ofloxacin
Brand names: Floxin, Ocuflox
Ofloxacin ear drops are an antibiotic medicine. They fight bacteria to treat ear infections.
Drug Pricing (NADAC)
Generic Price
$1.09/unit
Generic Available
Yes (16 manufacturers)
Pricing data from NADAC (CMS), effective December 25, 2024. Compare all drug costs →
What it does
This medicine treats ear infections caused by certain bacteria.
Common side effects
Application site reaction, Itching, Taste changes
Key warnings
You should not take this medicine if you are allergic to ofloxacin or other quinolone antibiotics, or any of the ingredients in the drops.
How It Works
Ofloxacin belongs to a class of drugs called fluoroquinolone antibiotics. It works by stopping the growth of bacteria. This helps to clear up the infection in your ear.
How to Take It
For outer ear infections, children 6 months to 13 years old should get 5 drops in the affected ear once a day for 7 days. People 13 years and older should get 10 drops in the affected ear once a day for 7 days. For middle ear infections, children 1 to 12 years old should get 5 drops in the affected ear twice a day for 10 days. People 12 years and older should get 10 drops in the affected ear twice a day for 14 days.
Pregnancy & Breastfeeding
Tell your doctor if you are pregnant or breastfeeding. It is not known if ofloxacin ear drops will harm an unborn baby or pass into breast milk.
Missed Dose
If you miss a dose, use it as soon as you remember. Then, continue with your regular dosing schedule.
Storage
Store at room temperature (68º to 77°F) and protect from light.
Side Effects (from patient reports)
Based on 2,798 FDA adverse event reports.
FDA Adverse Event Report Analysis
Detailed analysis of 7,063 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 1999–2025.
Total Reports
7,063
Death-Related Reports
597
Hospitalization Reports
2,611
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | DRUG INEFFECTIVE | 345 |
| 2 | EYE PAIN | 345 |
| 3 | OFF LABEL USE | 306 |
| 4 | HEADACHE | 284 |
| 5 | PAIN | 278 |
| 6 | FATIGUE | 257 |
| 7 | NAUSEA | 251 |
| 8 | ARTHRALGIA | 247 |
| 9 | DIARRHOEA | 243 |
| 10 | ACUTE KIDNEY INJURY | 242 |
| 11 | ANXIETY | 208 |
| 12 | RENAL FAILURE | 206 |
| 13 | DYSPNOEA | 203 |
| 14 | PYREXIA | 203 |
| 15 | CHRONIC KIDNEY DISEASE | 194 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
You should not take this medicine if you are allergic to ofloxacin or other quinolone antibiotics, or any of the ingredients in the drops.
Known Drug Interactions
70% increase Ciprofloxacin Similar to cimetidine. albuterol, systemic and inhaled mebendazole amoxicillin medroxyprogesterone ampicillin, with or without sulbactam methylprednisolone atenolol metronidazole azithromycin metoprolol caffeine, dietary ingestion nadolol cefaclor nifedipine co-trimoxazole (trimethoprim and sulfamethoxazole) nizatidine diltiazem norfloxacin dirithromycin ofloxacin enflurane omeprazole famotidine prednisone, prednisolone felodipine ranitidine finasteride rifabutin hydrocortisone roxithromycin isoflurane Sorbitol (purgative doses do not inhibit theophylline absorpti...
Mechanism: Ofloxacin can stop your liver from breaking down theophylline as fast as it should. This can lead to a significant increase in the amount of theophylline in your system.
What to do: Your doctor may need to lower your theophylline dose while you take this antibiotic. Seek medical help immediately if you feel very restless or have a seizure.
In all case studies to date (cimetidine, ciprofloxacin, digoxin, norfloxacin, ofloxacin, and ranitidine), dosing the concomitant medication 2 hours before sucralfate eliminated the interaction.
Mechanism: Sucralfate interferes with how your body absorbs ofloxacin, which can stop the antibiotic from working correctly.
What to do: You should take ofloxacin at least 2 hours before taking sucralfate. This helps make sure the antibiotic is fully absorbed into your system.
Common Questions
How do I warm the ear drops?
How long should I lie down after putting in the drops?
Can I use these drops if my eardrum is perforated?
How many times should I pump the tragus?
What should I do if I get dizzy after using the drops?
Can I use these drops for an eye infection?
What if my symptoms don't improve after using the drops?
Can I use these drops if I am allergic to ciprofloxacin?
How long should I use these drops?
Can I share these ear drops with someone else?
What are the common side effects of ofloxacin?
Does ofloxacin interact with other medications?
What drug class is ofloxacin?
Is ofloxacin safe during pregnancy?
Has ofloxacin been recalled?
Active Recalls
CGMP Deviations:
Akorn, Inc.
Related Medications in Fluoroquinolone Antibiotic
Other drugs grouped near ofloxacin — same-class peers and common alternatives.
amikacin
Amikin
Amikacin is an antibiotic medicine.
Compare with ofloxacin →
amoxicillin
Amoxil
Amoxicillin and Clavulanate Potassium is a combination medicine used to fight bacterial infections.
Compare with ofloxacin →
amoxicillin/clavulanate
Augmentin
Augmentin is a combination of two medicines, amoxicillin and clavulanate.
Compare with ofloxacin →
ampicillin/sulbactam
Unasyn
Unasyn is a combination of two antibiotics that fights bacteria in your body.
Compare with ofloxacin →
azithromycin
Zithromax, Z-Pack
Azithromycin is an antibiotic that fights bacteria.
Compare with ofloxacin →
Medication Guides
Understanding Drug Interactions
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FDA requirements, cost savings, and when the difference matters
Narrow Therapeutic Index Drugs
Why some drugs demand precise dosing and monitoring
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
Related Health & Safety Data
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Medicare procedure pricing for 9,297 procedures
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What the FDA Data Shows for ofloxacin
The FDA label for ofloxacin (sold under brand names such as Floxin, Ocuflox) classifies it as a prescription-only medication in the Fluoroquinolone Antibiotic class. This medicine treats ear infections caused by certain bacteria. Official labeling lists 3 commonly reported side effects, including Application site reaction, Itching, Taste changes.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 2,798 voluntary reports. The database also lists 2 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated major severity. NADAC pricing from CMS shows a generic unit cost of $1.09.
Report counts do not establish causation — a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history (currently 1 recall record on file), and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice — always consult a licensed healthcare provider before starting, stopping, or changing any medication.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.
Last updated: June 23, 2023
Read our methodology — how this data is sourced, computed, and verified.
All federal data sources used on this page
- FDA Orange Book — approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed — NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) — post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm — standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files — federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database — current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages