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Ofloxacin

Ofloxacin is a fluoroquinolone antibiotic used as tablets for certain bacterial infections (lungs, skin, and urinary and genital tract), as eye drops for bacterial conjunctivitis and corneal ulcers, and as ear drops for certain ear infections.

Brand names FloxinOcufloxOfloxacin OticOfloxacin Ophth Soln
Drug class Quinolone Antimicrobial
Rx Forms 3
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 42 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

✓No current FDA shortage listed · checked Oct 5, 2026
Other forms & routes:
Ofloxacin at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Ofloxacin is an older fluoroquinolone antibiotic, on the U.S. market since about 1990 and available as a generic; the tablets (for certain lung, skin and genital infections) have largely given way to newer relatives, while the eye and ear drops remain familiar choices for bacterial conjunctivitis (pinkeye), corneal ulcers and ear infections. Most people tolerate the tablets well; nausea, headache, dizziness and trouble sleeping are the side effects people notice most. The tablets carry a boxed warning for serious, sometimes permanent tendon, nerve and brain effects, so stop and call your prescriber at the first tendon pain, tingling or numbness, or change in mood or thinking.

Clinical pearls

  • Take tablets at least two hours apart from antacids, sucralfate, iron, or multivitamins with zinc, which can block absorption.
  • Tendon risk runs higher if you are over 60, take a corticosteroid, or have had a kidney, heart, or lung transplant.
  • If you have diabetes, check your blood sugar more often, since ofloxacin can push it too low or too high.
  • If you take warfarin or theophylline, make sure the prescriber knows, since ofloxacin can strengthen warfarin and raise theophylline levels.
How you get itPrescription only
Comes asEye drops, Ear drops, Tablet
Earliest FDA record1990
Companies listing it with the FDA27
FDA label last updatedJan 2, 2026
FDA’s strongest warning (boxed)None on the label

Patient information guide A plain-language walkthrough of Ofloxacin, written from its FDA label.

What Ofloxacin is used for

▾

Ofloxacin treats bacterial infections, depending on the form.

  • Ofloxacin tablets (adults): acute bacterial flare-ups of chronic bronchitis (only if no alternative), community-acquired pneumonia, uncomplicated skin and skin structure infections, uncomplicated urethral and cervical gonorrhea, nongonococcal urethritis and cervicitis due to chlamydia, and mixed urethra and cervix infections.
  • Ofloxacin, Ocuflox eye drops: bacterial conjunctivitis and corneal ulcers.
  • Ofloxacin Otic ear drops: otitis externa (6 months and older), chronic suppurative otitis media with perforated eardrums (12 and older), and acute otitis media in children 1 year and older with ear tubes.

How Ofloxacin works

▾

Ofloxacin is a fluoroquinolone antibacterial. It is used only against susceptible bacteria and does not work on viruses.

Ofloxacin dosage

▾

Tablets are swallowed, usually every 12 hours, for a set number of days that depends on the infection. Gonorrhea may be treated with a single dose. Food does not change how much is absorbed.

  • Eye drops: one to two drops, with a schedule that starts frequent and tapers.
  • Ear drops: usually once daily for seven days for otitis externa; warm the bottle first.

Follow your prescriber and the label exactly.

Dosing details from the FDA-approved label

From the Ofloxacin prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • Otitis externa, pediatric patients (6 months to 13 years old) - otic solution
    • Five drops (0.25 mL, 0.75 mg ofloxacin) instilled into the affected ear once daily for seven days
    • Warm bottle in hand for one or two minutes; lie with affected ear upward for five minutes after instilling
  • Otitis externa, patients 13 years and older - otic solution
    • Ten drops (0.5 mL, 1.5 mg ofloxacin) instilled into the affected ear once daily for seven days
    • Warm bottle in hand for one or two minutes; lie with affected ear upward for five minutes after instilling
  • Acute otitis media in pediatric patients (one to 12 years old) with tympanostomy tubes
    • Five drops (0.25 mL, 0.75 mg ofloxacin) instilled into the affected ear twice daily for ten days
    • Pump the tragus 4 times; remain in position for five minutes
  • Chronic suppurative otitis media with perforated tympanic membranes, patients 12 years and older
    • Ten drops (0.5 mL, 1.5 mg ofloxacin) instilled into the affected ear twice daily for fourteen days
    • Pump the tragus 4 times; remain in position for five minutes
  • Bacterial conjunctivitis - ophthalmic solution
    • Days 1 and 2: one to two drops every two to four hours in the affected eye(s)
    • Days 3 through 7: one to two drops four times daily
  • Bacterial corneal ulcer - ophthalmic solution
    • Days 1 and 2: one to two drops into the affected eye every 30 minutes, while awake
    • Awaken at approximately four and six hours after retiring and instill one to two drops
    • Days 3 through 7 to 9: one to two drops hourly, while awake
    • Days 7 to 9 through treatment completion: one to two drops, four times daily
  • Oral tablets: acute bacterial exacerbation of chronic bronchitis, community acquired pneumonia, uncomplicated skin and skin structure infections
    • 400 mg q12h for 10 days (daily dose 800 mg)
    • Creatinine clearance 20 to 50 mL/min: usual unit dose q24h after normal initial dose; < 20 mL/min: 1/2 the usual unit dose q24h
  • Oral tablets: nongonococcal cervicitis/urethritis due to C. trachomatis; mixed infection of urethra and cervix due to C. trachomatis and N. gonorrhoeae
    • 300 mg q12h for 7 days (daily dose 600 mg)
    • Same renal adjustment as above
  • Oral tablets: acute pelvic inflammatory disease
    • 400 mg q12h for 10 to 14 days (daily dose 800 mg)
    • Same renal adjustment as above
  • Oral tablets: acute uncomplicated urethral and cervical gonorrhea; uncomplicated cystitis; complicated UTIs; prostatitis
    • Gonorrhea: 400 mg single dose, 1 day
    • Cystitis due to E. coli or K. pneumoniae: 200 mg q12h for 3 days
    • Cystitis due to other approved pathogens: 200 mg q12h for 7 days
    • Complicated UTIs: 200 mg q12h for 10 days
    • Prostatitis due to E. coli: 300 mg q12h for 6 weeks
    • Maximum: 400 mg per day in severe liver disorders (e.g., cirrhosis)
    • Same renal adjustment as above; cirrhosis: maximum 400 mg per day not to be exceeded
Read the label’s full dosing text

DOSAGE AND ADMINISTRATION: The recommended dosage regimen for the treatment of bacterial conjunctivitis is: Days 1 and 2 Instill one to two drops every two to four hours in the affected eye(s). Days 3 through 7 Instill one to two drops four times daily. The recommended dosage regimen for the treatment of bacterial corneal ulcer is: Days 1 and 2 Instill one to two drops into the affected eye every 30 minutes, while awake. Awaken at approximately four and six hours after retiring and instill one to two drops. Days 3 through 7 to 9 Instill one to two drops hourly, while awake. Days 7 to 9 through treatment completion Instill one to two drops, four times daily.

Read the full Dosage and Administration section on DailyMed →

Ofloxacin side effects

▾

Most people tolerate ofloxacin, but some side effects are common with the tablets.

Common side effects

  • Nausea
  • Headache
  • Trouble sleeping (insomnia)
  • Dizziness
  • Diarrhea
  • Vomiting
  • Vaginal itching or vaginitis in women
  • Rash or itching

When to get medical help

  • Tendon pain, swelling, or a snap: stop the medicine and call your doctor right away
  • Tingling, numbness, burning, pain, or weakness in your hands or feet
  • Hallucinations, severe anxiety, depression, confusion, severe headache, or seizures
  • Worsening muscle weakness or trouble breathing if you have myasthenia gravis
  • Rash, swelling of the face or throat, trouble breathing, or other signs of a serious allergic reaction
  • Severe or lasting diarrhea, during treatment or even months after
  • Sudden severe chest, stomach, or back pain (possible aortic aneurysm or dissection)
  • Very low or high blood sugar, especially if you have diabetes

Call your doctor right away for tendon pain, tingling or numbness, mood or thinking changes, severe allergic reactions, or severe diarrhea.

Ofloxacin warnings and precautions

▾
  • Boxed warning: disabling, possibly permanent tendon, nerve, and brain effects, and worsening of myasthenia gravis.
  • Tendon rupture risk is higher over age 60, with corticosteroids, and with organ transplants.
  • Seizures and psychiatric effects can occur; use caution with epilepsy.
  • Serious allergic reactions can happen, often after the first dose.
  • C. difficile diarrhea can occur during or after treatment.
  • Aortic aneurysm and dissection risk.
  • Blood sugar can go too high or too low, especially in people with diabetes.

Ofloxacin interactions

▾

Several drugs and supplements can change how ofloxacin works or add to its risks.

  • Antacids, sucralfate, iron, and zinc multivitamins: reduce absorption; separate by two hours.
  • Theophylline: levels can rise.
  • Warfarin: stronger blood-thinning effect.
  • Insulin and diabetes medicines: blood sugar swings.
  • NSAIDs: may raise the risk of seizures.

Interactions listed in the FDA-approved label

From the Ofloxacin prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • Antacids containing calcium, magnesium, or aluminum; sucralfate; divalent or trivalent cations such as iron; multivitamins containing zinc; didanosine chewable/buffered tablets or pediatric powder for oral solution: Quinolones form chelates with these cations and absorption may be substantially reduced, resulting in systemic levels considerably lower than desired. Do not take within the two-hour period before or within the two-hour period after ofloxacin administration.
  • Caffeine: Interactions between ofloxacin and caffeine have not been detected.
  • Cimetidine: Cimetidine has interfered with the elimination of some quinolones, increasing half-life and AUC; the potential for interaction with ofloxacin has not been studied.
  • Cyclosporine: Elevated serum cyclosporine levels have been reported with some other quinolones; interaction with ofloxacin has not been studied.
  • Drugs metabolized by cytochrome P450 enzymes (e.g., cyclosporine, theophylline/methylxanthines, warfarin): Most quinolones inhibit cytochrome P450 enzyme activity, which may prolong the half-life of drugs also metabolized by this system.
  • Non-steroidal anti-inflammatory drugs: Concomitant use with a quinolone, including ofloxacin, may increase the risk of CNS stimulation and convulsive seizures.
  • Probenecid: Probenecid with certain other quinolones has been reported to affect renal tubular secretion; its effect on ofloxacin elimination has not been studied.
  • Theophylline: Steady-state theophylline levels may increase; ofloxacin may prolong theophylline half-life, elevate serum levels, and increase risk of theophylline-related adverse reactions (including seizures). Closely monitor theophylline levels and adjust theophylline dosage if appropriate.
  • Warfarin: Some quinolones have been reported to enhance the effects of warfarin or its derivatives. Closely monitor prothrombin time or other suitable coagulation test.
  • Antidiabetic agents (e.g., insulin, glyburide/glibenclamide): Disturbances of blood glucose, including hyperglycemia and hypoglycemia, have been reported with concurrent quinolones and an antidiabetic agent. Careful monitoring of blood glucose is recommended.
Read the label’s full interactions text

Drug Interactions: Specific drug interaction studies have not been conducted with Ofloxacin Ophthalmic Solution. However, the systemic administration of some quinolones has been shown to elevate plasma concentrations of theophylline, interfere with the metabolism of caffeine, and enhance the effects of the oral anticoagulant warfarin and its derivatives, and has been associated with transient elevations in serum creatinine in patients receiving cyclosporine concomitantly.

Read the full Drug Interactions section on DailyMed →

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

Before taking Ofloxacin

▾
  • Do not use the eye drops if you are allergic to ofloxacin or other quinolones.
  • Avoid if you have myasthenia gravis or past fluoroquinolone tendon or nerve problems.
  • Tell your doctor about seizure disorders, diabetes, kidney problems, or an aortic aneurysm.
  • Tablet safety is not established under age 18, in pregnancy, or while breastfeeding.
  • Tendon risk is higher if you are over 60 or take corticosteroids.

Ofloxacin overdose

▾

Information on overdose is limited. In one reported case of a very large intravenous dose, the person had drowsiness, nausea, dizziness, flushing, facial numbness, slurred speech, and disorientation, which mostly resolved within hours. The label says the stomach should be emptied, the person observed, and hydration maintained. Dialysis does not remove ofloxacin efficiently.

How your body processes Ofloxacin

▾

Ofloxacin tablets are about 98% absorbed and peak in the blood in one to two hours. Most of the drug leaves through the kidneys unchanged. Food does not change the amount absorbed, only delays the peak. Kidney problems slow clearance, so tablet doses may need adjusting. With eye drops, blood levels are far lower than with tablets.

How to store Ofloxacin

▾

Store at 20° to 25°C (68° to 77°F) .

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

145

Supplements & herbs that interact with Ofloxacin

145 supplements and herbal products have documented interactions with Ofloxacin in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 8
  • Moderate · 115
  • Minor · 22
Every supplement checked against Ofloxacin — ranked by severity The full interaction hub: 8 major · 115 moderate · 22 minor · every one linked to its full report. Check Ofloxacin against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

11

Nutrient depletion considerations

Ofloxacin has been associated with lower levels of 11 nutrients in the clinical literature. This does not mean a deficiency will occur — it means these may be worth discussing with your pharmacist or healthcare provider, especially with long-term use.

Evidence & significance mix
  • Higher significance · 10
  • Moderate · 1
See the full Ofloxacin nutrient depletion report

Educational information from a licensed clinical database (Natural Medicines) — not medical advice. Do not start or stop medications or supplements without professional guidance.

Ofloxacin: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Ofloxacin — the kind of thing our pharmacy team would talk through with you at the counter.

What is ofloxacin used for?

▾
It is an antibiotic for certain bacterial infections. Tablets treat things like pneumonia, skin infections, and some urethral and cervical infections. Eye drops treat bacterial conjunctivitis and corneal ulcers, and ear drops treat certain ear infections.

How should I take it?

▾
Follow the schedule on your label. Tablets are usually taken about every 12 hours. Keep antacids, iron, and zinc multivitamins at least two hours before or after. For ear drops, warm the bottle in your hand first and lie with the ear up for five minutes.

What side effects are common?

▾
With the tablets, the most common are nausea, headache, trouble sleeping, dizziness, and diarrhea. Women may also notice vaginal itching. These are often mild, but tell me if they bother you.

When should I call my doctor right away?

▾
Stop the medicine and call if you have tendon pain or swelling, tingling or numbness, confusion, hallucinations, or a rash or swelling. Also call for severe diarrhea or sudden severe chest or back pain.

Can I take it with my other medicines?

▾
Tell me about everything you take. Warfarin, theophylline, insulin, diabetes pills, and NSAIDs need extra care with ofloxacin. Antacids and iron can block absorption of the tablets.

Is it safe in pregnancy or for children?

▾
Safety of the tablets has not been established in people under 18, in pregnancy, or while breastfeeding. Talk with your prescriber about whether it is right for you or your child.

Is Ofloxacin available over the counter?

▾
No. Ofloxacin is a prescription medicine: every Ofloxacin product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

When was Ofloxacin first available?

▾
The earliest FDA record we hold for Ofloxacin is from 1990: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Ofloxacin was first used.

Who makes Ofloxacin?

▾
27 companies currently list Ofloxacin products in the FDA's NDC Directory, including A-S Medication Solutions, NuCare Pharmaceuticals,Inc., Proficient Rx LP. That count includes repackagers and distributors as well as manufacturers (companies that sell only the raw ingredient are not counted), so fewer companies actually make it; the label on your bottle names the one that supplied yours.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Ofloxacin on HelloPharmacist

Detailed data & references for Ofloxacin Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Ofloxacin forms and strengths (how it comes)

Ofloxacin is available in 3 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Eye drops

In the eye
Brands Ocuflox Ofloxacin Ophth Soln
How this form is used
What it may be used for
  • Ocuflox and ofloxacin ophthalmic solutions treat bacterial conjunctivitis.
  • Ocuflox and ofloxacin ophthalmic solutions treat bacterial corneal ulcers.
Important instructions
  • Ocuflox and ofloxacin eye drops for conjunctivitis are used every two to four hours at first, then four times daily.
  • For corneal ulcers, ocuflox and ofloxacin eye drops are used very frequently at first, then less often, as directed.
  • Use one to two drops in the affected eye(s) as your prescriber directs.
Available strengths 1 strength
70 FDA-listed product records ⓘ

Ear drops

In the ear
Brands Ofloxacin Otic
How this form is used
What it may be used for
  • Ofloxacin Otic solution 0.3% treats otitis externa in adults and children 6 months and older.
  • Ofloxacin Otic treats chronic suppurative otitis media in patients 12 and older with perforated eardrums.
  • Ofloxacin Otic treats acute otitis media in children 1 year and older with ear tubes.
Important instructions
  • Ofloxacin Otic is placed in the affected ear, usually once daily for seven days for otitis externa.
  • Warm the Ofloxacin Otic bottle in your hand for one or two minutes to avoid dizziness from cold drops.
  • Lie with the affected ear up for the drops, and stay in that position for five minutes.
  • Repeat for the other ear if needed.
Available strengths 1 strength
65 FDA-listed product records ⓘ

Tablet

By mouth
How this form is used
What it may be used for
  • Ofloxacin tablets treat flare-ups of chronic bronchitis only when there is no alternative treatment.
  • Ofloxacin tablets treat community-acquired pneumonia and uncomplicated skin infections.
  • Ofloxacin tablets treat gonorrhea and chlamydia infections of the urethra and cervix.
  • Ofloxacin tablets are for adults with mild to moderate infections.
Important instructions
  • Ofloxacin tablets are taken by mouth, usually every 12 hours; gonorrhea may use a single dose.
  • Ofloxacin tablets can be taken with food, which does not change how much is absorbed.
  • Kidney problems may require a dose change for ofloxacin tablets.
  • Keep antacids, iron, and zinc multivitamins two hours away from ofloxacin tablets.
Available strengths 3 strengths
15 FDA-listed product records ⓘ

Ofloxacin on the U.S. market: products, makers and brands

How Ofloxacin appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

27 companies list 82 Ofloxacin product records with the FDA, mostly as eye drops, ear drops, tablet; the earliest marketing or approval year on record is 1990. Brand names on the directory include Floxin, Ocuflox, Ofloxacin Otic and 1 more; the rest are generics.

3
Dose forms ⓘ
27
Labelers (makers, repackagers, distributors)
5
Brand names
82
FDA-listed product records ⓘ
1990
Earliest FDA record ⓘ

FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

Also listed with the FDA, not a patient dose form: Powder (3) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

A-S Medication Solutions12%
NuCare Pharmaceuticals,Inc.10%
Proficient Rx LP10%
Remedyrepack Inc.7%
Lifestar Pharma LLC5%
Preferred Pharmaceuticals Inc.5%
Other makers51%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

How widely Ofloxacin is used (Medicaid data)

A general measure of how commonly Ofloxacin is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Ofloxacin is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

1,194,981
Medicaid prescriptions filled (Q1–Q4 2025)
$23.6M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Ofloxacin prescribed? Of the 1,601 medications we measure, Ofloxacin ranks #149 by Medicaid prescriptions — more than 91% of them.

Where Ofloxacin ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Ofloxacin product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 3 mg/mL otic solution is the most-dispensed Ofloxacin product — about 59% of these Medicaid prescriptions.

ofloxacin 3 MG/ML Otic Solution Most dispensed

706,749 Medicaid prescriptions (Q1–Q4 2025) 59% of Ofloxacin prescriptions shown $15.5M gross reimbursement (before rebates) ≈ $22 per prescription (gross)

Summed across the 18 of 47 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 242446

ofloxacin 3 MG/ML Ophthalmic Solution

488,232 Medicaid prescriptions (Q1–Q4 2025) 41% of Ofloxacin prescriptions shown $8.2M gross reimbursement (before rebates) ≈ $17 per prescription (gross)

Summed across the 20 of 71 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 312075

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Ofloxacin, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 38 of 118 listed Ofloxacin NDCs with Medicaid activity.

Compare Ofloxacin products

A representative set of FDA-listed product records for Ofloxacin — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 82 of 82 products — FDA National Drug Code Directory. See every product, package size and price: browse all 82 Ofloxacin NDCs →

Ofloxacin side effects reported to the FDA (FAERS)

After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Ofloxacin — a signal of what to watch for, not proof the drug caused it.

The effects most often named in FDA reports that mention Ofloxacin are eye pain, headache, pain; about 76% of the reports were classed as serious. These are voluntary reports, so they show what people report, not how often it happens.

7,263
Reports mentioning it
76%
Reported as serious
12
Distinct effects shown
Most reported effects
Eye Pain
348
Headache
289
Pain
280
Fatigue
272
Nausea
260
Arthralgia
256
Diarrhoea
250
Acute Kidney Injury
246
Anxiety
215
Dyspnoea
212
Age groups
Elderly · 802Adult · 666Child · 45Adolescent · 29Infant · 10Neonate · 5

Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Ofloxacin in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.

Ofloxacin FDA approval history

How Ofloxacin went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.

Ofloxacin was first approved by the FDA in 1990 (Brand: FLOXIN · Janssen Pharms); the first generic version was approved in 2002. It remains available in U.S. pharmacies today.

1990
Brand approved
Brand: FLOXIN · Janssen Pharms
2002
First generic approved
Lower-cost ANDA competition begins
2026
Available today
Active in U.S. pharmacies

Source: Drugs@FDA.

Ofloxacin recall history

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list one Ofloxacin recall since July 2021. It is no longer listed as ongoing. A recall names specific lots from one company, so check the lot number on your own bottle rather than assuming every product is affected; your pharmacist can check whether your supply came from an affected lot.

Class II Apr 13, 2022 · Terminated · Mckesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse
  • Ofloxacin Otic Solution 0.3%, 5 mL bottle, Rx only, MFG: Amneal/Akyma Pharmaceuticals, NDC 69238-1615-3 Lots: McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that i… FDA record D-1114-2022 →

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Ofloxacin RxCUI 7623 4 dose forms · 6 strengths
  1. Dose form (SCDF) Injectable Solution RxCUI 377110 No current FDA listing
    Clinical drug / strength (SCD) 2 MG/ML RxCUI 250095
  2. Dose form (SCDF) Ophthalmic Solution RxCUI 377402 In current FDA listings
    Clinical drug / strength (SCD) 3 MG/ML RxCUI 312075
  3. Dose form (SCDF) Oral Tablet RxCUI 373141 In current FDA listings
    Clinical drug / strength (SCD) 200 MG RxCUI 198048 300 MG RxCUI 198049 400 MG RxCUI 198050
  4. Dose form (SCDF) Otic Solution RxCUI 377450 In current FDA listings
    Clinical drug / strength (SCD) 3 MG/ML RxCUI 242446

Look up RxCUI 7623 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

💵 What Ofloxacin costs pharmacies (NADAC benchmark)

The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.

FormStrengthPharmacy acquisition benchmark
Solution · Auricular (otic) 3 mg/mL $0.979–$1.11 per mL NDC details & price history
Solution/ Drops · Ophthalmic 3 mg/mL $1.11–$1.24 per mL NDC details & price history
Solution/ Drops · Auricular (otic) 3 mg/mL $1.11 per mL NDC details & price history
Why show this? Your out-of-pocket cost depends on insurance, pharmacy markup, and discounts — but the acquisition benchmark tells you whether the medication itself is inexpensive or costly, which strengths cost more per dose, and whether a cash-price quote is in a reasonable range. Each row links to the NDC-level record with its full price history.

Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.

Ofloxacin brand names

Ofloxacin is sold under 4 brand names in the FDA directory — Floxin, Ocuflox, Ofloxacin Otic, Ofloxacin Ophth Soln. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Floxin Ocuflox Ofloxacin Otic Ofloxacin Ophth Soln

Who makes Ofloxacin: manufacturers and labelers

27 companies list Ofloxacin products with the FDA. By number of product records, the largest are A-S Medication Solutions, NuCare Pharmaceuticals,Inc., Proficient Rx LP. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

A-S Medication Solutions 10 NuCare Pharmaceuticals,Inc. 8 Proficient Rx LP 8 Remedyrepack Inc. 6 Lifestar Pharma LLC 4 Preferred Pharmaceuticals Inc. 4 Bryant Ranch Prepack 3 Cadila Pharmaceuticals Limited 3 Modavar Pharmaceuticals LLC 3 Redpharm Drug 3 Somerset Therapeutics, LLC 3 Amneal Pharmaceuticals NY LLC 2 Apotex Corp. 2 Asclemed USA, Inc. 2 Bausch & Lomb Incorporated 2 Caplin Steriles Limited 2 Direct Rx 2 Leading Pharma, LLC 2 NorthStar RxLLC 2 Rising Pharma Holdings, Inc. 2 St. Mary's Medical Park Pharmacy 2 Sportpharm LLC 2 Armas Pharmaceuticals Inc. 1 Allergan, Inc. 1

…and 3 more on the FDA NDC directory.

Ofloxacin drug class (RxNorm)

Ofloxacin belongs to the Quinolone Antimicrobial class.

Pharmacologic class Quinolone Antimicrobial
Drug family (ATC) Fluoroquinolones, Fluoroquinolones, Antiinfectives

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

Sources for this Ofloxacin page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Jan 2, 2026
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Ofloxacin.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Ofloxacin after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
42
Finished products in the current FDA directory
82
Companies listing them (makers, repackagers, distributors)
27
FDA labeler codes behind them ⓘ
30
Linked representative label ⓘ
Rising Pharmaceuticals, Inc.
Linked label effective
Jan 2, 2026
Composite sections available
17
Linked SPL Set ID
c76d8dc7-9a66-471b-814b-ef7f3605ec93
Linked SPL Document ID
95b0ceb9-743b-41ae-9131-235156325482
Open the linked representative label on DailyMed ↗

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Rising Pharmaceuticals, Inc. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →