FDA-filed SPL labeling · retrieved through openFDA

Gentamicin Ophthalmic

Gentamicin ophthalmic is an antibiotic eye preparation used to treat bacterial infections of the eye, including conjunctivitis, corneal ulcers, and eyelid infections.

Brand names Garamycin OphthalmicGenopticGentakGentasolGentafair +3 more
Drug class ⓘ Aminoglycoside Antibacterial
Rx Forms 2 Route Ophthalmic
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 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 21 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 →

At a glance
Linked label effectiveJun 14, 2024
Clinical labels in scope ⓘ21
AvailabilityRx
Earliest approval/marketing year ⓘ1966
FDA-listed product records ⓘ45
Boxed warningNone found in compared labels
How we combine label and product data →
✓No current FDA shortage listed · checked Sep 24, 2026
Other forms & routes:
↩ All forms of Gentamicin Injection Topical
⭐ Gentamicin Ophthalmic at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Gentamicin ophthalmic solution is an effective antibiotic eye drop for treating bacterial eye infections such as conjunctivitis, corneal ulcers, and eyelid infections. Use it exactly as directed — drops in the eye only, never injected. If eye pain suddenly worsens or you notice vision changes during treatment, reach out to your doctor promptly.
How we write & review this content — our editorial policy →

📖 Gentamicin Ophthalmic: Patient Information Guide

A plain-language walkthrough of Gentamicin Ophthalmic — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for▾

Gentamicin ophthalmic is an antibiotic used to treat bacterial infections of the eye and surrounding structures. Gentamicin Sulfate Ophthalmic Solution is indicated for:

  • Conjunctivitis (bacterial pink eye)
  • Keratitis and keratoconjunctivitis (bacterial infections of the cornea)
  • Corneal ulcers caused by susceptible bacteria
  • Blepharitis and blepharoconjunctivitis (bacterial eyelid infections)
  • Acute meibomianitis (infection of the eyelid oil glands)
  • Dacryocystitis (bacterial infection of the tear duct)
⚙️How it works▾

Gentamicin belongs to a class of antibiotics called aminoglycosides. It works by locking onto a structure inside bacteria called the ribosome — the part responsible for building proteins the bacteria need to survive and multiply. By blocking protein synthesis, gentamicin kills the bacteria directly. It is effective against both gram-positive and gram-negative bacteria.

Some bacteria can develop resistance to gentamicin, which is one reason it's important to use the full prescribed course and only for confirmed or suspected bacterial infections.

💊How it's taken▾

Gentamicin Sulfate Ophthalmic Solution is instilled as eye drops directly into the affected eye(s). For most infections, one or two drops are used every four hours. In more serious infections, your doctor may increase this to two drops every hour.

  • Use only in the eye — this solution must never be injected
  • Follow your prescriber's exact instructions for how often to use it
  • If you miss a dose, use it as soon as you remember — but skip it if it's almost time for the next dose
🤒Side effects — in detail▾

The most commonly reported side effects with gentamicin ophthalmic preparations are mild and related to the eye itself:

  • Burning or stinging when drops are applied
  • Eye redness (conjunctival hyperemia)
  • Non-specific conjunctivitis
  • Minor surface damage to the eye (conjunctival epithelial defects)

Less common but more serious reactions include allergic reactions, a significant drop in platelets (thrombocytopenic purpura), and hallucinations. Bacterial and fungal corneal ulcers have also been reported during treatment. If any of these occur, contact your doctor promptly.

⚠️Warnings & precautions▾
  • For eye use only — never inject: Gentamicin sulfate ophthalmic solution must never be injected into or around the eye. Injecting it under the conjunctiva or into the front chamber of the eye could cause serious damage.
  • Corneal ulcers during treatment: Bacterial and fungal corneal ulcers have developed in some patients using gentamicin ophthalmic preparations. Seek care immediately if eye pain suddenly worsens or vision changes.
  • Allergic reactions: Stop use and get medical help if you experience swelling, rash, or difficulty breathing.
  • Rare serious reactions: Thrombocytopenic purpura (unusual bruising or bleeding due to low platelet count) and hallucinations have been reported rarely.
🔀What it interacts with▾

The FDA label for gentamicin ophthalmic solution does not identify specific drug, food, or supplement interactions for the eye drop formulation.

    This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

    📋Before taking it▾
    • Do not use if you are allergic to gentamicin or any other ingredient in the product — this is a contraindication
    • Tell your doctor about all eye conditions you have before starting treatment
    • This solution is strictly for use in the eye and must never be injected under any circumstances
    🔬Pharmacokinetics — how your body processes it▾

    When gentamicin is given by injection (not the eye drop route), it is rapidly absorbed and reaches peak blood levels within 30 to 60 minutes. It is mostly cleared from the body through the kidneys — about 70% or more is recoverable in the urine within 24 hours, largely unchanged. In people with kidney disease, the drug clears more slowly and can build up in the body. There is minimal penetration of gentamicin into eye tissues when given by injection, which is why direct application to the eye as drops is used for eye infections.

    📦How to store it▾

    Store at or below 25°C (77°F).

    📄 Written from Gentamicin Ophthalmic’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

    🩺 Pharmacist Counseling Corner

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

    What kind of eye infection does this treat — can I use it for any red or irritated eye? ▾
    Gentamicin eye drops treat bacterial eye infections specifically — things like bacterial conjunctivitis (pink eye), corneal ulcers, and eyelid infections. They won't work against viral infections (like those caused by herpes) or fungal infections. If you're not sure what's causing your symptoms, it's worth checking with your doctor before starting treatment.
    How do I use the eye drops correctly? ▾
    The usual dose is one or two drops placed directly into the affected eye every four hours. If your infection is more severe, your doctor may tell you to use two drops every hour. Always wash your hands before applying the drops, tilt your head back, and try not to let the dropper tip touch your eye or any surface to keep it clean.
    My eyes sting after I put the drops in — is that normal? ▾
    Yes, a brief burning or stinging sensation right after applying the drops is the most commonly reported side effect, and it's generally harmless. Some redness or minor irritation is also fairly common. These usually settle down quickly. If the discomfort is severe or doesn't ease up, let your doctor know.
    Are there any serious side effects I should watch out for? ▾
    While uncommon, gentamicin eye drops can occasionally cause a worsening of a corneal ulcer, or — rarely — an allergic reaction, unusual bruising or bleeding, or even hallucinations. If you notice sudden, sharp eye pain, vision changes, a white spot on your eye, unexplained bruising, or any unusual thoughts, get medical attention right away.
    Can I inject this solution around my eye if drops aren't working well? ▾
    Absolutely not — this is one of the most important safety points. This solution must never be injected into or around the eye, under any circumstances. Injecting it could cause serious harm. It is only meant to be placed on the surface of the eye as drops.
    What if I forget a dose? ▾
    If you miss a dose, apply it as soon as you remember. But if it's almost time for your next scheduled dose, just skip the missed one and carry on as normal. Don't double up to make up for a missed dose — just stay on track and finish the full course your doctor prescribed.
    Is Gentamicin Ophthalmic available over the counter? ▾
    Gentamicin Ophthalmic is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.
    When was Gentamicin Ophthalmic first available? ▾
    Gentamicin Ophthalmic has been available in the United States since at least 1966, based on FDA approval history (Drugs@FDA) and product marketing records.
    Who makes Gentamicin Ophthalmic? ▾
    Gentamicin Ophthalmic is supplied by 15 manufacturers listed in the FDA NDC Directory, including NuCare Pharmaceuticals,Inc., Proficient Rx LP, A-S Medication Solutions.

    💬 Answers drafted from Gentamicin Ophthalmic’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

    🧰 Keep exploring

    🌿Drug & Supplement CheckerGentamicin Ophthalmic vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Gentamicin Ophthalmic NDCs & costs 🅰️Browse Drugs A–ZLook up any medication

    💊 How Gentamicin Ophthalmic comes

    Gentamicin Ophthalmic is available in 2 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 Gentamicin Sulfate Opth Solution
    How this form is used
    What it may be used for
    • Gentamicin Sulfate Ophthalmic Solution treats bacterial eye infections including conjunctivitis, keratitis, corneal ulcers, blepharitis, and dacryocystitis
    • Indicated for infections caused by susceptible bacteria such as Staphylococcus aureus, Pseudomonas aeruginosa, and Neisseria gonorrhoeae
    Important instructions
    • Gentamicin Sulfate Ophthalmic Solution: instill one or two drops into the affected eye(s) every four hours
    • For severe infections, Gentamicin Sulfate Ophthalmic Solution may be used as two drops every hour as directed by your doctor
    • For external use in the eye only — never inject this solution
    Available strengths 1 strength
    3 mg/mL
    41 FDA-listed product records ⓘ

    Eye ointment

    In the eye
    Brands Gentak
    Available strengths 1 strength
    3 mg/g
    4 FDA-listed product records ⓘ

    📊 Gentamicin Ophthalmic across the U.S. market

    How Gentamicin Ophthalmic 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.

    2
    Dose forms ⓘ
    15
    Manufacturers
    3
    Brand names
    45
    FDA-listed product records ⓘ
    1966
    First marketed ⓘ

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

    NuCare Pharmaceuticals,Inc.16%
    Proficient Rx LP13%
    A-S Medication Solutions9%
    RPK Pharmaceuticals, Inc.9%
    Direct Rx7%
    Preferred Pharmaceuticals Inc.7%
    Other makers40%

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

    📈 How widely Gentamicin Ophthalmic is used

    A general measure of how commonly Gentamicin Ophthalmic 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 Gentamicin Ophthalmic 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.

    84,328
    Medicaid prescriptions filled (Q1–Q4 2025)
    $984,347 gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

    How commonly is Gentamicin Ophthalmic prescribed? Of the 1,597 medications we measure, Gentamicin Ophthalmic ranks #533 by Medicaid prescriptions — more than 67% of them.

    Where Gentamicin Ophthalmic ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
    Total prescriptions — #533 of 1,597
    #528 Acamprosate 89,900 Rx #529 Bupivacaine / Epinephr... 89,693 Rx #530 Glyburide 89,361 Rx #531 Fluticasone / Vilanter... 85,370 Rx #532 Loratadine / Pseudoeph... 84,649 Rx #533 Gentamicin Ophthalmic 84,328 Rx #534 Ruxolitinib 84,308 Rx #535 Vibegron 84,266 Rx #536 Valbenazine 83,640 Rx #537 Colestipol 83,276 Rx #538 Risankizumab-rzaa Inje... 82,904 Rx

    Utilization by Gentamicin Ophthalmic 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.

    gentamicin 3 MG/ML Ophthalmic Solution

    84,328 Medicaid prescriptions (Q1–Q4 2025) 100% of Gentamicin Ophthalmic prescriptions shown $984,347 gross reimbursement (before rebates) ≈ $12 per prescription (gross)

    Summed across the 2 of 33 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 310467

    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 Gentamicin Ophthalmic, 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 2 of 33 listed Gentamicin Ophthalmic NDCs with Medicaid activity.

    🔍 Compare Gentamicin Ophthalmic products

    A representative set of FDA-listed product records for Gentamicin Ophthalmic — 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 45 of 45 products — FDA National Drug Code Directory. See every product, package size and price: browse all 45 Gentamicin Ophthalmic NDCs →

    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) Gentamicin Ophthalmic RxCUI 1596450 7 dose forms · 18 strengths
    1. Dose form (SCDF) Injectable Solution RxCUI 1870216 No current FDA listing
      Clinical drug / strength (SCD) 5 MG/ML RxCUI 102770 10 MG/ML RxCUI 239204 40 MG/ML RxCUI 313996 100 MG/ML RxCUI 1485222
    3. Dose form (SCDF) Irrigation Solution RxCUI 1870319 No current FDA listing
      Clinical drug / strength (SCD) 100 MG/ML RxCUI 1090525
    4. Dose form (SCDF) Ophthalmic Ointment RxCUI 1870220 In current FDA listings
      Clinical drug / strength (SCD) 0.003 MG/MG RxCUI 310466
    5. Dose form (SCDF) Ophthalmic Solution RxCUI 1870228 In current FDA listings
      Clinical drug / strength (SCD) 3 MG/ML RxCUI 310467 15 MG/ML RxCUI 106871
    6. Dose form (SCDF) Topical Cream RxCUI 1870264 No current FDA listing
      Clinical drug / strength (SCD) 1 MG/ML RxCUI 197735
    7. Dose form (SCDF) Topical Ointment RxCUI 1870479 No current FDA listing
      Clinical drug / strength (SCD) 0.001 MG/MG RxCUI 310465

    Look up RxCUI 1596450 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.

    🏷️ Sold under these brand names

    Garamycin Ophthalmic Genoptic Gentak Gentasol Gentafair Ocu-Mycin Garasol Gentamicin Sulfate Opth Solution

    🏭 Manufacturers & labelers

    NuCare Pharmaceuticals,Inc. 7 Proficient Rx LP 6 A-S Medication Solutions 4 RPK Pharmaceuticals, Inc. 4 Direct Rx 3 Preferred Pharmaceuticals Inc. 3 Remedyrepack Inc. 3 Akorn 2 Asclemed USA, Inc. 2 Bausch & Lomb Incorporated 2 Direct_Rx 2 NuCare Pharmaceuticals, Inc. 2 Pacific Pharma, Inc. 2 Sandoz Inc 2 Medsource Pharmaceuticals 1

    RxNorm drug class

    Gentamicin Ophthalmic belongs to the Aminoglycoside Antibacterial class.

    Pharmacologic class Aminoglycoside Antibacterial
    Drug family (ATC) Other antibiotics for topical use, Other aminoglycosides, Antibiotics

    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.

    🔬 Where this comes from

    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 Jun 14, 2024
    🏭
    Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Gentamicin Ophthalmic.
    📈
    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 Gentamicin Ophthalmic after exact ingredient or ingredient-combination matching and applicable route/form matching
    Clinical labels in scope
    21
    NDC products indexed
    45
    Distinct labelers/manufacturers represented
    15
    Linked representative label ⓘ
    NuCare Pharmaceuticals,Inc.
    Linked label effective
    Jun 14, 2024
    Composite sections available
    13
    Linked SPL Set ID
    85424b40-5c2d-421d-e053-2991aa0a7771
    Linked SPL Document ID
    1ade255c-bb1d-b03f-e063-6294a90a6d78
    Open the linked representative label on DailyMed ↗
    NDC package records associated with this linked SPL 1

    How we combine label and product data

    HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 21 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

    Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. NuCare Pharmaceuticals,Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

    This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.