Ofloxacin
Active ingredient · 3 therapeutic classes
Sold as OCUFLOX
- Drug class
- Fluoroquinolones
- Availability
- Prescription only
- Routes
- Ophthalmic, Oral, Auricular (Otic)
- Markets covered
- 3
- Products on record
- 17
- FDA reports (12 mo)
- 393
Overview
Plain-language summary, compiled from the cited regulatory records
Ofloxacin is a fluoroquinolone antibiotic [1]. It is approved for treating certain infections caused by susceptible bacteria [1]. Specifically, Ofloxacin Otic Solution 0.3% is indicated for otitis externa in adults and pediatric patients aged 6 months and older, and for chronic suppurative otitis media in patients 12 years and older with perforated tympanic membranes [1]. The susceptible microorganisms for these indications include *Escherichia coli*, *Pseudomonas aeruginosa*, *Staphylococcus aureus*, and *Proteus mirabilis* [1].
Ofloxacin is available under various brand names [1]. In the past 12 months, there have been 393 adverse event reports associated with Ofloxacin [2]. The most frequently reported adverse events include eye pain, off-label use, eye irritation, headache, and eye swelling [2].
This is not medical advice. Consult a qualified healthcare professional.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| US United States | FDA | 8 | September 2, 2025 |
| GB United Kingdom | MHRA | 8 | April 24, 2026 |
| CA Canada | Health Canada | 1 | March 22, 2025 |
USUnited States· FDA
8 products
Uses
INDICATIONS AND USAGE
Ofloxacin ophthalmic solution is indicated for the treatment of infections caused by susceptible strains of the following bacteria in the conditions listed below: CONJUNCTIVITIS: Gram-positive bacteria: Staphylococcus aureus Staphylococcus epidermidis Streptococcus pneumoniae Gram-negative bacteria: Enterobacter cloacae Haemophilus influenzae Proteus mirabilis Pseudomonas aeruginosa CORNEAL ULCERS: Gram-positive bacteria: Staphylococcus aureus Staphylococcus epidermidis Streptococcus pneumoniae Gram-negative bacteria: Pseudomonas aeruginosa Serratia marcescens* Anaerobic species: Propionibacterium acnes *Efficacy for this organism was studied in fewer than 10 infections.
How to take
GBUnited Kingdom· MHRA
8 products
Uses
1): - upper and lower urinary tract infections; - lower respiratory tract infections such as acute exacerbation of chronic bronchitis or pneumonia if caused by Gram-negative bacteria. Ofloxacin is not the treatment of choice for community acquired pneumonia; - uncomplicated urethral and cervical gonorrhoea; - non-gonococcal urethritis and cervicitis.
Consideration should be given to official guidance on the appropriate use of anti-bacterial agents.
How to take
CACanada· Health Canada
1 product
Uses
OCUFLOX® (ofloxacin) is indicated for the treatment of conjunctivitis when caused by susceptible strains of the following bacteria: Gram Positive Bacteria • Staphylococcus aureus • Staphylococcus epidermidis • Streptococcus pneumoniae Gram Negative Bacteria • Haemophilus influenza To reduce the development of drug-resistant bacteria and maintain the effectiveness of OCUFLOX and other antibacterial drugs, OCUFLOX should be used only to treat infections that are proven or strongly suspected to be caused by bacteria.
1 Pediatrics Pediatrics (< 18 years of age): Based on the data submitted and reviewed by Health Canada, the safety and efficacy of OCUFLOX in pediatric patients has not been established. Therefore, Health Canada has not authorized an indication for pediatric use.
3 Pediatrics. 2 Geriatrics Geriatrics (> 65 years of age): No comparative data are available to Health Canada; therefore, Health Canada has not authorized an indication for geriatric use.
Drug interactions
Known interactions involving Ofloxacin. Select one for details. This list is informational and not a complete interaction checker.
Showing 240 of 600. Type above to find a specific drug.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
- [1]FDA DailyMed · 0c01de7a-a885-4b… · revised September 2, 2025 [PDF]
- [2]MHRA (UK) · PLPI464200021 · revised April 24, 2026
- [3]Health Canada (DPD) · 02143291 · revised March 22, 2025
- [4]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.