear, common in children, causing ear pain, fever, and sometimes hearin...
Swimmer's Ear
An infection of the outer ear canal, often from water staying in the ear, causing itching, pain, and discharge...
Frequently Asked Questions
What is Ofloxacin used for?
FDA labeling lists the approved uses shown above under "Labeled uses." This summary is informational; only a qualified prescriber can determine whether a medication is appropriate for you.
What are the most commonly reported side effects of Ofloxacin?
The table above shows adverse reactions and the highest frequencies reported in placebo-controlled trials summarized in current FDA labeling for Ofloxacin. Individual risk varies.
Does Ofloxacin require lab monitoring?
Monitoring needs vary. Ask your healthcare provider whether any lab tests apply while taking Ofloxacin.
Where does this information come from?
All clinical facts on this page were extracted from the current FDA-registered product labeling for this ingredient, published by manufacturers through NIH DailyMed. See the source link below.
Medical disclaimer: Educational content extracted from public FDA labeling. Not medical advice. Always consult a qualified healthcare professional before starting, stopping, or changing any medication.