FDA-filed SPL labeling · retrieved through openFDA

Loteprednol Ophthalmic

Loteprednol is a corticosteroid eye medication used to treat inflammatory conditions of the eye and post-operative inflammation following ocular surgery.

Brand names AlrexEysuvisInveltysLotemaxLotemax SM +1 more
Drug class ⓘ Corticosteroid
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 26 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 effectiveMar 11, 2025
Clinical labels in scope ⓘ26
AvailabilityRx
Earliest approval/marketing year ⓘ1998
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 23, 2026
⭐ Loteprednol Ophthalmic at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Loteprednol ophthalmic drops are a targeted steroid that calms eye inflammation from conditions like allergic conjunctivitis, certain infections, and post-surgical swelling. Use it only as directed and for the shortest time needed, since prolonged use raises the risk of increased eye pressure and cataracts. Keep all follow-up appointments so your doctor can monitor your eye pressure and make sure the treatment is working safely.
How we write & review this content — our editorial policy →

📖 Loteprednol Ophthalmic: Patient Information Guide

A plain-language walkthrough of Loteprednol 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▾

Loteprednol ophthalmic is a steroid eye medication used for several inflammatory conditions of the eye's surface and front chamber.

  • Allergic conjunctivitis (red, itchy eyes from allergies)
  • Acne rosacea affecting the eye
  • Superficial punctate keratitis (tiny sores on the cornea's surface)
  • Herpes zoster keratitis (eye inflammation from shingles)
  • Iritis and cyclitis (inflammation inside the front of the eye)
  • Selected infectious conjunctivitides (certain types of pink eye), when reducing inflammation is worth the risk of steroid use
  • Post-operative inflammation following ocular (eye) surgery
  • Eysuvis is specifically approved for short-term use (up to two weeks) for steroid-responsive inflammatory eye conditions
⚙️How it works▾

Loteprednol is a corticosteroid (steroid) that works by blocking inflammation in the eye. It interferes with the release of arachidonic acid — a chemical building block the body uses to make prostaglandins and leukotrienes, which are the key triggers of swelling, redness, and pain. By cutting off this chain reaction, loteprednol calms the inflammatory response in the eye's surface tissues and front chamber.

Loteprednol is specially designed to break down quickly into inactive metabolites (byproducts) once it has done its job, which keeps very little of the drug from being absorbed into the bloodstream. Plasma levels after eye drop use are generally too low to detect, which helps reduce the risk of whole-body steroid side effects.

💊How it's taken▾

Eysuvis eye drops are instilled one to two drops into each affected eye four times daily for up to two weeks. Shake the bottle gently for two to three seconds before each use, and wash your hands well beforehand.

  • Do not let the dropper tip touch your eye or any surface
  • If you use other eye drops, wait at least 5 minutes between Eysuvis and the other drops
  • If you miss a dose, use it as soon as you remember
  • Do not continue use beyond 10 days without your doctor re-examining your eyes and checking your eye pressure
🤒Side effects — in detail▾

Most side effects from loteprednol eye drops are mild and affect the eye directly.

  • Blurred or abnormal vision
  • Burning or stinging when the drops go in
  • Itching, redness, or discharge
  • Dry eyes or watery eyes
  • Feeling of something in the eye
  • Sensitivity to light
  • Headache, runny nose, or sore throat (less common, non-eye effects)

More serious reactions — including increased eye pressure, cataract formation, or new or worsening eye infections — can develop with prolonged use and require prompt medical attention. Tell your doctor right away if your vision changes, eye pain worsens, or you notice signs of infection.

⚠️Warnings & precautions▾
  • Raised eye pressure (IOP): Prolonged steroid use can increase pressure inside the eye, potentially leading to glaucoma and optic nerve damage. Eye pressure should be monitored if you use this medication for 10 days or more.
  • Cataracts: Long-term use may cause a posterior subcapsular cataract — a specific type of clouding at the back of the lens.
  • Infection risk: Steroids can suppress the eye's defenses, making bacterial, fungal, or viral infections more likely or harder to spot. Fungi are a particular concern with long-term use.
  • Herpes simplex: If you have a history of herpes simplex eye disease, use with great caution — steroids can cause a flare-up and worsen the infection.
  • Delayed healing: Using steroids after cataract surgery may slow healing and increase the risk of certain complications. In eyes with thinning of the cornea or sclera, steroid drops have been associated with perforation (a hole forming).
  • Contact lenses: Do not wear contact lenses during treatment.
🔀What it interacts with▾

There are limited drug interactions specific to loteprednol eye drops, but there are important things to be aware of:

  • Soft contact lenses: The preservative benzalkonium chloride in loteprednol preparations can be absorbed by soft contact lenses and may cause eye irritation — do not wear soft lenses during treatment.
  • Other eye drops: If you are using additional eye drops, wait at least 5 minutes after instilling Eysuvis before using them, to avoid washing out the medication.

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 loteprednol if you have most viral eye infections (such as dendritic herpes keratitis, vaccinia, or varicella), a fungal eye infection, or a mycobacterial eye infection
  • Tell your doctor if you have ever had a herpes simplex eye infection — this medication requires extra caution in that situation
  • Tell your doctor if you have glaucoma or high eye pressure — steroids can raise it further
  • If you are pregnant, discuss risks carefully with your doctor; animal studies showed fetal harm at higher (oral) doses
  • If you are breastfeeding, talk to your doctor — it is not known whether this drug passes into breast milk
  • Loteprednol ophthalmic gel has been studied and found safe and effective in children from birth to 11 years old
  • Older adults do not require dose adjustments — no differences in safety or effectiveness have been found compared to younger patients
📡Pharmacodynamics — effects in the body▾

Loteprednol reduces the key signs of eye inflammation — swelling (edema), capillary dilation (widening of tiny blood vessels), and the migration of white blood cells (leukocytes) into inflamed tissue. It also inhibits fibrin deposition, the formation of new blood vessels, and the development of scar tissue. Like other corticosteroids, it can raise intraocular pressure (pressure inside the eye), which is one of the main side effects monitored during use.

🔬Pharmacokinetics — how your body processes it▾

When applied as eye drops, loteprednol is highly lipid-soluble (fat-soluble), which helps it penetrate into eye cells where it acts. It undergoes extensive metabolism — breaking down quickly into inactive byproducts, primarily a compound called Δ¹ cortienic acid etabonate. Blood levels after recommended ophthalmic dosing are below detectable limits (less than 1 ng/mL), meaning very little reaches the general circulation. This limited systemic absorption helps reduce the risk of whole-body steroid side effects.

📦How to store it▾

Store upright at 15º to 25º C (59º to 77º F).

📄 Written from Loteprednol 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 Loteprednol Ophthalmic — the kind of thing our pharmacy team would talk through with you at the counter.

What exactly is loteprednol eye drops used for? ▾
It's a steroid eye drop used to calm inflammation in and around the eye. That includes allergic conjunctivitis (red, itchy eyes from allergies), certain types of pink eye, inflammation inside the front of the eye like iritis, and inflammation after eye surgery. Eysuvis is a brand specifically approved for short-term use — up to two weeks.
How do I use Eysuvis correctly? ▾
Shake the bottle gently for a couple of seconds before each use. Wash your hands, then put one to two drops into each affected eye four times a day. Try not to let the dropper tip touch your eye or any surface — that can contaminate the bottle. If you're also using other eye drops, wait at least 5 minutes between them.
Can I wear my contact lenses while using this? ▾
No — you should not wear contact lenses during your course of treatment. The preservative in loteprednol eye drops can be absorbed into soft contact lenses and may irritate your eyes. Once your treatment is finished and your doctor says it's okay, you can go back to wearing them.
What side effects should I watch out for? ▾
Mild burning, stinging, or blurry vision right after putting the drops in is common and usually settles quickly. What you really want to watch for are signs of something more serious: worsening eye pain, significant vision changes, or signs of a new eye infection like increased redness, discharge, or pain. These need a call to your doctor right away. Using steroid drops for too long without monitoring can also raise the pressure inside your eye, so stick to the recommended duration.
Is it safe to use if I've had a herpes eye infection in the past? ▾
You need to be upfront with your doctor about that history. Steroid eye drops can cause a herpes simplex eye infection to flare up or get worse. It doesn't necessarily mean you can't use it, but your doctor will need to monitor you closely and weigh the risks carefully before prescribing it.
I'm pregnant — is this eye drop safe to use? ▾
There aren't well-controlled studies in pregnant women, so the risk isn't fully known. Animal studies showed potential for birth defects at higher oral doses. Since the eye drops deliver very small amounts that barely reach the bloodstream, the risk is likely much lower — but you should still discuss this with your doctor so they can weigh the benefits against the potential risks for your situation.
Is Loteprednol Ophthalmic available over the counter? ▾
Loteprednol 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 Loteprednol Ophthalmic first available? ▾
Loteprednol Ophthalmic has been available in the United States since at least 1998, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Loteprednol Ophthalmic? ▾
Loteprednol Ophthalmic is supplied by 13 manufacturers listed in the FDA NDC Directory, including Bausch & Lomb Incorporated, Alcon Laboratories, Inc., Bausch & Lomb Americas Inc..

💬 Answers drafted from Loteprednol 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 CheckerLoteprednol Ophthalmic vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Loteprednol Ophthalmic NDCs & costs 🅰️Browse Drugs A–ZLook up any medication

💊 How Loteprednol Ophthalmic comes

Loteprednol 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 Alrex Eysuvis Inveltys Lotemax Loteprednol Etabonate
How this form is used
What it may be used for
  • Eysuvis is used to treat steroid-responsive inflammatory conditions of the eye, such as allergic conjunctivitis and related conditions
  • Eysuvis is used for short-term treatment of eye inflammation, for up to two weeks
Important instructions
  • Eysuvis: Shake the bottle for two to three seconds before each use
  • Eysuvis: Instill one to two drops into each affected eye four times daily for up to two weeks
  • Eysuvis: Wash your hands thoroughly before use, and do not let the dropper tip touch any surface
  • Eysuvis: If using other eye drops, wait at least 5 minutes before or after instilling Eysuvis
Available strengths 4 strengths
2 mg/mL 2.5 mg/mL 5 mg/mL 10 mg/mL
31 FDA-listed product records ⓘ

Eye ointment

In the eye
Brands Lotemax Lotemax SM Loteprednol Etabonate
Available strengths 2 strengths
3.8 mg/g 5 mg/g
14 FDA-listed product records ⓘ

📊 Loteprednol Ophthalmic across the U.S. market

How Loteprednol 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 ⓘ
13
Manufacturers
6
Brand names
45
FDA-listed product records ⓘ
1998
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.

Bausch & Lomb Incorporated27%
Alcon Laboratories, Inc.11%
Bausch & Lomb Americas Inc.11%
Armas Pharmaceuticals Inc.9%
Amneal Pharmaceuticals NY LLC7%
Padagis US LLC7%
Other makers29%

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

📈 How widely Loteprednol Ophthalmic is used

A general measure of how commonly Loteprednol 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 Loteprednol 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.

34,076
Medicaid prescriptions filled (Q1–Q4 2025)
$10.3M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Loteprednol Ophthalmic prescribed? Of the 1,596 medications we measure, Loteprednol Ophthalmic ranks #710 by Medicaid prescriptions — more than 56% of them.

Where Loteprednol Ophthalmic ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #710 of 1,596
#705 Trospium / Xanomeline 35,066 Rx #706 Furosemide Injection 34,727 Rx #707 Vedolizumab Injection 34,599 Rx #708 Iron Dextran Injection 34,405 Rx #709 Penicillin G (Potassiu... 34,354 Rx #710 Loteprednol Ophthalmic 34,076 Rx #711 Loteprednol Etabonate 34,076 Rx #712 Zaleplon 33,889 Rx #713 Ampicillin 33,801 Rx #714 Gentamicin Injection 33,521 Rx #715 Benralizumab Injection 33,442 Rx

Utilization by Loteprednol 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.

Other Loteprednol Ophthalmic products — combination packs and listings not yet matched to a specific clinical product (kept visible so every prescription is accounted for)

34,076 Medicaid prescriptions (Q1–Q4 2025) 100% of Loteprednol Ophthalmic prescriptions shown $10.3M gross reimbursement (before rebates) ≈ $302 per prescription (gross)

Summed across the 26 of 82 listed NDC products with Medicaid activity.

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 Loteprednol 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 26 of 82 listed Loteprednol Ophthalmic NDCs with Medicaid activity.

🔍 Compare Loteprednol Ophthalmic products

A representative set of FDA-listed product records for Loteprednol 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 Loteprednol Ophthalmic NDCs →

🏷️ Sold under these brand names

Alrex Eysuvis Inveltys Lotemax Lotemax SM Loteprednol Etabonate

🏭 Manufacturers & labelers

Bausch & Lomb Incorporated 12 Alcon Laboratories, Inc. 5 Bausch & Lomb Americas Inc. 5 Armas Pharmaceuticals Inc. 4 Amneal Pharmaceuticals NY LLC 3 Padagis US LLC 3 Sentiss Pharmaceuticals LLC 3 Sun Pharmaceutical Industries, Inc. 3 Akorn 2 NorthStar RxLLC 2 Lupin Pharmaceuticals, Inc. 1 Oceanside Pharmaceuticals 1 Sportpharm LLC 1

RxNorm drug class

Loteprednol Ophthalmic belongs to the Corticosteroid class.

Pharmacologic class Corticosteroid
Drug family (ATC) Corticosteroids, plain
How it works Corticosteroid Hormone Receptor Agonists

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 Mar 11, 2025
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Loteprednol 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 Loteprednol Ophthalmic after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
26
NDC products indexed
45
Distinct labelers/manufacturers represented
13
Linked representative label ⓘ
Alcon Laboratories, Inc.
Linked label effective
Mar 11, 2025
Composite sections available
23
Linked SPL Set ID
a2169d82-4275-4ab6-a1c3-c274080b815c
Linked SPL Document ID
db147c65-ed03-4af5-af1f-86b9ff51148a
Open the linked representative label on DailyMed ↗

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 26 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. Alcon Laboratories, 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.