Prescription medication · Fluoroquinolone Antibiotic
ofloxacin
Also sold as Floxin, Ocuflox. This medicine treats ear infections caused by certain bacteria.
Data updated 2026-05-15
- 7,063
- FDA reportsLightly reported
- 2
- InteractionsFew interactions
- 1
- Recall record
What the data shows
ofloxacin (Floxin) is a prescription Fluoroquinolone Antibiotic, reported less often than most tracked drugs (7,063 FDA reports), with 2 documented drug interactions.
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
ofloxacin (Floxin) is a prescription Fluoroquinolone Antibiotic. This medicine treats ear infections caused by certain bacteria.
Ofloxacin ear drops are an antibiotic medicine. They fight bacteria to treat ear infections.
Verify with FDA → · CMS NADAC pricing →
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.
The sections below are summarized in plain English from ofloxacin's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
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.
This is a plain-language summary of ofloxacin's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.
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.
This is a plain-language summary of ofloxacin's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.
Missed Dose
If you miss a dose, use it as soon as you remember. Then, continue with your regular dosing schedule.
This is a plain-language summary of ofloxacin's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.
Storage
Store at room temperature (68º to 77°F) and protect from light.
Side Effects (from patient reports)
Based on 7,063 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for ofloxacin, by number of reports
- Eye pain
Eye pain
345 reports
- Headache
Headache
284 reports
- Pain
Pain
278 reports
- Tiredness
Tiredness
257 reports
- Feeling sick to your stomach
Feeling sick to your stomach
251 reports
- Joint pain
Joint pain
247 reports
- Diarrhea
Diarrhea
243 reports
- Sudden kidney damage
Sudden kidney damage
242 reports
- Feeling worried or nervous
Feeling worried or nervous
208 reports
- Kidney failure
Kidney failure
206 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for ofloxacin each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where ofloxacin sits
ofloxacin has more FDA adverse-event reports than 31% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is ofloxacin; the line is the median (50th percentile).
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
Reports Mentioning Death
597
8.5% of reports — not proof of cause
Hospitalization Reports
2,611
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 2 | EYE PAIN | 345 |
| 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 |
| 16 | CONDITION AGGRAVATED | 184 |
| 17 | VISION BLURRED | 166 |
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...
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.
This is a plain-language summary of interactions documented in FDA labeling, not individualized advice. Ask a pharmacist or prescriber before combining medications.
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
How CYP450 enzymes, inhibitors, and inducers affect your medications
Generic vs Brand Name Drugs
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
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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 7,063 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.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.
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